EN ISO 8537:2016
Current
The latest, up-to-date edition.
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
04-13-2016
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
ISO 8537:2016 specifies 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. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 8537:2001-03 | Identical |
| ISO 8537:2016 | Identical |
| NBN EN ISO 8537 : 2016 | Identical |
| NEN EN ISO 8537 : 2016 | Identical |
| NS EN ISO 8537 : 1994 | Identical |
| I.S. EN ISO 8537:2016 | Identical |
| PN EN ISO 8537 : 2016 | Identical |
| SN EN ISO 8537 : 2016 | Identical |
| UNI EN ISO 8537 : 2008 | Identical |
| SS-EN ISO 8537:2016 | Identical |
| UNI EN ISO 8537 : 2016 | Identical |
| UNE-EN ISO 8537:2016 | Identical |
| BS EN ISO 8537:2016 | Identical |
| NF EN ISO 8537 : 2016 | Identical |
| DIN EN ISO 8537:2008-10 | Identical |
| UNI EN 13976-2 : 2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| UNE-EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| PREN 13976-2 : DRAFT 2016 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 16/30333925 DC : 0 | BS EN 13976-2 - RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| I.S. EN 13976-2:2011 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| BS EN 13976-2:2011 | Rescue systems. Transportation of incubators System requirements |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| EN 13976-2:2011 | Rescue systems - Transportation of incubators - Part 2: System requirements |
| DIN EN 13976-2:2016-03 (Draft) | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| DIN EN 13976-2:2011-08 | RESCUE SYSTEMS - TRANSPORTATION OF INCUBATORS - PART 2: SYSTEM REQUIREMENTS |
| 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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