IEC 60601-1:2005/ISH1:2008 - Interpretation sheet 1 - Medical electrical equipment

Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Feuille d'interprétation 1 - Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles

General Information

Status

Published

Publication Date

24-Apr-2008

ICS

11.040.01 - Medical equipment in general

Technical Committee

SC 62A - Common aspects of medical equipment, software, and systems

Current Stage

PPUB - Publication issued

Start Date

30-Jun-2008

Completion Date

25-Apr-2008

Ref Project

Relations

Revised

IEC 60601-1:2005 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Effective Date

05-Sep-2023

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IEC 60601-1:2005/ISH1:2008 - Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Released:4/25/2008

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IEC 60601-1:2005/ISH1:2008 - Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Released:4/25/2008

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Standards Content (Sample)

IEC 60601-1:2005/ISH1:2008 - I...

Publication IEC 60601-1 (Third edition – 2005) I-SH 01

MEDICAL ELECTRICAL EQUIPMENT –
Part 1: General requirements for basic safety
and essential performance
INTERPRETATION SHEET 1
This interpretation sheet has been prepared by SC 62A: Common aspects of electrical
equipment used in medical practice
The text of this interpretation sheet is based on the following documents:
ISH Report on voting
62A/599/ISH 62A/613/RVD
Full information on the voting for the approval of this interpretation sheet can be found in the
report on voting indicated in the above table.
___________
Subclause 1.1
This subclause is clarified by the following:
IEC 60601-1 does not apply to medical gas pipeline systems covered by ISO 7396-1, Medical
gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum.
NOTE Subclause 6.3 of ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm
signals.
This clarification will remain valid until a new version of IEC 60601-1 is published.

___________
April 2008
Publication CEI 60601-1 (Troisième édition – 2005) I-SH 01

A
...

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