03/104519 DC : DRAFT FEB 2003
Withdrawn
Withdrawn
BS ISO 11737-3 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA
Published date
11-23-2012
Publisher
Withdrawn date
07-23-2013
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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Origin of bioburden and bioburden control
4.1 Origins of bioburden
4.2 Nature of bioburden data
4.3 Monitoring of bioburden
5 Sample size
6 Sampling frequency
7 Limit setting
8 Trend analysis
9 Evaluation and corrective action
Annex A (informative) Probability of a Shewhart Control Chart for
Bioburden Data detecting a Tenfold Change in Bioburden level
with changing Sample Size and within Sample Variability
Bibliography
| Committee |
CH/198
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| ISO 14160:2011 | Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
| 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 11134:1994 | Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization |
| ISO 11137:1995 | Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization |
Summarise
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