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STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 01-01-2016
Publisher: National Standards Authority of Ireland
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 ForewordEuropean forewordForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 Types of syringes5 Requirements6 Packaging7 Information supplied by the manufacturerAnnex A (normative) - Fluid for determination of acidity/alkalinity and extractable metalsAnnex B (normative) - Test method for air leakage past syringe piston during aspiration and for separation of rubber stopper and plungerAnnex C (normative) - Test method for determination of forces required to operate pistonAnnex D (normative) - Test method for determination of dead spaceAnnex E (normative) - Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compressionAnnex F (normative) - Test method for air leakage past nozzle/hub or needle/barrel unions during aspirationAnnex G (normative) - Preparation of extract for test for pyrogenicity and toxicityAnnex H (normative) - Syringe sizes and graduated scalesBibliographyAnnex ZA (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC amended by Directive 2007/47/EEC
Defines 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.
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