Sterilization is a top priority when making and using medical devices. There are a number of standards on the subject. One of the primary documents, part of the harmonized standards for the medical device directive 93/42/eec, has just been updated. This new EN 1422 2014 Edition is now available. Titled “Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods,” this is a technical revision of the standard. It supersedes the EN 1422:1997+A1:2009 edition. You’ll need to purchase it if you use the document in your business.
Let’s get right into the changes, since there are quite a number of them:
- The scope of the document has changed, explicitly excluding sterilizers using the injection of EO (ethylene oxide) or EO mixtures into packages or flexible chambers.
- The referenced documents (normative references) section has been updated.
- The layout of the standard has been modified to harmonize it with the standard for LTSF (Low temperature steam and formaldehyde) sterilization (EN 14180).
- Additional requirements from the machinery directive (caused by the revision of directive 2007/47/ec) have been addressed. An example of this will be found in the changes to tables ZA.1 and ZA.2 in Annex ZA.
- An environmental checklist has been added.
- All requirements are now based on performance instead of design.
- Annex B is completely revised.
- Annex D is deleted.
You’ll remember to review the Annex ZA thoroughly, since it provides you with the relationship of this standard with the EU directive and is an integral part of the document. Also, Annexes A, B, and C are normative, which means you must comply. Annexes E and ZA are just informative and do not carry the same compliance requirements.
You have a number of choices for procuring the EN standards. (And there will be even more choices at Document Center by the end of the summer!) If you need the document immediately, order the BS EN 1422 2014 Edition. However, your copy will be in paper format. Prefer to get your EN as a pdf download? The DIN EN 1422 2014 edition will be available soon for delivery both in paper and pdf format. This German publication is available in English from Document Center and provides delivery options not possible with the BS publications. The content and validity of the document remain the same.
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