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ISO 11737-3:2004

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Sterilization of medical devices Microbiological methods Part 3: Guidance on evaluation and interpretation of bioburden data

Available format(s)

PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

03-14-2019

Language(s)

English

Published date

07-13-2004

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.

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Withdrawn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

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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