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BIOLOGICAL EVALUATION

New!! ANSI/AAMI/ISO 10993-12:2007, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials. See more information

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1099312
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New!! ANSI/AAMI/ISO 22442-1:2007, Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management. See more information

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2244201
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New!!ANSI/AAMI/ISO 22442-2:2007, Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling. See more information

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2244202
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New!!ANSI/AAMI/ISO 22442-3:2007, Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents. See more information

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2244203
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ELECTROMEDICAL EQUIPMENT

New!! AAMI TIR36:2007, Validation of software for regulated processes.See more information

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TIR36
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Coming Soon!! ANSI/AAMI EC38:2007, Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. See more information

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EC38
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IMPLANTS AND ARTIFICIAL ORGANS

New!! ANSI/AAMI PC69:2007, Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators.  See more information

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PC69
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STERILIZATION

New!! AAMI TIR34:2007, Water for the reprocessing of medical devices. See more information

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TIR34
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New!! AAMI TIR37:2007, Sterilization of health care products -- Radiation -- Guidance on sterilization of human tissue-based products. See more information

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