Popular Standards |
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AAMI 10993-16 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES FROM MEDICAL DEVICES |
AAMI 10993-17 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES |
AAMI 10993-2 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 2: ANIMAL PROTECTION REQUIREMENTS |
AAMI 10993-3 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY AND REPRODUCTIVE TOXICITY |
AAMI 10993-6 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCALEFFECTS AFTER IMPLANTATION |
AAMI 11134 | STERILIZATION OF HEALTH CARE PRODUCTS-REQUIREMENTS FOR VALIDATION AND ROUTING CONTROL-INDUSTRIAL MOIST HEAT STERILIZATION |
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 11140-1 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
AAMI 11140-3 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART3: CLASS 2 INDICATOR SYSTEMS FOR USE IN THE BOWIE AND DICK-TYPE STEAM PENETRATION TEST |
AAMI 11140-4 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPEFOR DETECTION OF STEAM PENETRATION |
AAMI 11140-5 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART5: CLASS 2 INDICATORS FOR BOWIE AND DICK-TYPE AIR REMOVAL TESTS |
AAMI 14971 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES |
AAMI 15223 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING AND INFORMATION TO BE SUPPLIED |
AAMI 15223-1 | MEDICAL DEVICES - SYMBOLS TO BE USED WITH MEDICAL DEVICE LABELS, LABELING, AND INFORMATION TO BE SUPPLIED - PART 1: GENERAL REQUIREMENTS |
AAMI 17665-1 | STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATIONPROCESS FOR MEDICAL DEVICES |
AAMI 18472 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL AND CHEMICAL INDICATORS - TEST EQUIPMENT |
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 60601-2-2 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF HIGH FREQUENCY SURGICAL EQUIPMENT |
AAMI 60601-2-50 | MEDICAL ELECTRICAL EQUIPMENT, PART 2-50: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT PHOTOTHERAPY EQUIPMENT |
AAMI AT6 | AUTOLOGUS TRANSFUSION DEVICES |
AAMI BE78 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 10: TEST FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY |
AAMI BE83 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
AAMI BEBK3 | STANDARDS AND RECOMMENDED PRACTICES |
AAMI BF64 | LEUKOCYTE REDUCTION FILTERS |
AAMI BF7 | BLOOD TRANSFUSION MICRO-FILTERS |
AAMI BIOT7 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES 1997 EDITION |
AAMI BIOT8 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, SUPPLEMENT |
AAMI BIOT9 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, SUPPLEMENT 2 |
AAMI BIOT9-S-293 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, THREE-BOOK SET: BIOT7, BIOT8 AND BIOT9 |
AAMI BP22 | BLOOD PRESSURE TRANSDUCERS |
AAMI BP23 | INTERCHANGEABILITY AND PERFORMANCE OF RESISTIVE BRIDGE TYPE BLOOD PRESSURE TRANSDUCERS |
AAMI CEC | THE CLINICAL ENGINEERING COLLECTION |
AAMI DF2 | CARDIAC DEFIBRILLATOR DEVICES |
AAMI DF39 | AUTOMATIC EXTERNAL DEFIBRILLATORS AND REMOTE-CONTROL DEFIBRILLATORS |
AAMI DF80 | MEDICAL ELECTRICAL EQUIPMENT, PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF CARDIAC DEFIBRILLATORS [INCLUDING AUTOMATED EXTERNALDEFIBRILLATORS] |
AAMI EC11 | DIAGNOSTIC ELECTROCARDIOGRAPHIC DEVICES |
AAMI EC12 | DISPOSABLE ECG ELECTRODES |
AAMI EC13 | CARDIAC MONITORS, HEART RATE METERS AND ALARMS |
AAMI EC38 | AMBULATORY ELECTROCARDIOGRAPHS |
AAMI EC53 | ECG CABLES AND LEADWIRES |
AAMI EC57 | TESTING AND REPORTING PERFORMANCE RESULTS OF CARDIAC RHYTHM AND ST SEGMENT MEASUREMENT ALGORITHMS |
AAMI EC71 | STANDARD COMMUNICATIONS PROTOCOL FOR COMPUTER-ASSISTED ELECTROCARDIOGRAPHY |
AAMI EQ56 | RECOMMENDED PRACTICES FOR A MEDICAL EQUIPMENT MANAGEMENT PROGRAM |
AAMI ES1 | SAFE CURRENT LIMITS FOR ELECTROMEDICAL APPARATUS |
AAMI ES60601-1 | MEDICAL ELECTRICAL EQUIPMENT, PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
AAMI GVR-058 | GOOD HOSPITAL PRACTICE: ETHYLENE OXIDE GAS - VENTILATION RECOMMENDATIONS AND SAFE USE |
AAMI HE | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
AAMI HE48 | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
AAMI HE74 | HUMAN FACTORS DESIGN PROCESS FOR MEDICAL DEVICES |
AAMI HF18 | ELECTROSURGICAL DEVICES |
AAMI HFMD | AN INTRODUCTION TO HUMAN FACTORS IN MEDICAL DEVICES |
AAMI ID26 | MEDICAL ELECTRICAL EQUIPMENT PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFUSION PUMPS AND CONTROLLERS |
AAMI ID54 | ENTERAL FEEDING SET ADAPTERS AND CONNECTORS |
AAMI II36 | MEDICAL ELECTRICAL EQUIPMENT, PART 2: PARTICULAR REQUIREMENTS FOR SAFETY OF BABY INCUBATORS |
AAMI II51 | TRANSPORT INFANT INCUBATORS |
AAMI INDEX | THE AAMI RESOURCE CATALOG (STANDARDS, TRAINING AND EDUCATIONAL PROGRAMS, AND RESOURCES FOR MEDICAL TECHNOLOGY PROFESSIONALS) |
AAMI MDS | DEVELOPING SAFE, EFFECTIVE, AND RELIABLE MEDICAL SOFTWARE |
AAMI MIR2 | GUIDELINE FOR ADMINISTERING MEDICAL INSTRUMENTATION MAINTENANCE |
AAMI NS14 | IMPLANTABLE SPINAL CORD STIMULATORS |
AAMI NS15 | IMPLANTABLE PERIPHERAL NERVE STIMULATORS |
AAMI NS28 | INTRACRANIAL PRESSURE MONITORING DEVICES |
AAMI NS4 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS |
AAMI PAC49 | PACEMAKER EMERGENCY INTERVENTION SYSTEM |
AAMI PB70 | LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES |
AAMI PC69 | ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY- EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
AAMI PROC | AAMI STANDARDS PROGRAM NATIONAL AND INTERNATIONAL (U.S. TAG) POLICIES AND PROCEDURES MANUALS |
AAMI QUALITY SYSTEM SET | THE QUALITY SYSTEMS COMPENDIUM SET |
AAMI RD16 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS-HEMODIALYZERS, HEMODIAFILTERS, HEMOFILTERS, AND HEMOCONCENTRATORS |
AAMI RD17 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS-EXTRACORPOREAL BLOODCIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS, AND HEMOFILTERS |
AAMI RD47 | REUSE OF HEMODIALYZERS |
AAMI RD5 | HEMODIALYSIS SYSTEMS |
AAMI RD52 | DIALYSATE FOR HEMODIALYSIS |
AAMI RD61 | CONCENTRATES FOR HEMODIALYSIS |
AAMI RD62 | WATER TREATMENT EQUIPMENT FOR HEMODIALYSIS APPLICATIONS |
AAMI RS | PROCESS CONTROL GUIDELINES FOR GAMMA RADIATION STE |
AAMI SP10 | MANUAL, ELECTRONIC, OR AUTOMATED SPHYGMOMANOMETERS |
AAMI SP9 | NON-AUTOMATED SPHYGMOMANOMETERS |
AAMI ST11135 | MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDESTERILIZATION |
AAMI ST1135 | MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDESTERILIZATION |
AAMI ST19 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION |
AAMI ST21 | BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES IN HEALTH CARE FACILITIES |
AAMI ST24 | AUTOMATIC, GENERAL PURPOSE ETHYLENE OXIDE STERILIZERS AND EO STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES |
AAMI ST27 | GUIDELINE FOR INDUSTRIAL ETHYLENE OXIDE STERILIZATION OF MEDICAL DEVICES |
AAMI ST29 | RECOMMENDED PRACTICE FOR DETERMINING RESIDUAL ETHYLENE OXIDE IN MEDICAL DEVICES |
AAMI ST30 | DETERMINING RESIDUAL ETHYLENE CHLOROHYDRIN AND ETHYLENE GLYCOL IN MEDICAL DEVICES |
AAMI ST32 | GUIDELINES FOR GAMMA RADIATION STERILIZATION |
AAMI ST33 | GUIDELINES FOR THE SELECTION AND USE OF REUSABLE RIGID STERILIZATION CONTAINER SYSTEMS FOR ETHYLENE OXIDE STERILIZATION AND STEAM STERILIZATION IN HEALTH CARE FACILITIES |
AAMI ST34 | GUIDELINE FOR THE USE OF ETHYLENE OXIDE AND STEAM BIOLOGICAL INDICATORS IN INDUSTRIAL STERILIZATION PROCESSES |
AAMI ST35 | GOOD HOSPITAL PRACTICE: SAFE HANDLING AND BIOLOGICAL DECONTAMINATION OF MEDICAL DEVICES IN HEALTH CARE FACILITES AND IN NONCLINICAL SETTINGS. |
AAMI ST37 | FLASH STERILIZATION - STEAM STERILIZATION OF PATIENT CARE ITEMS FOR IMMEDIATE USE |
AAMI ST40 | TABLE-TOP DRY HEAT (HEATED AIR) STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
AAMI ST41 | ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS |
AAMI ST42 | STEAM STERILIZATION AND STERILITY ASSURANCE USING TABLE-TOP STERILIZERS IN OFFICE-BASED, AMBULATORY-CARE MEDICAL, SURGICAL. AND DENTAL FACILITIES |
AAMI ST43 | GOOD HOSPITAL PRACTICE: ETHYLENE OXIDE GAS - VENTILATION RECOMMENDATIONS AND SAFE USE |
AAMI ST44 | BIER/EO GAS VESSELS |
AAMI ST45 | BIER/STEAM VESSELS *** THIS PUBLICATION IS NOW INCLUDED IN THE 2002 EDITION OF THE AAMI ST44 *** |
AAMI ST46 | STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
AAMI ST50 | DRY HEAT (HEATED AIR) STERILIZERS |
AAMI ST55 | TABLE-TOP STEAM STERILIZERS |
AAMI ST58 | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE 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 |
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 |
AAMI ST65 | PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES |
AAMI ST66 | STERILIZATION OF HEALTHCARE PRODUCTS - CHEMICAL INDICATORS - PART 2 : CLASS 2 INDICATORS FOR AIR REMOVAL TEST SHEETS AND PACKS |
AAMI ST67 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR PRODUCTS LABELED 'STERILE' |
AAMI ST72 | BACTERIAL ENDOTOXIN - TEST METHODOLOGIES, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING |
AAMI ST77 | CONTAINMENT DEVICES FOR REUSABLE MEDICAL DEVICE STERILZATION |
AAMI ST79 | COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES |
AAMI ST8 | HOSPITAL STEAM STERILIZERS |
AAMI ST81 | STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE PROCESSING OF RESTERILIZABLE MEDICAL DEVICES |
AAMI STBK04-3 | STERILIZATION, PART 3: INDUSTRIAL PROCESS CONTROL |
AAMI STBK5 | STANDARDS AND RECOMMENDED PRACTICES - STERILIZATION |
AAMI STBK6 | STANDARDS AND RECOMMENDED PRACTICES - STERILIZATION *******VOLUMES 1 & 2 SOLD SEPARATELY SEE AAMI STBK6-1 AND 2******* |
AAMI STBK6-1 | PART 1: STERILIZATION IN HEALTH CARE FACILITIES |
AAMI STBK6-2 | PART 2: STERILIZATION EQUIPMENT |
AAMI STBK6-3 | STERILIZATION PART 3: INDUSTRIAL PROCESS CONTROL |
AAMI STBK6-S | AAMI STANDARDS AND RECOMMENDED PRACTICES - STERILIZATION THREE BOOK SET |
AAMI STBK8-1 | STERILIZATION IN HEALTH CARE FACILITIES |
AAMI STBK8-2 | STERILIZATION EQUIPMENT |
AAMI STBK8-3 | INDUSTRIAL PROCESS CONTROL |
AAMI STBK8-S | STANDARDS AND RECOMMENDED PRACTICES |
AAMI STBK9-1 | PART 1: STERILIZATION IN HEALTH CARE FACILITIES |
AAMI STBK9-2 | PART 2: STERILIZATION EQUIPMENT |
AAMI STBK9-3 | PART 3: INDUSTRIAL PROCESS CONTROL |
AAMI STBK9-S | STANDARDS AND RECOMMENDED PRACTICES - STERILIZATION PART 1 HEALTH CARE FACILITIES, PART 2 EQUIPMENT PART 3 PROCESS CONTROL |
AAMI STBKCD | AAMI STANDARDS ON CD - STERILIZATION EDITION |
AAMI STBKCDXL | STERILIZATION STANDARDS MULTIMEDIA SET - ALL 3 BOOKS, PART1, 2 AND 3 - PLUS CDROM |
AAMI SW68 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES 1ED. |
AAMI SYMBOLS | MEDICAL EQUIPMENT SYMBOLS AND SAFETY SIGNS - CLIP ART CD (640 STANDARDIZED GRAPHICAL SYMBOLS) |
AAMI TAR2 | ISSUES IN HEMODIALYSIS - SYSTEM PERFORMANCE WATER PURITY AND TREATMENT COST REIMBURSEMENT AND REGULATION |
AAMI TIR 13409 | STERILIZATION OF HEALTH CARE PRODUCTS RADIATION STERILIZATION SUBSTANTIATION OF 25 GY AS A STERILIZATION DOSE FOR SMALL OR INFREQUENT PRODUCTION BATCHES |
AAMI TIR11 | SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES |
AAMI TIR11139 | STERILIZATION OF HEALTH CARE PRODUCTS - VOCABULARY |
AAMI TIR12 | DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR DEVICE MANUFACTURERS |
AAMI TIR13 | PRINCIPLES OF INDUSTRIAL MOIST HEAT STERILIZATION |
AAMI TIR14 | CONTRACT STERILIZATION FOR ETHYLENE OXIDE |
AAMI TIR15 | ETHYLENE OXIDE STERILIZATION EQUIPMENT, PROCESS CONSIDERATIONS, AND PERTINENT CALCULATIONS |
AAMI TIR16 | PROCESS DEVELOPMENT AND PERFORMANCE QUALIFICATION FOR ETHYLENE OXIDE STERILIZATION - MICROBIOLOGICAL ASPECTS |
AAMI TIR16142 | GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
AAMI TIR17 | RADIATION STERILIZATION MATERIAL QUALIFICATION |
AAMI TIR18 | GUIDANCE ON ELECTROMAGNETIC COMPATIBILITY OF MEDICAL DEVICES FOR CLINICAL / BIOMEDICAL ENGINEERS - PART 1: RADIATED RADIO-FREQUENCYELECTROMAGNETIC ENERGY |
AAMI TIR19 | GUIDANCE FOR ANSI/AAMI/ISO 10993-7:1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
AAMI TIR20 | PARAMETRIC RELEASE FOR ETHYLENE OXIDE STERILIZATION |
AAMI TIR21 | SYSTEMS USED TO FORECAST REMAINING PACEMAKER BATTERY SERVICE LIFE |
AAMI TIR22 | GUIDANCE FOR ANSI/AAMI/ISO 11607, PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1 AND PART 2:2006 |
AAMI TIR23 | SIGNAL AVERAGING |
AAMI TIR24 | ACQUISITION AND USE OF PHYSIOLOGIC WAVEFORM DATABASES FOR TESTING OF MEDICAL DEVICES |
AAMI TIR25 | CHEMICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
AAMI TIR26 | VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS |
AAMI TIR27 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION SUBSTANTIATION OF 25KGY AS A STERILIZATION DOSE METHOD VD MAX *** NO LONGER AVAILABLE *** |
AAMI TIR28 | PRODUCT ADOPTION AND PROCESS EQUIVALENCY FOR ETHYLENE OXIDE STERILIZATION |
AAMI TIR29 | GUIDE FOR PROCESS CONTROL IN RADIATION STERILIZATION |
AAMI TIR30 | A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES |
AAMI TIR31 | PROCESS CHALLENGE DEVICES/TEST PACKS FOR USE IN HEALTH CARD FACILITIES |
AAMI TIR32 | MEDICAL DEVICE SOFTWARE RISH MANAGEMENT |
AAMI TIR33 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - SUBSTANTIATION OF A SELECTED STERILIZATION DOSE - METHOD VDMAX (REPLACES AAMI TIR27) |
AAMI TIR34 | WATER FOR THE REPROCESSING OF MEDICAL DEVICES |
AAMI TIR35 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION STERILIZATION - ALTERNATIVE SAMPLING PLANS FOR VERIFICATION DOSE EXPERIMENTS AND STERILIZATION DOSE AUDITS |
AAMI TIR37 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF HUMAN TISSUE-BASED PRODUCTS |
AAMI TIR4 | APNEA MONITORING BY MEANS OF THORACIC IMPEDANCE PNEUMOGRAPHY |
AAMI TIR7 | CHEMICAL STERILANTS AND HIGH-LEVEL DISINFECTANTS: A GUIDE TO SELECTION AND USE |
AAMI TIR8 | MICROBIOLOGICAL METHODS FOR GAMMA IRRADIATION STERELIZATION OF MEDICAL DEVICES |
AAMI TIR9 | EVALUATION OF CLINICAL SYSTEMS FOR INVASIVE BLOOD PRESSURE MONITORING |
AAMI VP20 | CARDIOVASCULAR IMPLANTS - VASCULAR GRAFT PROSTHESES |
AAMI WQD | WATER QUALITY FOR DIALYSIS: CURRENT CONCEPTS IN HEMODIALYZER REPROCESSING |
AAMI/ISO 10993-11 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 11: TESTS FOR SYSTEMIC TOXICITY |
AAMI/ISO 10993-14 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS |
AAMI/ISO 10993-15 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATIONAND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
AAMI/ISO 10993-2 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 2: ANIMAL WELFARE REQUIREMENTS |
AAMI/ISO 10993-7 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDESTERILIZATION RESIDUALS |
AAMI/ISO 11134 | STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION |
AAMI/ISO 11135 | MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATON |
AAMI/ISO 11137-2 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
AAMI/ISO 11607 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES ***** X-REF ANSI/AAMI/ISO 11607-1 AND ANSI/AAMI/ISO 11607-2 |
AAMI/ISO 11737-1 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: DETERMINATION OF A POPULATION OF MICROORGANISMS ON PRODUCTS |
AAMI/ISO 14971 | MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (SAME AS ISO/IEC 14971 ED3) |
AAMI/ISO 15225 | NOMENCLATURE - SPECIFICATION FOA A NOMENCLATURE SYSTEM FOR MEDICALDEVICES FOR THE PURPOSE OF REGULATORY DATA EXCHANGE |
AAMI/ISO 5840 | CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES |
ANSI/AAMI/IEC 60601-1-2 | |
ANSI/AAMI/IEC 60601-2-2 | |
ANSI/AAMI/IEC 60601-2-50 | |
ANSI/AAMI/IEC 60601-21 | MEDICAL ELECTRICAL EQUIPMENT, PART 2: PARTICULAR REQUIREMENTS FOR THE SAFETY OF INFANT RADIANT WARMERS |
ANSI/AAMI/IEC 62304 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE CYCLE PROCESSES |
ANSI/AAMI/IEC TIR 62296 | CONSIDERATIONS OF UNADDRESSED SAFETY ASPECTS IN THE SECOND EDITIONOF IEC 60601-1 AND PROPOSALS FOR NEW REQUIREMENTS |
ANSI/AAMI/IEC TIR 62348 | MAPPING BETWEEN THE CLAUSES OF THE THIRD EDITION OF IEC 60601-1 AND THE 1988 EDITION AS AMENDED |
ANSI/AAMI/IEC TIR60878 | GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE |
ANSI/AAMI/ISO 10993-10 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 11: TESTS FOR SYSTEMIC TOXICITY |
ANSI/AAMI/ISO 10993-4 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 4: SELECTION OF TESTS FOR INTERACTIONS WITH BLOOD |
ANSI/AAMI/ISO 10993-5 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 5: TEST FOR IN VITRO CYTOTOXICITY |
ANSI/AAMI/ISO 10993-7 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 7: ETHYLENE OXIDE STERILIATION RESIDUALS |
ANSI/AAMI/ISO 10993-8 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS (SAME AS ISO 10993-8: 2000) |
ANSI/AAMI/ISO 10993-9 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES, PART 9: FRAMEWORK FOR IDENTIFICATION AND QUALIFICATION |
ANSI/AAMI/ISO 11135 | MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
ANSI/AAMI/ISO 11135-1 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF STERILIZATION PROCESS FOR MEDICAL DEVICES |
ANSI/AAMI/ISO 11137 | STERILIZATION OF HEALTH CARE PRODUCTS - VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION ***ALSO S/S BY ANSI/AAMI/ISO 11137-2 AND ANSI/AAMI/ISO 11137-3*** |
ANSI/AAMI/ISO 11137-1 | STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
ANSI/AAMI/ISO 11137-2 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 2: ESTABLISHING THE STERILIZATION DOSE |
ANSI/AAMI/ISO 11137-3 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3. GUIDANCE ON DOSIMETRIC ASPECTS |
ANSI/AAMI/ISO 11138-1 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
ANSI/AAMI/ISO 11138-2 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES |
ANSI/AAMI/ISO 11138-3 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 3: BIOLOGICAL INDICATORS FOR MOIST HEAT STERILIZATION PROCESSES |
ANSI/AAMI/ISO 11138-4 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT STERILIZTION PROCESSES |
ANSI/AAMI/ISO 11138-5 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES |
ANSI/AAMI/ISO 11140-1 | |
ANSI/AAMI/ISO 11140-3 | |
ANSI/AAMI/ISO 11140-4 | STANDARD FOR HAND-HELD MOTOR-OPERATED ELECTRIC TOOLS - SAFETY - PART 1: GENERAL REQUIREMENTS |
ANSI/AAMI/ISO 11140-5 | STANDARD FOR HAND-HELD MOTOR-OPERATED ELECTRIC TOOLS - SAFETY - PART 1: GENERAL REQUIREMENTS |
ANSI/AAMI/ISO 11607 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES |
ANSI/AAMI/ISO 11607-1 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING |
ANSI/AAMI/ISO 11607-2 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESS |
ANSI/AAMI/ISO 11737-1 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 1: ESTIMATION OF THE POPULATION |
ANSI/AAMI/ISO 11737-2 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE VALIDATION OF STERILIZATIONPROCESS |
ANSI/AAMI/ISO 11737-3 | STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 3: GUIDANCE ON EVALUATION AND INTERPRETATION OF BIOBURDEN DATA |
ANSI/AAMI/ISO 13485 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
ANSI/AAMI/ISO 13488 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9002 |
ANSI/AAMI/ISO 14155-1 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
ANSI/AAMI/ISO 14155-2 | CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
ANSI/AAMI/ISO 14160 | STERILIZATION OF SINGLE-USE MEDICAL DEVICES INCORPORATING MATERIALS OF ANIMAL ORIGIN-VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY LIQUID CHEMICAL STERILANTS |
ANSI/AAMI/ISO 14161 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE AND INTERPRETATION OF RESULTS |
ANSI/AAMI/ISO 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 |
ANSI/AAMI/ISO 14971 | |
ANSI/AAMI/ISO 15674 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - HARD SHELL CARDIOTOMY/VENOUS RESERVOIR SYSTEMS (WITH/WITHOUT FILTER) AND SOFTVENOUS RESERVOIR BAGS |
ANSI/AAMI/ISO 15675 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - CARDIOPULMONARY BYPASS SYSTEMS - ARTERIAL BLOOD LINE FILTERS |
ANSI/AAMI/ISO 15882 | CHEMICAL INDICATORS - GUIDANCE ON THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
ANSI/AAMI/ISO 22442-1 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 1: APPLICATION OF RISK MANAGEMENT |
ANSI/AAMI/ISO 22442-2 | MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING |
ANSI/AAMI/ISO 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 (TSI) AGENTS |
ANSI/AAMI/ISO 25539-1 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES |
ANSI/AAMI/ISO 7198 | CARDIOVASCULAR IMPLANTS - TUBUAL VASCULAR PROSTHESES |
ANSI/AAMI/ISO 7199 | CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - BLOOD-GAS EXCHANGERS (OXYGENATORS) |
ANSI/AAMI/ISO TIR 11139 | STERILIZATION OF HEALTH CARE PRODUCTS--VOCABULARY |
ANSI/AAMI/ISO TIR 15843 | 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 |
ANSI/AAMI/ISO TIR 16142 | MEDICAL DEVICES - GUIDANCE ON THE SELECTION OF STANDARDS IN SUPPORT OF RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES |
ANSI/AAMI/ISO TIR 19218 | MEDICAL DEVICES - CODING STRUCTURE FOR ADVERSE EVENT TYPE AND CAUSE |
ANSI/AAMI/ISO TIR10993-19 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 19: PHYSICO-CHEMICAL, MORPHOLOGICAL AND TOPOGRAPHICAL CHARACTERIZATIONOF MATERIALS |
ANSI/AAMI/ISO TIR10993-20 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 20: PRINCIPLES AND METHODS FOR IMMUNOTOXICOLOGY TESTING OF MEDICAL DEVICES |
ANSI/AAMI/ISO TIR14969 | MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE FOR THE APPLICATION OF ISO 13485:2003 |
