Publisher : ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION-INTERNATIONAL ORG- FOR STANDARDIZATION

AAMI/ISO 13408-6:2005/(R)2013 & A1:2013 PDF

Aseptic processing of health care products - Part 6: Isolator systems

Document status: Active

$149.00
AAMI/ISO 13408-7:2012/(R)2018 PDF

Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products

Document status: Active

$184.00
AAMI/ISO 13485:1996 PDF

Quality systems - Medical devices - Particular requirements for the application of ISO 9001

Document status: Active

$61.00
AAMI/ISO 13485:2003/(R)2009 PDF

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

Document status: Active

$215.00
AAMI/ISO 13488 PDF

Quality systems - Medical devices - Particular requirements for the application of ISO 9002

Document status: Active

$61.00
AAMI/ISO 13958:2009 PDF

Concentrates for hemodialysis and related therapies

Document status: Active

$121.00
AAMI/ISO 13959:2009 PDF

Water for hemodialysis and related therapies

Document status: Active

$110.00
AAMI/ISO 14117:2012 PDF

Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices

Document status: Active

$301.00
AAMI/ISO 14155-1:2003/(R)2008 PDF

Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirements

Document status: Active

$99.00
AAMI/ISO 14155-2:2003/(R)2008 PDF

Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans

Document status: Active

$88.00