Transfusion equipment for medical use Transfusion sets for single use, gravity feed

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

02-29-2016

Publisher

British Standards Institution

Foreword
1 Scope
2 Normative references
3 General requirements
4 Materials
5 Physical requirements
6 Chemical requirements
7 Biological requirements
8 Labelling
9 Packaging
10 Disposal
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 EC Directive 93/42/EEC on medical devices

Describes requirements for single-use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

This part of ISO 1135 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.

In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 1135.

Committee	CH/212
DevelopmentNote	Supersedes 02/564513 DC. (08/2004) Together with BS EN ISO 3826-1 and BS EN ISO 3826-3, supersedes BS 2463-1(1990) and BS 2463-2(1989). (04/2007) Supersedes 08/30184486 DC. (05/2010) Supersedes 13/30283691 DC. (02/2016)
DocumentType	Standard
Pages	28
PublisherName	British Standards Institution
Status	Current
Supersedes	13/30283691 DC : 0 BS EN ISO 1135-4:2012 BS 2463-1:1990 08/30184486 DC : DRAFT JUNE 2008 02/564513 DC : DRAFT OCT 2002 BS 2463-2:1989

Standards	Relationship
NF EN ISO 1135-4 : 2016	Identical
UNI EN ISO 1135-4 : 2012-06	Identical
UNE-EN ISO 1135-4:2016	Identical
NBN EN ISO 1135-4 : 2016	Identical
I.S. EN ISO 1135-4:2015	Identical
NEN EN ISO 1135-4 : 2016	Identical
ISO 1135-4:2015	Identical
DIN EN ISO 1135-4:2016-06	Identical
NS EN ISO 1135-4 : 2012	Identical
EN ISO 1135-4 : 2015 COR 2016	Identical

ISO 3826-2:2008	Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
ISO 10993-4:2017	Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
EN 15986:2011	Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 3826-1:2013	Plastics collapsible containers for human blood and blood components Part 1: Conventional containers
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
IEC 80416-1:2008	Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
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 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
ISO 17665-1:2006	Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

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BS EN ISO 1135-4:2015

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

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