BS PD ISO/TS 19930:2017

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

BSI Group , 12/01/2017

Publisher: BS

File Format: PDF

$132.00$264.16

Description

Standard By:BSI Group , 12/01/2017

Published:12/01/2017

Pages:32

ISBN(s):9780580951619

File Size:1 file , 960 KB

Language:English

Note:This product is unavailable in Ukraine, Russia, Belarus

BS PD ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10-6.Cross References:ISO 14040ICH Q1A(R2)EN 556-1ISO 22442-1ISO 20857 ISO 9001ISO 14161ISO 9004ISO 11137-1ANSI/AAMI ST67 ISO 10993ISO 22442-2ISO 11137-2ISO 14971ISO 14937 ISO/IEC Guide 51AAMI TIR17ISO 22442-3ISO 11607-2ISO 11135-1ISO 13408ISO 14160ISO 90003ISO 17665-1ISO 14001ISO 11607-1ISO 9000:2005 (R09) Ed 3ISO 25424:2009 Ed 1ISO/TS 13004:2013ASTM F1980 - 07

BS PD ISO/TS 19930:2017

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

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