标准编号：ISO 15883-4:2018
中文名称：清洗消毒器 第4部分：采用化学消毒不耐热内窥镜的清洗消毒器的要求和试验
英文名称：Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
发布日期：2018-11
标准范围
This document specifies the particular requirements, including performance criteria for washer-
disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile
endoscopes.
This document also specifies the performance requirements for the cleaning and disinfection of the
washer-disinfector and its components and accessories which can be required to achieve the necessary
performance criteria.
The methods, instrumentation and instructions required for type testing, works testing, validation
(installation, operational and performance qualification on first installation), routine control and
monitoring, and requalification of WD periodically and after essential repairs, are also specified.
NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of
activities covered by this document.
NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other
thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this
method of disinfection.
WD complying with the requirements of this document are not intended for cleaning and disinfection
of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or
sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5).
The specified performance requirements of this document do not ensure the inactivation or removal of
the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of
cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or
other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector.
NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement
on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.
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