Snapshot of Road map for CE-certification-from-Notified-Body

Product

Images

CE Compliance Requirements

Applicable Standards

Approximate Time

Surgical Face Mask
  • EN 14683 Full Testing
  • Technical File
  • Appointment of European Authorised Representative
  • Registration with Competetnt Body
  • EN 14683 2 MONTHS
    N 95 Masks
  • EN 149 Full Testing from Notified Body Laboratory
  • Technical File
  • Appointment of European Authorised Representative
  • Registration with Notified Body
  • EN 149 5 MONTHS
    Safety Goggles
  • EN 166 Full Testing from Notified Body Laboratory
  • Technical File
  • Appointment of European Authorised Representative
  • Registration with Notified Body
  • EN 166 10 weeks
    PPE Coveralls
  • EN 13688 + EN 14605 + EN 14126 Full Testing from Accredited Laboratory
  • Technical File
  • EN 13688 + EN 14605 + EN 14126 3 Months
    Automatic Hand Sanitizer
  • EN 60335 Full Testing from ISO 17025 Accredited Lab
  • Technical File
  • Registration with Notified Body
  • EN 60335 40 days
    Spray Disinfectant Tunnel
  • EN 60335 Full Testing from ISO 17025 Accredited Lab
  • Technical File
  • Registration with Notified Body
  • EN 60335 40 days
    Face Shield
  • ASTM F 1862 and 16CFR1610 Testing from ISO 17025 Accredited Lab
  • Registration with Third Party Certification Body
  • ASTM F 1862 and 16CFR1610 40 days