标准规范-国际标准-ANSI

ANSI TIR61289-2011 High frequency surgical equipment C Operation and maintenance.pdf
ANSI TIR60878-2003 Graphical symbols for electrical equipment in medical practice.pdf
ANSI TIR37137-2014 Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants.pdf
ANSI TIR24971-2013 Medical devices - Guidance on the application of ISO 14971.pdf
ANSI TIR24-1999 Acquisition and use of physiologic waveform databases for testing of medical devices.pdf
ANSI TIR22442-4-2011 Medical devices utilizing animal tissues and their derivatives - Part 4 Principles for elimination and or inactivation of transmissible spongiform encephalopat.pdf
ANSI TIR19218-2-2012 Medical devices - Hierarchal coding structure for adverse events - Part 2 Evaluation codes.pdf
ANSI TIR19024-2016 Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli (GME) to a patient during cardiopulmonary bypass.pdf
ANSI TIR17665-3-2014 Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam ste.pdf
ANSI TIR17137-2014 Cardiovascular implants and extracorporeal systems C Cardiovascular absorbable implants.pdf
ANSI TIR16775-2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2.pdf
ANSI TIR15499-2017 Biological evaluation of medical devices-Guidance on the conduct of biological evaluation within a risk management process.pdf
ANSI TIR15499-2012 Biological evaluation of medical devices CGuidance on the conduct of biological evaluation within a risk management process.pdf
ANSI TIR14969-2004 Medical devices-Quality management systems- Guidance on the application of ISO 13485 2003.pdf
ANSI TIR13004-2013 Sterilization of health care products-Radiation-Substantiation of a selected sterilization dose Method VDmax SD.pdf
ANSI TIR12417-2011 Cardiovascular implants and extracorporeal systems C Vascular device-drug combination products.pdf
ANSI TIR11139-2006 Sterilization of health care products Vocabulary.pdf
ANSI TIR10993-20-2006 Biological evaluation of medical devices - Part 20 Principles and methods for immunotoxicology testing of medical devices.pdf
ANSI TIR10993-19-2006 Biological evaluation of medical devices - Part 19 Physico-chemical morphological and topographical characterization of materials.pdf
ANSI TIR10974-2018 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device.pdf
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