What is ISO 7886‑2 about?
ISO 7886 discusses Sterile hypodermic syringes for single use. ISO 7886‑2 outlines requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above. Sterile hypodermic syringes are made of plastic materials and intended for use with power-driven syringe pumps.
It is essential for the manufacturer of one of these components to liaise with the manufacturer of the other when considering changes in design, to ensure satisfactory operation of the system.
Note: ISO 7886 does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer, and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
Who is ISO 7886‑2 for?
ISO 7886‑2 on sterile hypodermic syringes for single use is useful for:
- Manufacturers for Sterile hypodermic syringes
- Test centres and medical laboratories for Sterile hypodermic syringes
- Regulatory authorities
Why should you use ISO 7886‑2?
The absolute criterion of performance is achieved by the combination of the power-driven syringe pump and the syringe working as a complete system. The dependence of one element of the system on the performance of the other is a key factor.
ISO 7886‑2 guideline provides general requirements, limits for acidity or alkalinity, Limits for extractable metals, lubricant, tolerance on graduated capacity, syringe design, performance, packaging, and information to be supplied by manufacturers. This ensures satisfactory operation and improves the quality of sterile hypodermic syringes for single use.
What’s changed since the last update?
BS EN ISO 7886‑2:2020 supersedes ISO 7886‑2:1996, which has been withdrawn. BS EN ISO 7886‑2:2020 has some technical changes with respect to ISO 7886‑2:1996. These include:
- Syringe sizes 1 ml to 5 ml were added to the scope of this document
- Overall flow rate requirement was removed from Clause 14 as it is predominantly affected by the barrel inner diameter (ID), which is addressed in Clause 11
- Pump test speeds were adjusted for each syringe size to better reflect the range of speeds used in general clinical settings