ISO standards play an essential role in the medical device industry by ensuring that all the products are safe, reliable, and fulfil regulatory demands. These ISO standards for medical devices manage manufacturers in areas such as quality management systems, biocompatibility, risk management, and also product performance. Following ISO standards also helps decrease risk and improve product quality, which secures global market access because worldwide regulatory authorities know these ISO standards. Now, here is the blog to check all the details related to the ISO standards of medical devices.
Who Formed ISO Standards For Medical Devices?
ISO standards for International Organization for Standardization, it’s an independent, non-governmental international organization along with 169 national standards bodies.
Table of ISO Standards for Medical Devices
In this table, you will get to know about each ISO Standards for Medical Devices and what it denotes to you. The standards are formed to keep all the things updated and as per the guidelines of the CDSCO. It shows that the product is safe to use for consumers and can be sold in the market freely.
| S No. | ISO Standards | Standard Description |
|---|---|---|
| 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 healthcare 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 healthcare products Radiation Part 1: Necessities for improvement, approval and routine control of a disinfection interaction for clinical gadgets |
| 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 of connected medical devices or connected health software Part 1: Application of risk management |
| 18 | IEC/TR 80002-1 | Medical device software Part 1: Direction on the utilization of ISO 14971 for clinical gadget programming |
| 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 10993-4 | Biological Evaluation of Medical Devices Part 4: Selection of tests for interactions with blood |
| 23 | ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity |
| 24 | ISO 27186 | Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices Dimensional and test requirements |
| 25 | 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 |
| 26 | ISO 15883-1 | Washer Disinfectors Part 1: General requirements, terms, definitions and tests |
| 27 | ISO 15883-2 | Washer Disinfectors Part 2: Prerequisites and tests for washer-disinfectors utilizing warm sterilization for careful instruments, sedative hardware, bowls, dishes, recipients, utensils, china, and so on. |
| 28 | ISO 15883-5 | Washer Disinfectors Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy |
| 29. | ISO 9626 | Stainless steel needle tubing for the manufacture of medical devices Requirements and test methods |
| 30. | ISO 11117 | Gas cylinders Valve protection caps and guards Design, construction and tests |
| 31. | 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 |
| 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 Data to be given by the clinical gadget maker for the handling of clinical gadgets 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 |
| 36. | ISO 12052 | Health informatics Digital imaging and communication in medicine (DICOM) including workflow and data management |
| 37. | ISO 14117 | Active implantable medical devicesElectromagnetic compatibility EMC test conventions for implantable cardiovascular pacemakers, implantable cardioverter defibrillators and heart resynchronization gadgets |
| 38. | ISO 19223 | Lung ventilators and related equipment Vocabulary and semantics |
| 39. | ISO/IEEE 11073-10101 | Health informatics Device interoperability Part 10101: Point-of-care medical device communication Nomenclature |
| 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 | Careful curtains, outfits and clean air suits, utilized as clinical gadgets, for patients, clinical staff and gear Test technique to decide the protection from wet bacterial entrance |
| 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 Non-electrically 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 |
Why ISO Standards for Medical Devices Matter in the Medical Industry?
ISO standards matter in the medical industry the most as they help manufacturers by promoting continual improvement, adhering to regulatory requirements, and guaranteeing patients’ safety. All the ISO standards offer set up for organizations to grow and improve the quality management system, process of risk management and also security information practices that coordinate with international best practices.
Non-ISO Standards
Besides, ISO standards, the medical standards and the medical industry manufacturers are managed by many non-ISO standards and regulatory needs that make sure that every patient is safe, products are efficient, and improvements are continuous. These incorporate yet are not restricted to:-
- IWA1 –
- American Society for Quality (ASQ) standards.
- Standards Council of Canada (SCC) standards.
- USP 797 Pharmaceutical Compounding
- HIPAA (Health Insurance Portability and Accountability Act)
- USP 800 Hazardous Drugs
- ANSI/AAMI EC13
- ANSI/AAMI ST79
- ASTM F1862
- ASTM F2100
- CLSI M100
Conclusion – ISO Standards for Medical Devices
ISO standards are essential for medical devices to be safe, effective, and reliable. By adhering to these special standards, manufacturers can increase their products, decrease dangers, and earn trust from customers nationwide. ISO standards assist in quality management, software development and sterilization procedure.
FAQ
How do ISO Standards Help in the Validation of Medical Device Software?
ISO standards, such as IEC 62304, support guiding the development and testing of software utilized in medical devices. This makes sure that software is correct, and reliable and decreases the possibilities of failure and harm.
How Does ISO 14155 Ensure that Clinical Trials for Medical Devices are Safe and Reliable?
ISO 14155 establish rules for how clinical trial of medical devices needs to be carried out. It guarantees that the trials are morally, safely and completed so doctors and patients can trust the result.
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