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
International Electrotechnical Committee
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 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
202 ELECTROMAGNETIC DISTURBANCES - 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) - ELECTROMAGNETIC
DISTURBANCES created by HF SURGICAL
EQUIPMENT
Bibliography
Index of defined terms used in this particular standard
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES.
| Document Type | Standard |
| Status | Current |
| Publisher | International Electrotechnical Committee |
| Committee | TC 62 |
