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BS PD ISO/TS 19930:2017
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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
standard by BSI Group, 12/01/2017
Full Description
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 14040
ICH Q1A(R2)
EN 556-1
ISO 22442-1
ISO 20857
ISO 9001
ISO 14161
ISO 9004
ISO 11137-1
ANSI/AAMI ST67
ISO 10993
ISO 22442-2
ISO 11137-2
ISO 14971
ISO 14937
ISO/IEC Guide 51
AAMI TIR17
ISO 22442-3
ISO 11607-2
ISO 11135-1
ISO 13408
ISO 14160
ISO 90003
ISO 17665-1
ISO 14001
ISO 11607-1
ISO 9000:2005 (R09) Ed 3
ISO 25424:2009 Ed 1
ISO/TS 13004:2013
ASTM F1980 - 07
All current amendments available at time of purchase are included with the purchase of this document.
M00012437
2021-02-16
New product
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
standard by BSI Group, 12/01/2017