ANSI/AAMI/ISO 18472:2022
Current
The latest, up-to-date edition.
Sterilization of health care products—Biological and chemical indicators—Test equipment
Hardcopy , PDF
English
13-12-2021
Specifies requirements for test equipment to be used to test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series and test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140-1:2014.
| DocumentType |
Standard
|
| ISBN |
978-1-57020-860-7
|
| Pages |
41
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| 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/IEC Guide 99:2007 | International vocabulary of metrology — Basic and general concepts and associated terms (VIM) |
| ISO 11140-4:2007 | Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration |
| ISO/TR 10013:2001 | Guidelines for quality management system documentation |
| IEC 60751:2008 | Industrial platinum resistance thermometers and platinum temperature sensors |
| ISO 11139:2018 | Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards |
| ISO 11140-5:2007 | Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests |
| IEC 60584-1:2013 | Thermocouples - Part 1: EMF specifications and tolerances |
| 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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