ANSI/AAMI/ISO 11140-1:2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Sterilization of health care products - Chemical indicators - Part 1: General requirements.
English
10-09-2014
06-05-2025
This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the process parameter(s) specified for a sterilization process.
| Committee |
TC 198
|
| DocumentType |
Test Method
|
| ISBN |
1-57020-576-0
|
| Pages |
35
|
| ProductNote |
THIS STANDARD ALSO REFERS TO :EN 552
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 11140-1:2014 | Identical |
| ANSI/AAMI ST91:2021 | Flexible and semi-rigid endoscope processing in health care facilities |
| AAMI TIR56:2013(R2024) | Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices |
| ISO/IEC 17050-1:2004 | Conformity assessment — Supplier's declaration of conformity — Part 1: General requirements |
| ISO 15882:2008 | Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 556-1:2001 | Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| EN 14180:2014 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
| ISO 20857:2010 | Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO/TS 11139:2006 | Sterilization of health care products — Vocabulary |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 14161:2009 | Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
| EN 13060:2014 | Small steam sterilizers |
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