DIN EN ISO 15883-2-2009
清洗消毒器.第3部分:对外科器械,麻醉设备,碗,碟,接收器,器具,玻璃器具等进行热消毒的清洗消毒器的试验方法和要求(ISO 15883-2-2006).英文版本DIN EN ISO 15883-2-2006

Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006); English version of DIN EN

DIN EN ISO 15883-2-2009 发布历史

This part of ISO 15883 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. NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1. The specified performance requirements of this part of IS~ 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 If it is considered that priori protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation.

DIN EN ISO 15883-2-2009由德国标准化学会 DE-DIN 发布于 2009-09，并于 2009-09-01 实施。

DIN EN ISO 15883-2-2009 在中国标准分类中归属于: C47 公共医疗设备，在国际标准分类中归属于: 11.080.10 消毒设备。

DIN EN ISO 15883-2-2009 发布之时，引用了标准

• EN 10088-2 *， 2014-10-01 更新
• ISO 4017 紧固件.六角头螺钉.产品等级A和B*， 2022-06-28 更新
• ISO 5356-2 麻醉和呼吸设备.锥形连接器.第2部分:螺纹承重连接器.修改件1*， 2019-07-29 更新
• ISO 5361 气管管.第5部分:袖带和气管的要求和试验方法
• ISO 5362 麻醉气囊
• ISO 5367 麻醉和呼吸器. 呼吸组和连接器*， 2014-10-01 更新
• ISO 15883-1-2006 洗涤消毒器.第1部分:一般要求、术语、定义和试验
• ISO 17664 医疗保健品加工医疗器械生产企业提供的医疗器械加工信息第2部分:非关键医疗器械*， 2021-02-25 更新
• ISO/TS 15883-5-2005 洗涤消毒器.第5部分:试验土和清洁效果的实验说明方法

* 在 DIN EN ISO 15883-2-2009 发布之后有更新，请注意新发布标准的变化。

DIN EN ISO 15883-2-2009的历代版本如下：

• 2009年09月 DIN EN ISO 15883-2-2009 清洗消毒器.第3部分:对外科器械,麻醉设备,碗,碟,接收器,器具,玻璃器具等进行热消毒的清洗消毒器的试验方法和要求(ISO 15883-2-2006).英文版本DIN EN ISO 15883-2-2006

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标准号

DIN EN ISO 15883-2-2009

发布日期

2009年09月

实施日期

2009年09月01日

废止日期

无

中国标准分类号

C47

国际标准分类号

11.080.10

发布单位

DE-DIN

引用标准

EN 10088-2 ISO 4017 ISO 5356-2 ISO 5361 ISO 5362 ISO 5367 ISO 15883-1-2006 ISO 17664 ISO/TS 15883-5-2005

被代替标准

DIN EN ISO 15883-2/A1-2009

适用范围

This part of ISO 15883 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. NOTE 1 Thermal disinfection can be achieved by rinsing the load with hot water, exposure to steam or combination of the two. The requirements specified in this part of ISO 15883 are applicable in conjunction with the general requirements specified in ISO 15883-1. The specified performance requirements of this part of IS~ 15883 may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 2 If it is considered that priori protein can be present, particular care is needed in the choice of disinfectants and cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit its removal or inactivation.

DIN EN ISO 15883-2-2009系列标准

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