Compliance with the state of art standards is the preferred route to demonstrate compliance with the applicable General Safety and Performance Requirements of the MDR or with the Essential Requirements of the UK Regulation. As few standards are currently harmonized to the regulations, when being assessed against the Regulation, understanding and meeting the requirements of EN 60601 is crucial. EN 60601 represents a state-of-the-art standard and can therefore be applied to show conformity with the applicable Regulations requirements.
Medical electrical equipment and systems
EN 60601 is a group of standards equivalent to the international series of standards IEC 60601 and comprises over 70 individual standards.
For manufacturers to place medical electrical equipment in the EU or Great Britain market a CE or UKCA Certification is required.
Explore EN60601 additional resources
Learn more about EN 60601 and how BSI electrical medical equipment testing services.
What is EN 60601?
Medical electrical equipment and systems.
What is EN 60601 - all you need to know
EN 60601 refers to a series of international standards that pertain to the basic safety and essential performance of medical electrical equipment.
Do you know what the requirements of EN 60601 are?
EN 60601 specifies a set of requirements that medical electrical equipment and systems must meet to ensure safety and essential performance.
Do you know that EN 60601 is part of several schemes globally?
Several schemes operate for EN 60601 to facilitate compliance, certification and market access for medical electrical equipment.
Steps towards compliance with EN 60601
Achieving EN 60601 compliance involves several steps.
Access the standard
An online tool developed by BSI that transforms how medical device and IVD manufacturers manage their regulatory information.
Covers the safety and essential performance of medical electrical equipment and related systems.
EN 60601 testing for your medical electrical equipment
BSI provides you with global reach through local expertise by offering several local testing facilities that allow manufacturers to save time and resources otherwise needed for overseas or long-distance shipments.
Are you an active medical device manufacturer?
Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, contact our expert team who will guide you through the process.
EN 60601 series
EN 60601 covers the safety and essential performance of medical electrical equipment and related systems.
EN 60601-1 Part One or General Standard
EN 60601-1 Part One or General Standard covers basic safety and essential performance for all medical electrical equipment.
EN 60601-2 Part Two or Particular Standards
EN 60601-2 Part Two or Particular Standards include the requirements for specific product groups.
Collateral Standards include requirements for specific aspects related to medical electrical equipment and systems.