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prEN ISO 11140-6

Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO/DIS 11140-6:2021)

General information
Draft
Base Documents
ISO/DIS 11140-6; prEN ISO 11140-6
Directives or regulations
None
Standard history
Status
Date
Type
Name
05.03.2002
Main
This International Standard specifies the performance requirements and test methods for chemical indicators and hollow devices and porous devices within which they are intended to function, to be used for testing the steam penetration performance of type B cycles of small steam sterilizers; small steam sterilizers are defined in EN 13060. The hollow and porous devices described in this standard do not substantiate their suitability as surrogate devices for lumened, hollow and porous medical devices used in health care facilities. Chemical indicators used with a porous device specified in this standard are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). The relevant sections of this International Standard covering porous loads specify the requirements for — a reference porous device to be used in the small load test for porous loads in small steam sterilizers and as a reference device by which alternative porous devices can be shown to be equivalent in performance according to this standard; ie, a textile test pack in which steam penetration is judged by thermometric means; — an alternative porous device equivalent in performance to the reference porous device; ie, an alternative porous device, usually commercially manufactured, of any design. Chemical indicator systems used with a hollow load device specified in this standard are designed to demonstrate the adequacy of steam penetration into a hollow device in small steam sterilizers (see EN 13060). The relevant sections of this International Standard covering hollow loads specify the requirements for — a reference hollow device used as a reference device in this standard; ie, a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator; — an alternative hollow device employing the same specific test load as defined for the reference hollow device and an indicator system designed specifically for use in the reference hollow test load; ie, a lumened device with an attached capsule in which steam penetration is judged by visual examination of an indicator system; — an alternative hollow device equivalent in performance to the reference hollow device; ie, an alternative hollow device, usually commercially manufactured, of any design.
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