EU Commission Updates Recognized Standards List for PPE Regulation

The Commission of the European Union (EU) has released an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Regulation (EU) 2016/425 concerning personal protective equipment (or PPE).

The PPE Regulation, which took effect in April 2018, replaced the EU’s original PPE Directive (89/686/EEC). The Regulation is aligned with the EU’s new Legislative Framework policy and includes slight modifications to the scope and risk categorization of products.

Under the Regulation, personal protective equipment is defined as “equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person’s health and safety hazards.” Specifically excluded from the scope of the Regulation is equipment designed specifically for use by armed forces or law enforcement personnel, equipment to be used for self-defense (except for that intended for sporting activities), and equipment intended for the protection or rescue of individuals on vessels or aircraft.

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Demystifying IEC 60601: A Practical Guide For Understanding The Standards

This whitepaper demystifies the IEC 60601 family of medical electrical safety standards, explaining general, collateral, and particular requirements and how they impact global market access. It offers practical guidance on integrating compliance, risk management, and testing strategies early to streamline regulatory approval and accelerate time to market.

The extensive list of CEN and Cenelec standards was published in the Official Journal of the European Union and replaces all previously published standards lists for the Regulation.

Read the complete updated standards list for the EU’s PPE Regulation.

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