prEN ISO 15883-2
清洗消毒机 第2部分：对关键和半关键医疗器械采用热消毒的清洗消毒机的要求和测试 (ISO/DIS 15883-2:2023)

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices (ISO/DIS 15883-2:2023)

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标准号

prEN ISO 15883-2

发布单位

欧洲标准化委员会

 

 

被代替标准

EN ISO 15883-2:2009

适用范围

ISO 15883-2:2006 specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. The requirements in ISO 15883-2:2006 apply in addition to the general requirements specified in ISO 15883-1. The specified performance requirements of ISO 15883-2:2006 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.

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