04/30078095 DC : DRAFT JUL 2004
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ISO 11138-1 - STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
31-07-2006
23-11-2012
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
| Committee |
LBI/35
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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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