BS EN ISO 14161:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
Hardcopy , PDF
English
01-31-2010
05-01-2019
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators
6 Selection of supplier
7 Biological indicators in process development
8 Biological indicators in sterilization validation
9 Biological indicators in routine monitoring
10 Results
11 Application of biological indicator standards
12 Culture conditions
13 Third-party requirements
14 Personnel training
15 Storage and handling
16 Disposal of biological indicators
Annex A (informative) - Microbiological inactivation kinetics
and enumeration techniques
Annex B (informative) - Process challenge devices
Annex C (informative) - Formulae for fraction negative methods
for D value calculations
Annex D (informative) - Examples of documentation for
biological indicators prepared by the
user
Annex E (informative) - Calculation of z value
Annex F (informative) - D value determination by survivor curve
method
Annex G (informative) - Survival-kill response characteristics
Bibliography
Specifies 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 |
CH/198
|
| DevelopmentNote |
Supersedes 97/125276 DC (03/2005) Supersedes 08/30149503 DC. (01/2010)
|
| DocumentType |
Standard
|
| Pages |
72
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 14161:2009 | Identical |
| UNE-EN ISO 14161:2010 | Identical |
| NF EN ISO 14161 : 2009 | Identical |
| ISO 14161:2009 | Identical |
| NS EN ISO 14161 : 2009 | Identical |
| DIN EN ISO 14161:2010-03 | Identical |
| EN ISO 14161:2009 | Identical |
| NEN EN ISO 14161 : 2009 | Identical |
| NBN EN ISO 14161 : 2009 | Identical |
| ISO/IEC 17025:2005 | General requirements for the competence of testing and calibration laboratories |
| ISO 19011:2011 | Guidelines for auditing management systems |
| ISO 11138-3:2017 | Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| ISO 11737-2:2009 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| ISO 14937:2009 | Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| AAMI TIR31 : 2008 | PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARE FACILITIES |
| ISO 11138-2:2017 | Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
| ISO/IEC 17011:2004 | Conformity assessment — General requirements for accreditation bodies accrediting conformity assessment bodies |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 18472:2006 | Sterilization of health care products — Biological and chemical indicators — Test equipment |
| 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 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO/IEC Guide 2:2004 | Standardization and related activities — General vocabulary |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 11138-4:2017 | Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes |
| ISO 11138-5:2017 | Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes |
| 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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