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.
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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
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.
| Committee |
TC 62
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-8623-4
|
| Pages |
166
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-1-11:2015/A1:2021 | Identical |
| IEC 60601-1-11:2015 | Identical |
| IEC 60601-1-11:2015/AMD1:2020 | Identical |
| EN 60601-1-12:2015/A1:2020 | Identical |
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