CAN/CSA Z21647-07 (R2012):2007 Edition
$35.10
Medical Electrical Equipment – Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors
| Published By | Publication Date | Number of Pages |
| CSA | 2007-03-01 | 64 |
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.
