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BS EN ISO 1135-5 : 2015

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BS EN ISO 1135-5 : 2015

TRANSFUSION EQUIPMENT FOR MEDICAL USE - PART 5: TRANSFUSION SETS FOR SINGLE USE WITH PRESSURE INFUSION APPARATUS

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 General requirements<br>5 Materials<br>6 Physical requirements<br>7 Chemical requirements<br>8 Biological requirements<br>9 Labelling<br>10 Packaging<br>11 Disposal<br>Annex A (normative) - Physical tests<br>Annex B (normative) - Chemical tests<br>Annex C (normative) - Biological tests<br>Annex D (normative) - Storage volume<br>Bibliography<br>Annex ZA (informative) - Relationship between this<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;European Standard and the Essential<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Requirements of EU Directive 93/42/EEC on<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Medical devices

Abstract

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

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Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/212
Supersedes
  • 13/30283694 DC : 0