AAMI has just released their adoption of the ISO/TS 16775 that was released back in May. This new document is numbered ANSI/AAMI/ISO TIR16775, “Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2.” It replaces AAMI TIR22, “Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006,” which is now obsolete.
AAMI, the Association for the Advancement of Medical Instrumentation, is the U.S. TAG (Technical Advisory Group) to the ISO committee that developed the ISO/TS 16775. Since the harmonization of U.S. standards to international standards is a high priority for both business and the standards community, this close working relationship is a boon. It means that we are able to adopt the ISO standard as written, and to withdraw the TIR22 that previously addressed this topic.
Similarly to the many European adoptions of ISO standards, this publication contains administrative material on the cover sheet and the first 9 introductory pages. However, beginning with the Foreward on page x, the AAMI adoption is identical to the ISO edition.
Which edition should you use? Let’s take a look at the pros and cons for each.
1. From a technical point of view there is no difference between the 2 editions.
2. The cost of the U.S. adoption is less than that of the ISO original. This is a benefit for AAMI as the U.S. Tag. They are able to publish the adoption under their own publication number and set their own price.
3. The ISO document was released prior to the ANSI/AAMI adoption. Using a source edition of a standard usually (but not always) means that you’ll be able to purchase new editions sooner. This is due to the administrative processes of adoption in many cases.
4. You should always take into consideration any certification requirements when choosing the edition you’ll purchase. There is nothing as discouraging than to get a valid copy of a standard only to have your auditor reject it because it does not come from the “correct” jurisdiction.
You can get your copy of this Technical Information Report (TIR) from Document Center Inc. via our webstore at www.document-center.com or by contacting our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). It’s available in paper format, for pdf download or as part of your Standards Online multi-user access subscription service. You’ll find any number of support services available from Document Center Inc. to help make your use and maintenance of these types of conformance documents easier. Make us your Standards Experts!
