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UNI EN ISO 14161 : 2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS
Superseded date

08-27-2022

Published date

01-01-2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators
   5.1 General
   5.2 Test organism suspension for direct inoculation of
        products
   5.3 Inoculated carriers
   5.4 Self-contained biological indicators
   5.5 Other biological indicators
6 Selection of supplier
   6.1 General
   6.2 Documentation
7 Biological indicators in process development
   7.1 General
   7.2 Overkill approach
   7.3 Combined biological indicator and bioburden method
   7.4 Bioburden method
8 Biological indicators in sterilization validation
   8.1 General
   8.2 Placement and handling of biological indicators
   8.3 Sterilizer qualification
   8.4 Performance qualification
   8.5 Review and approval of validation
   8.6 Requalification
9 Biological indicators in routine monitoring
   9.1 General
   9.2 Placement and handling of biological indicators
   9.3 Process challenge device (PCD)
10 Results
   10.1 General
   10.2 Interpretation of results
11 Application of biological indicator standards
   11.1 General assessment of biological indicator
        performance by the user
   11.2 Nominal population of test organism
   11.3 Resistance determination
   11.4 z value determination
   11.5 F(T, z) equivalent sterilization value determination
   11.6 Establishing spore-log-reduction (SLR)
   11.7 Sterility assurance level (SAL) calculation
   11.8 Test equipment
12 Culture conditions
   12.1 General
   12.2 Incubation temperature
   12.3 Incubation period
   12.4 Choice of growth medium
13 Third-party requirements
   13.1 General
   13.2 Minimum requirements for replicates and total number
        of biological indicators
   13.3 Test equipment
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

Supplies 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. Also relates to biological indicators for which International Standards exist.

DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

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
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/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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