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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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date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

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
Pages
0
PublisherName
Code of Federal Regulations
Status
Superseded
SupersededBy

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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
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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
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AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
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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
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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
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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
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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
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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)
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AAMI ISO 5841-2 : 2014 IMPLANTS FOR SURGERY - CARDIAC PACEMAKERS - PART 2: REPORTING OF CLINICAL PERFORMANCE OF POPULATIONS OF PULSE GENERATORS OR LEADS
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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
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SAE ARP 5674 : 2012 SAFETY CONSIDERATIONS FOR AIRCRAFT-MOUNTED LASERS PROJECTED INTO THE NAVIGABLE AIRSPACE
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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 REDLINE 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 ARP 6253 : 2017 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
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 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
ASME PTB 12 : 2017 GUIDELINES FOR ADDRESSING DATA GAPS AND RECORDKEEPING FOR ASME B31.4, B31.8 AND B31.8S FOR PIPELINE INTEGRITY MANAGEMENT
ASME PVHO 1 : 2016 SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY

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