eCFR Reference Browser

---

title: "21 CFR §898.11"

source: "https://www.ecfr.gov/current/title-21/section-898.11"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "898"

part_subject: "PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES"

subpart_code: "B"

subpart_subject: "Requirements for Specific Medical Devices"

section_number: "898.11"

section_subject: "Applicability."

cfr_reference: "21 CFR 898.11"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

Electrode lead wires and patient cables intended for use with a medical device shall be subject to the performance standard set forth in § 898.12.

§898.11 - Applicability.