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IEC 60601-1-11 : 2.0EN+(REDLINE+VERSION)

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IEC 60601-1-11 : 2.0EN+(REDLINE+VERSION)

MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT

International Electrotechnical Committee

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Table of Contents

FOREWORD
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
8 Protection against excessive temperatures and other HAZARDS
9 Accuracy of controls and instruments and protection
   against hazardous outputs
10 Construction of ME EQUIPMENT
11 Protection against strangulation or asphyxiation
12 Additional requirements for ELECTROMAGNETIC EMISSIONS
   of ME EQUIPMENT and ME SYSTEMS
13 Additional requirements for ALARM SYSTEMS of ME EQUIPMENT
   and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and labelling requirements
        for ME EQUIPMENT and ME SYSTEMS
Annex C (informative) - Symbols on marking
Bibliography
Index of defined terms used in this collateral standard

Abstract

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, and specified by the MANUFACTURER in the instructions for use.

General Product Information

Document Type Standard
Status Current
Publisher International Electrotechnical Committee
Committee TC 62