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BS EN IEC 80601-2-77:2021+A1:2023:2024 Edition

BS EN IEC 80601-2-77:2021+A1:2023:2024 Edition

$198.66

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 2024 62
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PDF Catalog

PDF Pages PDF Title
2 undefined
5 Blank Page
6 Annex ZA(normative)Normative references to international publicationswith their corresponding European publications
7 English
CONTENTS
9 FOREWORD
12 INTRODUCTION
13 INTRODUCTION to Amendment 1
14 201.1 Scope, object and related standards
16 201.2 Normative references
201.3 Terms and definitions
19 201.4 General requirements
Tables
Table 201.101 – List of essential performance requirements
20 201.5 General requirements for testing of me equipment
201.6 Classification of me equipment and me systems
201.7 Me equipment identification, marking and documents
Figures
Figure 201.101 – Graphic symbol for maximum patient mass and safe working load
21 Figure 201.102 – Graphic symbol for mass of mounted part
22 Table 201.102 – Colours and meanings of indicator lights for rase and rass
23 201.8 Protection against electrical hazards from me equipment
24 201.9 * Protection against mechanical hazards of me equipment and me systems
27 201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
28 201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions for me equipment
29 201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.16 * Me systems
30 201.17 * Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic disturbances – Requirements and tests
206 * Usability
32 Annexes
33 Annex D (informative) Symbols on marking
Table 201.D.101 – Symbols for marking rase or its parts
34 Annex AA (informative) Particular guidance and rationale
35 Figure 201.AA.101 – Examples of mechanical interface attachments
37 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
39 Figure 201.AA.104 – Typical essential performance items of rase
43 Figure 201.AA.105 – Example of risk assessment related to structural component
46 Annex BB (informative) Equations for the calculation of the overall system stopping performance and minimum distances
47 Figure 201.BB.101 – Relationship between t1 and t2
48 Annex CC (informative) Stopping functions of the rase
Table 201.CC.101 – Different stopping functions
50 Annex DD (informative) Alternative method to demonstrate structural integrity throughout the expected service life of the rase
Table 201.DD.101 – Alternative to safety factors: life testing
53 Annex EE (informative) Example of a testing method of the immunity test forhf surgical equipment emissions
56 Bibliography
58 Index of defined terms used in this particular standard

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BS EN IEC 80601-2-77:2021+A1:2023
$198.66