CSA ISO Z14161:2011(R2020)
Current
Current
The latest, up-to-date edition.
Sterilization of health care products — Biological indicators — Guidance for the selection, use and interpretation of results
Available format(s)
PDF
Language(s)
French, English
Published date
16-09-2020
Publisher
Excluding VAT
This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| ISBN |
978-1-55491-598-8
|
| Pages |
114
|
| PublisherName |
Canadian Standards Association
|
| Status |
Current
|
| Standards | Relationship |
| ISO 14161:2009 | Identical |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 11737-2:2019 | Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 19011:2018 | Guidelines for auditing management systems |
| ISO/IEC 17025:2017 | General requirements for the competence of testing and calibration laboratories |
| ISO 9001:2008 | Quality management systems — Requirements |
| 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/IEC 17011:2017 | Conformity assessment — Requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO/IEC Guide 2:1996 | Standardization and related activities — General vocabulary |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 13485:2003 | Medical devices — Quality management systems — Requirements for regulatory purposes |
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