What is ISO 7886-4- Sterile hypodermic syringes with re-use prevention feature about?
BS EN ISO 7886-4 is the fourth part of a multi-part series that specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle and intended for the aspiration of fluids or the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.
Note 1: ISO 7886-4 does not apply to syringes made of glass, auto-disable syringes for fixed-dose immunization, and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in ISO 7886-4.
Note 2: Syringes designed to reduce the risk of needle-stick injuries can also comply with this document about their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in ISO 7886-4.
Who is ISO 7886-4- Sterile hypodermic syringes with re-use prevention feature for?
ISO 7886-4 on sterile hypodermic syringes with re-use prevention feature is relevant to-
- Sterile hypodermic syringes manufacturers
- Medical laboratories
Why should you use ISO 7886-4- Sterile hypodermic syringes with re-use prevention feature?
ISO 7886-4 prevents intentional (misuse) or accidental reuse of syringes and is intended to cover syringes that are rendered inoperable, either during or upon completion or after delivery of the intended dose.
Syringes designed to reduce the risk of needle-stick injuries can also comply with ISO 7886-4 regarding their re-use prevention properties.
ISO 7886-4 assists the users with basic requirements and design for sterile hypodermic syringes which helps in the achievement of expected quality standards.
What’s changed since the last update?
BS EN ISO 78864:2019 supersedes ISO 78864:2006, which is withdrawn. BS EN ISO 78864:2019 has made some technical changes compared to ISO 78864:2006, these include:
- Terminology in the Introduction is clarified
- General reference updated.
- Test of syringes: Harmonized definitions with ISO 78863 and clarified text
- Figure 1 is removed and substituted with a reference to the figure in ISO 78861
- Barrel dimension – the additional 20 % capacity is removed
- Dimensions in the design section are clarified
