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AAMI 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

21-11-2019

Language(s)

English

Published date

30-09-2009

Publisher

Association for the Advancement of Medical Instrumentation

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of ISO 14161:2009
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 the application of biological indicators in the development, validation, and routine monitoring of sterilization processes.

Committee
WG 04
DevelopmentNote
Supersedes AAMI ST34 (05/2001)
DocumentType
Standard
ISBN
157020368-7
Pages
84
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy
Supersedes

Standards Relationship
ISO 14161:2009 Identical

AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE
AAMI ST40 : 2004 : R2010 TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI TIR39:2009 GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES
AAMI TIR39:2009(R2017) GUIDANCE ON SELECTING A MICROBIAL CHALLENGE AND INOCULATION SITES FOR STERILIZATION VALIDATION OF MEDICAL DEVICES
AAMI ST63 : 2002 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT
AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
ANSI/AAMI ST58:2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
AAMI ST77 : 2013 CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILIZATION
ANSI/AAMI ST8:2013(R2018) HOSPITAL STEAM STERILIZERS
AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
AAMI TIR56:2013(R2020) GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES
AAMI TIR56 : 2013 GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES
AAMI ST67 : 2011 : R2017 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
AAMI TIR16 : 2017 MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
AAMI ST40 : 2004 TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES

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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Hardcopy - English
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