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EVS-EN IEC 80601-2-77:2021

Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

General information

Valid from 15.10.2021
Base Documents
IEC 80601-2-77:2019; EN IEC 80601-2-77:2021
ICS Groups
11.040.01 Medical equipment in general 11.040.30 Surgical instruments and materials
Directives or regulations
None

Standard history

Status
Date
Type
Name
01.02.2024
Main + amendment
EVS-EN IEC 80601-2-77:2021+A1:2023
29.12.2023
Amendment
EVS-EN IEC 80601-2-77:2021/A1:2023
15.10.2021
Main
EVS-EN IEC 80601-2-77:2021
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.

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Standard monitoring
English (PDF 1 MB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English