ISO 11137-2 PDF

Once the sterilization dose has been established, periodic audits must be performed at a defined and documented frequency. The audits are performed to determine the continued validity of the sterilization dose. Additionally, an audit should be performed following any change that could significantly affect the level or nature of the bioburden. The changes in the way a product is made, in materials used, or a change in the manufacturing facilities may also require a dose audit. In the absence of any such changes, the audit must be performed at three-month intervals to detect any changes in the bioburden that could require an augmentation in the sterilization dose. Environmental monitoring review Verification dose experiment Environmental Monitoring The environmental monitoring of the manufacturing facility is essential for tracking and investigating any changes in the bioburden number or type.

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Sign Up Below! The new Edition is being released in the various national adoptions from the members of the EU now. This update leaves the adopted ISO Edition untouched — the changes are all to the Annex material.

It is the European adoption of ISO So it is an important part of the documentation requirements for many medical device manufacturers who sell products in Europe. First, the introductory material includes clarification of what documents should be used as referenced standards. Then, since the document continues to adopt the ISO without any modifications, the balance of the changes are contained in the Annexes ZA, ZB, and ZC — one for each of the directives it applies to.

So it will be no surprise that this update seeks to clarify the situation as regards to the ISO material. There is the addition of 4 notes at the beginning of each of the 3 Annexes.

Note 1 provides you with a straight-forward statement of the expectation of the reduction of risk. The third column for each table has been expanded. This means, in part, that only sterilization using ionized radiation is covered by the publication. And it is now emphasized that other aspects of manufacture not relating to sterilization are not covered by this document. The previous other notes continue to be in force. When will it be mandatory to meet this new edition?

First, when the update is formally accepted and added to the harmonized lists, there will be the cessation date for the Edition included on the list itself. And even though this has not yet taken place, it is expected to be processed without issue.

Secondly, the member nations of Europe have until December to adopt this document and withdraw any conflicting or duplicating standards. How do I comply with these changes to the Annexes? The new material in the Annexes seems to indicate that your company policy with regards to risk management will be at scrutiny. And you may also need to prove compliance in this regards for the covered device as well.

Order on our webstore, www. Or contact our staff by phone , fax or email info document-center. What national adoption should I purchase? The SS EN ISO in English is expected to be released any day now and will be available in paper format, for pdf download and as part of our Standards Online multi-user subscription service.


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