I.S. EN ISO 8537:2016
Current
The latest, up-to-date edition.
STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
Hardcopy , PDF
English
01-01-2016
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
National Foreword
European foreword
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
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC amended by Directive 2007/47/EEC
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