ISO TS 22421-2021 pdf free download – Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
This document specifies the common requirements for sterilizers used for terminal sterilization ofmedical devices in health care facilities.This document covers sterilizers that operate with a variety ofsterilizing 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 thesterilization cycle, or requirements for performance testing,validation or routine control of sterilizersbecause these depend on the respective sterilization method.
This document does not supersede or modify requirements or test methods of published standardsapplying 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 ofpathogens 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, therewill be elements that are applicable to industrial applications.
2Normative references
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references, only the edition cited applies.Forundated references, the latest edition of the referenced document (including any amendments) applies.IS0 3746,Acoustics —Determination of sound power levels and sound energy levels of noise sources usingsound pressure —Survey method using an enveloping measurement surface over a reflecting plane
ISO 8573-1,Compressed air -Part 1: Contaminants and purity classes
ISO 14937:2009,Sterilization of health care products — General requirements for characterizationof a sterilizing agent and the development, validation and routine control of a sterilization process formedical devices
ISO 20417,Medical devices — Information to be provided by the manufacturer
IEC 61010-2-040, Safety requirements for electrical equipment for measurement, control, and laboratoryuse —Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medicalmaterials
IEC 61326-1,Electrical equipment for measurement, control and laboratory use -—EMC requirements —Part 1: General requirements
Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and lEC maintain terminological databases for use in standardization at the following addresses:- ISO Online browsing platform: available at https://www.iso.org/obp
—IEC Electropedia: available at http://www.electropedia.org/
3.1
access device
means by which entry to restricted parts of equipment is achievedNote 1 to entry: This can be by dedicated key, code, or tool.
[SOURCE: ISO 11139:2018,3.4]
3.2
accompanying information
information accompanying or marked on a sterilizer and containing information for the user or thoseaccountable for the installation,use,maintenance, decommissioning and disposal of the sterilizer,particularly regarding safe use
Note 1 to entry: The accompanying information can be regarded as part of the sterilizer.ISO TS 22421 pdf download