14/30296389 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
Hardcopy , PDF
English
30-09-2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Packaging
6 Information supplied by the manufacturer
Annex A (normative) - Method for preparation
of extracts
Annex B (informative) - Fragmentation Test for
Medical Needles
Annex C (informative) - Determination of flow rate
through the needle
Annex D (informative) - Test method for measuring
the penetration force and drag force for needles
Annex E (informative) - Needle bonding strength test method
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
BS EN ISO 7864.
| Committee |
CH/84
|
| DocumentType |
Draft
|
| Pages |
37
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| 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 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 |
| 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 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 |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements |
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