ISO 7886-1, Sterile hypodermic syringes for single use – Part 1: Syringes for manual use, has been updated. The new 2nd Edition is available from Document Center Inc. in both paper format and for pdf download. This is part of the ISO 8776 series for hypodermic syringes used for humans.
Part 1 specifically addresses single-use manual syringes. These syringes can be made with or without a needle. They can be made of a number of types of materials. The user typically fills and injects fluids using the needle, rather than as a pre-filled syringe.
The standard was originally released as the 1st Edition in 1993 and updated with a Corrigendum (correction sheet) in 1995. So there is a lengthy list of updates in the new 2017 Edition. These changes include:
- A clarified scope paragraph
- New referenced documents, terms and definitions
- The component drawing of the syringe was clarified
- General requirements have been included
- Syringe test methods have been revised
- Labeling requirement updated
- Syringe lubricants have been clarified
- The annex on materials was deleted
- Annex E was replaced
- Annex F was added
The previous 1st Edition of ISO 7886-1 has been adopted by the EU and the adoption of this new 36-page 2nd Edition is in the works. It should be accepted at the Regional level at the end of the month. Adoption and publication by each European Nation will follow. Because it is part of the harmonized standards set for the old Medical Device Directive, I expect there will be a list for the replacement Regulation that includes your transition time as well.
Medical Device Standards like the ISO 7886-1 are integral to the successful operation of our healthcare system. If this is your business and you need a copy of this new release, please use Document Center Inc. for your purchase. We are an authorized distributor of ISO standards and many other conformance publications. Use our webstore www.document-center.com to search for and order from our catalog of over 1 million records. Here’s a direct link to the order page for the ISO 7886-1 for your convenience.
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