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AAMI - Advancy Safety in Medical Technology

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AAMI Standards Publications Available from Normadoc

 

QUALITY MANAGEMENT, GENERAL SAFETY, AND DESIGN
ANSI/AAMI ES60601-1:2005/(R)2012 (IEC 60601-1:2005, MOD) and C1:2009/(R)2012, A2:2010/(R)2012
Medical electrical equipment, Part 1: General requirements for basic safety and essential performance, 1ed and 2009 and 2010 Amendments
AAMI HE75:2009
Human factors engineering - Design of medical devices, 3ed
ANSI/AAMI/IEC 62304:2006
Medical device software - Software life cycle processes, 2ed
ANSI/AAMI/IEC 62366:2007
Medical devices - Application of usability engineering to medical devices, 2ed
ANSI/AAMI/IEC 60601-1-2:2007/(R)2012
Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests, 2ed
ANSI/AAMI HA60601-1-11:2011 (IEC 60601-1-11:2010, MOD)
Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environment
ANSI/AAMI/IEC 80001-1:2010
Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities, 1ed
ANSI/AAMI/ISO 13485:2003/(R)2009
Medical devices—Quality management systems—System requirements for regulatory purposes, 2ed
ANSI/AAMI/ISO TIR14969:2004
Medical devices—Quality management systems—Guidance on the application of ISO 13485, 2ed
ANSI/AAMI/ISO 14971:2007/(R)2010
Medical devices—Application of risk management to medical devices, 3ed
ANSI/AAMI/ISO 15223-1:2007/(R)2012 and A1:2008/(R)2012
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements, 1ed and 2008 Amendment
ANSI/AAMI/ISO 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, 1ed
ANSI/AAMI/ISO 15225:2010
Nomenclature - Medical device nomenclature data structure, 2ed
ANSI/AAMI/ISO 80369-1:2010
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements, 1ed
AAMI TIR18:2010
Guidance on electromagnetic compatibility of medical devices in healthcare facilities, 2ed
AAMI TIR24:1999
Acquisition and use of physiologic waveform databases for testing of medical devices, 1ed
AAMI TIR32:2004
Medical device software risk management, 1ed
AAMI TIR36:2007
Validation of software for regulated processes, 1ed
ANSI/AAMI/IEC TIR60878:2003
Graphical symbols for electrical equipment in medical practice, 1ed
ANSI/AAMI/IEC TIR62296:2003
Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements, 1ed
ANSI/AAMI/IEC TIR62348:2006
Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended, 1ed
ANSI/AAMI/IEC TIR62354:2009
General testing procedures for medical electrical equipment, 1ed
ANSI/AAMI/IEC TIR80002-1:2009
Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software, 1ed
ANSI/AAMI/ISO TIR16142:2005
Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ANSI/AAMI/ISO TIR19218-1:2011
Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes, 2ed
BIOLOGICAL EVALUATION OF MEDICAL DEVICES
ANSI/AAMI/ISO 10993-1:2009
Part 1: Evaluation and testing within a risk management process, 4ed
ANSI/AAMI/ISO 10993-2:2006/(R)2010
Part 2: Animal welfare requirements, 2ed
ANSI/AAMI/ISO 10993-3:2003/(R)2009
Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity, 2ed
ANSI/AAMI/ISO 10993-4:2002 and A1:2006
Part 4: Selection of tests for interactions with blood, 2ed and 2006 Amendment
ANSI/AAMI/ISO 10993-5:2009
Part 5: Tests for in vitro cytotoxicity, 3ed
ANSI/AAMI/ISO 10993-6:2007/(R)2010
Part 6: Tests for local effects after implantation, 2ed
ANSI/AAMI/ISO 10993-7:2008
Part 7: Ethylene oxide sterilization residuals, 3ed
ANSI/AAMI/ISO 10993-9:2009
Part 9: Framework for identification and quantification of potential degradation products, 3ed
ANSI/AAMI/ISO 10993-10:2010
Part 10: Tests for irritation and skin sensitization, 3ed
ANSI/AAMI/ISO 10993-11:2006/(R)2010
Part 11: Tests for systemic toxicity, 2ed
ANSI/AAMI/ISO 10993-12:2007
Part 12: Sample preparation and reference materials, 3ed
ANSI/AAMI/ISO 10993-13:2010
Part 13: Identification and quantification of degradation products from polymeric medical devices, 2ed
ANSI/AAMI/ISO 10993-14:2001/(R)2006
Part 14: Identification and quantification of degradation products from ceramics, 1ed
ANSI/AAMI/ISO 10993-15:2000/(R)2006
Part 15: Identification and quantification of degradation products from metals and alloys, 1ed
ANSI/AAMI/ISO 10993-16:2010
Part 16: Toxicokinetic study design for degradation products and leachables, 2ed
ANSI/AAMI/ISO 10993-17:2002/(R)2008
Part 17: Establishment of allowable limits for leachable substances, 1ed
ANSI/AAMI BE83:2006/(R)2011
Part 18: Chemical characterization of materials
ANSI/AAMI/ISO 14155:2011
Clinical investigation of medical devices for human subjects -- Good clinical practice, 3ed
ANSI/AAMI/ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management, 1ed
ANSI/AAMI/ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling, 1ed
ANSI/AAMI/ISO 22442-3:2007
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents, 1ed
AAMI TIR19:1998 and A1:1999
Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals, 1ed and 1999 Amendment
ANSI/AAMI/ISO TIR10993-19:2006
Biological evaluation of medical devices - Part 19: Physio-chemical, morphological and topographical characterization of materials, 1ed
ANSI/AAMI/ISO TIR10993-20:2006
Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices, 1ed
ANSI/AAMI/ISO TIR22442-4:2010
Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes,1ed
Standards Publications Available from AAMI (continued)
BIOMEDICAL EQUIPMENT
ANSI/AAMI AT6:2005(R)2011
Autologous transfusion devices, 3ed
ANSI/AAMI BF7:1989/(R)2011
Blood transfusion micro-filters, 2ed
ANSI/AAMI BF64:2002/(R)2011
Leukocyte reduction filters, 1ed
ANSI/AAMI BP22:1994/(R)2011
Blood pressure transducers, 2ed
ANSI/AAMI EC11:1991/(R)2007
Diagnostic electrocardiographic devices, 2ed
ANSI/AAMI EC12:2000/(R)2010
Disposable ECG electrodes, 3ed
ANSI/AAMI EC38:2007
Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems, 3ed
ANSI/AAMI EC53:1995/(R)2008 and A1:1998/(R)2008
ECG cables and leadwires, 1ed and 1998 Amendment
ANSI/AAMI EC57:1998/(R)2008
Testing and reporting performance results of cardiac rhythm and ST segment measurement algorithms, 2ed
ANSI/AAMI EC71:2001/(R)2007
Standard communications protocol—Computer assisted electrocardiography, 1ed
ANSI/AAMI EQ56:1999/(R):2008
Recommended practices for a medical equipment management program, 1ed
ANSI/AAMI ID26:2004/(R)2009
Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers, 3ed
ANSI/AAMI ID54:1996/(R)2012
Enteral feeding set adapters and connectors, 1ed
AAMI NS4:1986/(R)2009
Transcutaneous electrical nerve stimulators, 1ed
ANSI/AAMI NS28:1988/(R)2010
Intracranial pressure monitoring devices, 1ed
ANSI/AAMI PB70:2003/(R)2009
Liquid barrier performance and classification of protective apparel and drapes in health care facilities, 1ed
ANSI/AAMI PC69:2007
Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators, 2ed
ANSI/AAMI/IEC 60601-2-2:2009
Medical electrical equipment, Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, 5ed
ANSI/AAMI/IEC 60601-2-4:2010
Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators, 5ed
ANSI/AAMI/IEC 60601-2-19:2009
Medical electrical equipment - Part 2-19: Particular requirements for basic safety and essential performance of baby incubators, 4ed
ANSI/AAMI/IEC 60601-2-20:2009
Medical electrical equipment - Part 2-20: Particular requirements for basic safety and essential performance of transport incubators, 3ed
ANSI/AAMI/IEC 60601-2-21:2009
Medical electrical equipment - Part 2-21: Particular requirements for basic safety and essential performance of infant radiant warmers, 2ed
ANSI/AAMI/IEC 60601-2-27:2011
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment, 4ed
ANSI/AAMI/IEC 60601-2-50:2009
Medical electrical equipment - Part 2-50: Particular requirements for basic safety and essential performance of infant phototherapy equipment, 2ed
ANSI/AAMI/IEC 80601-2-58:2008
Medical electrical equipment - Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery, 1ed
ANSI/AAMI/IEC 80601-2-30:2009
Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers, 1 ed
ANSI/AAMI/ISO 5840:2005/(R)2010
Cardiovascular implants—Cardiac valve prostheses, 4ed
ANSI/AAMI/ISO 7198:1998/2001/(R)2010
Cardiovascular implants—Tubular vascular prostheses, 3ed
ANSI/AAMI/ISO 7199:2009 and A1/2012
Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators), 2ed and 2012 Amendment
ANSI/AAMI/ISO 14708-3:2008
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators, 1ed
ANSI/AAMI/ISO 14708-4:2008
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps, 1ed
ANSI/AAMI/ISO 14708-5:2010
Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
ANSI/AAMI/ISO 15674:2009
Cardiovascular implants and artificial organs—Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags, 2ed
ANSI/AAMI/ISO 15675:2009
Cardiovascular implants and artificial organs—Cardiopulmonary bypass systems—Arterial line blood filters, 2ed
ANSI/AAMI/ISO 25539-1:2003/(R)2009 and A1:2005/(R)2009
Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses, 1ed and 2005 Amendment
ANSI/AAMI/ISO 25539-2:2008
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents, 1ed
ANSI/AAMI/ISO 27185:2012
Cardiac rhythm management devices - Symbols to be used with cardiac rhythm management device labels, and information to be supplied - General requirements, 1ed
ANSI/AAMI/ISO 27186:2010
Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements, 1ed
ANSI/AAMI/ISO 81060-1:2007
Non invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type, 1ed
ANSI/AAMI/ISO 81060-2:2009
Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type, 1ed.
AAMI TIR4:1989
Apnea monitoring by means of thoracic impedance pneumography, 1ed
AAMI TIR9:1992
Evaluation of clinical systems for invasive blood pressure monitoring, 1ed
AAMI TIR11:2005
Selection and use of protective apparel and surgical drapes in health care facilities, 2ed
AAMI TIR21:1998
Systems used to forecast remaining pacemaker battery service life, 1ed
AAMI TIR23:1999
Signal averaging, 1ed
AAMI TIR41:2011
Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators, 1ed
AAMI TIR42:2010
Evaluation of particulates associated with vascular medical devices, 1ed
ANSI/AAMI/ISO TIR12417:2011
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products,1ed
ANSI/AAMI/ISO TIR23810
:2012
Cardiovascular implants and artificial organs - Checklist for preoperative extracorporeal circulation equipment setup, 1ed
ANSI/AAMI/IEC TIR61289:2011
High frequency surgical equipment - Operation and maintenance, 1ed
Standards Publications Available from AAMI (continued)
STERILIZATION
ANSI/AAMI ST8:2008
Hospital steam sterilizers, 5ed
ANSI/AAMI ST24:1999/(R)2009
Automatic, general-purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed
ANSI/AAMI ST40:2004/(R)2010
Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2ed
ANSI/AAMI ST41:2008
Ethylene oxide sterilization in health care facilities: Safety and effectiveness, 4ed
ANSI/AAMI ST50:2004/(R)2010
Dry heat (heated air) sterilizers, 2ed
ANSI/AAMI ST55:2010
Table-top steam sterilizers, 2ed
ANSI/AAMI ST58:2005/(R)2010
Chemical sterilization and high-level disinfection in health care facilities, 2ed
ANSI/AAMI ST65:2008
Processing of reusable surgical textiles for use in health care facilities, 2ed
ANSI/AAMI ST67:2011
Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile,' 2ed
ANSI/AAMI ST72:2011
Bacterial endotoxins—Test methods, routine monitoring and alternatives to batch testing, 2ed
ANSI/AAMI ST77:2006
Containment devices for reusable medical device sterilization, 1ed
ANSI/AAMI ST79:2010, A2:2010 and A2:2011
Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 2ed and 2010/2011 amendments
ANSI/AAMI ST81:2004/(R)2010
Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1ed
ANSI/AAMI/ISO 10993-7:2008
Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization residuals, 3ed
ANSI/AAMI/ISO 11135-1:2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices, 4ed
ANSI/AAMI/ISO TIR11135-2:2008
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of AAMI/ISO 11135-1, 1ed
ANSI/AAMI/ISO 11137-1:2006/ (R)2010
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11137-2:2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ANSI/AAMI/ISO 11137-3:2006/ (R)2010
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ANSI/AAMI/ISO 11138-1:2006/ (R)2010
Sterilization of health care products - Biological indicators - Part 1: General requirements, 2ed
ANSI/AAMI/ISO 11138-2:2006/ (R)2010
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes, 3ed
ANSI/AAMI/ISO 11138-3:2006/ (R)2010
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
ANSI/AAMI/ISO 11138-4:2006/ (R)2010
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
ANSI/AAMI/ISO 11138-5:2006/ (R)2010
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ANSI/AAMI/ISO 11140-1:2005/ (R)2010
Sterilization of health care products - Chemical indicators - Part 1: General requirements, 2ed
ANSI/AAMI/ISO 11140-3:2007
Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
ANSI/AAMI/ISO 11140-4:2007
Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
ANSI/AAMI/ISO 11140-5:2007
Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs, 2ed
ANSI/AAMI/ISO 11607-1:2006/(R)2010
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging, 3ed
ANSI/AAMI/ISO 11607-2:2006/(R)2010
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes, 1ed
ANSI/AAMI/ISO 11737-1:2006
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products, 2ed
ANSI/AAMI/ISO 11737-2:2009
Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, 2ed
ANSI/AAMI/ISO 13408-1:2008/(R)2011
Aseptic processing of health care products - Part 1: General requirements, 1ed
ANSI/AAMI/ISO 13408-2:2003
Aseptic processing of health care products - Part 2: Filtration, 1ed
ANSI/AAMI/ISO 13408-3:2006
Aseptic processing of health care products - Part 3: Lyophilization, 1ed
ANSI/AAMI/ISO 13408-4:2005
Aseptic processing of health care products - Part 4: Clean-in-place technologies, 1ed
ANSI/AAMI/ISO 13408-5:2006
Aseptic processing of health care products - Part 5: Sterilization in place, 1ed
ANSI/AAMI/ISO 13408-6:2005
Aseptic processing of health care products - Part 6: Isolator systems
ANSI/AAMI/ISO 14160:2011
Sterilization of healthcare products-Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives-Requirements for characterization, development, validation, and routine control of a sterilization process for medical devices, 2ed
ANSI/AAMI/ISO 14161:2009
Sterilization of health care products—Biological indicators—Guidance for the selection, use, and interpretation of results, 3ed
ANSI/AAMI/ISO 14937:2009
Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices, 2ed
ANSI/AAMI/ISO 15882:2008
Chemical indicators— Guidance for selection, use, and interpretation of results, 4ed
ANSI/AAMI ST15883-1:2009 (ISO 15883-1:2006, MOD)
Washer-disinfectors, Part 1: General requirements, terms and definitions and tests, 1ed
ANSI/AAMI/ISO 17665-1:2006
Sterilization of health care products -- Moist heat -- Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices, 3ed
ANSI/AAMI/ISO 18472:2006/(R)2010
Sterilization of health care products - Biological and chemical indicators - Test equipment, 1ed
ANSI/AAMI/ISO 20857:2010
Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of an industrial sterilization process for medical devices, 1ed
Standards Publications Available from AAMI (continued)
AAMI TIR12:2010
Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, 3ed
AAMI TIR14:2009
Contract sterilization for ethylene oxide, 2ed
AAMI TIR15:2009
Physical aspects of ethylene oxide sterilization, 2ed
AAMI TIR16:2009
Microbiological aspects of ethylene oxide sterilization, 2ed
AAMI TIR17:2008
Compatibility of materials subject to sterilization, 2ed
AAMI TIR22:2007 and A1:2008
Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices - Part 1 and Part 2:2006, 2ed and 2008 Amendment
AAMI TIR28:2009
Product adoption and process equivalence for ethylene oxide sterilization, 2ed
AAMI TIR29:2002
Guide for process control in radiation sterilization, 1ed
AAMI TIR30:2011
A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, 2ed
AAMI TIR31:2008
Process challenge devices/test packs for use in healthcare facilities, 2ed
AAMI TIR33:2005
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax, 1ed
AAMI TIR34:2007
Water for the reprocessing of medical devices, 1ed
AAMI TIR35:2006
Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits, 1ed
AAMI TIR37:2007
Sterilization of health care products—Radiation—Guidance on sterilization of human tissue-based products, 1ed
AAMI TIR39:2009
Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices, 1ed
AAMI TIR40:2009
Sterilization of health care products - Radiation - Guidance on dose setting utilizing a Modified Method 2, 1ed
ANSI/AAMI/ISO TIR11139:2006
Sterilization of health care products—Vocabulary, 2ed
ANSI/AAMI/ISO TIR17665-2:2009
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1, 1ed
DIALYSIS
ANSI/AAMI RD47:2008
Reprocessing of hemodialyzers, 4ed
ANSI/AAMI/IEC 60601-2-16:2008
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment, 4ed
ANSI/AAMI/ISO 8637:2010
Cardiovascular implants and artificial organs - Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators, 4ed
ANSI/AAMI/ISO 8638:2010
Cardiovascular implants and artificial organs - Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters, 4ed
ANSI/AAMI/ISO 11663:2009
Quality of dialysis fluid for hemodialysis and related therapies, 1ed
ANSI/AAMI/ISO 13958:2009
Concentrates for hemodialysis and related therapies, 2ed
ANSI/AAMI/ISO 13959:2009
Water for hemodialysis and related therapies, 2ed
ANSI/AAMI/ISO 23500:2011
Guidance for the preparation and quality management of fluids for hemodialysis and related therapies, 1ed
ANSI/AAMI/ISO 26722:2009
Water treatment equipment for hemodialysis applications and related therapies, 1ed
AAMI TIR43:2011
Ultrapure dialysate for hemodialysis and related therapies, 1ed
AAMI STANDARDS COLLECTIONS
STBK12-1
Sterilization, Part 1: Sterilization in Health Care Facilities (2012) (book)
STBK10-2
Sterilization, Part 2: Sterilization Equipment Design & Use (2010) (book)
STBK10-3
Sterilization, Part 3: Industrial Process Control (2010) (book)
STBK10-S
Sterilization 3-Book Set (Current Editions of Parts 1-3) (books)
STBKCD
AAMI Standards on CD—Sterilization (2012)
DSBK12
Dialysis (2012) (book)
DSBKCD
AAMI Standards on CD—Dialysis (2012)
DSBK12-S
Dialysis Set (Current edition of book and CD)
DSBK12-PDF
AAMI Standards on PDF—Dialysis (2012; immediate download)
BIOTCD
AAMI Standards on CD—Biological Evaluation of Medical Devices
HFCOL-CD
AAMI Standards on CD–Human Factors (2011)
SYMBCD
Medical Equipment Symbols and Safety Signs—Clip Art Collection (CD)
STDSCD