Medical Device Standards 

There are many standards that help manufacturers to comply with regulations that apply to medical devices. There are some standards that apply to the complete medical device lifecycle, e.g. the establishment and maintenance of a quality management systems and how to perform risk management throughout the lifecycle of the product. There are also other standards that apply to specific kinds of medical devices, e.g. if your medical device contains software. We highlight a few of these medical device standards.

What are the standards for medical devices?

Compliance with a regulation is mandatory while compliance with a standard is voluntary. However, many countries around the world have regulatory requirements that are covered (to a greater extent) by applicable standards, so complying with the medical device standards is often in your favour as a medical device manufacturer.

There are many standards that apply directly to medical devices. There are some standards that apply to a complete medical device lifecycle, e.g. the establishment and maintenance of a quality management systems and how to perform risk management throughout the lifecycle of the product. There are also other standards that apply to specific kinds of medical devices, e.g. if your medical device contains software.

In the end, every medical device has its own list of standards with which it needs to comply with to be ready for certification. This list depends on the type of the medical device.

ISO 13485

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes is an international standard that specifies the requirements for a quality management system (QMS) targeted to the medical devices industry and that applies throughout the medical device’s lifecycle.

ISO 13485 applies to all medical devices.

ISO 13485 is a medical device standard that has been created to be used from initial conception to production and post-production, and includes final decommissioning and disposal. Requirements for storage, distribution, installation and servicing, and the provision of related services are also specified.

The latest version of this medical device standard is ISO 13485:2016 and an organization can be certified to be ISO 13485 compliant.

Read more about ISO 13485 here.

ISO 14971

ISO 14971, Medical devices — Application of risk management to medical devices is a standard for the application of risk management to medical devices. This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle.

ISO 14971 applies to all medical devices.

ISO 14971 can help a manufacturer identify risks, incorporate safety features into the design of the medical device, establish protective measures that can protect or warn the user against potential risks, and provide detailed written safety guidance for the medical device.

The latest version of this medical device standard is ISO 14971:2019.

Read more about ISO 14971 here.

IEC 62304

IEC 62304, Medical device software — Software life cycle processes is a standard that defines the life cycle requirements for software that is used in a medical device.

IEC 62304 only applies to medical devices that contain software.

This standard helps manufacturers by describing processes, activities, and tasks that supports the establishment of a common framework for medical device software life cycle processes.

The latest version of this medical device standard is IEC 62304:2006.

IEC 60601-1

IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance is a standard that applies to the basic safety and essential performance of electrical medical equipment.

IEC 60601-1 is the parent of a series of standards relating to the safety of medical electrical equipment. This series contains Collateral Standards which specify additional requirements covering specific aspects, e.g. 60601-1-2 covering EMC (Electromagnetic Compatibility)

The IEC 60601-1 standard and its collateral standards only applies to electrical medical equipment.

How can I find out which standards apply to my medical device?

Every medical device has its own list of standards with which it needs to comply with to be ready for certification. This list depends on the type of the medical device.

If you would like to find out which standards apply to your medical device, please contact our team at regulations@arrowfast.tech.

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