TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 1135-5:2015)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
9 Labelling
10 Packaging
11 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Chemical tests
Annex C (normative) - Biological tests
Annex D (normative) - Storage volume
Bibliography
Annex ZA (informative) - Relationship between this
          European Standard and the Essential
          Requirements of EU Directive 93/42/EEC on
          Medical devices

Gives requirements for single use transfusion sets for use with pressure infusion equipment capable of generating pressures up to 200 kPa (2 bar).

DocumentType	Standard
Pages	38
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 1135-4:2012

Standards	Relationship
ISO 1135-5:2015	Identical
EN ISO 1135-5:2015	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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I.S. EN ISO 1135-5:2015

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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