BS EN ISO 11140-6:2022 - Page 2

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 | Status: Current

1 Scope This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060.

NOTE The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities.

1. a) Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for:
   1. — a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means;
   2. — an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design.
2. b) Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060). This document specifies the requirements for:
   1. — a reference hollow device (RHD) used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;
   2. — an alternative hollow device:
      1. — employing the same specific test load as defined for the RHD and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator;
      2. — equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.