I.S. EN IEC 80601-2-78:2020

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
206 USABILITY
208 * General requirements, tests and guidance for alarm systems in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS
210 * Process requirements for the development of PHYSIOLOGIC CLOSED-LOOP CONTROLLERS
211 * Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in the HOME HEALTHCARE ENVIRONMENT
Annexes
Annex A (informative) General guidance and rationale
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Guidance and examples of SITUATION AWARENESS
Bibliography
Index of defined terms used in this particular standard

This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.