• 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  21-11-2019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)

    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
    NFPA 1999 : 2018 PROTECTIVE CLOTHING AND ENSEMBLES FOR EMERGENCY MEDICAL OPERATIONS
    ASTM F 2394 : 2007 Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
    AAMI ST91 : 2015 FLEXIBLE AND SEMI-RIGID ENDOSCOPE PROCESSING IN HEALTH CARE FACILITIES
    AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
    MIL HDBK 516 : C AIRWORTHINESS CERTIFICATION CRITERIA
    BS ISO 5841-2 : 2014 IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS
    AAMI SW87 : 2012 APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS
    NSF 341 : 2012 HEALTH/FITNESS FACILITIES
    CLSI MM14 A : 1ED 2005 PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS
    SAE ARP 5293 : 2010 SAFETY CONSIDERATIONS FOR LASERS PROJECTED IN THE NAVIGABLE AIRSPACE
    ISEA Z308.1 : 2015 MINIMUM REQUIREMENTS FOR WORKPLACE FIRST AID KITS AND SUPPLIES
    12/30251292 DC : 0 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 INCITS 338 : 2003 HIGH-PERFORMANCE PARALLEL INTERFACE - 6400 MBIT/S OPTICAL SPECIFICATION (HIPPI-6400-OPT)
    ASTM E 2941 : 2014 : REDLINE Standard Practices for Extraction of Elements from Ores and Related Metallurgical Materials by Acid Digestion
    CSA C22.2 No. 80601-2-61 : 2014(R2019) MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    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
    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
    ASME PVHO 1 : 2016 SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY
    AAMI TIR36 : 2007 VALIDATION OF SOFTWARE FOR REGULATED PROCESSES
    AAMI TIR72 : 2017 DIALYSIS FLUID CHEMICAL COMPOSITION
    ASTM F 2407 : 2006 : R2013 : EDT 1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
    FAA AC 20-183 : 2014 LASER AIRWORTHINESS INSTALLATION GUIDANCE
    AAMI TIR16 : 2017 MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    ASTM F 1441 : 2003 Standard Specification for Soft-Tissue Expander Devices
    S.R. CEN TR 15640:2007 HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
    10/30203224 DC : 0 BS ISO 13022 - MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
    BS PD IEC PAS 63077 : 2016 GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT
    DI TCSP 82040 : 0 RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
    ANSI N42.46 : 2008 DETERMINATION OF THE IMAGING PERFORMANCE OF X-RAY AND GAMMA-RAY SYSTEMS FOR CARGO AND VEHICLE SECURITY SCREENING
    AAMI EQ56 : 2013 RECOMMENDED PRACTICES FOR A MEDICAL EQUIPMENT MANAGEMENT PROGRAM
    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
    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
    BS 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
    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)
    BS ISO 18362:2016 Manufacture of cell-based health care products. Control of microbial risks during processing
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    BS PD CEN/TR 15640 : 2007 HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
    AAMI TIR14 : 2016 CONTRACT STERILIZATION USING ETHYLENE OXIDE
    BS ISO 18190:2016 (published 2016-10) Anaesthetic and respiratory equipment. General requirements for airways and related equipment
    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
    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
    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
    BS 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)
    SAE ARP 6253 : 2017 LEDS AND AIRCRAFT APPLICATIONS
    NFPA 115 : 2016 LASER FIRE PROTECTION
    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)
    AAMI ST58 : 2013(R2018) CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES
    MIL HDBK 828 : C RANGE LASER SAFETY
    AAMI NS4 :2013 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS
    AAMI ST90 : 2017 PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES
    ANSI N42.44 : 2008 PERFORMANCE OF CHECKPOINT CABINET X-RAY IMAGING SECURITY SYSTEMS
    I.S. 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)
    I.S. 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
    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)
    AAMI TIR37 : 2013 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS
    NEMA/MITA 1 : 2015 GOOD REFURBISHMENT PRACTICES FOR MEDICAL IMAGING EQUIPMENT
    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
    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
    NEMA XR 31 : 2016 STANDARD ATTRIBUTES ON X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    AAMI ST67 : 2011 : R2017 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
    AAMI TIR55 : 2014 HUMAN FACTORS ENGINEERING FOR PROCESSING MEDICAL DEVICES
    AAMI TIR52 : 2014 ENVIRONMENTAL MONITORING FOR TERMINALLY STERILIZED HEALTHCARE PRODUCTS
    CSA C22.2 No. 61010.1 :2012 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - PART 1: GENERAL REQUIREMENTS
    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 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 TIR59 : 2017 INTEGRATING HUMAN FACTORS INTO DESIGN CONTROLS
    BS 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
    AAMI ISO 13022 : 2012 MEDICAL PRODUCTS CONTAINING VIABLE HUMAN CELLS - APPLICATION OF RISK MANAGEMENT AND REQUIREMENTS FOR PROCESSING PRACTICES
    FAA AC 70-1 : 2004 OUTDOOR LASER OPERATIONS
    07/30166162 DC : 0 BS IEC 60601-2-44 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-44: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY
    ASTM E 94/E94M : 2017 : REDLINE Standard Guide for Radiographic Examination Using Industrial Radiographic Film
    AAMI TIR15 : 2016 PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
    UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
    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
    AAMI TIR67 : 2018 PROMOTING SAFE PRACTICES PERTAINING TO THE USE OF STERILANT AND DISINFECTANT CHEMICALS IN HEALTH CARE FACILITIES
    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
    C22.2 NO. 243-17 Vacuum cleaners, blower cleaners, and household floor finishing machines (Binational standard with UL 1017)
    ASTM D 5765 : 2016 : REDLINE Standard Practice for Solvent Extraction of Total Petroleum Hydrocarbons from Soils and Sediments Using Closed Vessel Microwave Heating
    AAMI TIR69 : 2017 RISK MANAGEMENT OF RADIO-FREQUENCY WIRELESS COEXISTENCE FOR MEDICAL DEVICES AND SYSTEMS
    AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ANSI Z80.11 : 2012 : R2017 OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
    ASME PTB 12 : 2017 GUIDELINES FOR ADDRESSING DATA GAPS AND RECORDKEEPING FOR ASME B31.4, B31.8 AND B31.8S FOR PIPELINE INTEGRITY MANAGEMENT
    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 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
    BS EN 62368-1 : 2014 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS
    AAMI HE75 : 2009(R2013) HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    SCTE 203 : 2014 PRODUCT ENVIRONMENTAL REQUIREMENTS FOR CABLE TELECOMMUNICATIONS FACILITIES - TEST METHODS
    ASTM F 2038 : 2000 : R2005 Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I - Formulations and Uncured Materials
    NFPA 1582 : 2018 COMPREHENSIVE OCCUPATIONAL MEDICAL PROGRAM FOR FIRE DEPARTMENTS
    ISO 5841-2:2014 Implants for surgery Cardiac pacemakers Part 2: Reporting of clinical performance of populations of pulse generators or leads
    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)
    AAMI HE75 : 2009 HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES
    IEEE 730 : 2014 SOFTWARE QUALITY ASSURANCE PROCESSES
    AAMI ISO 5841-2 : 2014 IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS
    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
    AAMI ST24 : 1999 : R2005 AUTOMATIC, GENERAL-PURPOSE ETHYLENE OXIDE STERILIZERS AND ETHYLENE OXIDE STERILANT SOURCES INTENDED FOR USE IN HEALTH CARE FACILITIES
    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 - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    AAMI QSR : 1996 QUALITY SYSTEM REGULATION (21 CFR PARTS 808, 812 AND 820) - OCTOBER 1996
    I.S. EN 62368-1:2014 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED)
    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
    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
    ISO 18190:2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment
    ASTM F 2091 : 2015 : REDLINE Standard Specification for Acetabular Prostheses
    FAA AC 25-10 : 0 GUIDANCE FOR INSTALLATION OF MISCELLANEOUS, NON-REQUIRED ELECTRICAL EQUIPMENT
    ASTM F 2027 : 2016 : REDLINE Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
    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
    I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    EN 62368-1:2014/AC:2017-03 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED)
    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 E 1570 : 2011 : REDLINE PRACTICE FOR COMPUTED TOMOGRAPHIC (CT) EXAMINATION
    SAE ARP 6161 : 2011 FLIGHT COMPARTMENT GLARE
    CAN/CSA C22.2 No. 60601.2.43 : 2011(R2016) MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    ASTM F 1441 : 2003 : R2009 Standard Specification for Soft-Tissue Expander Devices
    ASTM F 1538 : 2003 : R2017 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
    ASTM E 2698 : 2010 Standard Practice for Radiological Examination Using Digital Detector Arrays
    ASTM E 2982 : 2014 Standard Guide for Nondestructive Testing of Thin-Walled Metallic Liners in Filament-Wound Pressure Vessels Used in Aerospace Applications
    ASTM F 881 : 1994 : R2014 Standard Specification for Silicone Elastomer Facial Implants
    ASTM F 2038 : 2000 : R2011 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured Materials
    ASTM F 1781 : 2015 : REDLINE Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
    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 2224 : 2009 : R2014 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    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 F 1581 : 2008 : EDT 1 Standard Specification for Composition of Anorganic Bone for Surgical Implants
    ASTM F 1538 : 2003 : EDT 1 Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
    ASTM E 1255 : 2016 : REDLINE Standard Practice for Radioscopy
    ASTM F 1441 : 2003 : R2014 Standard Specification for Soft-Tissue Expander Devices
    ASTM F 2665 : 2009 : R2014 Standard Specification for Total Ankle Replacement Prosthesis
    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
    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 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
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    ASTM F 2224 : 2009 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
    ASTM F 1581:2008 Standard Specification for Composition of Anorganic Bone for Surgical Implants
    ASTM F 2042 : 2000 Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
    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
    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
    ANSI Z80.27 : 2014 OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES
    AAMI TIR26 : 2000 VENTRICULAR ASSIST AND HEART REPLACEMENT SYSTEMS
    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)
    I.S. EN ISO 80601-2-61:2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    NSF T-BUTANOL : 2003 T-BUTANOL
    ISO 13022:2012 Medical products containing viable human cells — Application of risk management and requirements for processing practices
    EN ISO 80601-2-61 : 2011 MEDICAL ELECTRICAL EQUIPMENT - PART 2-61: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PULSE OXIMETER EQUIPMENT
    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
    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
    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
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    ASTM F 2083 : 2012 : REDLINE Standard Specification for Knee Replacement Prosthesis
    ISO/ASTM 51261:2013 Practice for calibration of routine dosimetry systems for radiation processing
    I.S. EN 60601-2-43:2010 MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
    I.S. 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 62368-1:2014 Audio/video, information and communication technology equipment - Part 1: Safety requirements
    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
    NFPA 30 HDBK : 2018 FLAMMABLE AND COMBUSTIBLE LIQUIDS CODE HANDBOOK
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    CSA C22.2 No. 62368-1 : 2014 AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS
    EN 60601-2-44:2009/A2:2016 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/A2:2016)
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    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
    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
    ISO 9919:2005 Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    IEC 61223-2-6:2006 Evaluation and routine testing in medical imaging departments ­ - Part 2­-6: Constancy tests ­ imaging performance of computed tomography X-ray equipment
    CAN/CSA-C22.2 No. 62841-1 : 2015 ELECTRIC MOTOR-OPERATED HAND-HELD TOOLS, TRANSPORTABLE TOOLS AND LAWN AND GARDEN MACHINERY - SAFETY - PART 1: GENERAL REQUIREMENTS
    IEC 62148-17:2013 Fibre optic active components and devices - Package and interface standards - Part 17: Transmitter and receiver components with dual coaxial RF connectors
    IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
    ISO 18113-1:2009 In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements
    ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 1: General requirements
    BS 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
    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 : B GENERAL GUIDELINES FOR ELECTRONIC EQUIPMENT
    UL 1017 : 2010 VACUUM CLEANERS, BLOWER CLEANERS, AND HOUSEHOLD FLOOR FINISHING MACHINES
    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)
    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)
    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 61223-3-2:2008 EVALUATION AND ROUTINE TESTING IN MEDICAL IMAGING DEPARTMENTS - PART 3-2: ACCEPTANCE TESTS - IMAGING PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT
    UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
    EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    EN ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    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)
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
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