INFUSION EQUIPMENT FOR MEDICAL USE - PART 13: GRADUATED FLOW REGULATORS FOR SINGLE USE WITH FLUID CONTACT (ISO 8536-13:2016)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2016

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.

European foreword
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
Annex A (normative) - Physical tests
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of Directive 93/42/EEC [OJ L 169]
         aimed to be covered

Gives requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions.

DocumentType	Standard
Pages	24
PublisherName	National Standards Authority of Ireland
Status	Current

Standards	Relationship
EN ISO 8536-13:2016	Identical
ISO 8536-13:2016	Identical

ISO 80000-4:2006	Quantities and units Part 4: Mechanics
EN ISO 8536-4:2013/A1:2013	INFUSION EQUIPMENT FOR MEDICAL USE - PART 4: INFUSION SETS FOR SINGLE USE, GRAVITY FEED (ISO 8536-4:2010/AMD 1:2013)
ISO 8536-4:2010	Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
EN ISO 80000-4:2013	Quantities and units - Part 4: Mechanics (ISO 80000-4:2006)

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I.S. EN ISO 8536-13:2016

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

Category

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