INFUSION EQUIPMENT FOR MEDICAL USE - PART 8: INFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS (ISO 8536-8:2015)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2015

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

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

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 Packaging
10 Labelling
11 Disposal
Annex A (normative) - Physical tests
Annex B (normative) - Storage volume
Annex ZA (informative) - Relationship between this
European Standard and the Essential Requirements
of EC Directive 93/42/EEC on medical devices
Bibliography

Provides users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).

DocumentType	Standard
Pages	30
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 8536-8:2004

Standards	Relationship
NEN EN ISO 8536-8 : 2015	Identical
NBN EN ISO 8536-8 : 2015	Identical
NS EN ISO 8536-8 : 2004	Identical
UNE-EN ISO 8536-8:2015	Identical
DIN EN ISO 8536-8:2015-11	Identical
UNI EN ISO 8536-8 : 2005	Identical
NF EN ISO 8536-8 : 2015	Identical
EN ISO 8536-8:2015	Identical
BS EN ISO 8536-8:2015	Identical
ISO 8536-8:2015	Identical

ISO 11137-1:2006	Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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 11135-1:2007	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 8536-9:2015	Infusion equipment for medical use Part 9: Fluid lines for single use with pressure infusion equipment
ISO 8536-4:2010	Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
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 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 8536-8:2015

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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