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14/30296389 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
Available format(s)

Hardcopy , PDF

Superseded date

09-30-2016

Language(s)

English

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Superseded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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