ISO 21647:2004
Withdrawn
View Superseded by
Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
Hardcopy , PDF
11-17-2004
09-23-2021
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.
| Committee |
ISO/TC 121/SC 1
|
| DevelopmentNote |
Supersedes ISO/DIS 21647, ISO 7767, ISO 9918 and ISO 11196. (11/2004) Supersedes ASTM F 1452 and ASTM F 1456 (05/2006)
|
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 21647 : 2009 | Identical |
| NF EN ISO 21647 : 2009 | Identical |
| NBN EN ISO 21647 : 2009 | Identical |
| NEN EN ISO 21647 : 2009 | Identical |
| NS EN ISO 21647 : 2009 | Identical |
| I.S. EN ISO 21647:2009 | Identical |
| PN EN ISO 21647 : 2009 | Identical |
| VDE 0750-2-55 : 2012 | Identical |
| BS EN ISO 21647:2009 | Identical |
| EN ISO 21647:2009 | Identical |
| BS EN ISO 21647:2004 | Equivalent |
| UNE-EN ISO 21647:2005 | Identical |
| UNE-EN ISO 21647:2009 | Identical |
A newer version of this standard is available.
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