TDS PDF

Quality systems—Medical devices—Particular requirements for the application of ISO 9002 Original standard ANSI AAMI ISO 13488-1996 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 13485-2016 (2019)

Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices Original standard ANSI AAMI ISO 14117-2019 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 14117-2019 (2025)

Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices Original standard ANSI AAMI ISO 14117-2019 (2025) in PDF full version. Additional info + preview on request

Document status: Active

Clinical investigation of medical devices for human subjects—Good clinical practice Original standard ANSI AAMI ISO 14155-2011 in PDF full version. Additional info + preview on request

Document status: Replaced by St ANSI AAMI ISO 14155-2020

Clinical investigation of medical devices for human subjects—Good clinical practice Original standard ANSI AAMI ISO 14155-2020 in PDF full version. Additional info + preview on request

Document status: Active

Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization, development, validation and routine control of a sterilization process for medical devices Original standard ANSI AAMI ISO 14160-2011 (2016) in PDF full version. Additional info + preview on request

Document status: Active