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EN 60601-1-8:2007/prAB

Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EN 60601-1-8:2007/prAB

General information

10.00   Proposal for new project registered   Jul 5, 2024

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.

This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in
ME EQUIPMENT and ME SYSTEMS.

It also provides guidance for the application of ALARM SYSTEMS.

Related legislation

Legislation related to this standard

2017/745

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

Legislation 2017/745

Life cycle

PREVIOUSLY

PUBLISHED
EN 60601-1-8:2007

NOW

IN_DEVELOPMENT
EN 60601-1-8:2007/prAB
10.00 Proposal for new project registered
Jul 5, 2024




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