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BS EN ISO 8537:2016

BS EN ISO 8537:2016

Current

Current

The latest, up-to-date edition.

Sterile single-use syringes, with or without needle, for insulin

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-30-2016

Publisher

British Standards Institution

This International Standard specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.

The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.

This International Standard excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

Committee
CH/84
DevelopmentNote
Renumbers and supersedes BS 7548(1992). 1995 version incorporates amendment 8538 to BS 7548(1992). Supersedes 87/54650 DC and 98/560722 DC. (04/2005) Supersedes 06/30141618 DC. (10/2008) Supersedes 14/30294895 DC.(05/2016)
DocumentType
Standard
Pages
40
PublisherName
British Standards Institution
Status
Current
Supersedes

BS 5081-2(1993) : 1993 AMD 9104 STERILE HYPODERMIC SYRINGES AND NEEDLES - SPECIFICATION FOR STERILE HYPODERMIC NEEDLES FOR SINGLE USE

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