标准号：ISO 8185-2007
实施状态：作废
中文名称：医用呼吸道加湿器.呼吸潮湿系统特殊要求
英文名称：Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems
发布日期：2007-07
被替代标准：ISO 80601-2-74-2017
代替标准：ISO 8185-1997;ISO/FDIS 8185-2007;ISO 8185 Technical Corrigendum 1-2001
采用标准：DIN EN ISO 8185-2007,IDT;DIN EN ISO 8185-2009,IDT;BS EN ISO 8185-2007,IDT;BS EN ISO 8185-2009,IDT;EN ISO 8185-2007,IDT;EN ISO 8185-2009,IDT;prEN ISO 8185-2008,IDT;NF S95-150-2007,IDT;NF S95-150-2009,IDT;S95-150PR,IDT;CAN/CSA-Z8185-08-2008,NEQ;SN EN ISO 8185-2007,IDT;SN EN ISO 8185-2010,IDT;OENORM EN ISO 8185-2007,IDT;OENORM EN ISO 8185-2009,IDT;OENORM EN ISO 8185-2009,IDT;PN-EN ISO 8185-2007,IDT;PN-EN ISO 8185-2009,IDT;SS-EN ISO 8185-2007,IDT;SS-EN ISO 8185-2009,IDT;UNE-EN ISO 8185-2008,IDT;UNE-EN ISO 8185-2009,IDT;KS P ISO 8185-2009,IDT;DS/EN ISO 8185-2007,IDT;DS/EN ISO 8185-2009,IDT;UNI EN ISO 8185-2008-2008,IDT;UNI EN ISO 8185-2009-2009,IDT;STN EN ISO 8185-2008,IDT;STN EN ISO 8185-2009,IDT;CSN EN ISO 8185-2007,IDT;CSN EN ISO 8185-2009,IDT;DS/EN ISO 8185-2007,IDT;DS/EN ISO 8185-2009,IDT;NEN-EN-ISO 8185-2007 en-2007,IDT;NEN-EN-ISO 8185-2009 en-2009,IDT
起草单位：ISO/TC 121
标准简介：IEC 60601-1:1988, Clause 1, applies, except as follows:
Amendment (add at the end of 1.1):
This International Standard includes requirements for the basic safety and essential performance of
humidification systems, as defined in 3.6. This International Standard also includes requirements for
individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire
breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube
controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes.
NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of
IEC 60601-1.
* This International Standard also includes requirements for active HME (heat and moisture exchanger)
devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the
HME to the patient. This International Standard is not applicable to passive HMEs, which return a portion of
the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and
moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and
describe methods for testing performance.
Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, this International
Standard has been prepared as a Particular Standard based on IEC 60601-1, which gives general
requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore
applicable to humidifiers not powered by electricity. Where this International Standard specifies that a
Clause of IEC 60601-1 applies, it means that the Clause applies only if the requirement is relevant to the
humidification system under consideration.
This International Standard is not applicable to devices commonly referred to as "room humidifiers" or
humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant
incubators.
This International Standard is not applicable to nebulizers used for the delivery of drugs to patients.
In the planning and design of products within the scope of this International Standard, it is advisable to give
due consideration to the environmental impact from the product during its life cycle. Environmental aspects
are addressed in Annex GG.
NOTE Additional aspects of environmental impact are addressed in ISO 14971.
文件格式：PDF
文件大小：509.94KB
文件页数：58
（以上信息更新时间为：2019-11-22）
ISO 8185-2007 医用呼吸道加湿器.呼吸潮湿系统特殊要求.pdf
(509.94 KB)
|
|
