标准号：ISO 21647-2004
实施状态：作废
中文名称：医疗电气设备.呼吸气监测器的基本安全和主要性能的特殊要求
英文名称：Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors
发布日期：2004-11
被替代标准：ISO 80601-2-55-2011
代替标准：ISO 7767-1997;ISO 9918-1993;ISO 11196-1995;ISO 11196 Technical Corrigendum 1-1997;ISO/FDIS 21647-2004
采用标准：DIN EN ISO 21647-2005,IDT;DIN EN ISO 21647-2009,IDT;ANSI/ASTM/ISO 21647-2006,IDT;BS EN ISO 21647-2004,IDT;BS EN ISO 21647-2009,IDT;EN ISO 21647-2004,IDT;EN ISO 21647-2009,IDT;prEN ISO 21647-2008,IDT;NF S95-190-2006,IDT;NF S95-190-2009,IDT;S95-190PR,IDT;CAN/CSA-Z21647-07-2007,IDT;SN EN ISO 21647-2005,IDT;SN EN ISO 21647-2009,IDT;SN EN ISO 21647/AC-2006,IDT;OENORM EN ISO 21647-2005,IDT;OENORM EN ISO 21647-2006,IDT;OENORM EN ISO 21647-2009,IDT;OENORM EN ISO 21647-2009,IDT;PN-EN ISO 21647-2005,IDT;PN-EN ISO 21647/AC-2006,IDT;UNE-EN ISO 21647-2005,IDT;UNE-EN ISO 21647-2009,IDT
起草单位：ISO/TC 121
标准简介：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.
文件格式：PDF
文件大小：374.22KB
文件页数：50
（以上信息更新时间为：2019-11-22）
ISO 21647-2004 医疗电气设备.呼吸气监测器的基本安全和主要性能的特殊要求.pdf
(374.22 KB)
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