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Standards Stack for Medical Devices

Name: Standards Stack for Medical Devices
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The map of ISO and IEC standards that apply to a typical medical device, from QMS through electrical safety, software, biocompatibility, and usability.

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0 of 10 lessons complete · up next: ISO 13485

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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.
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.
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.
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.
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.
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.
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.
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.
9

Standards

ISO 14155

Good clinical practice for clinical investigations of medical devices.

Why this term here: GCP for device clinical investigations.
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.

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Standards Stack for Medical Devices

ISO 13485

ISO 14971

IEC 60601-1

IEC 60601-1-2

IEC 62304

IEC 62366-1

ISO 10993-1

ISO 11135

ISO 14155

IEC 81001-5-1