CSA C22.2 No. 60601.2.27:2011
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-27: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHIC MONITORING EQUIPMENT
Hardcopy , PDF
10-07-2021
English
01-01-2016
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 of 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
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
202 Electromagnetic compatibility - Requirements and tests
208 General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical
systems
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Alarm diagrams of Clause 208/IEC
60601-1-8:2006
Bibliography
Index of defined terms used in this particular standard
Pertains to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT and hereinafter also referred to as ME EQUIPMENT.
| DevelopmentNote |
Supersedes CSA C22.2.601.2.27 (01/2007)
|
| DocumentType |
Standard
|
| Pages |
174
|
| ProductNote |
Reconfirmed EN
|
| PublisherName |
Canadian Standards Association
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| IEC 60601-2-27:2011 | Identical |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| IEC 60601-2-25:2011 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
| AAMI EC13 : 2002 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
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