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

84.1984.2185.3990.1390.1890.1990.2190.2290.2594.0294.05

HS Range

MRA/Harmonised Regulations related to the Standard

ASEAN Agreement on Medical Device Directive (AMDD)

ASEAN Body responsible for Standard

Medical Device Product Working Group (MDPWG)

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