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BS EN ISO 8536-13 : 2016

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BS EN ISO 8536-13 : 2016

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

British Standards Institution

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Table of Contents

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

Abstract

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.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/212
Supersedes
  • 15/30283697 DC : 0