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.
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.
Next Steps
Explore EN60601 additional resources
Learn more about EN 60601 and how BSI electrical medical equipment testing services.
EN 60601
Covers the safety and essential performance of medical electrical equipment and related systems.
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EN 60601-1 Part One covers safety and essential performance for all medical electrical equipment.
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EN 60601-2 Part Two covers the requirements for specific product groups.
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Collateral Standards cover requirements on specifics for medical electrical equipment & systems.
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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Insights & Media
EN 60601 series
EN 60601 covers the safety and essential performance of medical electrical equipment and related systems.
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StandardEN 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.
Access the Standard
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Standard
EN 60601-2 Part Two or Particular Standards
EN 60601-2 Part Two or Particular Standards include the requirements for specific product groups.
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Standard
Collateral Standards
Collateral Standards include requirements for specific aspects related to medical electrical equipment and systems.
Access the Standard