Expiration of Validity Date for EN ISO 14971

A

aeropel

#1
Hi there,

The OJ states the following: 14971:2009 expires on 21/3/2010. (it was published on 7.7 2010...) Did I misunderstood?
So what is the valid document today? The IEC 60601 3rd edition refers to 14971:2000 that certainly is not valid anymore.

Thanks for help.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: ISO 14971 validity

Maybe I am also confused, as the ISO web site lists ISO 14971:2007. I wasn't able to find any information on a replacement in development.
 
#3
Re: ISO 14971 validity

The latest OJ (Official Journal - the legal document indicating the current harmonised standards) is 2012C 123 published 27th April 2012.

See:
http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/

The pdf version linked to on this page is THE official version of the OJ.

The harmonised version of 14971 is EN ISO 14971:2009, which was first published (in the OJ, so becoming harmonised) on 7/7/2010 (column 3).

The version it replaced was EN ISO 14971:2007 (column 4).

That (2007) version ceased to be harmonised on 21/3/2010 (column 5).

Note in the title column (2) the reference to ISO 14971:2007. This is because the 2009 version is still based upon the 2007 ISO standard. The only difference between the ISO version and the EN ISO version is the addition of the "Annex Z" sections. These show how various parts of 14971 relate to the Essential Requirements of the European Medical Devices Directive(s) and are of no benefit outside Europe.
 

Marcelo

Inactive Registered Visitor
#4
Re: ISO 14971 validity

The OJ states the following: 14971:2009 expires on 21/3/2010.
This date related to the "Date of cessation of presumption of conformity of superseded standard" as written in the table. This is related to the older version which EN ISO 14971:2009 replaced (in this case, EN ISO 14971:2007).

So what is the valid document today?
EN ISO 14971:2009, until EN ISO 14971:2012 is published and harmonized.

The IEC 60601 3rd edition refers to 14971:2000 that certainly is not valid anymore.
The third edition related to the ISO version. Anyway, this "problem" will be solved in the incoming amendment to the third edition which will correct the reference to the new standard (the ISO 2007 version).

ISO web site lists ISO 14971:2007. I wasn't able to find any information on a replacement in development.
The international last version is ISO 14971:2007. There´s no replacement in development (what is in development is ISO TS 24971, which is a guidance on the application of ISO 14971).
 
A

aeropel

#5
Re: ISO 14971 validity

Will the ammnedment for the 3rd edition of 60601-1 be valid when issued? or are 3 years of transition?
 
C

Cybel

#7
Re: ISO 14971 validity

EN ISO 14971:2009, until EN ISO 14971:2012 is published and harmonized.

The third edition related to the ISO version. Anyway, this "problem" will be solved in the incoming amendment to the third edition which will correct the reference to the new standard (the ISO 2007 version).

Sorry, but the incoming amendment to the 60601-1 third edition will correct the reference to the ISO 2007 version of 14971? and what about the 14971:2012?
 

Marcelo

Inactive Registered Visitor
#8
Will the ammnedment for the 3rd edition of 60601-1 be valid when issued? or are 3 years of transition?
Valid as an standard - yes. Valid for regulatory purposes - yes and no. For example, in Europe, if you want to use an standard to gain presumption of conformity, you need to use harmonized standards, and until the amendment is harmonized, you cannot gain presumption of conformity.

However, as standards are voluntary, you can use the amendment justifying *usually by means of risk management) that the leve lof safety you acquire is the same as using the harmonized one.
 

Marcelo

Inactive Registered Visitor
#9
Sorry, but the incoming amendment to the 60601-1 third edition will correct the reference to the ISO 2007 version of 14971? and what about the 14971:2012?
I was talking about international standards (IEC 60601-1 and ISO 14971:2007.

In the case of the EN versions, they will probably use the last European versions of the international standards (so yes, the problem will be corrected anyway).


Please note that there´s no international 2012 version of ISO 14971, only the EN version (EN ISO 14971:2012)
 
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