14/30294895 DC : 0

Superseded

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BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN

Available format(s)

Hardcopy , PDF

Superseded date

30-04-2016

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Types of syringes
5 Requirements
6 Packaging
7 Information supplied by the manufacturer
Annex A (normative) - Fluid for determination of acidity/alkalinity and
        extractable metals
Annex B (normative) - Test method for air leakage past syringe piston
        during aspiration and for separation of rubber stopper
        and plunger
Annex C (normative) - Test method for determination of forces
        required to operate piston
Annex D (normative) - Test method for determination of dead space
Annex E (normative) - Test method for liquid leakage at syringe
        piston and syringe nozzle/hub or
        needle/barrel unions during compression
Annex F (normative) - Test method for air leakage past nozzle/hub
        or needle/barrel unions during aspiration
Annex G (normative) - Preparation of extract for test for pyrogenicity
        and toxicity
Annex H (normative) - Syringe sizes and graduated scales
Bibliography

BS EN ISO 8537.

Committee	CH/84
DocumentType	Draft
Pages	38
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 8537:2016

ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
IEC 62366:2007+AMD1:2014 CSV	Medical devices - Application of usability engineering to medical devices
ISO 81714-1:2010	Design of graphical symbols for use in the technical documentation of products Part 1: Basic rules
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 594-1:1986	Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements