BS PD ISO/TS 19930:2017

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.