Medical Device Use, Safety, and Quality Addressed in AAMI Standards

AAMI Standards Support Quality Healthcare

Popular AAMI Standards.

AAMI ES60601-1	Medical electrical equipment, Part 1: General requirements for basic safety and essential performance
AAMI 60601-1-2	Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral standard: Electromagnetic compatibility Requirements and tests
AAMI 14971 ERTA	Medical devices - Application of risk management to medical devices
AAMI 13485	Medical devices - Quality management systems - Requirements for regulatory purposes
AAMI EC53 ERTA	ECG cables and leadwires-Includes Erratum issued: 31 May 1998
AAMI 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing-FDA RECOGNIZED
AAMI 15223-1	Medical devices Symbols to be used with medical device labels, labeling, and information to be supplied Part 1: General requirements-Incorporates Amendment 1: 2008
AAMI 62304	Medical device software - Software life cycle processes
AAMI EC13	Cardiac monitors, heart rate meters, and alarms-Corrected Copy: 25 February 2008
AAMI TIR36	Validation of software for regulated processes
AAMI 60601-2-2	Medical electrical equipment, Part 2-2: Particular requirements for the safety of high frequency surgical equipment
AAMI EC11	Diagnostic electrocardiographic devices
AAMI 11135-1	Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI TIR14969	Medical devices Quality management systems Guidance on the application of ISO 13485:2003
AAMI TIR32	Medical device software risk management
AAMI TIR60878	Graphical symbols for electrical equipment in medical practice
AAMI 11737-1	Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
AAMI 10993-7	Biological Evaluation of Medical Devices, Part 7: Ethylene Oxide Sterilization Residuals-Only FDA RECOGNIZED if used in conjunction to AAMI TIR19: 1988; Replaces AAMI ST29: 1988 and AAMI ST30: 1989
AAMI TIR19 AMD 1	Guidance for ANSI/AAMI/ISO 10993-7:1995, Biological evaluation of medical deices Part 7: Ethylene oxide sterilization residuals Amendment
AAMI 11607-1	Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
AAMI 10993-4	Biological evaluation of medical devices - Part 4: Selection of tests for interaction with blood-Incorporates Amendment 1: 2006
AAMI EC57	Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
AAMI PC69 ERTA	Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers and implantable cardioverter
AAMI ST72	Bacterial Endotoxin - Test Methodologies, Routine Monitoring and Alternatives to Batch Testing-FDA RECOGNIZED
AAMI 11737-2	Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process-FDA RECOGNIZED
AAMI TIR12	Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers-2nd Edition
AAMI 10993-11	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
AAMI 11137-1	Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices-Also replaces AAMI ST31, AAMI ST32, AAMI TIR5
AAMI HE74	Human Factors Design Process for Medical Devices-FDA RECOGNIZED
AAMI 10993-12	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
AAMI SP10	Manual, electronic, or automated sphygmomanometers
AAMI 14155-1	Clinical investigation of medical devices for human subjects - Part 1: General requirements
AAMI 10993-5	BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 5: TEST FOR IN VITRO CYTOTOXICITY-FDA RECOGNIZED
AAMI TIR17	Compatibility of materials subject to sterilization
AAMI 17665-1	Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices-Former Designation: AAMI ST25
AAMI TIR33	Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method VDmax
AAMI 10993-2	Biological evaluation of medical devices - Part 2: Animal welfare requirements
AAMI TIR19218	Medical devices - Coding structure for adverse event type and cause
AAMI 10993-6	BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
AAMI TIR28	PRODUCT ADOPTION AND PROCESS EQUIVALENCY FOR ETHYLENE OXIDE STERILIZATION
AAMI ST79	Comprehensive guide to steam sterilization and sterility assurance in health care facilities-Incorporates Amendment 1: 2008; FDA RECOGNIZED
AAMI EC12	Disposable ECG Electrodes-FDA RECOGNIZED
AAMI TIR62348	Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended
AAMI DF80	Medical electrical equipment, Part 2: Particular requirements for the safety of cardiac defibrillators [including automated external defibrillators]-Also repalces AAMI TIR2
AAMI 11607-2	Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
AAMI 11137-2	Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose-Also replaces AAMI ST31, AAMI ST32, AAMI TIR5, and AAMI TIR27
AAMI 11135 ERTA	Medical devices Validation and routine control of ethylene oxide sterilization-Erratum issued: 20 January 1995 (print copy only) and Erratum issued: 6 April 2005 (PDF copy only)
AAMI 10993-3	Biological Evaluation of Medical Devices, Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
AAMI 10993-15	Biological evaluation of medical devices Part 15: Identification and quantification of degradation products from metals and alloys
AAMI 7198	CARDIOVASCULAR IMPLANTS - TUBUAL VASCULAR PROSTHESES-FDA RECOGNIZED
AAMI 15225	NOMENCLATURE - SPECIFICATION FOA A NOMENCLATURE SYSTEM FOR MEDICAL DEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE-Includes Amendment 1: 2004
AAMI TIR16	PROCESS DEVELOPMENT AND PERFORMANCE QUALIFICATION FOR ETHYLENE OXIDE STERILIZATION - MICROBIOLOGICAL ASPECTS-Updated material from AAMI ST27; Cited by FDA as
AAMI 60601-2-21	Medical electrical equipment, Part 2: Particular requirements for the safety of infant radiant warmers-FDA RECOGNIZED; Former Designation: AAMI II52; Incorporates Amendment 1: 2000
AAMI BP22	Blood Pressure Transducers-FDA RECOGNIZED;Incorporates Errata: 08/05/2004
AAMI 25539-1 AMD 1	Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses, Amendment 1: Test methods
AAMI TIR22	Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices Part 1 and Part 2:2006
AAMI ST81	Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices-FDA RECOGNIZED
AAMI TIR30	A Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
AAMI 11138-1	Sterilization of health care products - Biological indicators - Part 1: General requirements
AAMI TIR10993-19	Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
AAMI HE48	Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices
AAMI EC38	Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
AAMI 60601-2-50	Medical electrical equipment, Part 2-50: Particular requirements for the safety of infant phototherapy equipment
AAMI 10993-13	Biological evaluation of medical devices, Part 13: Identification and quantification of degradation products from polymeric devices.
AAMI TIR15	Ethylene Oxide Sterilization Equipment, Process Considerations and Pertinent Calculations-Updated material from AAMI ST27; Cited by FDA as
AAMI 10993-9	Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
AAMI 14155-2	Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
AAMI 14937	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-FDA RECOGNIZED
AAMI 11138-2	Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
AAMI HFMD	An Introduction to Human Factors in Medical Devices
AAMI 10993-14	BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCT FROM CERAMICS
AAMI 10993-17	Biological evaluation of medical devices Part 17: Methods for the establishment of allowable limits for leachable substances
AAMI ST58	Chemical sterilization and high-level disinfection in health care facilities
AAMI TIR14	Contract Sterilization for Ethylene Oxide-Updated material from AAMI ST27; Cited by FDA as
AAMI TIR16142	Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices-2006 printing
AAMI 10993-16	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES FROM MEDICAL DEVICES
AAMI 11138-3	Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
AAMI 11140-1	Sterilization of health care products - Chemical indicators - Part 1: General requirements
AAMI TIR20	PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION-Cited by FDA as
AAMI TIR62296	Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements
AAMI 11134	Sterilization of health care products?Requirements for validation and routine control?Industrial moist heat sterilization
AAMI TIR10993-20	Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
AAMI TIR29	GUIDE FOR PROCESS CONTROL IN RADIATION STERILIZATION-Cited by FDA as
AAMI TIR11139	Sterilization of health care products Vocabulary
AAMI ST67	Sterilization of health care products Requirements for products labeled Ã¢â‚¬Å“STERILEÃ¢â‚¬Â-FDA RECOGNIZED
AAMI TIR18	Guidance on Electromagnetic Compatibility of Medical Devices for Clinical/Biomedical Engineers - Part 1: Radiated Radio-Frequency Electromagnetic Energy
AAMI BE78	Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity-FDA RECOGNIZED; Incorporating Reaffirmed Amendment 1: 12/3/2008
AAMI HF18 ERTA	Electrosurgical Devices
AAMI TIR13	Principles of Industrial Moist Heat Sterilization-(Updated material from ANSI/AAMI ST25:1987 )
AAMI 11737-3	Sterilization of medical devices - Microbiological methods - Part 3: Guidance on evaluation and interpretation of bioburden data-FDA RECOGNIZED
AAMI TIR34	Water for the reprocessing of medical devices
AAMI PROC	AAMI STANDARDS PROGRAM National and International (U.S. TAG) Policies and Procedures Manuals
AAMI 18472	Sterilization of health care products - Biological and chemical indicators - Test equipment
AAMI ID26 ERTA	Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers
AAMI 11137-3	Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects-Also replaces AAMI ST31, AAMI ST32, AAMI TIR5
AAMI AT6	Autologous Transfusion Devices
AAMI 11607	Packaging for Terminally Sterilized Medical Devices
AAMI 14161	Sterilization of health care products Biological indicators Guidance for the selection, use, and interpretation of results-FDA RECOGNIZED
AAMI ST63	Sterilization of health care products Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices Dry heat-FDA RECOGNIZED
AAMI RD16	Cardiovascular implants and artificial organs-Hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators
AAMI NS15	Implantable peripheral nerve stimulators
AAMI 22442-3	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
AAMI EQ56	Recommended practices for a medical equipment management program
AAMI 15882	Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results-FDA RECOGNIZED
AAMI NS14	Implantable spinal cord stimulators
AAMI 11138-5	Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
AAMI ST41	Ethylene oxide sterilization in health care facilities: Safety and effectiveness-FDA RECOGNIZED
AAMI 22442-2	Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
AAMI 22442-1	Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
AAMI TIR4	Apnea Monitoring by Means of Thoracic Impedance Pneumography
AAMI ST24	Automatic, General-Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities-FDA RECOGNIZED
AAMI TIR35	Sterilization of health care products - Radiation sterilization - Alternative sampling plans for verification dose experiments and sterilization dose audits-Former designation: AAMI ST31, AAMI ST32, and AAMI TIR5
AAMI BE83	Biological evaluation of medical devices - Part 18: Chemical characterization of materials
AAMI NS28	Intracranial Pressure Monitoring Devices-FDA RECOGNIZED; Incorporates Errata: 06/2001
AAMI RD17	Cardiovascular implants and artificial organs Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters
AAMI 11140-3	Sterilization of health care products Chemical indicators Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
AAMI TIR21	Systems Used to Forecast Remaining Pacemaker Battery Service Life
AAMI ST40	Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities-FDA RECOGNIZED
AAMI NS4	Transcutaneous Electrical Nerve Stimulators
AAMI RD62	WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS
AAMI BF64	LEUKOCYTE REDUCTION FILTERS
AAMI PAC49	Pacemaker Emergency Intervention System
AAMI 15674	Cardiovascular implants and artificial organs Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
AAMI RD61	CONCENTRATES FOR HEMODIALYSIS
AAMI EC71	Standard communications protocol for computer-assisted electrocardiography
AAMI 11138-4	Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
AAMI BF7	Blood Transfusion Micro-Filters
AAMI 15675	Cardiovascular implants and artificial organs Cardiopulmonary bypass systems Arterial blood line filters
AAMI TIR23	Signal Averaging
AAMI TIR24	Acquisition and use of physiologic waveform databases for testing of medical devices
AAMI 7199	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
AAMI ST77	Containment devices for reusable medical device sterilization
AAMI RD52 AMD 1 & 2	Dialysate for hemodialysis, Amendment 1 Annex C: Special considerations for home hemodialysis and Amendment 2 Annex D: Self-assessment of compliance with recommendations for dialysate preparation
AAMI ST50	Dry Heat (Heated Air) Sterilizers-FDA RECOGNIZED
AAMI TIR11	Selection and use of protective apparel and surgical drapes in health care facilities
AAMI TIR37	Sterilization of health care products Radiation Guidance on sterilization of human tissue-based products
AAMI 14160	Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemical sterilants
AAMI ST35	Good Hospital Practice: Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings
AAMI ID54	Enteral Feeding Set Adapters and Connectors-FDA RECOGNIZED
AAMI II51	Transport Infant Incubators-FDA RECOGNIZED
AAMI 5840	Cardiovascular implants - Cardiac valve prostheses-FDA RECOGNIZED
AAMI RD47	Reprocessing of hemodialyzers-FDA RECOGNIZED
AAMI 11140-5	Sterilization of health care products Chemical indicators Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
AAMI TIR15844	Sterlization of Health Care Products - Radiation Sterlization - Selection of a Sterilization Dose for a Single Production Batch-Edition 1
AAMI TIR26	Ventricular assist and heart replacement systems
AAMI RD5	Hemodialysis Systems
AAMI ST8	Hospital Steam Sterilizers-FDA RECOGNIZED
AAMI II36	Medical electrical equipment, Part 2: Particular requirements for safety of baby incubators-FDA RECOGNIZED
AAMI ST65	PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
AAMI PB70	LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES-FDA RECOGNIZED
AAMI 11140-4	Sterilization of health care products Chemical indicators Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
AAMI ST55	Table-Top Steam Sterilizers-FDA RECOGNIZED
AAMI ST66	STERILIZATION OF HEALTHCARE PRODUCTS - CHEMICAL INDICATORS - PART 2 : CLASS 2 INDICATORS FOR AIR REMOVAL TEST SHEETS AND PACKS-FDA RECOGNIZED
AAMI 81060-1	Non-invasive sphygmomanometers Part 1: Requirements and test methods for non-automated measurement type
AAMI TIR31	PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARD FACILITIES
AAMI 13488	Quality systems Medical devices Particular requirements for the application of ISO 9002
AAMI TIR15843	STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - PRODUCT FAMILIES AND SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS, AND FREQUENCY OF STERILIZATION DOSE AUDITS-Cited by FDA as
AAMI TIR11135-2	Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1
AAMI 11137	Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization-Includes Amendment 1: 2002
AAMI 10993-8	Biological evaluation of medical devices - Part 8: Selection and qualification of reference materials for biological tests
AAMI 15223	Medical Devices - Symbols to be used with medical device labels, labeling and information to be supplied.-FDA RECOGNIZED; Includes Amendment 1: 11/5/2001 and Amendment 2: 4/23/2004
AAMI TIR27	Sterilization of Health Care Products - Radiation Sterilization Substantiation of 25kGy as a Sterilization Dose Method VD Max
AAMI ST44	BIER/EO Gas Vessels-FDA RECOGNIZED
AAMI VOL 2.1	Biomedical Equipment Part 1: General Safety and Design; Equipment for Therapy and Surgery 1995 Edition
AAMI DF2	Cardiac Defibrillator Devices
AAMI TIR7	Chemical sterilants and high level disinfectants: A guide to selection and use
AAMI MDS-331	Developing Safe, Effective, and Reliable Medical Software
AAMI ST43	Good Hospital Practice: Ethylene Oxide Gas - Ventilation Recommendations and Safe Use
AAMI ST34	Guideline for the Use of Ethylene Oxide and Steam Biological Indicators in Industrial Sterilization Processes-FDA RECOGNIZED
AAMI TAR10-331	Hemodialyzer Reuse: Issues and Solutions
AAMI HE	Human Factors Engineering Guidelines and Preferred Practices for the Design of Medical Devices, Second Edition *NOT CURRENT DOCUMENT
AAMI SW68	Medical Device Software - Software Life Cycle Processes
AAMI ST1135-331	Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization-Edition 1; Identical to ISO 11135; FDA RECOGNIZED; Errata 1/1/95
AAMI TIR8	Microbiological Methods for Gamma Irradiation Sterilization of Medical Devices
AAMI STBK8-1-331	Part 1: Sterilization in Health Care Facilities-Volume 1.1
AAMI BIOT2 PT 10	Part 10: Tests for Irritation and Sensitization-Available in Book Collection Only; FDA RECOGNIZED; Edition 1
AAMI BIOT2 PT 12	Part 12: Sample preparation and Reference Materials-Available in Collection Book Only; FDA RECOGNIZED
AAMI STBK9-2	PART 2: STERILIZATION EQUIPMENT
AAMI STBK8-3-331	Part 3: Industrial Process Control-Volume 1.3
AAMI BIOT2 PT 5	Part 5: Tests for Cytotoxicity: In Vitro Methods-Available in Book Collection Only; Edition 1
AAMI BIOT2 PT 7	Part 7: Ethylene Oxide Sterilization Residuals-Available in Book Collection Only; FDA RECOGNIZED; Edition 1
AAMI BIOT2 PT 9	Part 9: Degradation of Medical Devices Related to Biological Testing-Available in Book Collection Only; Edition 1
AAMI ST19	Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization
AAMI TIR13409	Sterilization of health care products?Radiation Sterilization?Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches-Includes Amendment 1: 2000
AAMI ST21	Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization
AAMI CEC	The Clinical Engineering Collection
AAMI DSBK8-331	Volume 3: Dialysis
AAMI BIO8-331 BOOK	Volume 4 - Biological Evaluation of Medical Devices-Supplement November 1998
AAMI DF39	Automatic External Defibrillators and Remote-Control Defibrillatiors
AAMI ST45	BIER/Steam Vessels-FDA RECOGNIZED
AAMI BIOT9	BIOLOGICAL EVALUATION OF MEDICAL DEVICES, SUPPLEMENT 2
AAMI VP20	Cardiovascular Implants - Vascular Graft Prosthesis-FDA RECOGNIZED
AAMI 25539-2	Cardiovascular implants Endovascular devices Part 2: Vascular stents
AAMI BG7199	Cardiovascular Implants and Artificial Organs - Blood-Gas Exchangers (Oxygenators)
AAMI TIR25	Chemical indicators Guidance for the selection, use, and interpretation of results
AAMI WQD-331	Current Concepts in Hemodialyzer Reprocessing; Water Quality for Dialysis-TWO-BOOK SET
AAMI TIR9	Evaluation of Clinical Systems for Invasive Blood Pressure Monitoring
AAMI ST37	Flash Sterilization - Steam Sterilization of Patient Care Items for Immediate Use
AAMI ST33	Guidelines for the Selection and Use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities-FDA RECOGNIZED
AAMI SP9	Non-Automated Sphygmomanometers
AAMI BIOT2 PT 1	Part 1: Guidance on Selection of Tests-Available in Book Collection Only; Edition 1
AAMI STBK9-1	PART 1: STERILIZATION IN HEALTH CARE FACILITIES
AAMI BIOT2 PT 11	Part 11: Tests for Systemic Toxicity-Available in Book Collection Only; Edition 1
AAMI BIOT2 PT 2	Part 2: Animal Welfare Requirements-Available in Book Collection Only; Edition 1
AAMI STBK8-2-331	Part 2: Sterilization Equipment-Volume 1.2
AAMI BIOT2 PT 3	Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity-Available in Book Collection Only; Edition 1
AAMI BIOT2 PT 4	Part 4: Selection of Tests for Interactions with Blood-Available in Book Collection Only; Edition 1
AAMI BIOT2 PT 6	Part 6: Tests for Local Effects After Implantation-Available in Book Collection Only; FDA RECOGNIZED; Edition 1
AAMI TIR6	Reuse of Hemodialyzer Blood Tubing-ANSI/AAMI RD47
AAMI ES1	Safe Current Limits for Electromedical Apparatus
AAMI TIR3	Selection and Use of Chemical Indicators for Steam Sterilization Monitoring in Health Care Facilities
AAMI ST42	Steam Sterilization and Sterility Assurance in Table-Top Sterilizers in Office-Based, Ambulatory Care, Medical, Surgical, and Dental Facilities
AAMI ST59	STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL
AAMI ST60	Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements-FDA RECOGNIZED
AAMI ST1134	Sterilization of Health Care Products - Requirements for Validation and Routine Control - Industrial Moist Heat Sterilization-Edition 1; Identical to ISO 11134; FDA RECOGNIZED
AAMI STBK04-3	STERILIZATION, PART 3: INDUSTRIAL PROCESS CONTROL
AAMI ECAR	Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms
AAMI GMP5	THE QUALITY SYSTEMS COMPENDIUM