03/104519 DC : DRAFT FEB 2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
BS ISO 11737-3 - STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA
07-23-2013
11-23-2012
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Withdrawn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 |
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