I.S. EN IEC 60601-2-66:2020
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems (IEC 60601-2-66:2019)
Hardcopy , PDF
English - French
29-04-2020
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FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.8 * Protection against electrical HAZARDS from ME EQUIPMENT
201.9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
201.10 * Protection against unwanted and excessive radiation HAZARDS
201.11 * Protection against excessive temperatures and other HAZARDS
201.12 * Accuracy of controls and instruments and protection against hazardous outputs
201.13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
201.14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.15 * Construction of ME EQUIPMENT
201.16 * ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
Annexes
Annex E (informative) Examples of the connection of the measuring device (MD) for measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT
Annex G (normative) Protection against HAZARDS of ignition of flammable anaesthetic mixtures
Annex H (informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation
Annex I (informative) ME SYSTEMS aspects
Annex J (informative) Survey of insulation paths
Annex K (informative) Simplified PATIENT LEAKAGE CURRENT diagrams
Annex L (normative) Insulated winding wires for use without interleaved insulation
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Abbreviations
Annex CC (informative) Essential performance
Annex DD (informative) Electromagnetic compatibility of ME EQUIPMENT
Bibliography
Index of defined terms used in this particular standard
This part of IEC 60601 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.
| Committee |
TC 29
|
| DocumentType |
Standard
|
| ISBN |
978-2-8322-7350-0
|
| Pages |
134
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. THIS STANDARD ALSO REFERS:ISO/FDIS 80000-8, IEC 62489-1:2010/AMD2:2017
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN IEC 60601-2-66:2020 | Identical |
| IEC 60601-2-66:2019 | Identical |
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