ISO 21647:2004 PDF
Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 40
- Дата публикации:
- 17 ноября 2004 г.
- Издание:
- ISO IS 21647 edition 1 version 1
- ICS:
- 11.040.10
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.
Технические детали
- Технический комитет
- ISO/TC 121/SC 1 - Breathing attachments and anaesthetic machines
- SKU
- ISO 21647:2004