mercoledì 19 agosto 2015

DENTAL INSTRUMENTS MANUFACTURED IN PAKISTAN INSTRUMENTS OF GOOD OR POOR QUALITY? ITA/ENG

-Intervista a Luca Martinelli esperto tecnico di dispositivi medici Consulente Tecnico d’Ufficio del tribunale di Lucca e Ispettore di Organismo di Certificazione e Organismo Notificato.
-Interview released by Luca Martinelli who has significant experience in medical devices, is a Technical Consultant of the Lucca Court of Justice and acts as Inspector for a well known Quality Management System Certification Body and also Notified Body.

Lei ha un esperienza trentennale di dispositivi per odontoiatria ed odontotecnica, cosa ne pensa degli strumenti pachistani?

Q: You possess a thirty years’ experience on dental and dental laboratory devices: what is your opinion on instruments manufactured in Pakistan



Sono anni che i fabbricanti italiani, europei ed americani importano impressionanti quantità di strumenti dal Pakistan e che li fanno diventare strumenti a proprio marchio: uesbasterebbe chiedere all’Ufficio delle Dogane o all’Ufficio di Sanità Marittima e Aerea di Frontiera oppure agli ispettori degli Organismi di Certificazione e Organismi Notificati (Norme ISO9001 ISO13485 marcatura CE) che ben conoscono i processi di fabbricazione e i fornitori delle aziende italiane ed europee certificate.



A: For a noticeable number of years dental companies in the U.S. and Europe have been importing significant quantities of instruments from Pakistan and marking them with their own brand thus pretending they were the manufacturers.  This statement could easily be confirmed by any Customs Office or by any Certification or Notified Body involved in the application of ISO 9001 (Quality Management) or ISO 13485 (Quality Management  for  Medical Devices and CE marking) all of which, as part of their Certifying  activities have become familiar with this issue.

Se non sono loro a fabbricarli come fanno a figurare come fabbricanti? Imbrogliano il consumatore?

Q: If these companies are not really manufacturing the instruments, how can they pretend they are? Are they effectively doing the consumer in?



Assolutamente no.

Secondo la legge chiunque può essere “Fabbricante” di dispositivi medici.

La legge infatti indica che è sufficiente immettere un dispositivo medico a proprio nome per essere considerati tali.

Il legislatore si è preoccupato principalmente di attribuire la responsabilità a un solo soggetto lasciando ad esso facoltà di far fabbricare il dispositivo medico anche a terzi e in qualunque luogo del mondo, individuandolo come unico responsabile della conformità ai requisiti di sicurezza.

In pratica anche un’azienda esclusivamente commerciale che compra dispositivi da terzi, magari anche già confezionati, può venderli a suo nome ed essere “Fabbricante” di strumenti.
 

A: Not exactly.

By law anybody can be a manufacturer of medical devices. According to law in fact it is sufficient for anyone to place on the market a medical device branded with his name for him to be considered as being the manufacturer.
The legislator has tended to concentrate all responsibilities in terms of conformity to safety prerequisites on whoever places the device on the market. In turn whoever places the device on the market can freely choose the name and location of the manufacturer.  

Però sugli strumenti spesso c’è scritto Made in Italy
Q: But ofter on the instruments there is the “Made in Italy” written
 
Il made i Italy è regolato da altra legge, la sua regolamentazione è un po’ complicata da spiegare in due parole. In proposito ho scritto un articolo sul sito dell’Associazione Nazionale ispettori Sanitari che è consultabile  al linkhttp://www.ispettorisanitari.it/NEWS/varie_2015/Dispositivi%20medici_martinelli.pdf 
oppure al link: 
A: “Made in Italy” written is regulated by another law. Its regulatory is complicated. I’ve written an article for Sanitary Inspectors National Association on this matter. You can see it at this link http://www.ispettorisanitari.it/NEWS/varie_2015/Dispositivi%20medici_martinelli.pdf 
Or 

Si dice che i fabbricanti pachistani non hanno la stessa esperienza e conoscenza di strumentario rispetto a quelli europei…
Q: It is a common opinion however that the Pakistani manufacturers do not possess the same level of experience and expertise of Europeans…


A fine ottocento iniziarono le costruzioni delle sale operatorie, divennero così necessari strumenti chirurgici sempre più specifici.

I chirurghi ideavano nuovi strumenti, in alcuni casi addirittura li costruivano di persona come Eugène-Louis Doyen (Parigi) che inventò e perfezionò numerosi strumenti per chirurgia, Koker e Pean che fecero costruire le prime pinze emostatiche con modelli ancora oggi in uso e così via.

C’era cioè una fortissima interazione fra chi doveva utilizzare gli strumenti e chi aveva le conoscenze e le attrezzature per fabbricarli. Esisteva una sinergia tra il medico e il fabbricante, un continuo scambio di “know-how” che giovava ad entrambi e sicuramente anche alla produzione di strumenti sempre più idonei allo scopo. Tutto questo si è perso nel corso degli anni.

Fabbricanti europei che realizzano realmente i prodotti o che realizzano veramente tutti quelli che hanno nel loro catalogo ce ne sono molto pochi. I loro strumenti non sono a buon mercato, costano parecchio perché la mano d’opera che serve per fabbricare ad esempio pinze, leve, portaghi, forbici ecc. ha un costo molto elevato.

Basterebbe guardare un diagramma di processo di fabbricazione, ad esempio di una pinza da estrazione, per rendersi conto della complessità e numerosità delle operazioni.



A: Towards the end of the 19th Century the first operating theatres started to make their appearance. This led to an increasing need for specific instruments to be made available.

At the time surgeons used to develop their own instruments. Some of them, such as, for instance Eugene-Louis Doyen of Paris even got involved into making instruments to their requirements and ideas. Some others such as Kocher and Pean developed haemostatic forceps which are still in use to this day.

In those pioneering days, there was a significant integration between those who used to instruments for their surgical activities and those who were knowledgeable and had the tools to manufacture them. This synergy between the surgeon and the manufacturer eventually led to a growth in know how which in turn led to the development of increasingly sophisticated instruments to the mutual advantage of both the user and the manufacturer.

This cooperation between user and manufacturer eventually disappeared.

European companies that really manufacture some or all of the products they have in their catalogue are extremely few.  This is due to instruments being largely handmade hence labour intensive, hence costly at European labour rates. 

The process chart that follows explains it all by showing the complex and long sequence of operations to convert two pieces of raw stainless steel into a dental extraction forceps.



Potrebbe gentilmente mostrarcene uno?

Q: Would it be possible for you to show us one?


Certamente.
A: By all means






















Torniamo all’esperienza dei pachistani…
Q: Let us go back to the experience of Pakistanis

Il Pakistan è il sesto paese più popoloso al mondo con i suoi circa duecento milioni di abitanti.
La sua storia di grande produttore di strumenti chirurgici è piuttosto singolare e relativamente recente.
Agli inizi del secolo scorso, nel tentativo di proporsi come riparatori di strumenti chirurgici nei confronti di un ospedale da campo inglese che si era insediato alle porte della città di Sialkot, gli artigiani locali passarono ben presto dalla semplice manutenzione/riparazione alla produzione vera e propria di strumenti identici a quelli cu facevano manutenzione.
Gli artigiani più intraprendenti dettero successivamente vita a un vero e proprio “pellegrinaggio” in Germania per acquisire il necessario “know how.
É così che i grandi produttori di strumentario tedeschi ‘conobbero’ il Pakistan.
Successivamente i produttori tedeschi realizzarono una serie di joint ventures che ebbero come sbocco una crescente delocalizzazione della produzione dalla Germania al Pakistan.
Nel 1940 il governo britannico sottoscrisse un accordo con il governo pachistano per la fornitura di tutto lo strumentario chirurgico necessario ad affrontare la seconda guerra mondiale.
La globalizzazione in questi ultimi decenni ha fatto il resto: i bassi costi di mano d’opera e le notevoli abilità manuali abbinate a un completo know how acquisito da anni hanno contribuito a far diventare il Pakistan uno dei punti di riferimento mondiale per la produzione di strumentario medicale. Questo ha determinato il quasi totale abbandono della produzione in loco da parte dei fabbricanti europei storici.


A: With a population of almost 200 million Pakistan is the sixth county in the world in terms of inhabitants.The history of Pakistan as by far the major manufacturer of dental and surgical instruments is peculiar and relatively recent.At the start of the last century a few blacksmiths decided they would propose themselves  for the maintenance and repair of the surgical instruments used by a hospital camp in the vicinity of Sialkot. In no time they showed considerable entrepreneurial spirit by starting to make replicas of a variety of instruments. This  entrepreneurial spirit eventually led  them to a sort of continued pilgrimage to Germany to improve their know how in terms of materials and workmanship, purchase adequate equipment to lathe, mill, grind, polish etc..In those days Germany was the world leader in the manufacture of dental and surgical instruments. Eventually some German companies decided they could benefit from the manual ability and low labour costs in Pakistan by entering into joint ventures with Pakistani companies.This eventually led to the final acquisition of the know how on the part of Pakistanis and to Pakistan eventually becoming a world manufacturer of dental and surgical instruments in lieu of Germany.Already in 1940 the British Government had signed an agreement with the Pakistani authorities whereby Pakistan would supply all surgical instruments which they expected would be required for World War II.The globalization which has taken place in the last decades coupled with the low labour costs and manual ability of the Pakistanis have contributed to historical manufacturers in German and elsewhere stopping  their manufacturing activities and to Pakistan becoming by far the biggest manufacturer of dental and surgical instruments.

Non conoscevo questa storia

Q: I was not aware of this history

La conoscono in pochi e comprensibilmente non c’è alcun interesse a divulgarla.


A: Few people know this history and understandably ‘European and American manufactuers’ do their best to avoid spreading.


Quindi la qualità degli strumenti pakistani è buona?

Q: But therefore is the quality of the Pakistani instruments good?

Qualità in sé per sé non significa niente.
La qualità di un prodotto è il rispetto di un requisito dichiarato dal veditore/fabbricante e/o richiesto esplicitamente dall’acquirente.
Le caratteristiche dichiarate del prodotto devono essere veritiere.
Le faccio un paradosso per capire meglio:
se io dichiaro che le mie ciabatte “Marca sconosciuta”  del costo di 5 euro durano tre giorni e oggettivamente dopo che l’acquirente le ha indossate queste durano almeno tre giorni allora sono ciabatte di qualità;
se io dichiaro che le mie ciabatte “Marca Famosissima”  del costo di 500 euro durano tre giorni e oggettivamente dopo che l’acquirente le ha indossate queste durano solo due giorni e mezzo allora NON sono ciabatte di qualità.
La valutazione va fatta quindi non genericamente su una provenienza geografica del prodotto bensì su uno specifico produttore a prescindere di dove esso sia.
Vale in ogni caso la regola per cui in qualsiasi paese si prenda in considerazione, Pakistan compreso, possono esserci fabbricanti che producono strumenti di qualità e fabbricanti che producono strumenti di qualità scadente.
Personalmente ho valutato centinaia di strumenti di fabbricazione pakistana e in alcuni casi sono risultati di gran lunga superiori ad alcune “Note” marche italiane ed europee.
Innumerevoli quantità di strumenti importati dal Pakistan vengono venduti sul mercato con marchi Italiani, europei o americani. Se le stesse aziende pachistane vendono ormai da anni anche a proprio nome e conquistano mercato anno dopo anno (anche sul nostro territorio), si può dedurre che la qualità degli strumenti Pakistani non deve essere tanto diversa da quella degli altri fabbricanti occidentali.


In conclusione quando si acquista uno strumento si deve valutare la qualità dello stesso, senza basarsi né sulla marca, né sulla provenienza né, tantomeno, sulle innumerevoli mirabolanti informazioni commerciali che troviamo scritte sui cataloghi.


A: The term Quality in itself means very little.The quality of a product is normally associated to the expectations following information given by the seller/manufacturer  or specifications given by the buyer.The declared characteristics of the product must be true.I will give you an example.If I buy for say 5 € an unbranded pair of slippers which according to the manufacturer will last me three days and they do last me three days then the quality is good.On the other hand if I buy a well-known brand of slippers for say 500 € .and I am told they will last me three days but effectively they only last me two days the quality is definitely not good.The evaluation of Quality therefore should not be based on the geographical source but rather on the ability of the manufacturer, no matter where he is located, to satisfy his customer that his quality claims are fully met.

In every case, the rule is that every country considered (Pakistan included) there may be manufacturers that produce good quality instrument and manufacturers that produce poor quality instruments.I have personally evaluated thousands of instruments manufactured in Pakistan. In a number of cases they have proved far better compared to well known Italian and European brands.
Millions and millions of instruments imported by Pakistan are sold on the market with Italian, European or American brands.If the same Pakistani companies have been selling for years even with their own brand and have been capturing the market year by year (also in our territory) we can deduce that the quality of a Pakistani istrument is not so much different from the one of western manufacturers.


In conclusion when buying an instrument, its quality has to be valuated without relying neither on the brand, nor on the provenance, nor on the countless amazing commercial information written on catalogs.

martedì 11 agosto 2015

RECALLED PRODUCTS ®

From: Recalled product web site.

"Millions of products are manufactured and used by consumers each year. Consumers rely upon the manufacturers to make safe products. Every year, however, thousands upon thousands of these products are recalled or deemed unsafe. Unsafe or faulty products often lead to preventable injuries or deaths."



MEDICAL DEVICES - EUROPEAN STANDARS - HARMONISED STANDARS

From ec.europa.eu

Summary list of titles and references harmonised standards under Directive 93/42/EEC for Medical devices

The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union.

Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal effect.

(Publication of titles and references of harmonised standards under Union harmonisation legislation)
ESO(1)
Reference and title of the standard
(and reference document)
First publication OJ
Reference of superseded standard
Date of cessation of presumption of conformity of superseded standard
Note 1
CEN
EN 285:2006+A2:2009
Sterilization - Steam sterilizers - Large sterilizers
02/12/2009 
EN 285:2006+A1:2008

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 455-1:2000
Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
30/09/2005 
EN 455-1:1993

Note 2.1 
Date expired
(30/04/2001) 
CEN
EN 455-2:2009+A2:2013
Medical gloves for single use - Part 2: Requirements and testing for physical properties
16/05/2014 
EN 455-2:2009+A1:2011

Note 2.1 
Date expired
(31/10/2014) 
CEN
EN 455-3:2006
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
09/08/2007 
EN 455-3:1999

Note 2.1 
Date expired
(30/06/2007) 
CEN
EN 455-4:2009
Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
07/07/2010 


CEN
EN 556-1:2001
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
31/07/2002 
EN 556:1994 + A1:1998

Note 2.1 
Date expired
(30/04/2002) 
EN 556-1:2001/AC:2006
15/11/2006 


CEN
EN 556-2:2003
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
09/08/2007 


CEN
EN 794-3:1998+A2:2009
Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
07/07/2010 
EN 794-3:1998

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 980:2008
Symbols for use in the labelling of medical devices
23/07/2008 
EN 980:2003

Note 2.1 
Date expired
(31/05/2010) 
CEN
EN 1041:2008
Information supplied by the manufacturer of medical devices
19/02/2009 
EN 1041:1998

Note 2.1 
Date expired
(31/08/2011) 
CEN
EN 1060-3:1997+A2:2009
Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
07/07/2010 
EN 1060-3:1997

Note 2.1 
Date expired
(31/05/2010) 
CEN
EN 1060-4:2004
Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
30/09/2005 


CEN
EN ISO 1135-4:2011
Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
27/04/2012 
EN ISO 1135-4:2010

Note 2.1 
Date expired
(30/04/2012) 
CEN
EN 1282-2:2005+A1:2009
Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
07/07/2010 
EN 1282-2:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 1422:1997+A1:2009
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
02/12/2009 
EN 1422:1997

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 1618:1997
Catheters other than intravascular catheters - Test methods for common properties
09/05/1998 


CEN
EN 1639:2009
Dentistry - Medical devices for dentistry - Instruments
07/07/2010 
EN 1639:2004

Note 2.1 
Date expired
(30/04/2010) 
CEN
EN 1640:2009
Dentistry - Medical devices for dentistry - Equipment
07/07/2010 
EN 1640:2004

Note 2.1 
Date expired
(30/04/2010) 
CEN
EN 1641:2009
Dentistry - Medical devices for dentistry - Materials
07/07/2010 
EN 1641:2004

Note 2.1 
Date expired
(30/04/2010) 
CEN
EN 1642:2011
Dentistry - Medical devices for dentistry - Dental implants
27/04/2012 
EN 1642:2009

Note 2.1 
Date expired
(30/04/2012) 
CEN
EN 1707:1996
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
17/05/1997 


CEN
EN 1782:1998+A1:2009
Tracheal tubes and connectors
07/07/2010 
EN 1782:1998

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 1789:2007+A1:2010
Medical vehicles and their equipment - Road ambulances
18/01/2011 


CEN
EN 1820:2005+A1:2009
Anaesthetic reservoir bags (ISO 5362:2000, modified)
07/07/2010 
EN 1820:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 1865-3:2012
Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
30/08/2012 
EN 1865:1999

Note 2.1 
Date expired
(31/12/2012) 
CEN
EN 1865-4:2012
Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
30/08/2012 
EN 1865:1999

Note 2.1 
Date expired
(31/10/2012) 
CEN
EN 1865-5:2012
Patient handling equipment used in road ambulances - Part 5: Stretcher support
30/08/2012 
EN 1865:1999

Note 2.1 
Date expired
(31/12/2012) 
CEN
EN 1985:1998
Walking aids - General requirements and test methods
10/08/1999 


This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN
EN ISO 3826-2:2008
Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008)
19/02/2009 


CEN
EN ISO 3826-3:2007
Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826-3:2006)
27/02/2008 


CEN
EN ISO 4074:2002
Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)
31/07/2002 
EN 600:1996

Note 2.1 
Date expired
(31/08/2005) 
EN ISO 4074:2002/AC:2008
02/12/2009 


CEN
EN ISO 4135:2001
Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
31/07/2002 
EN ISO 4135:1996

Note 2.1 
Date expired
(28/02/2002) 
CEN
EN ISO 5359:2008
Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)
23/07/2008 
EN 739:1998

Note 2.1 
Date expired
(30/06/2010) 
EN ISO 5359:2008/A1:2011
30/08/2012 
Date expired
(30/06/2012) 
CEN
EN ISO 5360:2009
Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
02/12/2009 
EN ISO 5360:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 5366-1:2009
Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
02/12/2009 
EN ISO 5366-1:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 5840:2009
Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
02/12/2009 
EN ISO 5840:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 7197:2009
Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
02/12/2009 
EN ISO 7197:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 7376:2009
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
02/12/2009 
EN ISO 7376:2009

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 7396-1:2007
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)
09/08/2007 
EN 737-3:1998

Note 2.1 
Date expired
(30/04/2009) 
EN ISO 7396-1:2007/A1:2010
07/07/2010 
Date expired
(31/07/2010) 
EN ISO 7396-1:2007/A2:2010
07/07/2010 
Date expired
(31/08/2010) 
CEN
EN ISO 7396-2:2007
Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
09/08/2007 
EN 737-2:1998

Note 2.1 
Date expired
(30/04/2009) 
CEN
EN ISO 7886-3:2009
Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
07/07/2010 
EN ISO 7886-3:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 7886-4:2009
Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature (ISO 7886-4:2006)
07/07/2010 
EN ISO 7886-4:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 8185:2009
Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
02/12/2009 
EN ISO 8185:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 8359:2009
Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)
02/12/2009 
EN ISO 8359:1996

Note 2.1 
Date expired
(21/03/2010) 
EN ISO 8359:2009/A1:2012
16/01/2015 
Date expired
(31/01/2013) 
CEN
EN ISO 8835-2:2009
Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)
02/12/2009 
EN ISO 8835-2:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 8835-3:2009
Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007)
02/12/2009 
EN ISO 8835-3:2007

Note 2.1 
Date expired
(21/03/2010) 
EN ISO 8835-3:2009/A1:2010
13/05/2011 
Date expired
(30/04/2011) 
CEN
EN ISO 8835-4:2009
Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
02/12/2009 
EN ISO 8835-4:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 8835-5:2009
Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
02/12/2009 
EN ISO 8835-5:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 9170-1:2008
Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008)
19/02/2009 
EN 737-1:1998

Note 2.1 
Date expired
(31/07/2010) 
CEN
EN ISO 9170-2:2008
Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)
19/02/2009 
EN 737-4:1998

Note 2.1 
Date expired
(31/07/2010) 
CEN
EN ISO 9360-1:2009
Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
02/12/2009 
EN ISO 9360-1:2000

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 9360-2:2009
Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)
02/12/2009 
EN ISO 9360-2:2002

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 9713:2009
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
02/12/2009 
EN ISO 9713:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10079-1:2009
Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
02/12/2009 
EN ISO 10079-1:1999

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10079-2:2009
Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
02/12/2009 
EN ISO 10079-2:1999

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10079-3:2009
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)
02/12/2009 
EN ISO 10079-3:1999

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10328:2006
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2006)
09/08/2007 


This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN
EN ISO 10524-1:2006
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
02/06/2006 
EN 738-1:1997

Note 2.1 
Date expired
(31/10/2008) 
CEN
EN ISO 10524-2:2006
Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
07/06/2009 
EN 738-2:1998

Note 2.1 
Date expired
(31/10/2008) 
CEN
EN ISO 10524-3:2006
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
07/09/2006 
EN 738-3:1998

Note 2.1 
Date expired
(31/10/2008) 
CEN
EN ISO 10524-4:2008
Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524-4:2008)
23/07/2008 
EN 738-4:1998

Note 2.1 
Date expired
(30/06/2010) 
CEN
EN ISO 10535:2006
Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006)
09/08/2007 
EN ISO 10535:1998

Note 2.1 
Date expired
(30/06/2007) 
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN
EN ISO 10555-1:2009
Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
02/12/2009 
EN ISO 10555-1:1996

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10651-2:2009
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
02/12/2009 
EN ISO 10651-2:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10651-4:2009
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
02/12/2009 
EN ISO 10651-4:2002

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10651-6:2009
Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
02/12/2009 
EN ISO 10651-6:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-1:2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
02/12/2009 
EN ISO 10993-1:2009

Note 2.1 
Date expired
(21/03/2010) 
EN ISO 10993-1:2009/AC:2010
18/01/2011 


CEN
EN ISO 10993-3:2014 (new)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
EN ISO 10993-3:2009

Note 2.1 
31/12/2015 
CEN
EN ISO 10993-4:2009
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
02/12/2009 
EN ISO 10993-4:2002

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
02/12/2009 
EN ISO 10993-5:1999

Note 2.1 
Date expired
(31/12/2009) 
CEN
EN ISO 10993-6:2009
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
02/12/2009 
EN ISO 10993-6:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-7:2008
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
19/02/2009 


EN ISO 10993-7:2008/AC:2009
07/07/2010 


CEN
EN ISO 10993-9:2009
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
02/12/2009 
EN ISO 10993-9:2009

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-11:2009
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
02/12/2009 
EN ISO 10993-11:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-12:2012
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
24/01/2013 
EN ISO 10993-12:2009

Note 2.1 
Date expired
(31/01/2013) 
CEN
EN ISO 10993-13:2010
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
18/01/2011 
EN ISO 10993-13:2009

Note 2.1 
Date expired
(31/12/2010) 
CEN
EN ISO 10993-14:2009
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
02/12/2009 
EN ISO 10993-14:2001

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-15:2009
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
02/12/2009 
EN ISO 10993-15:2000

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-16:2010
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
07/07/2010 
EN ISO 10993-16:2009

Note 2.1 
Date expired
(31/08/2010) 
CEN
EN ISO 10993-17:2009
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
02/12/2009 
EN ISO 10993-17:2002

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 10993-18:2009
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
02/12/2009 
EN ISO 10993-18:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
09/08/2007 
EN 550:1994

Note 2.1 
Date expired
(31/05/2010) 
CEN
EN ISO 11137-1:2006
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006)
07/09/2006 
EN 552:1994

Note 2.1 
Date expired
(30/04/2009) 
EN ISO 11137-1:2006/A1:2013
16/05/2014 
Date expired
(30/11/2014) 
CEN
EN ISO 11137-2:2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
16/05/2014 
EN ISO 11137-2:2012

Note 2.1 
Date expired
(30/11/2014) 
CEN
EN ISO 11138-2:2009
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
02/12/2009 
EN ISO 11138-2:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11138-3:2009
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
02/12/2009 
EN ISO 11138-3:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11140-1:2009
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
02/12/2009 
EN ISO 11140-1:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11140-3:2009
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)
02/12/2009 
EN ISO 11140-3:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11197:2009
Medical supply units (ISO 11197:2004)
02/12/2009 
EN ISO 11197:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11607-1:2009
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
02/12/2009 
EN ISO 11607-1:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11607-2:2006
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
07/09/2006 


CEN
EN ISO 11737-1:2006
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
07/09/2006 
EN 1174-2:1996
EN 1174-1:1996
EN 1174-3:1996


Note 2.1 
Date expired
(31/10/2006) 
EN ISO 11737-1:2006/AC:2009
02/12/2009 


CEN
EN ISO 11737-2:2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
07/07/2010 


CEN
EN ISO 11810-1:2009
Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)
02/12/2009 


CEN
EN ISO 11810-2:2009
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
02/12/2009 
EN ISO 11810-2:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11979-8:2009
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
02/12/2009 
EN ISO 11979-8:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 11990-1:2014 (new)
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)


CEN
EN ISO 11990-2:2014 (new)
Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)


CEN
EN 12006-2:1998+A1:2009
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
02/12/2009 
EN 12006-2:1998

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 12006-3:1998+A1:2009
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
02/12/2009 
EN 12006-3:1998

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 12183:2009
Manual wheelchairs - Requirements and test methods
07/07/2010 


CEN
EN 12184:2009
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
07/07/2010 


CEN
EN 12342:1998+A1:2009
Breathing tubes intended for use with anaesthetic apparatus and ventilators
07/07/2010 
EN 12342:1998

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 12470-1:2000+A1:2009
Clinical thermometers - Part 1: Metallic liquid-in-glass thermometers with maximum device
02/12/2009 
EN 12470-1:2000

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 12470-2:2000+A1:2009
Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
02/12/2009 
EN 12470-2:2000

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 12470-3:2000+A1:2009
Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
02/12/2009 
EN 12470-3:2000

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 12470-4:2000+A1:2009
Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
02/12/2009 
EN 12470-4:2000

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 12470-5:2003
Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device)
07/11/2003 


This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN
EN ISO 12870:2009
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
02/12/2009 
EN ISO 12870:2004

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 13060:2014 (new)
Small steam sterilizers
EN 13060:2004+A2:2010

Note 2.1 
31/12/2015 
CEN
EN ISO 13408-1:2011
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008)
19/08/2011 
EN 13824:2004

Note 2.1 
Date expired
(31/12/2011) 
EN ISO 13408-1:2011/A1:2013
16/05/2014 
Date expired
(30/11/2014) 
CEN
EN ISO 13408-2:2011
Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
19/08/2011 
EN 13824:2004

Note 2.1 
Date expired
(31/12/2011) 
CEN
EN ISO 13408-3:2011
Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
19/08/2011 
EN 13824:2004

Note 2.1 
Date expired
(31/12/2011) 
CEN
EN ISO 13408-4:2011
Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
19/08/2011 
EN 13824:2004

Note 2.1 
Date expired
(31/12/2011) 
CEN
EN ISO 13408-5:2011
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
19/08/2011 
EN 13824:2004

Note 2.1 
Date expired
(31/12/2011) 
CEN
EN ISO 13408-6:2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
19/08/2011 
EN 13824:2004

Note 2.1 
Date expired
(31/12/2011) 
CEN
EN ISO 13485:2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
30/08/2012 
EN ISO 13485:2003

Note 2.1 
Date expired
(31/08/2012) 
EN ISO 13485:2012/AC:2012
30/08/2012 


CEN
EN 13544-1:2007+A1:2009
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
07/07/2010 
EN 13544-1:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 13544-2:2002+A1:2009
Respiratory therapy equipment - Part 2: Tubing and connectors
07/07/2010 
EN 13544-2:2002

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 13544-3:2001+A1:2009
Respiratory therapy equipment - Part 3: Air entrainment devices
07/07/2010 
EN 13544-3:2001

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 13624:2003
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1)
30/09/2005 


CEN
EN 13718-1:2008
Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
19/02/2009 
EN 13718-1:2002

Note 2.1 
Date expired
(28/02/2009) 
CEN
EN 13718-2:2015 (new)
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances


CEN
EN 13726-1:2002
Test methods for primary wound dressings - Part 1: Aspects of absorbency
27/03/2003 


EN 13726-1:2002/AC:2003
02/12/2009 


CEN
EN 13726-2:2002
Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
27/03/2003 


CEN
EN 13727:2012
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1)
30/08/2012 
EN 13727:2003

Note 2.1 
Date expired
(30/11/2012) 
CEN
EN 13867:2002+A1:2009
Concentrates for haemodialysis and related therapies
02/12/2009 
EN 13867:2002

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 13976-1:2011
Rescue systems - Transportation of incubators - Part 1: Interface conditions
19/08/2011 
EN 13976-1:2003

Note 2.1 
Date expired
(30/11/2011) 
CEN
EN 13976-2:2011
Rescue systems - Transportation of incubators - Part 2: System requirements
19/08/2011 
EN 13976-2:2003

Note 2.1 
Date expired
(30/11/2011) 
CEN
EN 14079:2003
Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
30/09/2005 


CEN
EN 14139:2010
Ophthalmic optics - Specifications for ready-to-wear spectacles
18/01/2011 


CEN
EN ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)
27/04/2012 
EN ISO 14155:2011

Note 2.1 
Date expired
(30/04/2012) 
CEN
EN 14180:2003+A2:2009
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
07/07/2010 
EN 14180:2003+A1:2009

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 14348:2005
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)
30/09/2005 


CEN
EN ISO 14408:2009
Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
02/12/2009 
EN ISO 14408:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 14561:2006
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
15/11/2006 


CEN
EN 14562:2006
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)
15/11/2006 


CEN
EN 14563:2008
Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2)
19/02/2009 


CEN
EN ISO 14602:2011
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
27/04/2012 
EN ISO 14602:2010

Note 2.1 
Date expired
(30/04/2012) 
CEN
EN ISO 14607:2009
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
02/12/2009 
EN ISO 14607:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 14630:2009
Non-active surgical implants - General requirements (ISO 14630:2008)
02/12/2009 
EN ISO 14630:2008

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 14683:2005
Surgical masks - Requirements and test methods
02/06/2006 


CEN
EN ISO 14889:2009
Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)
02/12/2009 
EN ISO 14889:2003

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 14931:2006
Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
15/11/2006 


CEN
EN ISO 14937:2009
Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
07/07/2010 
EN ISO 14937:2000

Note 2.1 
Date expired
(30/04/2010) 
CEN
EN ISO 14971:2012
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
30/08/2012 
EN ISO 14971:2009

Note 2.1 
Date expired
(30/08/2012) 
CEN
EN ISO 15001:2011
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
27/04/2012 
EN ISO 15001:2010

Note 2.1 
Date expired
(30/04/2012) 
CEN
EN ISO 15002:2008
Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
19/02/2009 
EN 13220:1998

Note 2.1 
Date expired
(31/07/2010) 
CEN
EN ISO 15004-1:2009
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
02/12/2009 
EN ISO 15004-1:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 15747:2011
Plastic containers for intravenous injections (ISO 15747:2010)
27/04/2012 
EN ISO 15747:2010

Note 2.1 
Date expired
(30/04/2012) 
CEN
EN ISO 15798:2010
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
07/07/2010 


CEN
EN ISO 15883-1:2009
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
02/12/2009 
EN ISO 15883-1:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 15883-2:2009
Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)
02/12/2009 
EN ISO 15883-2:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 15883-3:2009
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
02/12/2009 
EN ISO 15883-3:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 15883-4:2009
Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
02/12/2009 
EN ISO 15883-4:2008

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN 15986:2011
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
13/05/2011 


CEN
EN ISO 16061:2009
Instrumentation for use in association with non-active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03-15)
07/07/2010 
EN ISO 16061:2008

Note 2.1 
Date expired
(28/02/2010) 
CEN
EN ISO 16201:2006
Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)
19/02/2009 


CEN
EN ISO 17510-1:2009
Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
02/12/2009 
EN ISO 17510-1:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 17510-2:2009
Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
02/12/2009 
EN ISO 17510-2:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 17664:2004
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
30/09/2005 


CEN
EN ISO 17665-1:2006
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)
15/11/2006 
EN 554:1994

Note 2.1 
Date expired
(31/08/2009) 
CEN
EN ISO 18777:2009
Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
02/12/2009 
EN ISO 18777:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 18778:2009
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
02/12/2009 
EN ISO 18778:2005

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 18779:2005
Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
30/09/2005 


CEN
EN ISO 19054:2006
Rail systems for supporting medical equipment (ISO 19054:2005)
07/09/2006 
EN 12218:1998

Note 2.1 
Date expired
(30/06/2008) 
CEN
EN 20594-1:1993
Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986)
18/11/1995 


EN 20594-1:1993/A1:1997
10/08/1999 
Date expired
(31/05/1998) 
EN 20594-1:1993/AC:1996
02/12/2009 


CEN
EN ISO 21534:2009
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
02/12/2009 
EN ISO 21534:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 21535:2009
Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2007)
02/12/2009 
EN ISO 21535:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 21536:2009
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007)
02/12/2009 
EN ISO 21536:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 21649:2009
Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
07/07/2010 
EN ISO 21649:2006

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 21969:2009
High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
07/07/2010 
EN ISO 21969:2006

Note 2.1 
Date expired
(31/05/2010) 
CEN
EN ISO 21987:2009
Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)
07/07/2010 


CEN
EN ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
27/02/2008 
EN 12442-1:2000

Note 2.1 
Date expired
(30/06/2008) 
CEN
EN ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
27/02/2008 
EN 12442-2:2000

Note 2.1 
Date expired
(30/06/2008) 
CEN
EN ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007)
27/02/2008 
EN 12442-3:2000

Note 2.1 
Date expired
(30/06/2008) 
CEN
EN ISO 22523:2006
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
09/08/2007 
EN 12523:1999

Note 2.1 
Date expired
(30/04/2007) 
This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN
EN ISO 22675:2006
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2006)
09/08/2007 


This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant Essential Requirements of the amended directive are appropriately covered.
CEN
EN ISO 23328-1:2008
Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328-1:2003)
19/02/2009 
EN 13328-1:2001

Note 2.1 
Date expired
(30/09/2008) 
CEN
EN ISO 23328-2:2009
Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
02/12/2009 
EN ISO 23328-2:2008

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 23747:2009
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
02/12/2009 
EN ISO 23747:2007

Note 2.1 
Date expired
(21/03/2010) 
CEN
EN ISO 25539-1:2009
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
02/12/2009 
EN ISO 25539-1:2008
EN 12006-3:1998+A1:2009


Note 2.1 
Date expired
(21/03/2010) 
EN ISO 25539-1:2009/AC:2011
30/08/2012 


CEN
EN ISO 25539-2:2009
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
02/12/2009 
EN ISO 25539-2:2008
EN 12006-3:1998+A1:2009


Note 2.1 
Date expired
(21/03/2010) 
EN ISO 25539-2:2009/AC:2011
30/08/2012 


CEN
EN ISO 26782:2009
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)
07/07/2010 


EN ISO 26782:2009/AC:2009
07/07/2010 


CEN
EN 27740:1992
Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)
18/11/1995 


EN 27740:1992/A1:1997
10/08/1999 
Date expired
(31/05/1998) 
EN 27740:1992/AC:1996
02/12/2009 


CEN
EN ISO 81060-1:2012
Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
30/08/2012 
EN 1060-2:1995+A1:2009
EN 1060-1:1995+A2:2009


Note 2.1 
Date expired
(31/05/2015) 
Cenelec
EN 60118-13:2005
Electroacoustics - Hearing aids -- Part 13: Electromagnetic compatibility (EMC)
19/01/2006 
EN 60118-13:1997

Note 2.1 
Date expired
(01/02/2008) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60522:1999
Determination of the permanent filtration of X-ray tube assemblies
14/11/2001 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60580:2000
Medical electrical equipment - Dose area product meters
13/12/2002 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1:2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
27/11/2008 
EN 60601-1:1990# + A11:1993# + A12:1993# + A13:1996# + A1:1993# + A2:1995
EN 60601-1-4:1996# + A1:1999
EN 60601-1-1:2001


Note 2.1 
Date expired
(01/06/2012) 
EN 60601-1:2006/AC:2010
18/01/2011 


EN 60601-1:2006/A1:2013
IEC 60601-1:2005/A1:2012
16/05/2014 
31/12/2017 
Addendum to Note 1 and Note 3 concerning dates of cessation of presumption of conformity when applying EN 60601-1:2006. The date of cessation of presumption of conformity when applying EN 60601-1:2006 is 31/12/2017. However the Annex ZZ to EN 60601-1:2006 ceases to specify the presumption of conformity with the Essential Requirements of Directive 93/42/EEC on 31/12/2015. As from 01/01/2016, only the clauses and sub-clauses of EN 60601-1:2006 corresponding to the clauses and sub-clauses referred to in Annex ZZ to EN 60601-1:2006/A1:2013 provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC, to the extent indicated in the Annex ZZ to EN 60601-1:2006/A1:2013.
Cenelec
EN 60601-1-1:2001
Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
14/11/2001 
EN 60601-1-1:1993
+ A1:1996

Note 2.1 
Date expired
(01/11/2003) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1-2:2007
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
27/11/2008 
EN 60601-1-2:2001
+ A1:2006 
Date expired
(01/06/2012) 
EN 60601-1-2:2007/AC:2010
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1-3:2008
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
27/11/2008 
EN 60601-1-3:1994

Note 2.1 
Date expired
(01/06/2012) 
EN 60601-1-3:2008/AC:2010
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1-4:1996
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
08/11/1997 


EN 60601-1-4:1996/A1:1999
IEC 60601-1-4:1996/A1:1999
08/11/1997 
Date expired
(01/12/2002) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1-6:2010
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
18/01/2011 
EN 60601-1-6:2007

Note 2.1 
Date expired
(01/04/2013) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1-8:2007
Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
27/11/2008 
EN 60601-1-8:2004
+ A1:2006

Note 2.1 
Date expired
(01/06/2012) 
EN 60601-1-8:2007/AC:2010
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1-10:2008
Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
27/11/2008 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-1-11:2010
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-1:1998
Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV
14/11/2001 


EN 60601-2-1:1998/A1:2002
IEC 60601-2-1:1998/A1:2002
13/12/2002 
Date expired
(01/06/2005) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-2:2009
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
07/07/2010 
EN 60601-2-2:2007

Note 2.1 
Date expired
(01/04/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-3:1993
Medical electrical equipment - Part 2: Particular requirements for the safety of short-wave therapy equipment
18/11/1995 


EN 60601-2-3:1993/A1:1998
IEC 60601-2-3:1991/A1:1998
18/11/1995 
Date expired
(01/07/2001) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-4:2003
Medical electrical equipment -- Part 2-4: Particular requirements for the safety of cardiac defibrillators
15/10/2003 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-5:2000
Medical electrical equipment - Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment
13/12/2002 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-8:1997
Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
14/11/2001 


EN 60601-2-8:1997/A1:1997
IEC 60601-2-8:1987/A1:1997
14/11/2001 
Date expired
(01/07/1998) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-10:2000
Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
13/12/2002 


EN 60601-2-10:2000/A1:2001
IEC 60601-2-10:1987/A1:2001
13/12/2002 
Date expired
(01/11/2004) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-11:1997
Medical electrical equipment - Part 2-11: Particular requirements for the safety of gamma beam therapy equipment
09/10/1999 


EN 60601-2-11:1997/A1:2004
IEC 60601-2-11:1997/A1:2004
09/10/1999 
Date expired
(01/09/2007) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-12:2006
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
22/12/2007 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-13:2006
Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
22/12/2007 


EN 60601-2-13:2006/A1:2007
IEC 60601-2-13:2003/A1:2006
22/12/2007 
Date expired
(01/03/2010) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-16:1998
Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment
09/10/1999 


EN 60601-2-16:1998/AC:1999
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-17:2004
Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
08/11/2005 
EN 60601-2-17:1996
+ A1:1996

Note 2.1 
Date expired
(01/03/2007) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-18:1996
Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment
09/10/1999 


EN 60601-2-18:1996/A1:2000
IEC 60601-2-18:1996/A1:2000
09/10/1999 
Date expired
(01/08/2003) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-19:2009
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
07/07/2010 
EN 60601-2-19:1996
+ A1:1996

Note 2.1 
Date expired
(01/04/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-20:2009
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
18/01/2011 
EN 60601-2-20:1996

Note 2.1 
Date expired
(01/09/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-21:2009
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
07/07/2010 
EN 60601-2-21:1994
+ A1:1996

Note 2.1 
Date expired
(01/04/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-22:1996
Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
17/05/1997 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-23:2000
Medical electrical equipment - Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment
14/11/2001 
EN 60601-2-23:1997

Note 2.1 
Date expired
(01/01/2003) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-24:1998
Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers
09/10/1999 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-25:1995
Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs
17/05/1997 


EN 60601-2-25:1995/A1:1999
IEC 60601-2-25:1993/A1:1999
13/12/2002 
Date expired
(01/05/2002) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-26:2003
Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs
08/11/2005 
EN 60601-2-26:1994

Note 2.1 
Date expired
(01/03/2006) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-27:2006
Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
26/07/2006 
EN 60601-2-27:1994

Note 2.1 
Date expired
(01/11/2008) 
EN 60601-2-27:2006/AC:2006
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-28:2010
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
18/01/2011 
EN 60601-2-28:1993

Note 2.1 
Date expired
(01/04/2013) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-29:2008
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
15/07/2009 
EN 60601-2-29:1999

Note 2.1 
Date expired
(01/11/2011) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-30:2000
Medical electrical equipment -- Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
14/11/2001 
EN 60601-2-30:1995

Note 2.1 
Date expired
(01/02/2003) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-33:2002
Medical electrical equipment -- Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis
15/10/2003 
EN 60601-2-33:1995
+ A11:1997

Note 2.1 
Date expired
(01/07/2005) 
EN 60601-2-33:2002/A1:2005
IEC 60601-2-33:2002/A1:2005
27/07/2006 
Date expired
(01/11/2008) 
EN 60601-2-33:2002/A2:2008
IEC 60601-2-33:2002/A2:2007
27/11/2008 
Date expired
(01/02/2011) 
EN 60601-2-33:2002/A2:2008/AC:2008
30/08/2012 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-34:2000
Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
15/10/2003 
EN 60601-2-34:1995

Note 2.1 
Date expired
(01/11/2003) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-36:1997
Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
09/10/1999 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-37:2008
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
27/11/2008 
EN 60601-2-37:2001
+ A1:2005
+ A2:2005

Note 2.1 
Date expired
(01/10/2010) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-39:2008
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
27/11/2008 
EN 60601-2-39:1999

Note 2.1 
Date expired
(01/03/2011) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-40:1998
Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment
09/10/1999 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-41:2009
Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis
18/01/2011 
EN 60601-2-41:2000

Note 2.1 
Date expired
(01/11/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-43:2010
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
18/01/2011 
EN 60601-2-43:2000

Note 2.1 
Date expired
(01/06/2013) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-44:2009
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
07/07/2010 
EN 60601-2-44:2001
+ A1:2003

Note 2.1 
Date expired
(01/05/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-45:2001
Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
14/11/2001 
EN 60601-2-45:1998

Note 2.1 
Date expired
(01/07/2004) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-46:1998
Medical electrical equipment -- Part 2-46: Particular requirements for the safety of operating tables
14/11/2001 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-47:2001
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
13/12/2002 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-49:2001
Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
13/12/2002 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-50:2009
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
07/07/2010 
EN 60601-2-50:2002

Note 2.1 
Date expired
(01/05/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-51:2003
Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
24/06/2004 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-52:2010
Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009)
13/05/2011 
EN 1970:2000# + A1:2005
EN 60601-2-38:1996# + A1:2000
 
Date expired
(01/06/2012) 
EN 60601-2-52:2010/AC:2011
30/08/2012 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60601-2-54:2009
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
18/01/2011 
EN 60601-2-28:1993
EN 60601-2-32:1994
EN 60601-2-7:1998
 
Date expired
(01/08/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60627:2001
Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids
13/12/2002 


EN 60627:2001/AC:2002
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60645-1:2001
Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers
13/12/2002 
EN 60645-1:1994

Note 2.1 
Date expired
(01/10/2004) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60645-2:1997
Audiometers - Part 2: Equipment for speech audiometry
17/05/1997 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60645-3:2007
Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration
27/11/2008 
EN 60645-3:1995

Note 2.1 
Date expired
(01/06/2010) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 60645-4:1995
Audiometers - Part 4: Equipment for extended high-frequency audiometry
23/08/1996 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 61217:2012
Radiotherapy equipment - Coordinates, movements and scales
30/08/2012 
EN 61217:1996
+ A1:2001
+ A2:2008

Note 2.1 
Date expired
(11/01/2015) 
Cenelec
EN 61676:2002
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
15/10/2003 


EN 61676:2002/A1:2009
IEC 61676:2002/A1:2008
07/07/2010 
Date expired
(01/03/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 62083:2009
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
18/01/2011 
EN 62083:2001

Note 2.1 
Date expired
(01/11/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 62220-1:2004
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
24/06/2004 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 62220-1-2:2007
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
27/11/2008 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 62220-1-3:2008
Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
15/07/2009 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 62304:2006
Medical device software - Software life-cycle processes
27/11/2008 


EN 62304:2006/AC:2008
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 62366:2008
Medical devices - Application of usability engineering to medical devices
27/11/2008 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 80601-2-35:2009
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
18/01/2011 
EN 60601-2-35:1996

Note 2.1 
Date expired
(01/11/2012) 
(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 80601-2-58:2009
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
07/07/2010 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
Cenelec
EN 80601-2-59:2009
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
18/01/2011 


(*): This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
CEN: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5500811; fax +32 2 5500819 (http://www.cen.eu)
CENELEC: Avenue Marnix 17, B-1000, Brussels, Tel.+32 2 5196871; fax +32 2 5196919 (http://www.cenelec.eu)
ETSI: 650, route des Lucioles, F-06921 Sophia Antipolis, Tel.+33 492 944200; fax +33 493 654716, (http://www.etsi.eu)

Note 1: Generally the date of cessation of presumption of conformity will be the date of withdrawal (“dow”), set by the European standardisation organisation, but attention of users of these standards is drawn to the fact that in certain exceptional cases this can be otherwise.
Note 2.1: The new (or amended) standard has the same scope as the superseded standard. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.2: The new standard has a broader scope than the superseded standard. On the date stated the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.
Note 2.3: The new standard has a narrower scope than the superseded standard. On the date stated the (partially) superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation for those products or services that fall within the scope of the new standard. Presumption of conformity with the essential or other requirements of the relevant Union legislation for products or services that still fall within the scope of the (partially) superseded standard, but that do not fall within the scope of the new standard, is unaffected.
Note 3: In case of amendments, the referenced standard is EN CCCCC:YYYY, its previous amendments, if any, and the new, quoted amendment. The superseded standard therefore consists of EN CCCCC:YYYY and its previous amendments, if any, but without the new quoted amendment. On the date stated, the superseded standard ceases to give presumption of conformity with the essential or other requirements of the relevant Union legislation.