Cross References:ISO 10993ISO 11135-1ISO 11137ISO/TS 12417ISO 14155:2011ISO 14630:2012ISO 14937ISO 14971:2007ISO/TR 15499ISO 17665-1ISO 25539-2:2008ISO 5840ISO 11607-1:2006 IEC 62366ASTM F2394-07(2013)ISO/IEC Guide 51:1999ISO/IEC Guide 63:2012ISO 10993-1ISO 11607-1ISO 11607-2ISO 13781 ISO/TR 14283:2004ISO 15223-1ISO/TR 15499ISO/IEC 17025ISO 37137ICH Q4B Annex 3ICH S1BICH S1C(R2)ICH S2(R1) ICH S3AICH S3B PKICH S4ICH S5(R2)ICH S6ICH S6(R1)ICH S7AICH S7BICH S8ICH M3(R2)EMA/INS/GMP/638479/2010MEDDEV 2.12/1:2012MEDDEV 2.12/2:2012ANSI/AAMI HE74AAMI TIR17AAMI TIR42:2010ASTM F1635-11ASTM F1980-07ASTM F2052-06e1ASTM F2119-07(2013)ASTM F2129-08ASTM F2182-11aASTM F2213-06(2011)ASTM F2503-08ASTM F2743-11ASTM F2902-12ASTM F2914-12USP 788USP 1788ASTM F2394-07(2013)