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

AAMI/ISO TIR15499:2012 PDF

Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

Document status: Active

$131.00
AAMI/ISO TIR15499:2017 PDF

Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process

Document status: Active

$178.00
AAMI/ISO TIR16142:2005 PDF

Medical devices- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Document status: Active

$154.00
AAMI/ISO TIR16775:2014 PDF

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

Document status: Active

$319.00
AAMI/ISO TIR16775:2023 PDF

Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1 and ISO 11607-2

Document status: Active

$407.00
AAMI/ISO TIR17137:2014 PDF

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants

Document status: Active

$178.00
AAMI/ISO TIR17665-2:2009/(R)2016 PDF

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1

Document status: Active

$275.00
AAMI/ISO TIR17665-3:2014/(R)2016 PDF

Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical product to a product family and processing category for steam sterilization

Document status: Active

$275.00
AAMI/ISO TIR19:1998 PDF

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals

Document status: [ Withdrawn ]

AAMI/ISO TIR19/A1:1999 PDF

Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals

Document status: [ Withdrawn ]