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ISO-11737-3 - REPLACED BY ISO-11737-1 - SUPERSEDED -- See the following: ISO-11737-1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.

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To find similar documents by classification:

07.100.10 (Medical microbiology Laboratory medicine, see 11.100)

11.080.01 (Sterilization and disinfection in general Including sterilization methods, air quality of surgery rooms, etc.)

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Document Number

ISO-11737-3

Revision Level

REPLACED BY ISO-11737-1

Status

Superseded

Publication Date

May 17, 2006

Committee Number

ISO/TC 198