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  • BSI
    BS EN ISO 7886-1:2018 Sterile hypodermic syringes for single use - Syringes for manual use
    Edition: 2019
    $442.60
    / user per year

Description of BS EN ISO 7886-1:2018 2019

This document specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.

Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.

It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).

Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.



Standard NumberBS EN ISO 7886-1:2018
TitleSterile hypodermic syringes for single use - Syringes for manual use
StatusConfirmed
Publication Date2019-10-21
ReplacesBS EN ISO 7886-1:1997
Identical National Standard OfISO 7886-1:2017, EN ISO 7886-1:2018
CorrectsBS EN ISO 7886-1:2018
DescriptorsLabels, Disposable, Medical equipment, Determination of content, Spectrophotometry, Injection instruments, Packaging, Position, Volume, Lubricants, Test equipment, Testing conditions, Volume measurement, Reducing agents, Leak tests, Dimensional tolerances, Design, Chemical-resistance tests, Olfactory analysis, Performance, Visual inspection (testing), Sterile equipment, Dimensions, Aqueous extraction methods, Pressure testing, Electrical testing, Force measurement, Marking, Electrical resistivity, Mechanical testing, Graduations, Graphic symbols, Syringes
ICS11.040.25 Syringes, needles and catheters
CommitteeCH/84
ISBN978 0 539 06881 8
PublisherBSI
Pages44

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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