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.
Legislation related to this standard
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Harmonized/Supporting
PUBLISHED
EN IEC 60601-2-83:2020
60.60
Standard published
Apr 3, 2020
PUBLISHED
EN IEC 60601-2-83:2020/A11:2021
IN_DEVELOPMENT
EN IEC 60601-2-83:2020/prA1:2022