VALIDATION SERVICES
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Toxicology & Biocompatibility
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ISO 10993
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ISO 10993-12
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ISO 10993-18
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ASTM F2459
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ISO 10993-5
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ISO 10993-3
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ICH S2(R1)
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OECD 471
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ASTM E1687-98
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OECD 473
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ISO 10993-4
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ASTM F756-13
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Sterilization Validation, Terminal Process for EO
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ISO 11135
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EN ISO 11135
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AAMI/TIR 16
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ISO 10993-7
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Sterilization Validation, Terminal Process for Radiation
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ISO 11137
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ISO 13004
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AAMI 11137
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ANSI 11137
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Sterilization Validations
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ISO 17665
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AAMI ST79
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Reusable Medical Device – Reprocessing Validations
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AAMI ST 91
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AAMI TIR 12
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AAMI TIR 30
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ISO 17664
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ISO 15883
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ASTM F2459
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ASTM F2847
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ISO 10993-5
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USP 87
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USP 788
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ISO 11737
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ISO 11135
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USP 85
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USP 643
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Packaging Validation and Testing
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ISO 11607
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ISO 11607-1
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ASTM D4169
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ASTM F1140
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ASTM F2096
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ASTM F1608
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ASTM F2638
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ASTM 2981
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ASTM F88
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ASTM F1929
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ASTM F2981
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ISO 5636
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ISTA 3A
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ASTM F1886
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Product Validation and Lot Release Testing
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ANSI 11737
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AAMI 11737
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ISO 11737
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ISO 11135
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USP 797
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USP 161
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USP 71
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EN 1174
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EP 2.6.1
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JP14 54
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ANSI 11137-2
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AAMI 11137-2
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ISO 1137-2
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USP 85
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USP 161
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USP 797
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EP 2.6.14
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AAMI TIR 33
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Class 100
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ISO Class 5
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AAMI ST72
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EP 2.6.14
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USP 788
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ISO 14708
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EN 45502
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ISO 1135-4
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ISO 8536-4
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Microbial Identification
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USP 71
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ISO 11737
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Tissue Services
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ISO 10993
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ISO 11607
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Disinfectant and Antimicrobial Efficacy Studies
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ASTM E2614
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ASTM E2315
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DIS/TSS-10
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ISO-FDA
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MIS105
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MIS110
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ASTM E2315
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ASTM E2149
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ISO 22196
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JIS Z 2801
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ASTM E2180
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Barrier Material Performance Tests
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ASTM F2100
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AAMI PB70
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EN 14683
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NIOSH 95
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AAMI PB70
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ISO 16603
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ISO 16604
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INDA
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AATCC 127
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ISO
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AATCC 42
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ASTM F1670
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ISO 16603
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ASTM F1671
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ISO 16604
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EN 13795
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EN ISO 11737-1
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EN 20811
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ISO 22610
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ISO 22612
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ISO 13938-1
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EN 29073-3
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ISO 9073-10
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General Physical Tests
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ASTM D3776
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ISO 2859
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ASTM D3578
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ASTM D3577
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ASTM D5250
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ASTM D6319
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ASTM D6124
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ASTM F1342
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ASTM F1671
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ASTM D5587
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ASTM D882
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ASTM D638
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ASTM D5034
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ASTM D5035
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EN 29073-3
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USP 645
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General Analytical Tests
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USP 643
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EP 2.2.44
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USP 645
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USP 921
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