EU Commission updates standards list for PPE Directive

The Commission of the European Union (EU) has an updated list of standards that can be used to demonstrate conformity with the essential requirements of its Directive 89/686/EEC concerning personal protective equipment.

For the purposes of the Directive, personal protective equipment (or PPE) is defined as “any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.” Specifically excluded from the scope of the Directive is equipment designed specifically for private use (such as seasonal outdoor clothing), equipment for use by armed forces or law enforcement personnel, and equipment intended for the protection or rescue of individuals on vessels or aircraft.

The extensive list of CEN and Cenelec standards was published in March 2013 in the Official Journal of the European Union, and replaces all previously published standards lists for the Directive.

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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.

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

 

 

 

 

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