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medical device, from QMS through electrical safety, software, biocompatibility, and usability. Your progress 0 of 10 lessons complete · up next: ISO 13485 [Start path](/terms/iso-13485?from=standards-stack) 1. 1 [ Standards ## ISO 13485 International standard for medical device quality management systems. Why this term here: The QMS standard that everything else assumes you already comply with. ](/terms/iso-13485?from=standards-stack)Mark done 2. 2 [ Standards ## ISO 14971 International standard for the application of risk management to medical devices. Why this term here: Risk management: cited by nearly every other standard on this list. ](/terms/iso-14971?from=standards-stack)Mark done 3. 3 [ Standards ## IEC 60601-1 General requirements for basic safety and essential performance of medical electrical equipment. Why this term here: General electrical safety for medical electrical equipment. ](/terms/iec-60601-1?from=standards-stack)Mark done 4. 4 [ Standards ## IEC 60601-1-2 EMC requirements for medical electrical equipment. Why this term here: The EMC collateral: increasingly cited on FDA and EU submissions. ](/terms/iec-60601-1-2?from=standards-stack)Mark done 5. 5 [ Standards ## IEC 62304 Lifecycle requirements for medical device software. Why this term here: Software lifecycle: applies whenever software is a device or in a device. ](/terms/iec-62304?from=standards-stack)Mark done 6. 6 [ Standards ## IEC 62366-1 Application of usability engineering to medical devices. Why this term here: Usability engineering lifecycle, harmonized to MDR and cited by FDA. ](/terms/iec-62366-1?from=standards-stack)Mark done 7. 7 [ Standards ## ISO 10993-1 Biological evaluation of medical devices within a risk management process. Why this term here: Biological evaluation: the entry point to the entire ISO 10993 series. ](/terms/iso-10993-1?from=standards-stack)Mark done 8. 8 [ Standards ## ISO 11135 Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. Why this term here: Ethylene oxide sterilization: the dominant EO validation standard. ](/terms/iso-11135?from=standards-stack)Mark done 9. 9 [ Standards ## ISO 14155 Good clinical practice for clinical investigations of medical devices. Why this term here: GCP for device clinical investigations. ](/terms/iso-14155?from=standards-stack)Mark done 10. 10 [ Cybersecurity ## IEC 81001-5-1 International standard defining secure-product-lifecycle activities for health software, including medical devices. Why this term here: Cybersecurity lifecycle for health software: harmonized to EU MDR. ](/terms/iec-81001-5-1?from=standards-stack)Mark done Finished the path? Test yourself with a quiz tailored to these 10 terms. [Take the Standards Stack for Medical Devices quiz](/quiz?path=standards-stack) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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