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BS EN ISO 8536-9 : 2015

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BS EN ISO 8536-9 : 2015

INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR SINGLE USE WITH PRESSURE INFUSION EQUIPMENT

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 Materials<br>5 Physical requirements<br>6 Chemical requirements<br>7 Biological requirements<br>8 Packaging<br>9 Labelling<br>10 Disposal<br>Annex A (normative) - Physical tests<br>Annex B (normative) - Chemical tests<br>Annex C (normative) - Storage volume<br>Annex ZA (informative) - Relationship between this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the Essential Requirements<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of EC Directive 93/42/EEC on medical devices<br>Bibliography

Abstract

Pertains to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/212
Supersedes
  • 13/30284770 DC : 0
  • 02/564516 DC : DRAFT OCT 2002