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
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.
WITHDRAWN
ISO 9918:1993
WITHDRAWN
ISO 11196:1995
WITHDRAWN
ISO 7767:1997
WITHDRAWN
ISO 11196:1995/Cor 1:1997
WITHDRAWN
ISO 21647:2004
95.99
Withdrawal of Standard
Dec 15, 2011
WITHDRAWN
ISO 21647:2004/Cor 1:2005