The ISO 13408 series covers sterilization of health care products, including medical devices, that cannot be terminally sterilized (sterilization in the final sealed container). For these types of products the use of aseptic handling, filling, transfer and packaging may be required to insure the safe delivery of a product to a customer.
Two amendments have been released for standards in the series: Amendment 1 for ISO 13408-1 2008 (2nd) Edition, “Aseptic Processing of Health Care Products – Part 1: General Requirements,” and Amendment 1 for ISO 13408-6 2005 (1st) Edition, “Aseptic Processing of Health Care Products – Part 6: Isolator Systems.” If you use either of these standards, it is critical that you get the new amendments right away. They are sold separately from the standards and they’re available now from Document Center Inc.
Amendment 1 for ISO 13408-1 contains 5 pages of corrections, termed “pen and ink” changes. These are minor but extensive changes to the standard that need to be met by the user. Most can be inserted into your copy of the 2nd edition by hand, however one of the tables (Figure A.1) will need to be replaced in it’s entirety.
Amendment 1 for ISO 13408-6 contains 4 pages of similar corrections. It makes changes to the foreword and to pages 1, 2, 3, 4, 6, 8, 9, 10, 11, 13, 14, 15 and 17. Get out your pen!
Here’s a list of all the standards that make up the ISO 13408 series:
- ISO 13408-1:2008, Aseptic processing of health care products — Part 1: General requirements
- ISO 13408-2:2003, Aseptic processing of health care products — Part 2: Filtration
- ISO 13408-3:2006, Aseptic processing of health care products — Part 3: Lyophilization
- ISO 13408-4:2005, Aseptic processing of health care products — Part 4: Clean-in-place technologies
- ISO 13408-5:2006, Aseptic processing of health care products — Part 5: Sterilization in place
- ISO 13408-6:2005, Aseptic processing of health care products — Part 6: Isolator systems
- ISO 13408-7:2012, Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
You can purchase all current and many obsolete ISO standards from your authorized dealer, Document Center Inc., at our web store: www.document-center.com. Or contact us by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to provide you with the services you need to keep your standards collection complete and correct! We’re your Standards Experts.
