ISO 21647:2004

Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors ISO 21647:2004

Publication date:   Nov 17, 2004

95.99 Withdrawal of Standard   Dec 15, 2011

General information

95.99 Withdrawal of Standard   Dec 15, 2011

ISO

ISO/TC 121/SC 1 Breathing attachments and anaesthetic machines

International Standard

11.040.10   Anaesthetic, respiratory and reanimation equipment

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Scope

ISO 21647:2004 specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. It supplements the requirements of IEC 60601-1:1988.
ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring.
ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents.
The requirements of ISO 21647:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
Environmental aspects are addressed in Annex CC. Additional aspects of environmental impact are addressed in ISO 14971.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 9918:1993

WITHDRAWN
ISO 11196:1995

WITHDRAWN
ISO 7767:1997

WITHDRAWN
ISO 11196:1995/Cor 1:1997

NOW

WITHDRAWN
ISO 21647:2004
95.99 Withdrawal of Standard
Dec 15, 2011

CORRIGENDA / AMENDMENTS

WITHDRAWN
ISO 21647:2004/Cor 1:2005

REVISED BY

ABANDON
ISO/WD 21647

WITHDRAWN
ISO 80601-2-55:2011

Relations

Adopted from IEC 80601-2-55