标准规范-国际标准-ANSI

ANSI AAMI 17664-2017 Processing of health care products-Information to be provided by the medical device manufacturer for the processing of medical devices.pdf
ANSI AAMI 16142-2-2017 Medical devices-Recognized essential principles of safety and performance of medical devices-Part 2 General essential principles and additional specific esse.pdf
ANSI AAMI 16142-1-2016 Medical devices-Recognized essential principles of safety and performance of medical devices-Part 1 General essential principles and additional specific esse.pdf
ANSI AAMI 15882-2008 Sterilization of health care products Chemical indicators Guidance for selection use and interpretation of results.pdf
ANSI AAMI 15676-2016 Cardiovascular implants and artificial organs-Requirements for singleuse tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO).pdf
ANSI AAMI 15675-2016 Cardiovascular implants and artificial organs-Cardiopulmonary bypass systems-Arterial blood line filters.pdf
ANSI AAMI 15674-2016 Cardiovascular implants and artificial organs - Hard-shell cardiotomy venous reservoir systems (with without filter) and soft venous reservoir bags.pdf
ANSI AAMI 15223-2-2010 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Part 2 Symbol development selection and validation.pdf
ANSI AAMI 15223-1-2016 Medical devices-Symbols to be used with medical device labels labelling and information to be supplied- Part 1 General requirements.pdf
ANSI AAMI 14971-2007 Medical devices Application of risk management to medical devices.pdf
ANSI AAMI 14937-2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development validation and routine control of .pdf
ANSI AAMI 14708-5-2010 Implants for surgery Active implantable medical devices Part 5 Circulatory support devices.pdf
ANSI AAMI 14708-4-2008 Implants for surgery Active implantable medical devices Part 4 Implantable infusion pumps.pdf
ANSI AAMI 14708-3-2017 Implants for surgery - Active implantable medical devices - Part 3 Implantable neurostimulators.pdf
ANSI AAMI 14708-1-2014 Implants for surgery - Active implantable medical devices - Part 1 General requirements for safety marking and for information to be provided by the manufact.pdf
ANSI AAMI 14408-2005 Tracheal tubes designed for laser surgery-Requirements for marking and accompanying information.pdf
ANSI AAMI 14161-2009 Sterilization of health care products Biological indicators Guidance for the selection use and interpretation of results.pdf
ANSI AAMI 14160-2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirem.pdf
ANSI AAMI 14155-2011 Clinical investigation of medical devices for human subjects C Good clinical practice (Corrected 16 December 2011 Includes change to subclause 7.3).pdf
ANSI AAMI 14117-2012 Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers implantable cardioverter defibrillat.pdf
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