ANSI/AAMI/ISO 11140-6:2024
Current
The latest, up-to-date edition.
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
Hardcopy , PDF
English
02-09-2024
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-880-5
|
| Pages |
51
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| ISO 11140-6:2022 | Identical |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| ISO/TS 17665-2:2009 | Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1 |
| EN 13060:2014+A1:2018 | Small steam sterilizers |
| ISO 11140-3:2007 | Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| ISO 2768-1:1989 | General tolerances — Part 1: Tolerances for linear and angular dimensions without individual tolerance indications |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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