Standard Swedish standard · SS-EN ISO 21647:2009

Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004 incl. Cor 1:2005)

Status: Withdrawn · Replaced by: SS-EN ISO 80601-2-55:2012

Scope
IEC 60601-1:1998, Clause 1, applies, except as follows.

Amendment (add at the end of 1.1):

This International Standard 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. This International Standard specifies requirements for
aa) anaesthetic gas monitoring,
bb) carbon dioxide monitoring,
cc) oxygen monitoring.

This International Standard is not applicable to monitors intended for use with flammable anaesthetic agents.

The requirements of this International Standard 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.

NOTE Additional aspects of environmental impact are addressed in ISO 14971.

Subjects

Anaesthetic, respiratory and reanimation equipment (11.040.10)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-69575

Edition: 2

Approved: 4/27/2009

No of pages: 64

Replaces: SS-EN ISO 21647:2004/AC:2006 , SS-EN ISO 21647:2004

Replaced by: SS-EN ISO 80601-2-55:2012