BS EN ISO 8537:2016
Current
The latest, up-to-date edition.
Sterile single-use syringes, with or without needle, for insulin
Hardcopy , PDF
English
30-04-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/84
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| DevelopmentNote |
Renumbers and supersedes BS 7548(1992). 1995 version incorporates amendment 8538 to BS 7548(1992). Supersedes 87/54650 DC and 98/560722 DC. (04/2005) Supersedes 06/30141618 DC. (10/2008) Supersedes 14/30294895 DC.(05/2016)
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| DocumentType |
Standard
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| Pages |
40
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| PublisherName |
British Standards Institution
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| Status |
Current
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| Supersedes |
This International Standard 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.
This International Standard 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).
| Standards | Relationship |
| DIN EN ISO 8537:2001-03 | Identical |
| EN ISO 8537:2016 | Identical |
| UNE-EN ISO 8537:2016 | Identical |
| SN EN ISO 8537 : 2016 | Identical |
| NBN EN ISO 8537 : 2016 | Identical |
| ISO 8537:2016 | Identical |
| NF EN ISO 8537 : 2016 | Identical |
| I.S. EN ISO 8537:2016 | Identical |
| NS EN ISO 8537 : 1994 | Identical |
| UNI EN ISO 8537 : 2008 | Identical |
| DIN EN ISO 8537:2008-10 | Identical |
| NEN EN ISO 8537 : 2016 | Identical |
| BS 5081-2(1993) : 1993 AMD 9104 | STERILE HYPODERMIC SYRINGES AND NEEDLES - SPECIFICATION FOR STERILE HYPODERMIC NEEDLES FOR SINGLE USE |
| 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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