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BS ISO 11197 : 2016

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BS ISO 11197 : 2016

MEDICAL SUPPLY UNITS

British Standards Institution

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Table of Contents

Foreword<br>Introduction<br>201.1 Scope, object and related standards<br>201.2 Normative references<br>201.3 Terms and definitions<br>201.4 General requirements<br>201.5 General requirements for testing <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME EQUIPMENT<br>201.6 Classification of ME EQUIPMENT and <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ME SYSTEMS<br>201.7 ME EQUIPMENT identification, marking<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and documents<br>201.8 Protection against electrical HAZARDS <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;from ME EQUIPMENT<br>201.9 Protection against mechanical HAZARDS<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of ME EQUIPMENT and ME SYSTEMS<br>201.10 Protection against unwanted and excessive<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;radiation HAZARDS<br>201.11 Protection against excessive temperatures<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and other HAZARDS<br>201.12 Accuracy of controls and instruments and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;protection against hazardous outputs<br>201.13 HAZARDOUS SITUATIONS and fault<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;conditions<br>201.14 PROGRAMMABLE ELECTRICAL MEDICAL<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SYSTEMS (PEMS)<br>201.15 Construction of ME EQUIPMENT<br>201.16 ME SYSTEMS<br>201.17 Electromagnetic compatibility of ME<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EQUIPMENT and ME SYSTEMS<br>202 MEDICAL ELECTRICAL EQUIPMENT - part 1-2<br>&nbsp;&nbsp;&nbsp;&nbsp;General requirements for BASIC SAFETY and<br>&nbsp;&nbsp;&nbsp;&nbsp;ESSENTIAL PERFORMANCE - Collateral<br>&nbsp;&nbsp;&nbsp;&nbsp;standard: Electromagnetic disturbances - <br>&nbsp;&nbsp;&nbsp;&nbsp;Requirements and tests<br>206 MEDICAL ELECTRICAL EQUIPMENT - part 1-6 <br>&nbsp;&nbsp;&nbsp;&nbsp;General requirements for BASIC SAFETY and <br>&nbsp;&nbsp;&nbsp;&nbsp;ESSENTIAL PERFORMANCE - Collateral<br>&nbsp;&nbsp;&nbsp;&nbsp;standard: Usability<br>Annex AA (informative) - Rationale<br>Bibliography

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT.

General Product Information

Document Type Standard
Status Current
Publisher British Standards Institution
Committee CH/121/6
Supersedes
  • 12/30262133 DC : 0