ISO 11737-3:2004
Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data
ISO 11737-3:2004 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices.
ISO 11737-3:2004 is not applicable to the use of bioburden data generated for establishing the extent of treatment to be applied in a sterilization process.
ISO 11737-3:2004 is not applicable to microbiological data generated from sampling the environment in manufacturing areas.
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TitlePage - Sterilization of medical devices— Microbiological methods—
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Origins of bioburden and bioburden control
Subclause2 - 4.1 Origins of bioburden
UntitledSubclause3 - 4.1.1 Contributors to bioburden include
UntitledSubclause3 - 4.1.2 In some cases, the most significant contributor to product or compo...
UntitledSubclause3 - 4.1.3 The method of manufacture of components can have an impact on their...
UntitledSubclause3 - 4.1.4 Product and component handling during assembly and other production...
UntitledSubclause3 - 4.1.5 The manufacturing environment and the extent of control of that env...
UntitledSubclause3 - 4.1.6 Assembly aids, such as compressed gasses, water, lubricants, etc., ...
UntitledSubclause3 - 4.1.7 Just as with automated assembly, automated packaging will contribut...
Subclause2 - 4.2 Nature of bioburden data
UntitledSubclause3 - 4.2.1 The examination of estimates of bioburden derived from a wide range...
UntitledSubclause3 - 4.2.2 A commonly observed characteristic of the frequency distributions o...
UntitledSubclause3 - 4.2.3 The extreme asymmetry of these skewed frequency distributions means...
Subclause2 - 4.3 Monitoring of bioburden
UntitledSubclause3 - 4.3.1 A bioburden monitoring programme does not control the bioburden on ...
UntitledSubclause3 - 4.3.2 The monitoring programme should include product manufactured using ...
UntitledSubclause3 - 4.3.3 The monitoring programme should be defined in a standard procedure....
Clause1 - 5 Sample size
Clause1 - 6 Sampling frequency
Clause1 - 7 Limit setting
UntitledSubclause2 - 7.1 Acceptable limits are stipulated for allowable bioburden levels in ac...
UntitledSubclause2 - 7.2 The limits used for monitoring bioburden data are based upon historic...
UntitledSubclause2 - 7.3 Bioburden data collected for a product may not precisely follow a wel...
UntitledSubclause2 - 7.4 In the absence of a fit to a mathematical distribution, it is possibl...
UntitledSubclause2 - 7.5 Control limits for a standard Shewhart control chart of the average b...
Clause1 - 8 Trend analysis
UntitledSubclause2 - 8.1 Bioburden data obtained over a period of time should be used to evalu...
UntitledSubclause2 - 8.2 Before statistical calculations can be performed on bioburden data, e...
UntitledSubclause2 - 8.3 There are a number of techniques for trending, which can be applied t...
UntitledSubclause2 - 8.4 In some instances it can be appropriate to utilise more than one of t...
Clause1 - 9 Evaluation and corrective action
UntitledSubclause2 - 9.1 Bioburden results that exceed established limits require investigation.
UntitledSubclause2 - 9.2 The initial phase of the investigation should be to determine whether...
UntitledSubclause2 - 9.3 If the results are due to laboratory error, the determination of biob...
UntitledSubclause2 - 9.4 If the original result is confirmed as a true finding, at least the f...
UntitledSubclause2 - 9.5 Based on the results of this investigation, specific corrective actio...
Bibliography - Bibliography
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TitlePage - Sterilization of medical devices— Microbiological methods—
Foreword - Foreword
Introduction - Introduction
Scope - 1 Scope
NormativeReference - 2 Normative references
Clause1 - 4 Origins of bioburden and bioburden control
Subclause2 - 4.1 Origins of bioburden
UntitledSubclause3 - 4.1.1 Contributors to bioburden include
UntitledSubclause3 - 4.1.2 In some cases, the most significant contributor to product or compo...
UntitledSubclause3 - 4.1.3 The method of manufacture of components can have an impact on their...
UntitledSubclause3 - 4.1.4 Product and component handling during assembly and other production...
UntitledSubclause3 - 4.1.5 The manufacturing environment and the extent of control of that env...
UntitledSubclause3 - 4.1.6 Assembly aids, such as compressed gasses, water, lubricants, etc., ...
UntitledSubclause3 - 4.1.7 Just as with automated assembly, automated packaging will contribut...
Subclause2 - 4.2 Nature of bioburden data
UntitledSubclause3 - 4.2.1 The examination of estimates of bioburden derived from a wide range...
UntitledSubclause3 - 4.2.2 A commonly observed characteristic of the frequency distributions o...
UntitledSubclause3 - 4.2.3 The extreme asymmetry of these skewed frequency distributions means...
Subclause2 - 4.3 Monitoring of bioburden
UntitledSubclause3 - 4.3.1 A bioburden monitoring programme does not control the bioburden on ...
UntitledSubclause3 - 4.3.2 The monitoring programme should include product manufactured using ...
UntitledSubclause3 - 4.3.3 The monitoring programme should be defined in a standard procedure....
Clause1 - 5 Sample size
Clause1 - 6 Sampling frequency
Clause1 - 7 Limit setting
UntitledSubclause2 - 7.1 Acceptable limits are stipulated for allowable bioburden levels in ac...
UntitledSubclause2 - 7.2 The limits used for monitoring bioburden data are based upon historic...
UntitledSubclause2 - 7.3 Bioburden data collected for a product may not precisely follow a wel...
UntitledSubclause2 - 7.4 In the absence of a fit to a mathematical distribution, it is possibl...
UntitledSubclause2 - 7.5 Control limits for a standard Shewhart control chart of the average b...
Clause1 - 8 Trend analysis
UntitledSubclause2 - 8.1 Bioburden data obtained over a period of time should be used to evalu...
UntitledSubclause2 - 8.2 Before statistical calculations can be performed on bioburden data, e...
UntitledSubclause2 - 8.3 There are a number of techniques for trending, which can be applied t...
UntitledSubclause2 - 8.4 In some instances it can be appropriate to utilise more than one of t...
Clause1 - 9 Evaluation and corrective action
UntitledSubclause2 - 9.1 Bioburden results that exceed established limits require investigation.
UntitledSubclause2 - 9.2 The initial phase of the investigation should be to determine whether...
UntitledSubclause2 - 9.3 If the results are due to laboratory error, the determination of biob...
UntitledSubclause2 - 9.4 If the original result is confirmed as a true finding, at least the f...
UntitledSubclause2 - 9.5 Based on the results of this investigation, specific corrective actio...
Bibliography - Bibliography