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ANSI/AAMI/ISO 11140-6:2024

Current

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

09-02-2024

€246.76
Excluding VAT

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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