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BS EN ISO 8536-4 : 2013

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED
Amended by

BS EN ISO 8536-4:2013+A1:2013

Available format(s)

Hardcopy , PDF

Withdrawn date

02-04-2020

Language(s)

English

Published date

01-01-2013

Publisher

British Standards Institution

1 Scope
2 Normative refere
3 General requirements
4 Designation
5 Materials
6 Physical requirements
7 Chemical requi
8 Biological requ
9 Labelling
10 Packaging
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Describes requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment.

Committee
CH/212
DevelopmentNote
Supersedes 02/564514 DC (09/2004) Supersedes 06/30160058 DC. (04/2007) 2013 Edition Re-Issued in August 2013 & incorporates AMD 1 2013. Supersedes 12/30255153 DC. (09/2013)
DocumentType
Standard
Pages
26
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
ISO 80000-4:2006 Quantities and units Part 4: Mechanics
ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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
ISO 291:2008 Plastics Standard atmospheres for conditioning and testing
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
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 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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Hardcopy - English
PDF - English
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