Standard name: Sterile hypodermic syringes for single use.
Applicable medical devices:
This standard applies to sterile plastic syringes which are intended for use immediately after filling, and not to be stored for an extended period of time. It excludes syringes which are to be used with insulin (see ISO 8537) and single-use syringes made of glass but specifies quality requirements for syringes used with power-driven syringe pumps and re-use prevention feature.
Smithers tests single-use hypodermic syringes (both with and without needles) to the tests specified in any part of this standard series.
Testing capabilities to ISO 7886 include:
- Tolerance of nominal/graduated capacity
- Graduate scale – scale, numbering, positioning, overall length
- Barrel – dimensions and finger grips
- Piston design, function, length, detachment and fit in the syringe barrel
- Visual examination (clarity, colour, presence of particles)
- Organoleptic (odour)
- Performance – dead space determination, freedom from air and liquid leakage, plunger movement, pull out forces and flow characteristics
We are also able to perform the following tests to this standard:
- Limits for acidity and alkalinity
- Limits for extractable metals
- Lubricant – visibility and Quantity
- Compatibility tests between syringes and injection fluids - Resistivity, Spectrophotometry
- Packaging – primary and secondary packs
In many instances, testing requirements are beyond the test method parameters set out in a standard. Alongside our standard testing services, our expert team are able to develop a custom testing program to meet your specific testing requirements and resolve and design or functionality issues you might have.
- ISO 7886-1: 2017 Syringes for manual use
- ISO 7886-2: 1997 Syringes for use with power-driven syringe pumps
- ISO 7886-3: 2005 Auto-disable syringes for fixed-dose immunization
- ISO 7886-4: 2006 Syringes with re-use prevention feature
Please note: In order for a Medical Device to be marketed in the European Union member countries it must bear the CE Mark designation and must comply with the updated standards as set by the Medical Device Directive. The information outlined above is to be used as reference for EN ISO 7886. The most current revision was used as stated on ISO site. Please refer to the appropiate competent standards agency in your country for full details and national implementation.
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