Standard

Medical electrical equipment and systems - EN 60601

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.

To place medical electrical equipment onto the European or Great Britain market manufacturers must obtain CE or UKCA Certification.

Compliance with the state of art standards is the preferred route to demonstrate compliance with the applicable General Safety and Performance Requirements (GSPRs) of the Medical Devices Regulation (MDR) (EU) 2017/745 or with the Essential Requirements (ER) 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.

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What is EN 60601?

Medical electrical equipment and systems.

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Compliance Navigator

An online tool developed by BSI that transforms how medical device and IVD device manufacturers manage their regulatory information.

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What is 60601 - all you need to know

IEC 60601 refers to a series of international standards that pertain to the basic safety and essential performance of medical electrical equipment.

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Do you know what the requirements of the EN 60601 are?

EN 60601 specifies a set of requirements that medical electrical equipment and systems must meet to ensure safety and essential performance.

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Did 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.

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Steps towards compliance with EN 60601

Achieving EN 60601 compliance involves several steps.

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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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