ISO-11737-3 › Historical Revision Information
Sterilization Of Medical Devices - Microbiological Methods - Part 3: Guidance On Evaluation and Interpretation Of Bioburden Data
ISO-11737-3
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2004 EDITION
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SUPERSEDED
-- See the following:
ISO-11737-1
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This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included (see B.12). This document does not address setting specific endotoxin limit specifications.
To find similar documents by classification:
07.100.10 (Medical microbiology Laboratory medicine, see 11.100)
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Document Number
ISO 11737-3:2004
Revision Level
2004 EDITION
Status
Superseded
Publication Date
July 1, 2004
Committee Number
ISO/TC 198