ISO 11608-1, “Needle-based injection systems for medical use – Requirements and test methods – Part 1: Needle-based injection systems,” has just been updated. The new 3rd Edition is available now from Document Center Inc. in paper format, for pdf format or as part of our Standards Online multi-user subscription service. It contains a myriad of changes to the 2nd Edition, which is now obsolete.
If you use ISO 11608-1, you’ll need this new edition. Here’s a list of technical changes that will affect your business:
- Legacy references to “pens” have been removed in favor of “NISs” (Needle-based Injection Systems).
- Clause 5.5 has been updated.
- Table 3 has been corrected in a couple of places.
- In clause 10.1, an explanation is added to Note 1.
- A number of changes have been made to clause 10.5.
- The temperature range in clause 10.8 has been changed.
- Corrections have been made to clauses 10.10.4 and 10.10.5.
- Modifications have been made to clause 13.2.3.
Of course, if you use this series of standards, you’ll want to know if additional changes are going to be made to the remainder of the parts of the series. While Part 1 is now updated, the rest of the series is unchanged as listed below:
- ISO 11608-2, 2nd Edition, Needle-based injection systems for medical use – Requirements and test methods – Part 2: Needles
- ISO 11608-3, 2nd Edition, Needle-based injection systems for medical use – Requirements and test methods – Part 3: Finished containers
- ISO 11608-4, 1st Edition, Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
- ISO 11608-5, 1st Edition, Needle-based injection systems for medical use – Requirements and test methods – Part 5: Automated functions
However, some changes are underway. There is a working draft for a Part 4 revision, which should be available as a draft for public comment in 2016. And there’s initial work being done on a new Part 6 (“Needle-based injection systems for medical use –Requirements and test methods — Part 6: Bolus Injectors”) and new Part 7 (“Needle-based injection systems — Part 7: Requirements for accessibility for persons with visual impairment”). No drafts on these two new parts are being distributed for comment at this time.
Of course, you need a copy of the new 3rd Edition for ISO 11608-1. Just go to the Document Center webstore at www.document-center.com and order now! Or if you prefer, contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). Since these are copyright documents, you’ll want to get your copies from an authorized dealer like Document Center Inc. And since we’ve been helping folks like you with standards since 1982, make us your Standards Experts!
