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INTERNATIONAL STANDARDS FOR MEDICAL DEVICES

ISO 10993 is a global standard that confirms medical devices are biocompatible. It ensures that the materials used are not toxic and do not cause adverse or harmful reactions such as irritation.

Testing involves a risk-based approach. This takes into account the intended application and also how long the device will be in contact with the human body. Devices are tested for:

  • cytotoxicity – to confirm that cells are not harmed
  • sensitisation – to ensure there are no allergic reactions
  • haemocompatibility – for devices that come into in contact with blood.

IEC 60601 is a widely recognised international standard that covers the basic safety and essential performance of medical electronics. Important aspects include electrical and mechanical safety, electromagnetic compatibility (EMC) and the environment in which the device will be used.

Again, a risk-based approach is used for testing. Tests are aligned closely with ISO 14971, the standard for risk management in medical devices. Compliance with ISO 60601 is essential for UKCA marking in the UK, CE marking in the EU, and FDA approval in the USA.

ISO 14971 sets out a structured process to quantify and manage risks in the development of medical devices. This includes the identification, estimation, evaluation, control and benefit analysis of risks.

Every medical device must have a formal risk management plan that defines the activities, responsibilities and acceptance criteria for managing risks throughout its operational life. Device lifecycles are critical, including design/development, production, use and post-marketing surveillance (such as monitoring incident reports and feedback from users).

ISO 13485 is a management quality standard that is often aligned with ISO 14971. It requires the implementation of comprehensive design and development processes (design planning, inputs and outputs, reviews/verifications and validation) along with documentation and traceability, production and process controls, correction and preventative actions (CAPA), customer and regulatory feedback, personnel competence and training.

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