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EVS-EN IEC 60601-2-83:2020+A11:2021

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment (IEC 60601-2-83:2019)

General information

Valid from 17.05.2021
Base Documents
IEC 60601-2-83:2019; EN IEC 60601-2-83:2020; EN IEC 60601-2-83:2020/A11:2021
ICS Groups
11.040.60 Therapy equipment
Directives or regulations
2017/745 Medical devices (MDR)

Standard history

Status
Date
Type
Name
Amendment
EN IEC 60601-2-83:2020/prA1:2022
17.05.2021
Main + amendment
EVS-EN IEC 60601-2-83:2020+A11:2021
15.04.2021
Amendment
EVS-EN IEC 60601-2-83:2020/A11:2021
15.04.2020
Main
EVS-EN IEC 60601-2-83:2020
IEC 60601-2-83:2019 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR.
The scope of this document includes all light sources except laser.

Required fields are indicated with *

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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