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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 (ISO 14161:2009)
15-09-2009
25-03-2022
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
ISO 14161:2009 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.ISO 14161:2009 applies to biological indicators for which International Standards exist.
| Committee |
CEN/TC 102
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN ISO 14161 : 2009 | Identical |
| ISO 14161:2009 | Identical |
| NS EN ISO 14161 : 2009 | Identical |
| DIN EN ISO 14161:2010-03 | Identical |
| NBN EN ISO 14161 : 2009 | Identical |
| BS EN ISO 14161:2009 | Identical |
| NEN EN ISO 14161 : 2009 | Identical |
| SS-EN ISO 14161:2009 | Identical |
| PN EN ISO 14161 : 2010 | Identical |
| I.S. EN ISO 14161:2009 | Identical |
| UNE-EN ISO 14161:2010 | Identical |
| 02/124462 DC : DRAFT DEC 2002 | BS EN 285 - STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
| I.S. EN 15424:2007 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN 15424:2007 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| DIN EN 15424:2007-08 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| I.S. EN ISO 25424:2011 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO 25424:2009 | Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| DIN EN ISO 25424:2011-09 | STERILIZATION OF MEDICAL DEVICES - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| BS EN ISO 25424:2011 | Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices |
| 04/30078099 DC : DRAFT JUL 2004 | ISO 11138-2 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: USE IN ASSESSING ETHYLENE OXIDE STERILIZATION PROCESSES |
| EN 15424:2007 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| UNE-EN ISO 25424:2011 | Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009) |
| 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 |