EU Directives to classify protective apparel
Directive 93/42/EEC: applies to medical devices and their accessories. Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer. These products are Class I non-sterile as they are used to limit cross contamination.
Directive 89/686/EEC1: commonly referred to as PPE (Personal Protective Equipment), this text lays down the conditions governing its placing on the market and free movement within the community and the basic safety requirements which PPE must satisfy in order to ensure the health protection and safety of users.