Title Of Document
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Abstract
IEC 60601-1:2005 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. For certain types of medical electrical equipment, these requirements are either supplemented or modified by the special requirements of a collateral or particular standard. Where particular standards exist, this standard should not be used alone.
Category of Standards
Category 1
Document number assigned by ASEAN
IEC 60601-1:2005
ICS
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Agreement on Medical Device Directive (AMDD)
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
Member States
ID
MM
SG
Date of harmonisation in ASEAN
Date of Latest Review
Links :
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance