Sterility of medical devices is essential and the ISO 11607 series has been the linchpin for ensuring it during the packaging process. Now the new ISO/TS 16775, “Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2,” helps you implement these two standards. As a technical specification, it is attempting to bridge the gap between the needs of two end-user communities — device manufacturers and health care facilities. It provides guidance and does not change the requirements of the ISO 11607-1 or ISO 11607-2.
Why would you want to use this document? It can help you understand the requirements of the ISO 11607 series. It separates suggestions by industry (Clause 3 for health care facilities and Clause 4 for the medical device industry). Various sections throughout the document have notes which provide additional information on specific cases. For example, when discussing the weight requirement of a device and it’s packaging, the note provides a range of acceptable weights for current national regulations.
The bulk of the text is actually found in the Annexes. With the inclusion of Annexes A to S, there’s a wealth of material provided for the user. Here’s some highlights.
Annex A addresses selection, evaluation and testing of packaging materials and sterile barrier systems. Step by step, the document reviews pertinent issues with suggested standards to help ensure compliance. For example, for puncture resistance, the Annex A recommends using ASTM D1709, ASTM D3420 and ASTM F1306.
Annex B covers sterilization considerations. This helps you confirm that the packaging method you’ve chosen for your device can actually withstand the sterilization method that will be used. Again, specific guidance is given along with relevant standards from a wide range of organizations that address each of the concerns raised.
Annex C provides you with examples of wrapping methods to be used for medical devices prior to sterilization. There is extensive use of figures to show you step-by-step methods of folding and wrapping your device.
Annexes D, E, F and G cover documentation, a set of forms that you can use as is in your facility. This is especially helpful, since standards are covered by copyright and usually not reproducible in any way. Annex D is a set of validation plan documents. Annex E covers installation qualification, that is checklists for confirming that your sterilization equipment will meet your sterilization requirements. Annex F does the same for operational qualification, the targets for various processes during testing, such as temperature, and so on. And Annex F provides you with forms for performance qualification. For example, one form for the wrapping process includes criteria, when sampling should take place, and what attributes provide quality assurance.
The Annex H gives you tools to address worst-case requirements, now used to support risk management. In other words, in order to show compliance, you have to confirm that even in the worst case scenario, the package still meets the requirements.
Speaking of risk analysis, Annex K gives you risk analysis tools that you’ll use both in identifying the areas of risk and the various ways to assess that risk. Annex L follows up with consideration for sampling plans, essential in monitoring those areas of known risk.
I know my customers will want to read the Annex O on test method validation. And Annex P on the use of contract packagers will also be of primary interest.
Lastly, I’d like to mention Annex R – Investigation failure. This area of compliance is essential — identifying and analyzing failure is essential to the development of a conforming process. You’ll get a detailed explanation of the areas where failure may occur, the tools you’ll use to determine root cause and the problem solving approaches you can use to rectify the situation.
The ISO/TS 16775’s bibliography has 108 references for further review.
If you use the ISO 11607 series and want to get this new guidance document, you can order your copy at the Document Center webstore, www.document-center.com. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’ve been supporting the medical device and healthcare industry since 1982. Make us your Standards Experts!
