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FDA-recognized standard · General Plastic Surgery/General Hospital

ISO 20698: Catheter systems for neuraxial application - Sterile and single-use catheters and accessories

Yes. FDA recognizes ISO 20698 First Edition 2018-07 as recognition 6-495, entered 2023-05-29.

Recognized editions of ISO 20698

FDA recognitions of ISO 20698, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
6-495 ISO 20698 First Edition 2018-07 2023-05-29 Complete —

Regulations

FDA lists these classification regulations against ISO 20698: 21 CFR 868.5120, 21 CFR 880.5440, 21 CFR 880.5860.

Product codes that cite ISO 20698

6 FDA product codes cite ISO 20698, including LKK, LNY, MAJ, PWH, PYR.

  • LKK
  • LNY
  • MAJ
  • PWH
  • PYR
  • QEH

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.