CEI EN 60601-1-11 : 2016
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
Hardcopy , PDF
English
01-01-2016
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
Annex ZA (normative) - Normative references to international
publications with their corresponding European
publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EU Directives
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.
| Committee |
CT 62
|
| DevelopmentNote |
Classificazione CEI 62-228. (08/2011) New child AMD 1 2022 is added
|
| DocumentType |
Standard
|
| Pages |
88
|
| ProductNote |
New child AMD 1 2022 is added
|
| PublisherName |
Comitato Elettrotecnico Italiano
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN 60601-1-11:2015 | Identical |
| IEC 60601-1-11:2015 | Identical |
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