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Standard

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.

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.

EN 60601

Covers the safety and essential performance of medical electrical equipment and related systems.

Medical Device
  • EN 60601-1 Part One covers safety and essential performance for all medical electrical equipment.

  • EN 60601-2 Part Two covers the requirements for specific product groups.

  • Collateral Standards cover requirements on specifics for medical electrical equipment & systems.

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Why BSI

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.

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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.

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