| 标准号 | 名称 | 采信 |
|---|
| ISO 780 | Packaging - Distribution packaging - Graphical symbols for handling and storage of packages | FDA |
| ISO 1135-4 | Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed | FDA |
| ISO 1797 | Dentistry - Shanks for rotary and oscillating instruments | FDA |
| 引用ISO 2859-1 | Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptanc | FDA |
| ISO 3107 | Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements | FDA |
| ISO 3630-1 | Dentistry - Endodontic instruments - Part 1: General requirements | FDA |
| ISO 3630-2 | Dentistry - Endodontic instruments - Part 2: Enlargers | FDA |
| ISO 3630-3 | Dentistry - Endodontic instruments - Part 3: Compactors | FDA |
| ISO 3630-4 | Dentistry - Endodontic instruments - Part 4: Auxiliary instruments | FDA |
| ISO 3630-5 | Dentistry - Endodontic instruments - Part 5: Shaping and cleaning instruments | FDA |
| ISO 3964 | Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)] | FDA |
| ISO 3990 | Dentistry - Evaluation of antibacterial activity of dental restorative materials, luting materia | FDA |
| ISO 4049 | Dentistry - Polymer-based restorative materials | FDA |
| ISO 4074 | Natural latex rubber condoms - Requirements and test methods | FDA |
| ISO 4090 | Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensio | FDA |
| ISO 4135 | Anaesthetic and respiratory equipment - Vocabulary | FDA |
| ISO 4311 | Anionic and non-ionic surface active agents - Determination of critical micellization concentrat | FDA |
| ISO 4823 | Dentistry - Elastomeric impression and bite registration materials | FDA |
| ISO 5139 | Dentistry - Polymer-based composite machinable blanks | FDA |
| ISO 5356-1 | Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets | FDA |
| ISO 5359 | Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases | FDA |
| ISO 5360 | Anaesthetic vaporizers - Agent specific filling systems | FDA |
| ISO 5361 | Anaesthetic and respiratory equipment - Tracheal tubes and connectors | FDA |
| ISO 5362 | Anaesthetic Reservoir Bags | FDA |
| ISO 5364 | Anaesthetic and respiratory equipment-Oropharyngeal airways | FDA |
| ISO 5366 | Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors | FDA |
| ISO 5367 | Anaesthetic and respiratory equipment - Breathing sets and connectors | FDA |
| ISO TS 5615 | Health informatics - Accelerating safe, effective and secure remote connected care and mobile he | FDA |
| ISO 5799 | Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determina | FDA |
| ISO 5832-1 | Implants for surgery - Metallic materials - Part 1: Wrought stainless steel | FDA |
| ISO 5832-2 | Implants for surgery - Metallic materials - Part 2: Unalloyed titanium | FDA |
| ISO 5832-3 | Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium allo | FDA |
| ISO 5832-4 | Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy | FDA |
| ISO 5832-5 | Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel | FDA |
| ISO 5832-6 | Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum a | FDA |
| ISO 5832-9 | Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel | FDA |
| ISO 5832-11 | Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium al | FDA |
| ISO 5832-12 | Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy | FDA |
| ISO 5834-1 | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form | FDA |
| ISO 5834-2 | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms | FDA |
| ISO 5834-3 | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 3: Accelerated ageing met | FDA |
| ISO 5834-4 | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 4: Oxidation index measur | FDA |
| ISO 5834-5 | Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 5: Morphology assessment | FDA |
| ISO 5838-1 | Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements | FDA |
| ISO 5838-2 | Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions | FDA |
| ISO 5838-3 | Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires | FDA |
| ISO 5840-1 | Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements | FDA |
| ISO 5840-2 | Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve su | FDA |
| ISO 5840-3 | Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted b | FDA |
| ISO 5841-3 | Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantabl | FDA |
| ISO 5910 | Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices | FDA |
| ISO 6009 | Hypodermic needles for single use - Colour coding for identification. | FDA |
| ISO 6474-1 | Implants for surgery - Ceramic materials - Part 1: Ceramic materials based on high purity alumin | FDA |
| ISO 6474-2 | Implants for surgery - Ceramic materials - Part 2: Composite materials based on a high-purity al | FDA |
| ISO 6872 | Dentistry - Ceramic materials | FDA |
| ISO 6873 | Dentistry - Gypsum products | FDA |
| ISO 6874 | Dentistry - Polymer-based pit and fissure sealants | FDA |
| ISO 6876 | Dentistry -- Root canal sealing materials | FDA |
| ISO 6877 | Dentistry - Endodontic obturating materials | FDA |
| ISO 7000 | Graphical symbols for use on equipment - Registered symbols | FDA |
| ISO 7010 | Graphical symbols - Safety colours and safety signs - Registered safety signs | FDA |
| ISO PAS 7020 | Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 58 | FDA |
| ISO 7153-1 | Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1 | FDA |
| ISO 7176 | Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements | FDA |
| ISO 7176-1 | Wheelchairs - Part 1: Determination of static stability | FDA |
| ISO 7176-2 | Wheelchairs - Part 2:Determination of dynamic stability of electrically powered wheelchairs | FDA |
| ISO 7176-3 | Wheelchairs - Part 3: Determination of effectiveness of brakes | FDA |
| ISO 7176-4 | Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination | FDA |
| ISO 7176-5 | Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space | FDA |
| ISO 7176-6 | Wheelchairs - Part 6: Determination of maximum speed of electrically powered wheelchairs | FDA |
| ISO 7176-7 | Wheelchairs - Part 7: Measurement of seating and wheel dimensions | FDA |
| ISO 7176-8 | Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths | FDA |
| ISO 7176-9 | Wheelchairs - Part 9: Climatic tests for electric wheelchairs | FDA |
| ISO 7176-10 | Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelc | FDA |
| ISO 7176-11 | Wheelchairs - Part 11: Test dummies | FDA |
| ISO 7176-13 | Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces | FDA |
| ISO 7176-14 | Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scoote | FDA |
| ISO 7176-15 | Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling | FDA |
| ISO 7176-19 | Wheelchairs - Part 19: Wheeled mobility devices for use as seats in motor vehicles | FDA |
| ISO 7176-21 | Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electr | FDA |
| ISO 7176-22 | Wheelchairs - Part 22: Set-up procedures | FDA |
| ISO 7176-25 | Wheelchairs - Part 25: Lead-acid batteries and chargers for powered wheelchairs - Requirements a | FDA |
| ISO 7176-28 | Wheelchairs Part 28: Requirements and test methods for stairclimbing devices | FDA |
| ISO 7176-30 | Wheelchairs --Part 30: Wheelchairs for changing occupant posture --Test methods and requirements | FDA |
| ISO 7176-31 | Wheelchairs -- Part 31: Lithium-ion battery systems and chargers for powered wheelchairs--Requir | FDA |
| ISO 7197 | Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Tec | FDA |
| ISO 7198 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular graf | FDA |
| ISO 7199 | Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) | FDA |
| ISO 7206-2 | Implants for surgery - Partial and total hip joint prostheses - Part 2: Articulating surfaces ma | FDA |
| ISO 7206-4 | Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of enduran | FDA |
| ISO 7206-6 | Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of enduran | FDA |
| ISO 7206-10 | Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resist | FDA |
| ISO 7206-12 | Implants for surgery - Partial and total hip joint prostheses - Part 12: Deformation test method | FDA |
| ISO 7206-13 | Implants for surgery - Partial and total hip joint prostheses - Part 13: Determination of resist | FDA |
| ISO 7207-1 | Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classifi | FDA |
| ISO 7207-2 | Implants for surgery - Components for partial and total knee joint prostheses - Part 2: Articula | FDA |
| ISO 7376 | Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation | FDA |
| ISO 7376-2 | Anaesthetic and respiratory equipment - Part 2: Video laryngoscopes | FDA |
| ISO 7405 | Dentistry - Evaluation of biocompatibility of medical devices used in dentistry | FDA |
| ISO 7439 | Copper-bearing contraceptive intrauterine devices - Requirements and tests | FDA |
| ISO 7488 | Dentistry - Mixing machines for dental amalgam | FDA |
| ISO 7491 | Dental materials - Determination of colour stability | FDA |
| ISO 7492 | Dentistry - Dental explorer | FDA |
| ISO 7494-1 | Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements | FDA |
| ISO 7494-2 | Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and | FDA |
| ISO 7551 | Dentistry - Endodontic absorbent points | FDA |
| ISO 7864 | Sterile hypodermic needles for single use - Requirements and test methods | FDA |
| ISO 7886-1 | Sterile hypodermic syringes for single use - Part 1: Syringes for manual use | FDA |
| ISO 7886-2 | Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe | FDA |
| ISO 7886-3 | Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immun | FDA |
| ISO 7886-4 | Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature | FDA |
| ISO 8009 | Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requ | FDA |
| ISO 8325 | Dentistry - Test methods for rotary instruments | FDA |
| ISO 8536-1 | Infusion equipment for medical use - Part 1: Infusion glass bottles | FDA |
| ISO 8536-2 | Infusion equipment for medical use - Part 2: Closures for infusion bottles | FDA |
| ISO 8536-3 | Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles | FDA |
| ISO 8536-4 | Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | FDA |
| ISO 8536-5 | Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed | FDA |
| ISO 8536-6 | Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles | FDA |
| ISO 8536-7 | Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for inf | FDA |
| ISO 8536-8 | Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion | FDA |
| ISO 8536-9 | Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion E | FDA |
| ISO 8536-10 | Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pr | FDA |
| ISO 8536-11 | Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infu | FDA |
| ISO 8537 | Sterile single-use syringes, with or without needle, for insulin | FDA |
| ISO 8600-1 | Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements | FDA |
| ISO 8600-3 | Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view a | FDA |
| ISO 8600-4 | Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width | FDA |
| ISO 8600-5 | Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of opt | FDA |
| ISO 8600-6 | Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary | FDA |
| ISO 8637-1 | Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemof | FDA |
| ISO 8637-2 | Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodia | FDA |
| ISO 8637-3 | Extracorporeal systems for blood purification - Part 3: Plasmafilters | FDA |
| ISO 8827 | Implants for surgery - Staples with parallel legs for orthopaedic use - General requirements | FDA |
| ISO 8828 | Implants for surgery -- Guidance on care and handling of orthopaedic implants | FDA |
| ISO 8835-7 | Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited log | FDA |
| ISO 8836 | Suction catheters for use in the respiratory tract | FDA |
| ISO 9168 | Dentistry - Hose connectors for air driven dental handpieces | FDA |
| ISO 9173-1 | Dentistry - Extraction forceps - Part 1: General requirements | FDA |
| ISO 9173-2 | Dentistry - Extraction forceps - Part 2: Designation | FDA |
| ISO 9173-3 | Dentistry - Extraction forceps - Part 3: Design | FDA |
| ISO 9236-1 | Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determinatio | FDA |
| ISO 9333 | Dentistry - Brazing materials | FDA |
| ISO 9360-1 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying resp | FDA |
| ISO 9360-2 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying resp | FDA |
| ISO 9394 | Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatib | FDA |
| ISO 9583 | Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgi | FDA |
| ISO 9584 | Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgi | FDA |
| ISO 9626 | Stainless steel needle tubing for the manufacture of medical devices - Requirements and test met | FDA |
| ISO 9680 | Dentistry - Operating lights | FDA |
| ISO 9687 | Dentistry - Graphical symbols for dental equipment [Including AMENDMENT 1 (2018)] | FDA |
| ISO 9693 | Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems | FDA |
| ISO 9873 | Dentistry - Intra-oral mirrors | FDA |
| ISO 9917-1 | Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements | FDA |
| ISO 9917-2 | Dentistry - Water-based cements - Part 2: Resin-modified cements | FDA |
| ISO 9997 | Dentistry - Cartridge Syringes | FDA |
| ISO 10012 | Measurement management systems - Requirements for measurement processes and measuring equipment | FDA |
| ISO 10079-1 | Medical suction equipment - Part 1: Electrically powered suction equipment | FDA |
| ISO 10079-2 | Medical suction equipment - Part 2: Manually powered suction equipment | FDA |
| ISO 10079-3 | Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure | FDA |
| ISO 10079-4 | Medical suction equipment - Part 4: General requirements | FDA |
| ISO 10139-1 | Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use | FDA |
| ISO 10139-2 | Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use | FDA |
| ISO 10271 | Dentistry - Corrosion test methods for metallic materials | FDA |
| ISO 10328 | Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods | FDA |
| ISO 10477 | Dentistry - Polymer-based crown and veneering materials | FDA |
| ISO 10535 | Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods | FDA |
| ISO 10555-1 | Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requi | FDA |
| ISO 10555-3 | Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters | FDA |
| ISO 10555-4 | Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheter | FDA |
| ISO 10555-5 | Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral ca | FDA |
| ISO 10555-6 | Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted port | FDA |
| ISO 10637 | Dentistry - Central suction source equipment | FDA |
| ISO 10650 | Dentistry - Powered polymerization activators | FDA |
| ISO 10651-4 | Lung ventilators - Part 4: Particular requirements for operator powered resuscitators | FDA |
| ISO 10651-5 | Lung ventilators for medical use - Particular requirements for basic safety and essential perfor | FDA |
| ISO 10873 | Dentistry - Denture adhesives | FDA |
| ISO 10936-2 | Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes u | FDA |
| ISO 10939 | Ophthalmic instruments - Slit-lamp microscopes | FDA |
| ISO 10940 | Ophthalmic instruments - Fundus cameras | FDA |
| ISO 10942 | Ophthalmic instruments - Direct ophthalmoscopes | FDA |
| ISO 10943 | Ophthalmic instruments - Indirect ophthalmoscopes | FDA |
| ISO TS 10974 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable m | FDA |
| ISO 10993-1 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk manageme | FDA |
| ISO 10993-2 | Biological Evaluation of medical devices - Part 2: Animal welfare requirements | FDA |
| ISO 10993-3 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and r | FDA |
| ISO 10993-4 | Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood | FDA |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | FDA |
| ISO 10993-6 | Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | FDA |
| ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Inclu | FDA |
| ISO 10993-9 | Biological evaluation of medical devices - Part 9: Framework for identification and quantificati | FDA |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | FDA |
| ISO 10993-11 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | FDA |
| ISO 10993-12 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | FDA |
| ISO 10993-13 | Biological evaluation of medical devices - Part 13: Identification and quantification of degrada | FDA |
| ISO 10993-14 | Biological evaluation of medical devices - Part 14: Identification and quantification of degrada | FDA |
| ISO 10993-15 | Biological evaluation of medical devices - Part 15: Identification and quantification of degrada | FDA |
| ISO 10993-16 | Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation p | FDA |
| ISO 10993-17 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leacha | FDA |
| ISO 10993-18 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device | FDA |