FDA-recognized standard · General Plastic Surgery/General Hospital

ISO 11810: Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition penetration flame spread and secondary ignition

Yes. FDA recognizes ISO 11810 Second edition 2015-12-15 as recognition 6-363, entered 2016-06-27.

Recognized editions of ISO 11810

FDA recognitions of ISO 11810, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
6-363 ISO 11810 Second edition 2015-12-15 2016-06-27 Complete —

Regulations

FDA lists these classification regulations against ISO 11810: 21 CFR 878.4370.

Product codes that cite ISO 11810

9 FDA product codes cite ISO 11810, including ERY, EYX, EYY, FNW, HMT.

  • ERY
  • EYX
  • EYY
  • FNW
  • HMT
  • HMW
  • KGW
  • LRO
  • MMP

Source: FDA Recognized Consensus Standards database, snapshot of 2026-09-01. Search every recognition in the Consensus Standards Lookup, or browse all standards with a page.