{"id":821,"date":"2026-04-16T06:08:33","date_gmt":"2026-04-16T06:08:33","guid":{"rendered":"https:\/\/satoriocs.com\/blogs\/?p=821"},"modified":"2026-04-16T06:08:34","modified_gmt":"2026-04-16T06:08:34","slug":"iso-standards-directory-complete-reference-list-for-medical-devices-ivds-cosmetics-healthcare","status":"publish","type":"post","link":"https:\/\/satoriocs.com\/blogs\/iso-standards-directory-complete-reference-list-for-medical-devices-ivds-cosmetics-healthcare\/","title":{"rendered":"ISO Standards Directory \u2013 Complete Reference List for Medical Devices, IVDs, Cosmetics &amp; Healthcare"},"content":{"rendered":"\n<p>The International Organization for Standardization (ISO) has released multiple updated standards for medical devices, IVDs, and healthcare systems in 2025 and 2026.<\/p>\n\n\n\n<p>This article provides a&nbsp;<strong>comprehensive list<\/strong>&nbsp;of key ISO standards relevant to medical device manufacturers, quality professionals, and regulatory affairs teams.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><tbody><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Top Medical Device Standards (Recently Published or Reviewed)<\/strong><strong><\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\"><strong>Sno.<\/strong><\/td><td><strong>Standard<\/strong><\/td><td><strong>Title<\/strong><\/td><td><strong>Published\/Reviewed<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">1<\/td><td>ISO 14155<\/td><td>Clinical investigation of medical devices for human subjects \u2014 Good clinical practice<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">2<\/td><td>ISO 20417<\/td><td>Medical devices \u2014 Information to be supplied by the manufacturer<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">3<\/td><td>ISO 10993-1<\/td><td>Biological evaluation of medical devices \u2014 Part 1: Requirements and general principles<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">4<\/td><td>ISO 80601-2-61<\/td><td>Medical electrical equipment \u2014 Part 2-61: Pulse oximeter equipment<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">5<\/td><td>ISO 80601-2-74<\/td><td>Medical electrical equipment \u2014 Part 2-74: Respiratory humidifying equipment<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">6<\/td><td>ISO 15223-1<\/td><td>Medical devices \u2014 Symbols to be used with information supplied by the manufacturer<\/td><td>2021 (Reviewed)<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">7<\/td><td>ISO 13485<\/td><td>Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">8<\/td><td>ISO 14971<\/td><td>Medical devices \u2014 Application of risk management<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">9<\/td><td>ISO 22367<\/td><td>Medical laboratories \u2014 Application of risk management to medical laboratories<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">10<\/td><td>ISO 80601-2-69<\/td><td>Medical electrical equipment \u2014 Part 2-69: Oxygen concentrator equipment<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">11<\/td><td>IEC 62366-1<\/td><td>Medical devices \u2014 Part 1: Application of usability engineering<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">12<\/td><td>IEC 62304<\/td><td>Medical device software \u2014 Software life cycle processes<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">13<\/td><td>ISO 15189<\/td><td>Medical laboratories \u2014 Requirements for quality and competence<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">14<\/td><td>ISO 7101<\/td><td>Healthcare organization management \u2014 Management systems for quality in healthcare organizations<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Biological Evaluation &amp; Biocompatibility Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">15<\/td><td>ISO 10993-12<\/td><td>Biological evaluation of medical devices \u2014 Part 12: Sample preparation and reference materials<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">16<\/td><td>ISO 10993-17<\/td><td>Biological evaluation of medical devices \u2014 Part 17: Toxicological risk assessment<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">17<\/td><td>ISO 10993-18<\/td><td>Biological evaluation of medical devices \u2014 Part 18: Chemical characterization<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">18<\/td><td>ISO 10993-23<\/td><td>Biological evaluation of medical devices \u2014 Part 23: Tests for irritation<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">19<\/td><td>ISO 10993-4<\/td><td>Biological evaluation of medical devices \u2014 Part 4: Tests for interactions with blood<\/td><td>2017<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">20<\/td><td>ISO 10993-10<\/td><td>Biological evaluation of medical devices \u2014 Part 10: Tests for skin sensitization<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">21<\/td><td>ISO 10993-5<\/td><td>Biological evaluation of medical devices \u2014 Part 5: Tests for in vitro cytotoxicity<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">22<\/td><td>ISO 10993-11<\/td><td>Biological evaluation of medical devices \u2014 Part 11: Tests for systemic toxicity<\/td><td>2017<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">23<\/td><td>ISO 10993-7<\/td><td>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><td>2008<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">24<\/td><td>ISO 10993-3<\/td><td>Biological evaluation of medical devices \u2014 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity<\/td><td>2014<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">25<\/td><td>ISO 10993-6<\/td><td>Biological evaluation of medical devices \u2014 Part 6: Tests for local effects after implantation<\/td><td>2016<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">26<\/td><td>ISO\/TR 24971<\/td><td>Medical devices \u2014 Guidance on the application of ISO 14971<\/td><td>2020<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Sterilization Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">27<\/td><td>ISO 11135<\/td><td>Sterilization of health-care products \u2014 Ethylene oxide<\/td><td>2014<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">28<\/td><td>ISO 11137-1<\/td><td>Sterilization of health care products \u2014 Radiation \u2014 Part 1: Requirements<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">29<\/td><td>ISO 17665<\/td><td>Sterilization of health care products \u2014 Moist heat<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">30<\/td><td>ISO 11607-1<\/td><td>Packaging for terminally sterilized medical devices \u2014 Part 1: Requirements<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">31<\/td><td>ISO 11607-2<\/td><td>Packaging for terminally sterilized medical devices \u2014 Part 2: Validation requirements<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">32<\/td><td>ISO 11737-1<\/td><td>Sterilization of health care products \u2014 Microbiological methods \u2014 Part 1: Population of microorganisms<\/td><td>2018<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">33<\/td><td>ISO 11737-2<\/td><td>Sterilization of health care products \u2014 Microbiological methods \u2014 Part 2: Tests of sterility<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">34<\/td><td>ISO 11737-3<\/td><td>Sterilization of health care products \u2014 Microbiological methods \u2014 Part 3: Bacterial endotoxin testing<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">35<\/td><td>ISO 14937<\/td><td>Sterilization of health care products \u2014 General requirements for characterization of a sterilizing agent<\/td><td>2009<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">36<\/td><td>ISO 22441<\/td><td>Sterilization of health care products \u2014 Low temperature vaporized hydrogen peroxide<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">37<\/td><td>ISO 11138-1<\/td><td>Sterilization of health care products \u2014 Biological indicators \u2014 Part 1: General requirements<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">38<\/td><td>ISO 11140-1<\/td><td>Sterilization of health care products \u2014 Chemical indicators \u2014 Part 1: General requirements<\/td><td>2014<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Cleanrooms &amp; Controlled Environments<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">39<\/td><td>ISO 14644-1<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 1: Classification of air cleanliness<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">40<\/td><td>ISO 14644-2<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 2: Monitoring to provide evidence of cleanroom performance<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">41<\/td><td>ISO 14644-3<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 3: Test methods<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">42<\/td><td>ISO 14644-4<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 4: Design, construction and start-up<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">43<\/td><td>ISO 14644-5<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 5: Operations<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">44<\/td><td>ISO 14644-7<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 7: Separative devices<\/td><td>2004<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">45<\/td><td>ISO 14644-8<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 8: Assessment of air cleanliness by chemical concentration<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">46<\/td><td>ISO 14644-9<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 9: Assessment of surface cleanliness for particle concentration<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">47<\/td><td>ISO 14644-10<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 10: Assessment of surface cleanliness for chemical contamination<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">48<\/td><td>ISO 14644-12<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 12: Specifications for monitoring air cleanliness<\/td><td>2018<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">49<\/td><td>ISO 14644-13<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 13: Cleaning of surfaces to achieve defined levels of cleanliness<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">50<\/td><td>ISO 14644-14<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 14: Assessment of suitability for use of equipment<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">51<\/td><td>ISO 14644-15<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 15: Assessment of suitability for use of equipment<\/td><td>2017<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">52<\/td><td>ISO 14644-16<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 16: Energy efficiency in cleanrooms<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">53<\/td><td>ISO 14644-17<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 17: Particle deposition rate applications<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">54<\/td><td>ISO 14644-18<\/td><td>Cleanrooms and associated controlled environments \u2014 Part 18: Assessment of suitability of consumables<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Software &amp; Digital Health Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">55<\/td><td>IEC 62304<\/td><td>Medical device software \u2014 Software life cycle processes<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">56<\/td><td>IEC 62366-1<\/td><td>Medical devices \u2014 Part 1: Application of usability engineering<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">57<\/td><td>IEC\/TR 62366-2<\/td><td>Medical devices \u2014 Part 2: Guidance on the application of usability engineering<\/td><td>2016<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">58<\/td><td>IEC 81001-5-1<\/td><td>Health software and health IT systems safety, effectiveness and security \u2014 Part 5-1: Security \u2014 Activities in the product life cycle<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">59<\/td><td>IEC 82304-1<\/td><td>Health software \u2014 Part 1: General requirements for product safety<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">60<\/td><td>ISO\/IEC 29138-1<\/td><td>Information technology \u2014 User interface accessibility \u2014 Part 1: User accessibility needs<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">61<\/td><td>ISO 27799<\/td><td>Health informatics \u2014 Information security management in health using ISO\/IEC 27002<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">62<\/td><td>ISO 81001-1<\/td><td>Health software and health IT systems safety, effectiveness and security \u2014 Part 1: Principles and concepts<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">63<\/td><td>IEC 80001-1<\/td><td>Application of risk management for IT-networks incorporating medical devices \u2014 Part 1: Safety, effectiveness and security<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>In Vitro Diagnostic (IVD) Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">64<\/td><td>ISO 15189<\/td><td>Medical laboratories \u2014 Requirements for quality and competence<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">65<\/td><td>ISO 22367<\/td><td>Medical laboratories \u2014 Application of risk management to medical laboratories<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">66<\/td><td>ISO 23640<\/td><td>In vitro diagnostic medical devices \u2014 Evaluation of stability of in vitro diagnostic reagents<\/td><td>2011<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">67<\/td><td>ISO 17511<\/td><td>In vitro diagnostic medical devices \u2014 Requirements for establishing metrological traceability<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">68<\/td><td>ISO 20916<\/td><td>In vitro diagnostic medical devices \u2014 Clinical performance studies using specimens from human subjects \u2014 Good study practice<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">69<\/td><td>ISO 5649<\/td><td>Medical laboratories \u2014 Concepts and specifications for the design, development, implementation and use of laboratory-developed tests<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">70<\/td><td>ISO 20387<\/td><td>Biotechnology \u2014 Biobanking \u2014 General requirements for biobanking<\/td><td>2018<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">71<\/td><td>ISO 20395<\/td><td>Biotechnology \u2014 Requirements for evaluating the performance of quantification methods for nucleic acid target sequences \u2014 qPCR and dPCR<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">72<\/td><td>CLSI EP Series<\/td><td>IVD performance evaluation standards<\/td><td>Various dates<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Medical Electrical Equipment (IEC 60601 Series)<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">73<\/td><td>IEC 60601-1-8<\/td><td>Medical electrical equipment \u2014 Part 1-8: General requirements for basic safety and essential performance \u2014 Collateral standard: Alarm systems<\/td><td>2006<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">74<\/td><td>IEC 60601-1-11<\/td><td>Medical electrical equipment \u2014 Part 1-11: General requirements for basic safety and essential performance \u2014 Collateral standard: Home healthcare environment<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">75<\/td><td>IEC 60601-1-12<\/td><td>Medical electrical equipment \u2014 Part 1-12: General requirements for basic safety and essential performance \u2014 Collateral standard: Emergency medical services environment<\/td><td>2014<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">76<\/td><td>IEC 80601-2-61<\/td><td>Medical electrical equipment \u2014 Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">77<\/td><td>IEC 80601-2-69<\/td><td>Medical electrical equipment \u2014 Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">78<\/td><td>IEC 80601-2-74<\/td><td>Medical electrical equipment \u2014 Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">79<\/td><td>IEC 80601-2-49<\/td><td>Medical electrical equipment \u2014 Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment<\/td><td>2018<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">80<\/td><td>IEC 80601-2-77<\/td><td>Medical electrical equipment \u2014 Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">81<\/td><td>IEC 80601-2-78<\/td><td>Medical electrical equipment \u2014 Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">82<\/td><td>IEC 80601-2-89<\/td><td>Medical electrical equipment \u2014 Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Labelling &amp; Symbols Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">83<\/td><td>ISO 20417<\/td><td>Medical devices \u2014 Information to be supplied by the manufacturer<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">84<\/td><td>ISO 15223-1<\/td><td>Medical devices \u2014 Symbols to be used with information to be supplied by the manufacturer \u2014 Part 1: General requirements<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">85<\/td><td>ISO 15223-2<\/td><td>Medical devices \u2014 Symbols to be used with medical device labels, labelling, and information to be supplied \u2014 Part 2: Symbol development, selection and validation<\/td><td>2010<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">86<\/td><td>ISO 18113-1<\/td><td>In vitro diagnostic medical devices \u2014 Information supplied by the manufacturer (labelling) \u2014 Part 1: Terms, definitions, and general requirements<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">87<\/td><td>ISO 18113-2<\/td><td>In vitro diagnostic medical devices \u2014 Information supplied by the manufacturer (labelling) \u2014 Part 2: In vitro diagnostic reagents for professional use<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">88<\/td><td>ISO 18113-3<\/td><td>In vitro diagnostic medical devices \u2014 Information supplied by the manufacturer (labelling) \u2014 Part 3: In vitro diagnostic instruments for professional use<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">89<\/td><td>ISO 18113-4<\/td><td>In vitro diagnostic medical devices \u2014 Information supplied by the manufacturer (labelling) \u2014 Part 4: In vitro diagnostic reagents for self-testing<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">90<\/td><td>ISO 18113-5<\/td><td>In vitro diagnostic medical devices \u2014 Information supplied by the manufacturer (labelling) \u2014 Part 5: In vitro diagnostic instruments for self-testing<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Quality Management &amp; Risk Management Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">91<\/td><td>ISO 13485<\/td><td>Medical devices \u2014 Quality management systems \u2014 Requirements for regulatory purposes<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">92<\/td><td>ISO 14971<\/td><td>Medical devices \u2014 Application of risk management to medical devices<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">93<\/td><td>ISO\/TR 24971<\/td><td>Medical devices \u2014 Guidance on the application of ISO 14971<\/td><td>2020<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">94<\/td><td>ISO 15378<\/td><td>Primary packaging materials for medicinal products \u2014 Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">95<\/td><td>ISO 7101<\/td><td>Healthcare organization management \u2014 Management systems for quality in healthcare organizations \u2014 Requirements<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">96<\/td><td>ISO 35001<\/td><td>Biorisk management for laboratories and other related organisations<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Implants &amp; Surgical Devices Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">97<\/td><td>ISO 14630<\/td><td>Non-active surgical implants \u2014 General requirements<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">98<\/td><td>ISO 5832-1<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 1: Wrought stainless steel<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">99<\/td><td>ISO 5832-2<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 2: Unalloyed titanium<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">100<\/td><td>ISO 5832-3<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 3: Wrought titanium 6-aluminium 4-vanadium alloy<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">101<\/td><td>ISO 5832-4<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 4: Cobalt-chromium-molybdenum casting alloy<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">102<\/td><td>ISO 5832-5<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 5: Wrought cobalt-chromium-tungsten-nickel<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">103<\/td><td>ISO 5832-6<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">104<\/td><td>ISO 5832-11<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 11: Wrought titanium 6-aluminium 7-niobium alloy<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">105<\/td><td>ISO 5832-12<\/td><td>Implants for surgery \u2014 Metallic materials \u2014 Part 12: Wrought cobalt-chromium-molybdenum alloy<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">106<\/td><td>ISO 5834-1<\/td><td>Implants for surgery \u2014 Ultra-high-molecular-weight polyethylene \u2014 Part 1: Powder form<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">107<\/td><td>ISO 5834-2<\/td><td>Implants for surgery \u2014 Ultra-high-molecular-weight polyethylene \u2014 Part 2: Moulded forms<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">108<\/td><td>ISO 5834-3<\/td><td>Implants for surgery \u2014 Ultra-high-molecular-weight polyethylene \u2014 Part 3: Accelerated ageing methods<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">109<\/td><td>ISO 5834-4<\/td><td>Implants for surgery \u2014 Ultra-high-molecular-weight polyethylene \u2014 Part 4: Oxidation index measurement method<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">110<\/td><td>ISO 5834-5<\/td><td>Implants for surgery \u2014 Ultra-high-molecular-weight polyethylene \u2014 Part 5: Morphology assessment method<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">111<\/td><td>ISO 5840-1<\/td><td>Cardiovascular implants \u2014 Cardiac valve prostheses \u2014 Part 1: General requirements<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">112<\/td><td>ISO 5840-2<\/td><td>Cardiovascular implants \u2014 Cardiac valve prostheses \u2014 Part 2: Surgically implanted heart valve substitutes<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">113<\/td><td>ISO 5840-3<\/td><td>Cardiovascular implants \u2014 Cardiac valve prostheses \u2014 Part 3: Heart valve substitutes implanted by transcatheter techniques<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">114<\/td><td>ISO 14607<\/td><td>Non-active surgical implants \u2014 Mammary implants \u2014 Specific requirements<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">115<\/td><td>ISO 21534<\/td><td>Non-active surgical implants \u2014 Joint replacement implants \u2014 Particular requirements<\/td><td>2021<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">116<\/td><td>ISO 21535<\/td><td>Non-active surgical implants \u2014 Joint replacement implants \u2014 Specific requirements for hip-joint replacement implants<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">117<\/td><td>ISO 21536<\/td><td>Non-active surgical implants \u2014 Joint replacement implants \u2014 Specific requirements for knee-joint replacement implants<\/td><td>2023<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">118<\/td><td>ISO 25539-1<\/td><td>Cardiovascular implants \u2014 Endovascular devices \u2014 Part 1: Endovascular prostheses<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">119<\/td><td>ISO 25539-2<\/td><td>Cardiovascular implants \u2014 Endovascular devices \u2014 Part 2: Vascular stents<\/td><td>2020<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">120<\/td><td>ISO 25539-3<\/td><td>Cardiovascular implants \u2014 Endovascular devices \u2014 Part 3: Vena cava filters<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">121<\/td><td>ISO 7198<\/td><td>Cardiovascular implants and extracorporeal systems \u2014 Vascular prostheses \u2014 Tubular vascular grafts and vascular patches<\/td><td>2016<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">122<\/td><td>ISO 14708-1<\/td><td>Implants for surgery \u2014 Active implantable medical devices \u2014 Part 1: General requirements for safety, marking and for information to be provided by the manufacturer<\/td><td>2014<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">123<\/td><td>ISO 14708-2<\/td><td>Implants for surgery \u2014 Active implantable medical devices \u2014 Part 2: Cardiac pacemakers<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">124<\/td><td>ISO 14708-3<\/td><td>Implants for surgery \u2014 Active implantable medical devices \u2014 Part 3: Implantable neurostimulators<\/td><td>2017<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">125<\/td><td>ISO 14708-4<\/td><td>Implants for surgery \u2014 Active implantable medical devices \u2014 Part 4: Implantable infusion pump systems<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">126<\/td><td>ISO 14708-5<\/td><td>Implants for surgery \u2014 Active implantable medical devices \u2014 Part 5: Circulatory support devices<\/td><td>2020<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">127<\/td><td>ISO 14708-6<\/td><td>Implants for surgery \u2014 Active implantable medical devices \u2014 Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">128<\/td><td>ISO 14708-7<\/td><td>Implants for surgery \u2014 Active implantable medical devices \u2014 Part 7: Particular requirements for cochlear and auditory brainstem implant systems<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Post-Market Surveillance &amp; Vigilance Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">129<\/td><td>ISO\/TR 20416<\/td><td>Medical devices \u2014 Post-market surveillance for manufacturers<\/td><td>2020<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">130<\/td><td>ISO\/TS 5137<\/td><td>Medical device maintenance management programme for healthcare delivery organizations (HDO)<\/td><td>2026<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">131<\/td><td>ISO\/TR 18965<\/td><td>Medical devices \u2014 Examples of the application of the risk management process to cardiac valve replacement and repair systems<\/td><td>2025<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\" colspan=\"4\"><strong>Cosmetic &amp; Personal Care Product Standards<\/strong><\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">132<\/td><td>ISO 22716<\/td><td>Cosmetics \u2014 Good Manufacturing Practices (GMP) \u2014 Guidelines on Good Manufacturing Practices<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">133<\/td><td>ISO 24444<\/td><td>Cosmetics \u2014 Sun protection test methods \u2014 In vivo determination of the sun protection factor (SPF)<\/td><td>2019<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">134<\/td><td>ISO 24442<\/td><td>Cosmetics \u2014 Sun protection test methods \u2014 In vivo determination of sunscreen UVA protection<\/td><td>2022<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">135<\/td><td>ISO 23675<\/td><td>Cosmetics \u2014 Sun protection test methods \u2014 In vitro determination of sun protection factor (SPF)<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">136<\/td><td>ISO 23698<\/td><td>Cosmetics \u2014 Measurement of the sunscreen efficacy by diffuse reflectance spectroscopy<\/td><td>2024<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">137<\/td><td>ISO 16128-1<\/td><td>Cosmetics \u2014 Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients \u2014 Part 1: Definitions for ingredients<\/td><td>2016<\/td><\/tr><tr><td class=\"has-text-align-center\" data-align=\"center\">138<\/td><td>ISO 16128-2<\/td><td>Cosmetics \u2014 Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients \u2014 Part 2: Criteria for ingredients and products<\/td><td>2017<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>How Satori One Click Solutions LLP Can Help<\/strong><\/h2>\n\n\n\n<p>We support medical device manufacturers with:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISO 13485 QMS implementation &amp; certification support<\/li>\n\n\n\n<li>ISO 14971 risk management file development<\/li>\n\n\n\n<li>ISO 10993 biological evaluation planning<\/li>\n\n\n\n<li>IEC 62304 software lifecycle documentation<\/li>\n\n\n\n<li>IEC 62366-1 usability engineering<\/li>\n\n\n\n<li>ISO 20417 labeling compliance<\/li>\n\n\n\n<li>Sterilization validation (ISO 11135, 11137, 17665)<\/li>\n\n\n\n<li>Cleanroom compliance (ISO 14644 series)<\/li>\n\n\n\n<li>Post &#8211; Market surveillance &amp; vigilance (ISO\/TR 20416)<\/li>\n\n\n\n<li>Regulatory submissions (FDA, CDSCO, TGA, Health Canada, EU MDR)<\/li>\n<\/ul>\n\n\n\n<p><strong>Contact us:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>&#x1f4e7;&nbsp;satoriocs@gmail.com<\/li>\n\n\n\n<li>&#x1f4de; +91 9829098077 \/ +91 9216598077<\/li>\n\n\n\n<li>&#x1f310;&nbsp;<a href=\"https:\/\/satoriocs.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">satoriocs.com<\/a><\/li>\n<\/ul>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The International Organization for Standardization (ISO) has released multiple updated standards for medical devices, IVDs, and healthcare systems in 2025 and 2026. This article provides a&nbsp;comprehensive list&nbsp;of key ISO standards relevant to medical device manufacturers, quality professionals, and regulatory affairs teams. Top Medical Device Standards (Recently Published or Reviewed) Sno. Standard Title Published\/Reviewed 1 ISO [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":825,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"pagelayer_contact_templates":[],"_pagelayer_content":"","footnotes":""},"categories":[1,4],"tags":[148,139,34],"class_list":["post-821","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home","category-medical-device-regulations-global-compliance","tag-iso","tag-iso-13485","tag-medical-device"],"_links":{"self":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/821","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/comments?post=821"}],"version-history":[{"count":1,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/821\/revisions"}],"predecessor-version":[{"id":826,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/posts\/821\/revisions\/826"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/media\/825"}],"wp:attachment":[{"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/media?parent=821"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/categories?post=821"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/satoriocs.com\/blogs\/wp-json\/wp\/v2\/tags?post=821"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}