Standards Equivalency EN ISO 101:2011

Damn standards! It is hard enough to keep up with the latest revisions, but even if you achieve that, who has time to actually read them to see what the changes are?

Is it necessary to get all of the "different" versions of what appears to be the same standard? ISO vs. EN ISO (harmonised or not) vs. BS EN ISO vs. ANSI/AAMI/ISO .... YUCK! 

Here is what I do.

1. Purchase ANSI/AAMI/ISO standard from AAMI. Why purchase from AAMI? Because they are the most economical source I have found for many medical device ISO/IEC standards if you purchase their AAMI Standards on CD Complete Collection.

2. Look at "Glossary of equivalent standards" in the ANSI/AAMI standard to see if the ANSI/AAMI version you have is "Identical" to the corresponding ISO/IEC standard. Most often, it is identical. Do not buy the pure ISO/IEC version if the ANSI/AAMI version is identical - you would be wasting your money.

3. To prove equivalence between the "normative" requirements of an EN ISO standard and the corresponding "normative" requirements of the ISO standard, I have the following recommendations.

3a. For EN harmonised standards under the Medical Device Directive go here, find the EN standard of interest, and then read the title of the standard. If the title shows an ISO or IEC standard in parenthesis after the title, I take this as proof that the normative requirements of the ISO/IEC standard are the same as the EN standard. If no ISO/IEC standard is shown in parenthesis then I would purchase the EN standard (damn!).

3b. For any EN standards go to the BSI website, and enter the numeric portion of the standard of interest into the "Search all products by" field. Click "Search" and it will bring you to the "BS EN" version of the standard. Click on the "BS EN" link and then click on "Product Details". Scroll down to "International Relationships" and read the words (err...letters, numbers, date, Identical).

Here is a worked example using  Medical Device Directive 93/42/EEC (MDD)

1. I own ANSI/AAMI/ISO 11607-1:2006.

2. The "Glossary of equivalent standards" in ANSI/AAMI/ISO 11607-1:2006 indicates it is "Identical" to ISO 11607-1:2006.

3a. The Medical Device Directive "Publication of titles and references of harmonised standards under the directive" lists EN ISO 11607-1:2009 as the harmonised standard. The  entry reads as follows:
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)

3b. At BSI website, when I search for 11607-1 I get this: BS EN ISO 11607-1:2009.
And when I click on it and go to Product Details, I see this:

International Relationships EN ISO 11607-1:2009 Identical, ISO 11607-1:2006 Identical

Conclusions

ANSI/AAMI/ISO 11607-1:2006 is identical to ISO 11607-1:2006.
ISO 11607-1:2006 is identical to EN ISO 11607-1:2009.
Do not buy EN ISO 11607-1:2009 unless curious about the informative Annex.

About EN Harmonised Standards and their "Informative" Annex

Many EN harmonised standards were updated to 2009 versions since the "informative" Annex that correlates the MDD/AIMDD/IVDD Essential Requirements (ERs) to the clauses of the standard was updated. It had to be updated since the ERs were revised per Directive 2007/47/EC which came into full force in 2010. In all cases I have come across so far, the normative requirements for new EN standards are identical to the corresponding ISO/IEC versions. If you have extra money to spend and are curious about the "informative" mappings between the clauses of the standard and the ERs, go ahead and buy the EN version.

My approach is sure to ruffle some feathers among the purists but I think it is practical and very defendable during Notified Body audits. If you have any problems with them, give me a call and I will give it a go!

Sam Lazzara

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