| 标准号 | 名称 | 采信 |
|---|
| ISO TS 10993-19 | Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topograp | FDA |
| ISO TS 10993-20 | Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology | FDA |
| ISO 10993-23 | Biological evaluation of medical devices - Part 23: Tests for irritation | FDA |
| ISO TR 10993-33 | Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - | FDA |
| ISO 11040-4 | Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes | FDA |
| ISO 11040-5 | Prefilled syringes - Part 5: Plunger stoppers for injectables | FDA |
| ISO 11073-90101 | Health informatics - Point-of-care medical device communication - Part 90101: Analytical instrum | FDA |
| ISO 11073-91064 | Health informatics - Standard communication protocol - Computer-assisted electrocardiography | FDA |
| ISO 11135 | Sterilization of health-care products - Ethylene oxide - Requirements for the development, valid | FDA |
| ISO 11137-1 | Sterilization of health care products - Radiation - Part 1: Requirements for development, valida | FDA |
| ISO 11137-2 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose | FDA |
| ISO 11137-3 | Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of de | FDA |
| ISO TS 11137-4 | Sterilization of health care products - Radiation - Part 4: Guidance on process control | FDA |
| ISO 11138-1 | Sterilization of health care products - Biological indicators - Part 1: General requirements | FDA |
| ISO 11138-7 | Sterilization of health care products - Biological indicators - Part 7: Guidance for the selecti | FDA |
| ISO 11138-8 | Sterilization of health care products - Biological indicators - Part 8: Method for validation of | FDA |
| ISO 11139 | Sterilization of health care products - Vocabulary of terms used in sterilization and related eq | FDA |
| ISO 11140-1 | Sterilization of health care products - Chemical indicators - Part 1: General requirements | FDA |
| ISO 11140-5 | Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bow | FDA |
| ISO 11143 | Dentistry - Amalgam separators | FDA |
| ISO 11146-1 | Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and b | FDA |
| ISO 11146-2 | Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and b | FDA |
| ISO 11195 | Gas mixers for medical use - Stand-alone gas mixers | FDA |
| ISO 11199-1 | Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: | FDA |
| ISO 11199-2 | Assistive products for walking manipulated by both arms - Requirements and test methods Part 2: | FDA |
| ISO 11318 | Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions an | FDA |
| ISO TR 11360 | Nanotechnologies - Methodology for the classification and categorization of nanomaterials | FDA |
| ISO 11491 | Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint | FDA |
| ISO 11499 | Dentistry - Single-use cartridges for local anaesthetics | FDA |
| ISO 11542-2 | Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials | FDA |
| ISO 11551 | Optics and optical instruments - Lasers and laser-related equipment - Test method for absorptanc | FDA |
| ISO 11554 | Optics and photonics - Lasers and laser-related equipment - Test methods for laser beam power, e | FDA |
| ISO 11607-1 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, steril | FDA |
| ISO 11607-2 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for formin | FDA |
| ISO 11608-1 | Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle- | FDA |
| ISO 11608-2 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double- | FDA |
| ISO 11608-3 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Contain | FDA |
| ISO 11608-4 | Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle- | FDA |
| ISO 11608-5 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automat | FDA |
| ISO 11608-6 | Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body | FDA |
| ISO 11608-7 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessi | FDA |
| ISO 11658 | Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications | FDA |
| ISO 11670 | Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional st | FDA |
| ISO 11712 | Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors | FDA |
| ISO 11737-1 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a pop | FDA |
| ISO 11737-2 | Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performe | FDA |
| ISO 11737-3 | Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin te | FDA |
| ISO 11810 | Lasers and laser-related equipment - Test method and classification for the laser-resistance of | FDA |
| ISO 11978 | Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendme | FDA |
| ISO 11979-1 | Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary | FDA |
| ISO 11979-2 | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods | FDA |
| ISO 11979-3 | Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods | FDA |
| ISO 11979-5 | Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility | FDA |
| ISO 11979-6 | Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing | FDA |
| ISO 11979-7 | Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses | FDA |
| ISO 11979-8 | Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements | FDA |
| ISO 11979-10 | Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lense | FDA |
| ISO 11980 | Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical invest | FDA |
| ISO 11981 | Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical co | FDA |
| ISO 11986 | Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservativ | FDA |
| ISO 11990 | Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft an | FDA |
| ISO 12005 | Lasers and laser-related equipment - Test methods for laser beam parameters - Polarization | FDA |
| ISO 12417-1 | Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - | FDA |
| ISO 12609-1 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and | FDA |
| ISO 12609-2 | Eyewear for protection against intense light sources used on humans and animals for cosmetic and | FDA |
| ISO 12865 | Ophthalmic instruments - Retinoscopes | FDA |
| ISO 13004 | Sterilization of health care products - Radiation - Substantiation of selected sterilization dos | FDA |
| ISO TR 13014 | Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materia | FDA |
| ISO 13017 | Dentistry - Magnetic attachments | FDA |
| ISO 13078 | Dentistry - Dental furnace - Test method for temperature measurement with separate thermocouple | FDA |
| ISO 13078-2 | Dentistry - Dental furnace - Part 2: Test method for evaluation of furnace programme via firing | FDA |
| ISO 13078-3 | Dentistry - Dental furnace - Part 3: Test method for the evaluation of high temperature sinterin | FDA |
| ISO TR 13121 | Nanotechnologies - Nanomaterial risk evaluation | FDA |
| ISO 13175-3 | Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phospha | FDA |
| ISO 13179-1 | Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coating | FDA |
| ISO 13212 | Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life | FDA |
| ISO 13356 | Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) | FDA |
| ISO 13397-1 | Periodontal curettes, dental scalers and excavators - Part 1: General requirements | FDA |
| ISO 13397-2 | Dentistry - Periodontal curettes, dental scalers and excavators - Part 2: Periodontal curettes o | FDA |
| ISO 13397-3 | Periodontal curettes, dental scalers and excavators - Part 3: Dental scalers - H-type | FDA |
| ISO 13397-5 | Dentistry - Periodontal curettes, dental scalers and excavators - Part 5: Jacquette scalers | FDA |
| ISO 13402 | Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosi | FDA |
| ISO 13408-1 | Aseptic processing of health care products - Part 1: General requirements [Including: Amendment | FDA |
| ISO 13408-2 | Aseptic processing of health care products - Part 2: Sterilizing filtration. | FDA |
| ISO 13408-3 | Aseptic processing of health care products - Part 3: Lyophilization | FDA |
| ISO 13408-4 | Aseptic processing of health care products - Part 4: Clean-in-place technologies | FDA |
| ISO 13408-5 | Aseptic processing of health care products - Part 5: Sterilization-in-place | FDA |
| ISO 13408-6 | Aseptic processing of health care products - Part 6: Isolator systems | FDA |
| ISO 13408-7 | Aseptic processing of health care products - Part 7: Alternate processes for medical devices and | FDA |
| ISO 13504 | Dentistry - General requirements for instruments and related accessories used in dental implant | FDA |
| ISO 13694 | Optics and Photonics - Lasers and laser-related equipment - Test methods for laser beam power (e | FDA |
| ISO 13695 | Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral charac | FDA |
| ISO 13696 | Optics and optical instruments -- Test methods for radiation scattered by optical components | FDA |
| ISO 13697 | Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectan | FDA |
| ISO 13779-2 | Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite | FDA |
| ISO 13779-3 | Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crys | FDA |
| ISO 13779-4 | Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength | FDA |
| ISO 13779-6 | Implants for surgery - Hydroxyapatite - Part 6: Powders | FDA |
| ISO 13781 | Implants for surgery - Homopolymers, copolymers and blends on poly(lactide) - In vitro degradati | FDA |
| ISO 13782 | Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications | FDA |
| ISO TS 14101 | Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT- | FDA |
| ISO 14117 | Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for impl | FDA |
| ISO 14155 | Clinical investigation of medical devices for human subjects - Good clinical practice | FDA |
| ISO 14160 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medica | FDA |
| ISO 14161 | Sterilization of health care products - Biological indicators - Guidance for the selection, use | FDA |
| ISO 14242-1 | Implants for surgery - Wear of total hip-joint prostheses - Part 1: Loading and displacement par | FDA |
| ISO 14242-2 | Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement | FDA |
| ISO 14242-3 | Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement par | FDA |
| ISO 14242-4 | Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under | FDA |
| ISO 14243-1 | Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and displacement pa | FDA |
| ISO 14243-2 | Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of measurement | FDA |
| ISO 14243-3 | Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement pa | FDA |
| ISO 14243-5 | Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the pat | FDA |
| ISO 14356 | Dentistry - Duplicating material | FDA |
| ISO 14408 | Tracheal tubes designed for laser surgery - Requirements for marking and accompanying informatio | FDA |
| ISO 14457 | Dentistry - Handpieces and motors | FDA |
| ISO 14607 | Non-active surgical implants - Mammary implants - Specific requirements | FDA |
| ISO 14630 | Non-active surgical implants -- General requirements | FDA |
| ISO 14644-1 | Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by | FDA |
| ISO 14644-2 | Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cl | FDA |
| ISO 14644-3 | Cleanrooms and associated controlled environments - Part 3: Test methods | FDA |
| ISO 14644-4 | Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up | FDA |
| ISO 14644-5 | Cleanrooms and associated controlled environments - Part 5: Operations | FDA |
| ISO 14644-7 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, | FDA |
| ISO 14644-8 | Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by | FDA |
| ISO 14644-9 | Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanlines | FDA |
| ISO 14644-10 | Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanline | FDA |
| ISO 14698-1 | Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General P | FDA |
| ISO 14698-2 | Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluatio | FDA |
| ISO 14708-1 | Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for s | FDA |
| ISO 14708-2 | Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers | FDA |
| ISO 14708-3 | Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators | FDA |
| ISO 14708-5 | Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices | FDA |
| ISO 14708-6 | Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for | FDA |
| ISO 14708-7 | Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for | FDA |
| ISO 14729 | Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods f | FDA |
| ISO 14730 | Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and | FDA |
| ISO 14801 | Dentistry - Implants - Dynamic loading test for endosseous dental implants | FDA |
| ISO 14879-1 | Implants for surgery - Total knee-joint prostheses - Part 1: Determination of endurance properti | FDA |
| ISO 14880-2 | Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations | FDA |
| ISO 14880-3 | Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other th | FDA |
| ISO 14880-4 | Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties | FDA |
| ISO 14937 | Sterilization of health care products - General requirements for characterization of a sterilizi | FDA |
| ISO 14971 | Medical devices - Application of risk management to medical devices | FDA |
| ISO 15004-1 | Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirement | FDA |
| ISO 15098 | Dentistry - Dental tweezers | FDA |
| ISO 15142-1 | Implants for surgery - Metal intramedullary nailing systems - Part 1: Intramedullary nails | FDA |
| ISO 15142-2 | Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components | FDA |
| ISO 15142-3 | Implants for surgery - Metal intramedullary nailing systems - Part 3: Connection devices and rea | FDA |
| ISO 15223-1 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part | FDA |
| ISO 15309 | Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polym | FDA |
| ISO 15367-1 | Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam | FDA |
| ISO 15367-2 | Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam | FDA |
| ISO 15747 | Plastic containers for intravenous injections | FDA |
| ISO 15752 | Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optica | FDA |
| ISO 15798 | Ophthalmic implants - Ophthalmic viscosurgical devices | FDA |
| ISO 15841 | Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)] | FDA |
| ISO 15882 | Sterilization of health care products - Chemical indicators - Guidance for selection, use and in | FDA |
| ISO 15912 | Dentistry - Refractory investment and die material | FDA |
| ISO 16037 | Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2 | FDA |
| ISO 16038 | Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condom | FDA |
| ISO 16087 | Implants for surgery - Roentgen stereophotogrammetric analysis for the assessment of migration o | FDA |
| ISO 16409 | Dentistry - Oral care products - Manual interdental brushes | FDA |
| ISO 16498 | Dentistry - Minimal dental implant data set for clinical use | FDA |
| ISO TS 16506 | Dentistry - Polymer-based luting materials containing adhesive components | FDA |
| ISO 16571 | Systems for evacuation of plume generated by medical device | FDA |
| ISO 16628 | Anaesthetic and respiratory equipment - Tracheobronchial tubes | FDA |
| ISO 16672 | Ophthalmic implants - Ocular endotamponades | FDA |
| ISO TS 16775 | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 | FDA |
| ISO 16840-10 | Wheelchair seating - Part 10: Resistance to ignition of postural support devices - Requirements | FDA |
| ISO 16971-1 | Ophthalmic instruments - Optical coherence tomographs - Part 1: Optical coherence tomographs for | FDA |
| ISO 17099 | Radiological protection - Performance criteria for laboratories using the cytokinesis block micr | FDA |
| ISO TS 17137 | Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants | FDA |
| ISO 17200 | Nanotechnology - Nanoparticles in powder form - Characteristics and measurements | FDA |
| ISO 17254 | Dentistry - Coiled springs for use in orthodontics [Including AMENDMENT 1 (2020)] | FDA |
| ISO 17296-2 | Additive manufacturing - General principles - Part 2: Overview of process categories and feedsto | FDA |
| ISO 17327-1 | Non-active surgical implants - Implant coating - Part 1: General requirements | FDA |
| ISO 17510 | Medical devices - Sleep apnoea breathing therapy - Masks and application accessories | FDA |
| ISO 17511 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of | FDA |
| ISO 17526 | Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers | FDA |
| ISO 17664-1 | Processing of health care products - Information to be provided by the medical device manufactur | FDA |
| ISO 17664-2 | Processing of health care products - Information to be provided by the medical device manufactur | FDA |
| ISO 17665 | Sterilization of health care products - Moist heat - Requirements for the development, validatio | FDA |
| ISO 17665-1 | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, v | FDA |
| ISO TS 17665-2 | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO | FDA |
| ISO 17730 | Dentistry - Fluoride varnishes | FDA |
| ISO 17853 | Wear of implant materials - Polymer and metal wear particles - Isolation and characterization | FDA |
| ISO 18082 | Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) l | FDA |
| ISO 18189 | Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of cont | FDA |
| ISO 18190 | Anaesthetic and respiratory equipment - General requirements for airways and related equipment | FDA |
| ISO 18192-1 | Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and | FDA |
| ISO 18192-2 | Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus rep | FDA |
| ISO 18192-3 | Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 3: Impingement | FDA |
| ISO 18193 | Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation | FDA |
| ISO 18242 | Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps [Including AMENDMEN | FDA |
| ISO 18250-3 | Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3 | FDA |
| ISO 18259 | Ophthalmic optics - Contact lens care products - Method to assess contact lens care products wit | FDA |
| ISO 18369-1 | Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendatio | FDA |
| ISO 18369-2 | Ophthalmic optics - Contact lenses - Part 2: Tolerances | FDA |
| ISO 18369-3 | Ophthalmic optics - Contact lenses - Part 3: Measurement Methods | FDA |