Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
洗衣机消毒器 - 第1部分:一般要求 术语和定义和测试(ISO 15883-1:2006)
发布日期:
2009-06-03
实施日期:
2009-06-03
ISO 15883-1:2006规定了清洗消毒器(WD)及其附件的一般性能要求,旨在用于清洁和消毒医疗,牙科,制药和医疗领域中使用的可重复使用的医疗设备和其他物品兽医实践。它规定了清洁和消毒的性能要求以及实现必要性能所需的附件。还规定了定期进行必要修理之后的验证,日常控制和监测和重新验证所需的方法和仪器。
旨在处理特定负载的洗衣机消毒器的要求在ISO 15883的后续部分中规定。对于旨在处理两种或多种不同类型负载的洗衣机消毒器,本标准所有相关部分的要求适用。
ISO 15883-1:2006没有规定用于洗衣或一般饮食用途的机器的要求。
ISO 15883-1:2006不包括旨在对负载消毒或被指定为“灭菌器”的机器的要求,这些规定在其他标准中规定。 EN 285。
本标准规定的性能要求可能无法确保灭活或
ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.
The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.
ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.
ISO 15883-1:2006 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285.
The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.
ISO 15883-1:2006 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.