SIS SS 87 457 10-1989
医疗用加湿器.安全要求

Humidifiers for medical use — Safety requirements


 

 

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标准号
SIS SS 87 457 10-1989
发布
1989年
发布单位
SE-SIS
当前最新
SIS SS 87 457 10-1989
 
 
适用范围
ISO 8185 is one of a series of International Standards based on IEC Publication 601-1; in IEC Publication 601-1 (the "General Standard"), this type of International Standard is referred to as a "Particular Standard". As statedin 1.3 of IEC Publication 601-1, the requirements of this International Standard take precedence ?ver those of IEC Publication 601-1. Humidifiers may be gas-powered, electrically powered or both. However, this International Standard has been prepared as a Particular Standard based on IEC Publication 601-1, whichgives 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 Publication 601-1 applies, it means that the clause applies only if the requirement is relevant to the humidifier under consideration. The scope and object given in clause 1 of IEC Publication 601-1 applies except that |J shall be replaced by the following: This International Standard specifies requirements for the safety of vaporizing and nebulizing humidifiers, inctuding those suitable for inclusion in breathing systems, for use with both intubated and non-intubated patients. This International Standard also includes requirements for delivery tubes and accessory devices intended to control humidifier or delivery tube heaters. Devices commonly referred to as "room humidifiers" and humidifiers used in heating, ventilation and air conditioning systems are outside the scope of this International Standard. It has not been found possible to include guidance on the matter of droplet size in the case of nebulizing humidifiers. A rationale for the most important requirements is given in annex 0. It is considered that a knowledge of the reasons for the requirements will not only facilitate the proper application of this International Standard, but will expedite any subsequent revision. This annex does not form an integral part of the standard.

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