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2025-08-12
UKCA60601-1 regulations
UKCA60601-1 regulations
UKCA 60601-1 refers to the United Kingdom Conformity Assessment (UKCA) mark and references the medical device safety standard EN 60601-1 (equivalent to the international standard IEC 60601-1). This standard sets out basic safety and essential performance requirements for electronic medical devices and systems. In short, UKCA 60601-1 ensures that medical devices sold in the UK meet safety standards to protect patients and users.
UKCA 60601-1 refers to the United Kingdom Conformity Assessment (UKCA) mark and references the medical device safety standard EN 60601-1 (equivalent to the international standard IEC 60601-1). This standard sets out basic safety and essential performance requirements for electronic medical devices and systems. In short, UKCA 60601-1 ensures that medical devices sold in the UK meet safety standards to protect patients and users.
