CFR 21(PTS800-1299) : 0
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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Superseded date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
Superseded by
Language(s)
English
Publisher
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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]
| DocumentType |
Standard
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| Pages |
0
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| PublisherName |
Code of Federal Regulations
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| Status |
Superseded
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| SupersededBy |
| ANSI Z80.27 : 2014 | OPHTHALMICS - IMPLANTABLE GLAUCOMA DEVICES |
| 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 |
| 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 |
| 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 |
| 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 ARP5560 | 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 AS8056 | 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 <emph type="bdit">in vivo</emph> 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 |
| 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 ARP5293 | 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 ARP5873A | 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 ARP5674 | 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 |
| DI-TCSP-82040 Base Document:2016 | RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) |
| IEEE N42.46-2008 | American National Standard for Determination of the Imaging Performance of X-Ray and Gamma-Ray Systems for Cargo and Vehicle Security Screening |
| 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 | Anaesthetic and respiratory equipment. General requirements for airways and related equipment |
| MIL-HDBK-828 Revision C:2017 | RANGE LASER SAFETY |
| AAMI NS4 :2013 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| IEEE 730-2014 | IEEE Standard for Software Quality Assurance Processes |
| ANSI/AAMI/ISO TIR16775:2014 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 |
| I.S. EN 62368-1:2014 | AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED) |
| FAA AC 25-10 : 0 | GUIDANCE FOR INSTALLATION OF MISCELLANEOUS, NON-REQUIRED ELECTRICAL EQUIPMENT |
| EN 62368-1:2014/AC:2017-03 | AUDIO/VIDEO, INFORMATION AND COMMUNICATION TECHNOLOGY EQUIPMENT - PART 1: SAFETY REQUIREMENTS (IEC 62368-1:2014, MODIFIED) |
| 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 F 2665 : 2009 : R2014 | Standard Specification for Total Ankle Replacement Prosthesis |
| ASTM F 2042 : 2000 | Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication |
| ISO 13022:2012 | Medical products containing viable human cells — Application of risk management and requirements for processing practices |
| 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 |
| 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) |
| 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 Constancy tests. Imaging performance of computed tomography 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) |
| 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 |
| AAMI ISO TIR 12417 : 2011 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS |
| 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 |
| 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 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 EN ISO 18113-1:2011 | In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements |
| SAE ARP6253A | LEDs and Aircraft Applications |
| NFPA 115 : 2016 | LASER FIRE PROTECTION |
| ANSI/AAMI ST58:2013(R2018) | CHEMICAL STERILIZATION AND HIGH-LEVEL DISINFECTION IN HEALTH CARE FACILITIES |
| ANSI/AAMI ST90:2017 | PROCESSING OF HEALTH CARE PRODUCTS - QUALITY MANAGEMENT SYSTEMS FOR PROCESSING IN HEALTH CARE FACILITIES |
| IEEE N42.44-2008 | American National Standard for the Performance of Checkpoint Cabinet X-Ray Imaging Security Systems |
| AAMI TIR37 : 2013 | STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - GUIDANCE ON STERILIZATION OF BIOLOGICS AND TISSUE-BASED PRODUCTS |
| ANSI/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 |
| C22.2 NO. 243-17 | Vacuum cleaners, blower cleaners, and household floor finishing machines (Binational standard with UL 1017) |
| AAMI HE75 : 2009 | HUMAN FACTORS ENGINEERING - DESIGN OF MEDICAL DEVICES |
| AAMI QSR : 1996 | QUALITY SYSTEM REGULATION (21 CFR PARTS 808, 812 AND 820) - OCTOBER 1996 |
| ISO 18190:2016 | Anaesthetic and respiratory equipment — General requirements for airways and related equipment |
| ASTM F 2091 : 2015 : REDLINE | Standard Specification for Acetabular Prostheses |
| 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) |
| UNI EN ISO 18113-1 : 2012 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
| ASTM E 1570 : 2011 : REDLINE | PRACTICE FOR COMPUTED TOMOGRAPHIC (CT) EXAMINATION |
| SAE ARP 6161 : 2011 | FLIGHT COMPARTMENT GLARE |
| 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 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 |
| 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 |
| 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 2211 : 2013 | Standard Classification for Tissue Engineered Medical Products (TEMPs) |
| ASTM F 2083 : 2012 : REDLINE | Standard Specification for Knee Replacement Prosthesis |
| 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 |
| 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 |
| CEI 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 |
| 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 |
| 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 |
| ASME PTB 12 : 2017 | GUIDELINES FOR ADDRESSING DATA GAPS AND RECORDKEEPING FOR ASME B31.4, B31.8 AND B31.8S FOR PIPELINE INTEGRITY MANAGEMENT |
| AHRI 681 (SI) : 2017 | PERFORMANCE RATING OF RESIDENTIAL AIR FILTER EQUIPMENT |
| AHRI 680 (I-P) : 2017 | PERFORMANCE RATING OF RESIDENTIAL AIR FILTER EQUIPMENT |
| ASME PVHO 1 : 2016 | SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY |
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