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BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
Hardcopy , PDF
30-04-2016
English
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
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