TS EN 14683 Surgical Mask Foundation Training

The TS EN 14683 Surgical Mask Foundation Training is a practical programme covering the scope of the European standard defining performance requirements and test methods for medical face masks, the CE marking obligation, and the technical file preparation process. The training addresses mask types (Type I, II, IIR), bacterial filtration efficiency (BFE), differential pressure and splash resistance tests, and applicable EU legislation. Participants learn about the process of working with a Notified Body, technical file content, and how to prepare the Declaration of Conformity. The training is aimed at surgical mask manufacturers, quality and compliance officers, R&D engineers, and medical product importers.

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1 day / 8 hours Besa Akademi

About the Training

TS EN 14683 is the European standard defining performance requirements and test methods for surgical masks. This training is aimed at manufacturers seeking compliance with the standard, and covers the CE marking obligation and technical file preparation process.

Who Should Attend?

  • Surgical or medical mask manufacturers
  • Quality control and product development engineers
  • Regulatory compliance and certification officers
  • Importers and distributor representatives

Training Content

  • Scope and revision history of TS EN 14683
  • Mask types: Type I, Type II, and Type IIR
  • Key performance tests: BFE, differential pressure, splash resistance, microbial cleanliness
  • Applicable EU legislation (MDR 2017/745, personal protective equipment regulation)
  • Working with a Notified Body
  • Technical file content and Declaration of Conformity (DoC) preparation
  • Quality control practices in the production process

Duration

1 day (8 hours)