• CFR 21(PTS800-1299) : 0

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299

    Available format(s):  Hardcopy

    Superseded date:  21-11-2019

    Language(s):  English

    Published date: 

    Publisher:  Code of Federal Regulations

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    Table of Contents - (Show below) - (Hide below)

    Part 800 - General
    Part 801 - Labeling
    Part 803 - Medical device reporting
    Part 806 - Medical devices; reports of corrections and removals
    Part 807 - Establishment registration and device listing for
                manufacturers and initial importers of devices
    Part 808 - Exemptions from Federal preemption of State and local
                medical device requirements
    Part 809 - In vitro diagnostic products for human use
    Part 810 - Medical device recall authority
    Part 812 - Investigational device exemptions
    Part 813 - [Reserved]
    Part 814 - Premarket approval of medical devices
    Part 820 - Quality system regulation
    Part 821 - Medical device tracking requirements
    Part 822 - Postmarket surveillance
    Part 860 - Medical device classification procedures
    Part 861 - Procedures for performance standards development
    Part 862 - Clinical chemistry and clinical toxicology devices
    Part 864 - Hematology and pathology devices
    Part 866 - Immunology and microbiology devices
    Part 868 - Anesthesiology devices
    Part 870 - Cardiovascular devices
    Part 872 - Dental devices
    Part 874 - Ear, nose, and throat devices
    Part 876 - Gastroenterology-urology devices
    Part 878 - General and plastic surgery devices
    Part 880 - General hospital and personal use devices
    Part 882 - Neurological devices
    Part 884 - Obstetrical and gynecological devices
    Part 886 - Ophthalmic devices
    Part 888 - Orthopedic devices
    Part 890 - Physical medicine devices
    Part 892 - Radiology devices
    Part 895 - Banned devices
    Part 898 - Performance standard for electrode lead wires and
                patient cables
    Part 900 - Mammography
    Part 1000 - General
    Part 1002 - Records and reports
    Part 1003 - Notification of defects or failure to comply
    Part 1004 - Repurchase, repairs, or replacement of electronic
                products
    Part 1005 - Importation of electronic products
    Part 1010 - Performance standards for electronic products: General
    Part 1020 - Performance standards for ionizing radiation emitting
                products
    Part 1030 - Performance standards for microwave and radio frequency
                emitting products
    Part 1040 - Performance standards for light-emitting products
    Part 1050 - Performance standards for sonic, infrasonic, and ultrasonic
                radiation-emitting products
    Part 1210 - Regulations under the Federal Import Milk Act
    Part 1230 - Regulations under the Federal Caustic Poison Act
    Part 1240 - Control of communicable diseases
    Part 1250 - Interstate conveyance sanitation
    Part 1251-1269 - [Reserved]
    Part 1270 - Human tissue intended for transplantation
    Part 1271 - Human cells, tissues, and cellular and tissue-based
                products
    Part 1272-1299 - [Reserved]

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher Code of Federal Regulations
    Status Superseded
    Superseded By

    Standards Referenced By This Book - (Show below) - (Hide below)

    ANSI Z80.27 : 2014 OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES
    DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
    AAMI SW87 : 2012 APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS
    ANSI INCITS 338 : 2003 HIGH-PERFORMANCE PARALLEL INTERFACE - 6400 MBIT/S OPTICAL SPECIFICATION (HIPPI-6400-OPT)
    AAMI ST65 : 2008 : R2013 PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    ISO/TR 27809:2007 Health informatics Measures for ensuring patient safety of health software
    ASTM F 2407 : 2006 : R2013 : EDT 1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    PREN ISO 80601-2-61 : DRAFT 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    UNI EN ISO 80601-2-61 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    13/30275206 DC : 0 BS ISO 5841-2 - IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS
    ASTM F 2394 : 2007 : R2017 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
    BS EN 62148-17:2014 Fibre optic active components and devices. Package and interface standards Transmitter and receiver components with dual coaxial RF connectors
    AAMI TIR59:2017 INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS
    BS EN 61223-3-2:2008 Evaluation and routine testing in medical imaging departments Acceptance tests. Imaging performance of mammographic X-ray equipment
    ASTM F 2665 : 2009 Standard Specification for Total Ankle Replacement Prosthesis
    CSA Z9919 : 2007 : R2012 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    ASTM F 2038 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    CAN/CSA-Z900.2.1-17 Tissues for assisted reproduction
    CSA C22.2 No. 61010.1 : 2012 : INC : UPD 2 :2016 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
    S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    AAMI ST24 : 1999 : R2013 AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
    AAMI AT6 : 2013 AUTOLOGOUS TRANSFUSION DEVICES
    BS EN ISO 80601-2-61:2011 Medical electrical equipment Particular requirements for basic safety and essential performance of pulse oximeter equipment
    ISO 18362:2016 Manufacture of cell-based health care products Control of microbial risks during processing
    ASTM F 1185 : 2003 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    AAMI TIR38 : 2015 MEDICAL DEVICE SAFETY ASSURANCE CASE REPORT GUIDANCE
    ASTM G 175 : 2013 : REDLINE Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Pressure Regulators Used for Medical and Emergency Applications
    ASTM E 2641 : 2009 : R2017 Standard Practice for Best Practices for Safe Application of 3D Imaging Technology
    AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
    CSA C22.2 No. 60601.2.43 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    ASTM F 2038 : 2000 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    ASTM F 1538 : 2003 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
    ASTM F 1185 : 2003 : R2014 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM F 754 : 2008 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
    ASTM E 1000 : 2016 : REDLINE Standard Guide for Radioscopy
    ASTM E 1741 : 2000 Standard Practice for Preparation of Airborne Particulate Lead Samples Collected During Abatement and Construction Activities for Subsequent Analysis by Atomic Spectrometry (Withdrawn 2009)
    ASTM D 5258 : 2002 : R2007 Standard Practice for Acid-Extraction of Elements from Sediments Using Closed Vessel Microwave Heating
    ASTM F 1538 : 2003 : R2009 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
    ASTM D 5258 : 2002 : R2013 Standard Practice for Acid-Extraction of Elements from Sediments Using Closed Vessel Microwave Heating
    ASTM F 3089 : 2014 Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
    CSA C22.2 No. 61010.1 : 2012 : INC : UPD 1 :2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    ASTM E 94 : 2004 : R2010 Standard Guide for Radiographic Examination
    ASTM F 2900 : 2011 Standard Guide for Characterization of Hydrogels used in Regenerative Medicine (Withdrawn 2020)
    ASTM F 1925 : 2017 : REDLINE Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    ASTM E 1647 : 2016 : REDLINE Standard Practice for Determining Contrast Sensitivity in Radiology
    NFPA 30 : 2018 FLAMMABLE AND COMBUSTIBLE LIQUIDS CODE
    CSA C22.2 No. 62368-1 : 2014 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS
    BS EN ISO 14630:2012 Non-active surgical implants. General requirements
    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
    I.S. EN 61223-2-6:2007 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 2-6: CONSTANCY TESTS - IMAGING PERFORMANCE OF COMPUTED TOMOGRAPHY X-RAY EQUIPMENT
    EN 62148-17:2014 Fiber optic active components and devices - Package and interface standards - Part 17: Transmitter and receiver components with dual coaxial RF connectors
    CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
    AAMI TIR26 : 2000 VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS
    NSF 341 : 2012 HEALTH/FITNESS FACILITIES
    ISEA Z308.1 : 2015 MINIMUM REQUIREMENTS FOR WORKPLACE FIRST AID KITS AND SUPPLIES
    12/30251292 DC BS ISO/ASTM 51261. Practice for calibration of routine dosimetry systems for radiation processing
    SAE ARP 5560 : 2014 SAFETY CONSIDERATIONS FOR HIGH-INTENSITY LIGHTS (HIL) DIRECTED INTO THE NAVIGABLE AIRSPACE
    ANSI/AAMI/IEC 60601-1-2:2014 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS
    14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
    11/30246243 DC : 0 BS EN 62148-17 - FIBRE OPTIC ACTIVE COMPONENTS AND DEVICES - PACKAGE AND INTERFACE STANDARDS - PART 17: TRANSMITTER AND RECEIVER COMPONENTS WITH DUAL COAXIAL RF CONNECTORS
    DIN ISO 13022 E : 2014 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    AAMI TIR52 : 2014(R2017) ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    BS EN 60601-2-44 : 2009 MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (IEC 60601-2-44:2009)
    ANSI Z80.11:2012 OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
    ASTM F 3225 : 2017 Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
    ASTM F 1185 : 2003 : R2009 Standard Specification for Composition of Hydroxylapatite for Surgical Implants
    ASTM F 1581 : 2008 : R2012 Standard Specification for Composition of Anorganic Bone for Surgical Implants
    CSA C22.2 No. 61010.1 : 2012 : INC : UPD 1 : 2015 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    ASTM F 882 : 1984 : R2002 Standard Performance and Safety Specification for Cryosurgical Medical Instruments (Withdrawn 2011)
    BS EN 60601-2-43:2010 Medical electrical equipment Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
    ANSI/AAMI ST55:2016 TABLE-TOP STEAM STERILIZERS
    09/30181956 DC : DRAFT MAY 2009 BS ISO 80601-2-61 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    ASTM F 2042 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    BS PAS 84(2008) : 2008 REGENERATIVE MEDICINE - GLOSSARY
    SAE AS 8056 : 2004(R2016) MINIMUM DESIGN AND PERFORMANCE OF AIRPLANE GALLEY IN-FLIGHT CARTS, CONTAINERS, AND ASSOCIATED COMPONENTS
    AAMI TIR67 : 2018 PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES
    AAMI ST72 : 2011 : R2016 BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
    ASTM F 2042 : 2000 : EDT 1 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    ASTM F 1672 : 2014 : REDLINE Standard Specification for Resurfacing Patellar Prosthesis
    ASTM F 2529 : 2013 Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
    CSA C22.2 No. 61010.1 : 2012 : FR SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    ISO 5841-2:2014 Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads
    AAMI ST24 : 1999 : R2005 AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
    AAMI TIR45 : 2012 GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE
    ARINC 805 : 2014 FIBER OPTIC TEST PROCEDURES
    ASTM F 881 : 1994 : R2000 Standard Specification for Silicone Elastomer Facial Implants
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    ASTM E 2641 : 2009 Standard Practice for Best Practices for Safe Application of 3D Imaging Technology
    ASTM F 2150 : 2013 : REDLINE Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products
    ASTM F 2407 : 2006 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    ASTM F 2887 : 2017 : REDLINE Standard Specification for Total Elbow Prostheses
    ASTM F 2224 : 2009 : R2014 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    ASTM F 2383 : 2011 : REDLINE Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)
    ASTM F 754 : 2008 : R2015 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders
    ASTM F 2394 : 2007 : R2013 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
    ASTM F 1609 : 2008 : R2014 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
    ASTM F 1609 : 2008 Standard Specification for Calcium Phosphate Coatings for Implantable Materials
    ASTM F 1581 : 2008 : R2016 Standard Specification for Composition of Anorganic Bone for Surgical Implants
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    ISO/TR 18112:2006 Clinical laboratory testing and in vitro diagnostic test systems In vitro diagnostic medical devices for professional use Summary of regulatory requirements for information supplied by the manufacturer
    SCTE 186 : 2016 PRODUCT ENVIRONMENTAL REQUIREMENTS FOR CABLE TELECOMMUNICATIONS
    Z462-18 Workplace electrical safety
    ANSI/AAMI ST79:2017 COMPREHENSIVE GUIDE TO STEAM STERILIZATION AND STERILITY ASSURANCE IN HEALTH CARE FACILITIES
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    NEMA XR 31:2016 Standard Attributes on X-ray Equipment for Interventional Procedures
    NEMA/MITA 1:2015 Good Refurbishment Practices for Medical Imaging Equipment
    NFPA 1999 : 2018 PROTECTIVE CLOTHING AND ENSEMBLES FOR EMERGENCY MEDICAL OPERATIONS
    MIL-HDBK-516 Revision C:2014 AIRWORTHINESS CERTIFICATION CRITERIA
    SAE ARP 5293 : 2010 SAFETY CONSIDERATIONS FOR LASERS PROJECTED IN THE NAVIGABLE AIRSPACE
    I.S. EN ISO 9919:2009 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
    AAMI TIR36 : 2007 VALIDATION OF SOFTWARE FOR REGULATED PROCESSES
    AAMI TIR72 : 2017 DIALYSIS FLUID CHEMICAL COMPOSITION
    ANSI/AAMI EQ56:2013 RECOMMENDED PRACTICES FOR A MEDICAL EQUIPMENT MANAGEMENT PROGRAM
    ANSI/AAMI NS4:2013(R2017) TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS
    AAMI ST24 : 1999 : R2009 AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
    BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
    ASTM F 2312 : 2011 : REDLINE Standard Terminology Relating to Tissue Engineered Medical Products
    CSA C22.2 No. 61010.1 :2012 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    ANSI/AAMI EQ89:2015 GUIDANCE FOR THE USE OF MEDICAL EQUIPMENT MAINTENANCE STRATEGIES AND PROCEDURES
    AAMI ST72 : 2011 BACTERIAL ENDOTOXIN - TEST METHODS, ROUTINE MONITORING AND ALTERNATIVES TO BATCH TESTING
    AAMI TIR50 : 2014 POST-MARKET SURVEILLANCE OF USE ERROR MANAGEMENT
    CSA Z9919 :2007 MEDICAL ELECTRICAL EQUIPMENT - PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT FOR MEDICAL USE
    DIN ISO 13022:2014-06 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES (ISO 13022:2012)
    SAE ARP 5873 : 2015 LED PASSENGER READING LIGHT ASSEMBLY
    AAMI ISO 5841-2 : 2014 IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS
    ANSI/AAMI PB70:2012 LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES
    AAMI TIR48 : 2015 QUALITY MANAGEMENT SYSTEM (QMS) RECOMMENDATIONS ON THE APPLICATION OF THE U.S. FDAS CGMP FINAL RULE ON COMBINATION PRODUCTS
    AAMI ST65 : 2008 PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    AAMI ST24:1999(R2018) AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
    CEN/TR 15640:2007 Health informatics - Measures for ensuring the patient safety of health software
    EN 60601-2-43:2010/A1:2018 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES (IEC 60601-2-43:2010/A1:2017)
    ASTM E 2981 : 2015 Standard Guide for Nondestructive Testing of the Composite Overwraps in Filament Wound Pressure Vessels Used in Aerospace Applications
    ASTM D 5258 : 2002 Standard Practice for Acid-Extraction of Elements from Sediments Using Closed Vessel Microwave Heating
    SAE ARP 5674 : 2012 SAFETY CONSIDERATIONS FOR AIRCRAFT-MOUNTED LASERS PROJECTED INTO THE NAVIGABLE AIRSPACE
    ASTM F 2903 : 2011 Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020)
    ASTM F 2212 : 2011 : REDLINE Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
    ASTM E 2662 : 2015 : REDLINE Standard Practice for Radiographic Examination of Flat Panel Composites and Sandwich Core Materials Used in Aerospace Applications
    ASTM F 881 : 1994 : R2006 Standard Specification for Silicone Elastomer Facial Implants
    ASTM E 94 : 2004 Standard Guide for Radiographic Examination
    CAN/CSA-C22.2 NO. 61010-1-12 (R2017) Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements (Tri-national standard, with UL 61010-1 and ANSI/ISA-61010-1 (82.02.01)
    ASTM F 2042 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
    EN ISO 80601-2-61:2011 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (ISO 80601-2-61:2011)
    I.S. EN 61223-3-2:2008 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
    IEC 62368-1:2014 Audio/video, information and communication technology equipment - Part 1: Safety requirements
    BS EN ISO 9919:2009 Medical electrical equipment. Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    IEC 61223-3-2:2007 Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
    CSA C22.2 No. 60950-1 :2007 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS
    CSA C22.2 No. 60950-1 : 2007 : INC : AMD 1 : 2011 : R2012 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS
    ISA 61010-1 : 2008 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    NASA STD 8719.24 : 2011 NASA EXPENDABLE LAUNCH VEHICLE PAYLOAD SAFETY REQUIREMENTS
    CSA C22.2 No. 60950-1 : 2007 : INC : AMD 2 : 2014 : R201200 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS
    CSA C22.2 No. 60950-1 : 2007 : R2012 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS
    CSA C22.2 No. 60950-1 : 2007 : INC : UPD 1 : 2011 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS
    CSA C22.2 No. 60950-1 : 2007 : INC : AMD 2 : 2014 : R2016 INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS
    MIL-HDBK-454 Revision B:2007 GENERAL GUIDELINES FOR ELECTRONIC EQUIPMENT
    EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    EN ISO 9919:2009 Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005)
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    NSF T-BUTANOL : 2003 T-BUTANOL
    ASTM F 2394 : 2007 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
    UNE-EN 60601-2-44:2010 Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
    BS ISO 5841-2:2014 Implants for surgery. Cardiac pacemakers Reporting of clinical performance of populations of pulse generators or leads
    CLSI MM14 A : 1ED 2005 PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS
    12/30239867 DC : 0 BS EN 62368-1 - AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS
    PD ISO/TR 27809:2007 Health informatics. Measures for ensuring patient safety of health software
    AAMI BF64 : 2012 LEUKOCYTE REDUCTION FILTERS
    PD IEC/PAS 63077:2016 Good refurbishment practices for medical imaging equipment
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