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AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
AAMI/ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
AAMI/ISO 15882:2008 (R2013) Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
AAMI/ISO 15676:2016 Cardiovascular implants and artificial organs - Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
AAMI/ISO 15675:2016 Cardiovascular implants and artificial organs - Cardiopulmonary bypass systems - Arterial blood line filters
AAMI/ISO 15674:2016 Cardiovascular implants and artificial organs - Hardshell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
AAMI/ISO 15223-2:2016 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
AAMI/ISO 15223-1:2016 (R2017) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
AAMI/ISO 14971:2007 (R2016) Medical devices - Risk management - Application of risk management to medical devices
AAMI/ISO 14937:2009 (R2013) Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
AAMI/ISO 14708-5:2010 (R2015) Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
AAMI/ISO 14708-4:2008 (R2011) Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps