BIOLOGICAL EVALUATION
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ANSI/AAMI/ISO 10993-16:2010, Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables. See more information
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1099316
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$35/$70 |
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1099316-PDF |
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ANSI/AAMI/ISO 10993-9:2009, Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products. See more information
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1099309
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$40/$80 |
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1099309-PDF |
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DIALYSIS EQUIPMENT
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ANSI/AAMI/ISO 8637:2010, Cardiovascular implants and artificial organs - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. See more information
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8637
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$40/$80 |
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8637-PDF |
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ANSI/AAMI/ISO 8638:2010, Cardiovascular implants and artificial organs - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters. See more information
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8638
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$40/$80 |
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8638-PDF |
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ELECTROMEDICAL EQUIPMENT
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AAMI TIR18:2010, Guidance on electromagnetic compatibility of medical devices in healthcare facilities. See more information
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TIR18
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$50/$100 |
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TIR18-PDF |
$50/$100 |
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ANSI/AAMI ES60601-1:2005/A2:2010, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, Amendment A2. See more information
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606011-A
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free |
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606011-A-PDF |
free |
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ANSI/AAMI HE75:2009, Human factors engineering - Design of medical devices. See more information
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HE75
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$135/$270 |
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HE75-CD |
$135/$270 |
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ANSI/AAMI/IEC TIR62354:2009, General testing procedures for medical electrical equipment. See more information
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62354
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62354-PDF |
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GENERAL ASPECTS OF MEDICAL DEVICES
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ANSI/AAMI/ISO 15225:2010, Medical devices - Quality management - Medical device nomenclature data structure. See more information
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15225
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$40/$80 |
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15225-PDF |
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IMPLANTS AND ARTIFICIAL ORGANS
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ANSI/AAMI/ISO 14708-5:2010, Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices. See more information
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1470805
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$55/$110 |
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1470805-PDF |
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ANSI/AAMI/ISO 27186:2010, Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements. See more information
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27186
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$60/$120 |
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27186-PDF |
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STERILIZATION
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AAMI TIR15:2009, Physical aspects of ethylene oxide sterilization. See more information
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TIR15
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TIR15-PDF |
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AAMI TIR16:2009, Microbiological aspects of ethylene oxide sterilization. See more information
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TIR16
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TIR16-PDF |
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AAMI TIR40:2009, Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2. See more information
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TIR40
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$45/$90 |
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TIR40-PDF |
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ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in health care facilities. See more information
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ST79
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$120/$240 |
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ST79-PDF |
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SYMBOLS
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ANSI/AAMI/ISO 15223-2:2010, Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation.
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1522302
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$40/$80 |
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1522302-PDF |
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