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ISO Standards for Medical Devices
The International Standardization Organization (ISO) creates international standards for various industries, including medical devices. These standards are crucial for building high-quality medical devices and ensuring regulatory compliance, as many ISO standards are recognized by authorities like the FDA and the EU. While ISO standards are not legally binding, they serve as essential guidelines for manufacturers. Read further some key ISO standards for medical devices:
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List of ISO Standards for Medical Devices
| No. | Standard | Name |
| 1. | ISO 13485 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| 2. | ISO 14971 | Medical devices — Application of risk management to medical devices |
| 3. | IEC 62304 | Medical device software — Software life cycle processes |
| 4 | ISO 62366-1 | Medical devices – Part 1: Application of usability engineering to medical devices |
| 5 | ISO 11135 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 6. | ISO 15223-1 | Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements |
| 7. | ISO 80369-1 | Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements |
| 8. | ISO 11607-1 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 9. | ISO 11607-2 | Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes |
| 10 | ISO 11137-1 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 11. | ISO 14155 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| 12. | ISO 19001 | In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
| 13 | ISO/TR 24971 | Medical devices — Guidance on the application of ISO 14971 |
| 14 | ISO 11737-2 | Sterilization of healthcare products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilized product |
| 15. | ISO 16571 | Systems for evacuation of plume generated by medical devices |
| 16. | ISO 20916 | In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice |
| 17. | IEC 80001-1 | Safety, effectiveness and security in the implementation and use for connected medical devices or connected health software — Part 1: Application of risk management |
| 18. | IEC/TR 80002-1 | Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software |
| 19. | IEC/TR 80002-2 | Medical device software — Part 2: Validation of software for medical device quality systems |
| 20. | IEC/TR 80002-3 | Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304) |
| 21. | ISO 10993-1 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| 22. | ISO 10993-2 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| 23 | ISO 10993-4 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| 24. | ISO 10993-5 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity |
| 25. | ISO 27186 | Active implantable medical devices — Four-pole connector system for implantable cardiac rhythm management devices — Dimensional and test requirements |
| 26. | ISO 15194 | In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation |
| 27 | ISO 15883-1 | Washer Disinfectors — Part 1: General requirements, terms and definitions and tests |
| 28. | ISO 15883-2 | Washer Disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. |
| 29 | ISO 15883-5 | Washer Disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy |
| 30. | ISO 9626 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
| 31. | ISO 11117 | Gas cylinders — Valve protection caps and guards — Design, construction and tests |
| 32. | ISO 16142-1 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 33. | ISO 16142-2 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| 34. | ISO 17664-1 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices |
| 35. | ISO 17664-2 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices |
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| 36. | ISO 12052 | Health informatics — Digital imaging and communication in medicine (DICOM) including workflow and data management |
| 37. | ISO 14117 | Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| 38 | ISO 19223 | Lung ventilators and related equipment — Vocabulary and semantics |
| 39 | ISO/IEEE | Health informatics — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature |
| 11073- 10101 | ||
| 40 | ISO 13482 | Robots and robotic devices — Safety requirements for personal care robots |
| 41. | ISO 18113-1 | In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements |
| 42 | ISO 22610 | Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration |
| 43. | ISO 23640 | In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents |
| 44. | ISO 23747 | Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
| 45. | ISO 28620 | Medical devices — Nonelectrically driven portable infusion devices |
| 46. | ISO 14708-1 | Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer |
| 47 | ISO 14708-2 | Medical devices — Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers |
| 48. | ISO 14708-5 | Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices |
| 49. | ISO 20417 | Medical devices — Information to be supplied by the manufacturer |
| 50. | ISO 22442-1 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| 51. | ISO 8871-1 | Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -1: Extractables in Aqueous Autoclaves |
| 52. | ISO 8871-2 | Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -2: Identification and Characterization |
| 53. | ISO 8871-3 | Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -3: Determination of Released-Particle Count |
| 54. | ISO 8871-4 | Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -4: Biological requirement and test method |
| 55. | ISO 8871-5 | Elastomeric Parts for Parenteral and For Devices for Pharmaceutical Use – Part -5: Functional Requirements and Testing |
| 56. | ISO 11040-4 | Pre-fillable Syringe, Part 4: Glass barrels for injectables and sterilized sub assembled syringes ready for filling |
| 57. | ISO 11040-5 | Pre-filled Syringes, Part 5: Plunger Stoppers for Injectables |
| 58. | ISO 11040-7 | Prefill able Syringe, Part 7: packaging systems for sterilized sub assembled syringes ready for filling |
| 59. | ISO 11040-8 | Requirements and test methods for finished prefilled syringes |
| 60. | ISO 4802-1 | Glassware – Hydrolytic Resistance of The Interior Surface of Glass Containers, Part 1: Determination By titration method And Classification |
| 61. | ISO 4802-2 | Glassware – Hydrolytic Resistance of The Interior Surface of Glass Containers, Part 2: Determination by Flame Spectrometry and Classification |
| 62 | ISO 15378 | Primary Packaging Materials for Medicinal Products – Particular Requirements for the Application of ISO 9001: 2008, With Reference to Good Manufacturing Practice (GMP) |
| 63 | ISO 10993-1 | Biological Evaluation of Medical Devices – Part-1: Evaluation and Testing |
| 64. | ISO 10993-7 | Biological Evaluation of Medical Devices – Part-7: Ethylene Oxide Sterilization Residuals |
| 65. | ISO 13485 | Medical Devices – Quality Management Systems – Requirements for Regulatory Purpose |
| 66 | ISO 7886 – 1 | Sterile hypodermic syringes for single use |
| 67. | ISO 14971 | Medical Devices- Application of Risk Management to Medical Devices |
| 68. | ISO 720 | Glass – Hydrolytic Resistance of Glass Grains a 121º C – Method of Test and Classification |
| 69. | ISO 7864 | Sterile Hypodermic Needles for Single Use |
| 70 | ISO 9626 | Stainless steel needle tubing for manufacture of medical devices |
| 71 | ISO 10993-4 | Biological evaluation of medical devices – Selection of tests for interactions with blood |
| 72. | ISO 10993-5 | Biological evaluation of medical devices – Tests for in vitro cytotoxicity |
| 73 | ISO 10993-6 | Biological evaluation of medical devices – Tests for local effects after implantation |
| 74. | ISO 10993-10 | Tests for irritation and skin sensitization |
| 75. | ISO 10993-11 | Test for systemic toxicity. |
As an ISO 13485 medical device consultant, we provide guidance about QMS to the medical device industries and make sure that our clients know the benefits of ISO 13485 Certification for their organization.
ISO 13485 CERTIFICATION- MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS — REQUIREMENTS FOR REGULATORY PURPOSES
Edition: 3rd edition
Publication Year: 2016
ISO/TC 210 Technical Committee For medical devices, quality management, and related general factors are important.
ISO 13485 outlines the quality management system criteria for medical device manufacturers (QMS). The standard lays out the QMS standards that must be met in order to demonstrate that the manufacturer is capable of producing safe and effective medical devices that suit user needs while also adhering to all applicable regulations.
ISO 14971 - MEDICAL DEVICES — APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
Edition: 3rd edition
Year of Publication: 2019
ISO/TC 210 Technical Committee For medical devices, quality management, and related general factors are important.
The procedure for risk management of medical devices, software as a medical device (SaMD), and in vitro medical devices is outlined in ISO 14971. The standard lays out a procedure for medical device manufacturers to identify hazards, assess the risks they pose, and implement risk controls. The standard’s definition of risk management applies to all stages of the medical device lifecycle and should be a continuous effort.
IEC 62304 - MEDICAL DEVICE SOFTWARE — SOFTWARE LIFE CYCLE PROCESSES
Edition: 1st
Year of Publication: 2015
ISO/TC 210 Technical Committee for medical devices, quality management, and related factors are important.
The IEC 62304 standard establishes a framework for the processes, activities, and tasks that occur during the lifecycle of medical device software. Software as a Medical Device (SaMD), software as a component of a medical device, or software utilized in the creation of a medical device are all covered by this standard.
ISO 62366-1 - MEDICAL DEVICES – PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES
Edition: 1st
Year of publication: 2015
Technical Committee: ISO/TC 210
The usability engineering process for medical devices, also known as human factors engineering, is outlined in ISO 62366-1. The standard provides manufacturers with instructions on how to assess and mitigate any hazards connected with the device’s routine use, as well as how to analyze, design, and evaluate the usability of their medical device.
ISO 11135 - STERILIZATION OF HEALTH-CARE PRODUCTS – ETHYLENE OXIDE – REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
Edition: 2nd
Year of Publication: 2014
ISO/TC 198 Sterilization of medical devices is a technical committee.
ISO 11135:2014 establishes requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both industrial and healthcare environments, taking into account the similarities and variations between the two applications.
ISO 15223-1 - MEDICAL DEVICES – SYMBOLS TO BE USED WITH INFORMATION TO BE SUPPLIED BY THE MANUFACTURER – PART 1: GENERAL REQUIREMENTS
Edition: 4th
Year of publication: 2021
ISO/TC 210 Quality management and related general elements for medical devices is a technical committee.
ISO 15223-1:2005 Specifies the symbols that medical device manufacturers will use to indicate certain information that they provide with their products. These symbols can be found on the medical equipment’s package, supporting material, or even on the device itself.
ISO 14155 - CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS- GOOD CLINICAL PRACTICE
Edition: 3rd
Year of publication: 2020
ISO/TC 194 Biological and clinical evaluation of medical devices is a technical committee.
Good clinical practice for clinical investigations involving human beings is defined by ISO 14155. The standard covers the planning, execution, and reporting of studies intended to assess the safety and efficacy of medical devices in real-world settings.
ISO 13482 - ROBOTS AND ROBOTIC DEVICES – SAFETY REQUIREMENTS FOR PERSONAL CARE ROBOTS
Edition: 1st
Year of publication: 2014
ISO/TC 299 Robotics is a Technical Committee.
The International Organization for Standardization (ISO) 13482 specifies the parameters for creating safe and effective personal care robots. The standard applies to mobile servant robots, physical assistance robots, and personal carrier robots, and covers their design, protective measures, and information. ISO 13482 identifies the dangers that these robots pose, as well as rules and standards for limiting or eliminating the risks that come with their use.
ISO 23640 - IN VITRO DIAGNOSTIC MEDICAL DEVICES — EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
Edition: 1st
Year of publication: 2011
Clinical laboratory testing and in vitro diagnostic test systems- ISO/TC 212 is Technical Committee.
ISO 23640 defines the criteria for determining the stability of reagents used in IVDs. When manufacturers are aiming to generate data for IVD reagent shelf life, IVD reagent stability after first opening, and the monitoring of IVD reagents already on the market, this standard can be employed.
We as an ISO 13485 consultant help to create the documents for ISO 13485 certification. Operon Strategist Medical Device Consultancy provides regulatory ISO standards guidance to their clients so that they can take maximum benefit of it. Also provides other QMS services like FDA 21 CFR Part 820 Quality System Regulations and MDSAP Regulations for medical device manufacturers. Contact us now.
