BS IEC 80601-2-77:2019:2021 Edition

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Medical electrical equipment – Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Published By	Publication Date	Number of Pages
BSI	2021	56

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Categories: 11.040.01 - Medical equipment in general, BSI

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IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

PDF Catalog

PDF Pages	PDF Title
2	undefined
4	English CONTENTS
6	FOREWORD
9	INTRODUCTION
10	201.1 Scope, object and related standards
11	201.2 Normative references
12	201.3 Terms and definitions
15	201.4 General requirements 201.5 General requirements for testing of me equipment Tables Table 201.101 – List of essential performance requirements
16	201.6 Classification of me equipment and me systems 201.7 Me equipment identification, marking and documents Figures Figure 201.101 – Graphic symbol for maximum patient mass and safe working load Figure 201.102 – Graphic symbol for mass of mounted part
18	Table 201.102 – Colours of indicator lights and their meaning for me equipment
19	201.8 Protection against electrical hazards from me equipment
20	201.9 * Protection against mechanical hazards of me equipment and me systems
23	201.10 Protection against unwanted and excessive radiation hazards 201.11 Protection against excessive temperatures and other hazards
24	201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.13 Hazardous situations and fault conditions for me equipment
25	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
26	206 * Usability
27	Annexes
28	Annex D(informative)Symbols on marking Table 201.D.101 – Symbols for marking rase or its parts
29	Annex AA(informative)Particular guidance and rationale
30	Figure 201.AA.101 – Examples of mechanical interface attachments
32	Figure 201.AA.102 – Example 1 of robotic surgery configuration:a case of laparoscopic rass Figure 201.AA.103 – Example 2 of robotic surgery configuration:a case of bone milling rase
34	Figure 201.AA.104 – Typical essential performance items of rase
38	Figure 201.AA.105 – Example of risk assessment related to structural component
41	Annex BB(informative)Equations for the calculation of the overall system stoppingperformance and minimum distances
42	Figure 201.BB.101 – Relationship between t1 and t2
43	Annex CC(informative)Stopping functions of the rase Table 201.CC.101 – Different stopping functions
45	Annex DD(informative)Alternative method to demonstrate structural integrity throughoutthe expected service life of the rase Table 201.DD.101 – Alternative to safety factors: life testing
48	Annex EE(informative)Example of a testing method of the immunity test forhf surgical equipment emissions
51	Bibliography
53	Index of defined terms used in this particular standard