Sterile hypodermic needles for single use. Requirements and test methods

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-09-2016

Publisher

British Standards Institution

This International Standard specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18mm to 1,2mm.

It does not apply to those devices that are covered by their own standard such as dental needles and pen needles.

Committee	CH/84
DevelopmentNote	Renumbers and supersedes BS 5081-2(1993) (09/1996) Supersedes 91/53632 DC and BS 5081-2(1987) 1996 Version incorporates amendment 9104 to BS 5081-2(1993) (06/2005) Supersedes 14/30296389 DC. (09/2016)
DocumentType	Standard
Pages	38
PublisherName	British Standards Institution
Status	Current
Supersedes	BS 5081-2(1993) : 1993 AMD 9104 BS 5081-2:1987 91/53632 DC : JUN 91 BS EN ISO 7864:1996 14/30296389 DC : 0

Standards	Relationship
NBN EN ISO 7864 : 2016	Identical
NS EN ISO 7864 : 1995	Identical
UNI EN ISO 7864 : 1998	Identical
NEN EN ISO 7864 : 2016	Identical
UNE-EN ISO 7864:2017	Identical
SN EN ISO 7864 : 2016	Identical
EN ISO 7864:2016	Identical
NF EN ISO 7864 : 1996	Identical
I.S. EN ISO 7864:2016	Identical
ISO 7864:2016	Identical
DIN EN ISO 7864:2015-01 (Draft)	Identical

ISO 8362-7:2006	Injection containers and accessories Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
EN ISO 23908:2013	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 23908:2011)
ISO 8362-2:2015	Injection containers and accessories — Part 2: Closures for injection vials
ISO 8537:2016	Sterile single-use syringes, with or without needle, for insulin
ISO 80369-20:2015	Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO/TR 19244:2014	Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
EN ISO 80369-1:2010	Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)
EN ISO 6009:2016	Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
ISO 8362-4:2011	Injection containers and accessories Part 4: Injection vials made of moulded glass
ISO 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO 8362-3:2001	Injection containers and accessories Part 3: Aluminium caps for injection vials
ISO 8362-6:2010	Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials
ISO 8362-5:2016	Injection containers and accessories Part 5: Freeze drying closures for injection vials
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 80369-1:2010	Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
ISO 8362-1:2009	Injection containers and accessories Part 1: Injection vials made of glass tubing
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
EN ISO 3696:1995	Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)
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 7000:2014	Graphical symbols for use on equipment Registered symbols
ISO 594-2:1998	Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
ISO 15223-1:2016	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
EN 20594-1:1993/A1:1997	CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - GENERAL REQUIREMENTS
ISO 6009:2016	Hypodermic needles for single use Colour coding for identification
EN 1707 : 1996	CONICAL FITTINGS WITH A 6 % (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT - LOCK FITTINGS
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 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)