TDS PDF
Aseptic processing of health care products—Part 7- Alternative processes for medical devices and combination products Original standard ANSI AAMI ISO 13408-7-2012 (2018) in PDF full version. Additional info + preview on request
Document status: Active
Medical devices—Quality management systems—Requirements for regulatory purposes Original standard ANSI AAMI ISO 13485-2016 in PDF full version. Additional info + preview on request
Document status: Replaced by St ANSI AAMI ISO 13485-2016 (2019)
Medical devices—Quality management systems—Requirements for regulatory purposes Original standard ANSI AAMI ISO 13485-2016 (2019) in PDF full version. Additional info + preview on request
Document status: Active
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