ISO 11737-3:2004
Withdrawn
View Superseded by
Sterilization of medical devices — Microbiological methods — Part 3: Guidance on evaluation and interpretation of bioburden data
English
07-13-2004
03-14-2019
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.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11737-3 (07/2004)
|
| DocumentType |
Standard
|
| Pages |
8
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| AAMI ISO 11737-3 : 2004 | Identical |
| NEN ISO 11737-3 : 2004 | Identical |
| I.S. EN ISO 22442-1:2020 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| 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 |
| ISO/TR 7871:1997 | Cumulative sum charts — Guidance on quality control and data analysis using CUSUM techniques |
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