Skip to content
Please enter a keyword to search

  • BS EN ISO 14161:2009

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-05-2019

    Language(s):  English

    Published date:  31-01-2010

    Publisher:  British Standards Institution

    Add To Cart

    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/198
    Development Note Supersedes 97/125276 DC (03/2005) Supersedes 08/30149503 DC. (01/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective