14/30294895 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 8537 - STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN
Hardcopy , PDF
04-30-2016
English
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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Superseded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 |
| 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 |
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