Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

041

Date of Entry 04/04/2016

FR Recognition Number

12-187

Standard

NEMA MS 3-2008 (R2020)
Determination of Image Uniformity in Diagnostic Magnetic Resonance Images

Scope/Abstract

This recommended practice covers steam sterilization in health care facilities. The recommendations are intended to promote assurance of sterility and guide health care personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§892.1000	System, Nuclear Magnetic Resonance Imaging	Class 2	LNH
§892.1000	System, Nuclear Magnetic Resonance Spectroscopic	Class 2	LNI
§892.1000	Coil, Magnetic Resonance, Specialty	Class 2	MOS

Relevant FDA Guidance and/or Supportive Publications*

Guidance for the Submission of Premarket Notification for Magnetic Resonance Diagnostic Devices. Document issued on: November 14, 1998

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073817.htm

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Jana Delfino

FDA/OC/CDRH/OPEQ/OIDRH/DRH/MREPB/

301-796-6503

jana.delfino@fda.hhs.gov

Sunder Rajan

FDA/OC/CDRH/OSEL/DBP/

301-796-4194

sunder.rajan@fda.hhs.gov

Standards Development Organization

NEMA

National Electrical Manufacturers Association