Some documents are essential for the Medical Device manufacturer. ISO 11137-1 2006 Edition, “Sterilization of Health Care Products – Radiation – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices,” is one such standard. And the new 10-page Amendment 1 for this 1st Edition has just been released.
This Part 1 of ISO 11137 describes requirements to provide a radiation sterilization process for sterilizing medical devices. Compliance with the requirements ensures that this activity is both reliable and reproducible. This allows for confidence in that there is a low level of probability that a viable microorganism is present on product after sterilization.
The new amendment 1 provides you with 4 pages of pen-and-ink changes that you’ll need to make to your copy of ISO 11137-1. Some changes are minor (replacing “ISO 11137-2:2006” with “ISO 11137-2” to reflect the fact that there is a new 2013 Edition of Part 2).
However, there other changes that are more substantial. They include 2 replacement entries in the Terms and definition section (3.29 and 3.31). Other sections with changes include 6.2.5, 12.1.1, 12.1.2.5, 12.1.3.1, 12.1.3.2, A8.4.1, A8.4.2.1, A.8.4.2.2, A8.4.2.3, and A.12.1.2.5.
If you’re using this standard, you’ll want to purchase the new Amendment 1 for ISO 11137-1. Go to our web store at www.document-center.com and order online. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We have been providing standards to the medical device community for many years now. We have the expertise to assist you with your standards requirements and questions. Make Document Center Your Standards Experts!
