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FDA-recognized standard · Cardiovascular

ISO 5841-3: Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers

Yes. FDA recognizes ISO 5841-3 Third edition 2013-04-15 as recognition 3-125, entered 2016-04-04.

Recognized editions of ISO 5841-3

FDA recognitions of ISO 5841-3, newest first (FDA database snapshot of 2026-09-01)
RecognitionEditionEnteredExtentTransition ends
3-125 ISO 5841-3 Third edition 2013-04-15 2016-04-04 Complete —

Regulations

FDA lists these classification regulations against ISO 5841-3: 21 CFR 870.3680.

Product codes that cite ISO 5841-3

5 FDA product codes cite ISO 5841-3, including DTB, LDF, NHW, NVN, NVY.

  • DTB
  • LDF
  • NHW
  • NVN
  • NVY

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.