I.S. EN 60601-1-11:2015&A1:2021
Current
The latest, up-to-date edition.
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 (IEC 60601-1-11:2015/A1:2020)
Hardcopy , PDF
English
02-08-2021
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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 EQUIPMEN and ME SYSTEMS
Annex C (informative) Symbols on marking
Bibliography
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