| Standard | Title | Recognised by |
|---|
| ISO 18369-4 | Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens material | FDA |
| ISO 18397 | Dentistry - Powered scaler | FDA |
| ISO 18472 | Sterilization of health care products - Biological and chemical indicators - Test equipment | FDA |
| ISO 18556 | Dentistry - Intraoral spatulas | FDA |
| ISO 18562-1 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evalu | FDA |
| ISO 18562-2 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests | FDA |
| ISO 18562-3 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests | FDA |
| ISO 18562-4 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests | FDA |
| ISO 18675 | Dentistry - Machinable ceramic blanks | FDA |
| ISO 18778 | Respiratory equipment - Particular requirements for basic safety and essential performance of in | FDA |
| ISO TS 18827 | Nanotechnologies - Electron spin resonance (ESR) as a method for measuring reactive oxygen speci | FDA |
| ISO 18835 | Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems | FDA |
| ISO 19023 | Dentistry - Orthodontic anchor screws | FDA |
| ISO 19223 | Lung ventilators and related equipment - Vocabulary and semantics. | FDA |
| ISO 19223-2 | Lung ventilators and related equipment - Vocabulary and semantics - Part 2: High frequency and j | FDA |
| ISO 19223-3 | Lung ventilators and related equipment - Vocabulary and semantics - Part 3: Respiratory care | FDA |
| ISO 19227 | Implants for surgery - Cleanliness of orthopedic implants - General requirements | FDA |
| ISO 19238 | Radiological protection - Performance criteria for service laboratories performing biological do | FDA |
| ISO TS 19736 | Dentistry - Bonding test between polymer teeth and denture base materials | FDA |
| ISO 19749 | Nanotechnologies - Measurements of particle size and shape distributions by scanning electron mi | FDA |
| ISO TS 19930 | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, sin | FDA |
| ISO 20126 | Dentistry - Manual toothbrushes - General requirements and test methods | FDA |
| ISO 20127 | Dentistry - Physical properties of powered toothbrushes | FDA |
| ISO 20160 | Implants for surgery - Metallic materials - Classification of microstructures for alpha+beta tit | FDA |
| ISO 20417 | Medical devices - Information to be supplied by the manufacturer | FDA |
| ISO 20608 | Dentistry - Powder jet handpieces and powders | FDA |
| ISO 20695 | Enteral feeding systems - Design and testing | FDA |
| ISO 20696 | Sterile urethral catheters for single use | FDA |
| ISO 20697 | Sterile drainage catheters and accessory devices for single use | FDA |
| ISO 20698 | Catheter systems for neuraxial application - Sterile and single-use catheters and accessories | FDA |
| ISO 20749 | Dentistry - Pre-capsulated dental amalgam | FDA |
| ISO 20795-1 | Dentistry - Base polymers - Part 1: Denture base polymers | FDA |
| ISO 20795-2 | Dentistry - Base polymers - Part 2: Orthodontic base polymers | FDA |
| ISO 20857 | Sterilization of health care products - Dry heat - Requirements for the development, validation | FDA |
| ISO TS 20914 | Medical laboratories - Practical guidance for the estimation of measurement uncertainty | FDA |
| ISO 21254-1 | Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: D | FDA |
| ISO 21254-2 | Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: T | FDA |
| ISO 21254-3 | Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: A | FDA |
| ISO TS 21362 | Nanotechnologies - Analysis of nano-objects using asymmetrical-flow and centrifugal field-flow f | FDA |
| ISO 21362 | Nanotechnologies -- Analysis of nano-objects using asymmetrical flow and centrifugal field-flow | FDA |
| ISO 21363 | Nanotechnologies - Measurements of particle size and shape distributions by transmission electro | FDA |
| ISO 21531 | Dentistry - Graphical symbols for dental instruments | FDA |
| ISO 21533 | Dentistry - Reprocessable cartridge syringes for intraligamentary injections | FDA |
| ISO 21535 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint | FDA |
| ISO 21536 | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint | FDA |
| ISO 21563 | Dentistry - Hydrocolloid impression materials | FDA |
| ISO 21606 | Dentistry - Elastomeric auxiliaries for use in orthodontics | FDA |
| ISO 21649 | Needle-free injectors for medical use -- Requirements and test methods | FDA |
| ISO 21672-1 | Dentistry - Periodontal probes - Part 1: General requirements | FDA |
| ISO TS 21726 | Biological evaluation of medical devices - Application of the threshold of toxicological concern | FDA |
| ISO 21850-1 | Dentistry - Materials for dental instruments - Part 1: Stainless steel | FDA |
| ISO 22052 | Dentistry - Compressed air source equipment | FDA |
| ISO 22112 | Dentistry - Artificial teeth for dental prostheses | FDA |
| ISO 22254 | Dentistry - Manual toothbrushes - Resistance of tufted portion to deflection | FDA |
| ISO 22441 | Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requiremen | FDA |
| ISO 22442-1 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk man | FDA |
| ISO 22442-2 | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, c | FDA |
| ISO 22442-3 | Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimi | FDA |
| ISO 22570 | Dentistry - Spoons and bone curettes | FDA |
| ISO 22622 | Implants for surgery - Wear of total ankle-joint prostheses - Loading and displacement parameter | FDA |
| ISO 22674 | Dentistry - Metallic materials for fixed and removable restorations and appliances | FDA |
| ISO 22679 | Cardiovascular implants - Transcatheter cardiac occluders | FDA |
| ISO 22683 | Dentistry - Rotational adaptability test between implant body and implant abutment in dental imp | FDA |
| ISO 22803 | Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery | FDA |
| ISO TR 22979 | Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical inves | FDA |
| ISO 23089-2 | Implants for surgery - Preclinical mechanical assessment of spinal implants and particular requi | FDA |
| ISO 23217 | Injection systems for self-administration by paediatric patients - Requirements and guidelines f | FDA |
| ISO 23298 | Dentistry - Test methods for machining accuracy of computer-aided milling machines | FDA |
| ISO 23371 | Anaesthetic and respiratory equipment - Cuff pressure indication, control and regulation devices | FDA |
| ISO 23409 | Male Condoms - Requirements and test methods for condoms made from synthetic materials | FDA |
| ISO 23450 | Dentistry - Intraoral camera | FDA |
| ISO 23500-1 | Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: G | FDA |
| ISO 23500-2 | Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: W | FDA |
| ISO 23500-3 | Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: W | FDA |
| ISO 23500-4 | Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: C | FDA |
| ISO 23500-5 | Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Q | FDA |
| ISO 23747 | Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmon | FDA |
| ISO 23907-1 | Sharps injury protection - Requirements and test methods - Sharps containers | FDA |
| ISO 23907-2 | Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers. | FDA |
| ISO 23908 | Sharps injury protection - Requirements and test methods - Sharps protection features for single | FDA |
| ISO 23940 | Dentistry - Excavators | FDA |
| ISO 24013 | Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of | FDA |
| ISO 24234 | Dentistry - Dental Amalgam | FDA |
| ISO 25539-1 | Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses | FDA |
| ISO 25539-2 | Cardiovascular implants - Endovascular devices - Part 2: Vascular stents | FDA |
| ISO 25539-3 | Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters | FDA |
| ISO 25539-4 | Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated e | FDA |
| ISO 25841 | Female condoms -- Requirements and test methods | FDA |
| ISO 26782 | Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced | FDA |
| ISO 26825 | Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used d | FDA |
| ISO 27020 | Dentistry - Brackets and tubes for use in orthodontics | FDA |
| ISO 27185 | Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Lab | FDA |
| ISO 27186 | Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm m | FDA |
| ISO 27427 | Anaesthetic and respiratory equipment - Nebulizing systems and components | FDA |
| ISO 28158 | Dentistry - Integrated dental floss and handles | FDA |
| ISO 28319 | Dentistry - Laser welding and filler materials | FDA |
| ISO 28399 | Dentistry - Products for external tooth bleaching | FDA |
| ISO 28888 | Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues | FDA |
| ISO 29022 | Dentistry - Adhesive - Notched-edge sheer bond strength test | FDA |
| ISO 29701 | Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocy | FDA |
| ISO 29942 | Prophylatic dams -- Requirements and test methods | FDA |
| ISO 29943-1 | Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based | FDA |
| ISO 29943-2 | Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies bas | FDA |
| ISO TS 37137-1 | Biological evaluation of absorbable medical devices - Part 1: General requirements. | FDA |
| ISO TS 80004-6 | Nanotechnologies - Vocabulary - Part 6: Nano-object characterization | FDA |
| ISO 80369-1 | Small-bore connectors for liquids and gases in healthcare applications - Part 1: General require | FDA |
| ISO 80369-2 | Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for | FDA |
| ISO 80369-3 | Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for | FDA |
| ISO 80369-6 | Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for | FDA |
| ISO 80369-7 | Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for | FDA |
| ISO 80369-20 | Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test me | FDA |
| ISO 80601-2-12 | Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-13 | Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-55 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essen | FDA |
| ISO 80601-2-56 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-61 | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-69 | Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essen | FDA |
| ISO 80601-2-70 | Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essen | FDA |
| ISO 80601-2-72 | Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential | FDA |
| ISO 80601-2-74 | Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-79 | Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-80 | Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-84 | Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essen | FDA |
| ISO 80601-2-85 | Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essen | FDA |
| ISO 80601-2-87 | Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential | FDA |
| ISO 80601-2-90 | Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential | FDA |
| ISO 81060-1 | Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measure | FDA |
| ISO 81060-2 | Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measur | FDA |
| ISO 81060-3 | Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurem | FDA |
| ISO TS 81060-5 | Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility | FDA |