标准编号：ISO/TS 22421:2021
中文名称：卫生保健产品的消毒 卫生保健设施中医疗设备终端消毒用灭菌器的一般要求
英文名称：Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
发布日期：2021-01
标准范围
This document specifies the common requirements for sterilizers used for terminal sterilization of
medical devices in health care facilities. This document covers sterilizers that operate with a variety of
sterilizing agents (alone or in combination) within a sealed vessel at different temperatures, above, at,
or below atmospheric pressure.
This document provides high-level requirements and respective test methods that are general in nature.
This document does not provide quantitative requirements for process parameters or parameters of the
sterilization cycle, or requirements for performance testing, validation or routine control of sterilizers
because these depend on the respective sterilization method.
This document does not supersede or modify requirements or test methods of published standards
applying to sterilizers, or future editions thereof.
This document does not apply to:
— sterilizers using radiation as the sterilizing agent;
— sterilizers for laboratory equipment;
— sterilizers used to prepare culture media;
— sterilizers used for bio-decontamination of laboratory or other waste including decontamination of
pathogens in a high risk category;
— systems used for bio-decontamination of rooms and isolator systems;
— systems used for sterilization in place; or
— washer-disinfectors.
NOTE Whilst this document provides requirements for sterilizers used in health care applications, there
will be elements that are applicable to industrial applications.
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