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Medical device standards are documents that define technical specifications, requirements and best practices for the design, production, testing and use of medical devices.
Standards help protect patients by making sure devices operate safely under various conditions. They also reduce risk by helping manufacturers identify potential hazards before devices reach patients.
Keeping up to date with medical device standards
Standards are constantly evolving. Staying informed is essential for manufacturers, regulatory teams and quality managers.
New ISO or IEC standards are regularly published at the international level. In addition, European standards are developed, some of which may be harmonised under EU regulations🡭.
In our e-shop, you can check whether a standard is harmonised by looking for “Directives and regulations” in the general information section for each standard.
Manually tracking tens of standards in multiple health care areas can be challenging. Instead, we offer a free Information service that delivers these updates directly to your e-mail.
It allows you to receive updates on the standards most relevant to your work across the health care technology field.
Start using the Information service
Register as a user or log in and subscribe to the Information service. Updates are sent only for selected ICS fields (at least one must be selected).
Medical device standards are included in ICS 11 – Health care technology. Select it to receive updates on new and revised standards across the health care technology field.
This covers medical devices, medical equipment, hospital and laboratory technologies, dentistry, sterilization and disinfection, pharmaceutics, first aid, aids for disabled persons, birth control and veterinary medicine.
We will send updates twice per month via e-mail, usually within the first and third working week of the month.
You can manage your Information service anytime through your user account, including adding or removing fields.
Key medical device standards
ISO 13485 – The internationally recognised standard for quality management in medical device manufacturing, ensuring consistent product quality and regulatory compliance throughout the device lifecycle.
ISO 14971 – defines the process for identifying, evaluating and controlling risks, helping manufacturers reduce potential harm and document risk mitigation measures.
IEC 60601 series sets safety and performance requirements for electrical medical devices. IEC 62366-1 guides usability engineering to reduce user errors, while IEC 62304 specifies software lifecycle requirements to ensure reliable and safe device software.
ISO 10993 – provides guidelines for evaluating the biological safety of device materials in contact with patients.
ISO 27799 – applies information security management to health care, helping protect patient data and ensure confidentiality, integrity and availability of health information.