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European standards for medical devices and personal protective equipment freely available

In response to the coronavirus outbreak european standardization organizations CEN and CENELEC agreed in collaboration with all their Members and after the request from the European Commission, to make freely available a series of standards for medical devices and personal protective equipment used in the context of the COVID-19 pandemic. You may download these standards on SFS webshop after having logged in.

For more information please read the press release on CEN-CENELEC website.

Dowloading the standards for medical devices and personal protective equipment

The standards listed below are made freely available. If you wish to download them, please log in the SFS webshop. The log-in is requed for watermarking the publications. If you do not yet have the user ID for SFS webshop, you need to register in the service. After login you can download the publications at the information page of each publication by clicking Open.

SFS-EN 149 Respiratory protective devices. Filtering half masks to protect against particles. Requirements, testing, marking

SFS-EN 166 Personal eye-protection. Specifications

SFS-EN 14126 Protective clothing. Performance requirements and tests methods for protective clothing against infective agents

SFS-EN 14605 Protective clothing against liquid chemicals. performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

SFS-EN 13795-1 Surgical clothing and drapes. Requirements and test methods. Part 1: Surgical drapes and gowns

SFS-EN 13795-2 Surgical clothing and drapes. Requirements and test methods. Part 2: Clean air suits

SFS-EN 455-1 Medical gloves for single use. Part 1: Requirements and testing for freedom from holes

SFS-EN 455-2 Medical gloves for single use. Part 2: Requirements and testing for physical properties

SFS-EN 455-3 Medical gloves for single use. Part 3: Requirements and testing for biological evaluation

SFS-EN 455-4 Medical gloves for single use. Part 4: Requirements and testing for shelf life determination

SFS-EN 14683 Medical face masks. Requirements and test methods

If you need the following SFS-EN ISO standards, please contact SFS customer service, email sales@sfs.fi, phone +358 9 1499 3353. They will be delivered through email. The standards will be licensed for read-only, and protected with FileOpen. For more information about FileOpen please visit SFS website.

SFS-EN ISO 374-5 Protective gloves against dangerous chemicals and micro-organisms. Part 5: Terminology and performance requirements for micro-organisms risks (ISO 374-5:2016)

SFS-EN ISO 13688 Protective clothing. General requirements

SFS-EN ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process