04/30078095 DC : DRAFT JUL 2004

Superseded

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ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS

Available format(s):

Superseded date: 31-07-2006

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

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

Foreword
Introduction
1 Scope
  1.1 General
  1.1 Exclusions
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
  4.1 Manufacturing controls
      4.1.1 Quality systems
      4.1.2 Traceability
      4.1.3 End product requirements
      4.1.4 Personnel
  4.2 Test organism
      4.2.1 Strain
      4.2.2 Originating inoculum for suspension
      4.2.3 Test organism count
  4.3 Information supplied by manufacturer (labeling)
  4.4 Storage and transport
5 Specific manufacturing requirements
  5.1 Suspensions
  5.2 Carrier, primary and secondary packaging
  5.3 Inoculated carrier
  5.4 Biological indicators
  5.5 Self-contained biological indicators
6 Determination of resistance
  6.1 General resistance requirements
  6.2 Test organism
  6.3 Population of Test organism
  6.4 Resistance characteristics
  6.5 Test conditions
7 Culture conditions
  7.1 Incubator
  7.2 Growth medium
  7.3 Incubation period
Annex A (normative) Determination of viable count
      A.1 General
      A.2 Minimum number of test samples
      A.3 Sample preparation
      A.4 Incubation and enumeration
Annex B (normative) Determination of growth inhibition by
                    carriers and primary packaging material
                    exposed to sterilization processes
      B.1 General
      B.2 Materials
      B.3 Methods
      B.4 Interpretation of results
      B.5 Determination of growth inhibition by packaging materials
Annex C (normative) D value determination by survivor curve method
      C.1 General
      C.2 Materials
      C.3 Procedure
Annex D (normative) D value determination by fraction negative
                    method
      D.1 General
      D.2 Materials
      D.3 Methods
          D.3.1 The Holcomb-Spearman-Karber Procedure (HSKP)
          D.3.2 The Limited Holcomb-Spearman-Karber-Procedure (LHSKP)
          D.3.3 The Stumbo-Murphy-Cochran-Procedure (SMCP)
Annex E (normative) Survival-kill response characteristic
      E.1 General
      E.2 Materials
      E.3 Method
Annex F (normative) Relationship between components of
                    biological indicators
Bibliography
Annex ZA (normative) Normative reference to international
                     publication with their relevant
                     European publications

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Comment Closes On
Committee	LBI/35
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 11138-1:2017

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

ISO 10241:1992	International terminology standards Preparation and layout
ISO 690:2010	Information and documentation Guidelines for bibliographic references and citations to information resources
ISO 11607-2:2006	Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11138-3:2017	Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
ISO 11135:2014	Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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 8601:2004	Data elements and interchange formats Information interchange Representation of dates and times
ISO 11607-1:2006	Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 17666:2016	Space systems — Risk management
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 11137:1995	Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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 15223:2000	Medical devices Symbols to be used with medical device labels, labelling and information to be supplied

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