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BS EN ISO 7864:2016

Current

Current

The latest, up-to-date edition.

Sterile hypodermic needles for single use. Requirements and test methods

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-09-2016

€254.76
Excluding VAT

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

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.

ISO 8362-7:2006 Injection containers and accessories Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
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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
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 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)

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