ISO 7886-4 Sterile Disposable Hypodermic Syringes - Part 4: Anti-Reuse Syringes

EUROLAB laboratory provides testing and compliance services within the scope of ISO 7886-4 standard. This part of the ISO 7886 standard, developed by the International Organization for Standardization (ISO), specifies the design guidelines for sterile disposable hypodermic syringes made of plastic and rubber materials with or without a needle and intended for the aspiration of fluids or the injection of fluids immediately after filling, and the syringe may be rendered unusable after use.

This document does not apply to glass syringes, auto-disable syringes for fixed dose vaccination, and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards may apply when syringes are used for any purpose other than those specified in this document.

NOTE Syringes designed to reduce the risk of needlestick injuries may also comply with this document for their anti-reuse features, but it should be emphasized that the needle-pinch prevention features of syringes are not covered in this document.

The preparation of this document has been considered a high priority requirement to prevent intentional (misuse) or accidental reuse of syringes. The reuse of injection equipment in the absence of sterilization has led to an increasing transmission of blood-borne pathogens.

World Health Organization (WHO), both fixed dose immunization and general/therapeutic and restructuring of vaccines. For the purpose of this document, auto disable is used for the type 1 anti-reuse feature, which operates automatically during or after the intended single use.

Both WHO and ISO agreed that while leaving ISO 7886-1 and ISO 7886-2 in place, additional sections of ISO 7886 would be required to cover syringes with anti-reuse features. Because the large number of devices in common use without modification is not intended to comply with recommended anti-reuse specifications.

This document is intended to cover syringes that become inoperable during, or after, delivery of the intended dose. These syringes are not covered by ISO 7886-1 and ISO 7886-3. ISO 7886-2 covers syringes used with powered pumps. Given the diversity of clinical applications, the optimal reuse prevention feature that offers the highest level of reuse prevention should be considered for each specific intended use.

It is recognized that syringes designed to reduce the risk of needlestick injuries may also comply with this document for their anti-reuse properties, although it should be stressed that the needle-stick prevention features of syringes are not addressed in this document in themselves. this document.

Among the services provided by our organization within the framework of material testing services, there are also ISO 7886-4 standard tests. Do not hesitate to contact our laboratory EUROLAB for your testing and certification requests.