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
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.
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 8537:2008-10 | Identical |
| NEN EN ISO 8537 : 2016 | Identical |
| EN ISO 8537:2016 | Identical |
| BS EN ISO 8537:2016 | Identical |
| NBN EN ISO 8537 : 2016 | Identical |
| ISO 8537:2016 | Identical |
| NF EN ISO 8537 : 2016 | Identical |
| NS EN ISO 8537 : 1994 | Identical |
| DIN EN ISO 8537:2001-03 | Identical |
| UNE-EN ISO 8537:2016 | Identical |
| ISO 15223-2:2010 | Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation |
| ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| ISO 11608-5:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions |
| ISO 11608-1:2014 | Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| 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 |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| 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 |
| EN ISO 80369-7:2017 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01) |
| EN ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016) |
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