Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

031

Date of Entry 08/06/2013 

FR Recognition Number

12-253

Standard

IEC  60976 Edition 2.0 2007-10
Medical electrical equipment - Medical electron accelerators - Functional performance characteristics

Scope/Abstract

This International Standard applies to medical ELECTRON ACCELERATORS when used, for therapy purposes, in human medical practice.

This standard applies to medical ELECTRON ACCELERATORS which deliver a RADIATION BEAM of either X-RADIATION or ELECTRON RADIATION with NOMINAL ENERGIES in the range 1 MeV to 50 MeV at maximum ABSORBED DOSE RATES between 0,001 Gy s-1 and 1 Gy s-1 at 1 m from the RADIATION SOURCE and at NORMAL TREATMENT DISTANCES between 50 cm and 200 cm from the RADIATION SOURCE.

The present standard describes measurements and test procedures to be performed by the MANUFACTURER at the design and construction stage of a medical ELECTRON ACCELERATOR but does not specify ACCEPTANCE TESTS to be performed after installation at the purchaser's site. The accompanying report, IEC 60977, however, does suggest that many of the test procedures are appropriate for ACCEPTANCE TESTS.

The measurement conditions described in the present standard differ from those previously in use. This applies particularly to the PHANTOM position for measurements and the measurement of distances from the ISOCENTRE. These new conditions should be substituted for and not be added to previous methods.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

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

Regulation Number	Device Name	Device Class	Product Code
§892.5050	Accelerator, Linear, Medical	Class 2	IYE

Relevant FDA Guidance and/or Supportive Publications*

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

Nancy Wersto   FDA/OC/CDRH/OPEQ/OIDRH/DRH/NMRTB/   301-796-6548   nancy.wersto@fda.hhs.gov

Amarjeet Bhullar   FDA/OC/CDRH/OPEQ/OIDRH/DMQS/PMB/   301-796-5917   Amarjeet.Bhullar@fda.hhs.gov

Standards Development Organization

IEC International Electrotechnical Commission http://www.iec.ch/

FDA Specialty Task Group (STG)

Radiology

*These are provided as examples and others may be applicable.