Description
This manual sets forth guidance and procedures for field testing microwave ovens for compliance with the microwave emission and safety interlock operation requirements of the Federal radiation safety performance standard. It presents background material and complete instructions for carrying out the necessary tests and also describes procedures for completing form FD 2536, "Microwave Oven Field Test Record," which is used to report the data to the Bureau of Radiological Health. It has been prepared to provide a detailed reference document that will be particularly useful to FDA, State, and local radiation control personnel responsible for the field testing of microwave ovens.
Scope & Applicability
Product Classes
4The specific product category subject to this guidance.
product listed under 21 CFR 1002.61; compliance survey instruments for microwave ovens; Compliance survey instruments for microwave oven compliance; The subject of the compliance survey instruments being calibrated.; Compliance survey instruments for microwave ovens.
Ovens produced prior to the effective date and not certified.; Ovens manufactured before the performance standard was effective
Ovens required to meet the standard and have certification labels.
Stakeholders
5Personnel who perform testing programs for enforcement of the performance standard.
Regional Radiological Health Representative
ensure that the function of all controls are clearly understood by the surveyor.
Provides decoding information for manufacture dates and model lists.
Entity responsible for submitting NDINs
Regulatory Context
Attributes
6Specific topic of importance for diagnostic x-ray equipment.; Required on identification labels in Month and Year format.; Determines which performance standards are applicable; required on identification labels
change the response time in the Slow position to the 3 seconds allowed by the standard
Operating frequency for specific General Electric combination ranges.; Unless testing an oven known to operate at 915 MHz
wavelength of the microwave frequencies involved; Standard microwave frequency for household ovens; Operating frequency for virtually all microwave ovens.; frequency selector switch should always be set to 2450
applies to all ovens manufactured on or after October 6, 1971
ovens manufactured before the effective date of the standard; All prestandard ovens provide only continuous power.
Identified Hazards
Hazards
8The Bureau conducts programs to limit exposure to ionizing and nonionizing radiations.
risks due to strong emissions from the MR system
Microwave emission above the specified limits
minimize the possibility of probe damage or self-exposure to excessive levels of microwave energy.
Risk if ovens are operated without a load.
Radiation leakage that must be monitored and controlled for safety.; Potential leakage or bursts of energy during door opening.; The specific tests to be performed on microwave ovens are closed-door leakage, door-opening leakage, and failed interlock.
door must be designed to prevent the escape of the microwave energy
result in oven damage, e.g., due to overheating of the magnetron
Related CFR Sections (1)
- 21CFR1030.10§ 1030.10 Microwave ovens.
(a) Applicability. The provisions of this standard are applicable to microwave ovens manufactured after October 6, 1971.Read full regulation →
See Also (6)
- Manufacture and Certification of Laser Kits (Laser Notice 13) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) (Status: Final)
- Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) (Status: Final)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Procedures for Laboratory Testing of Microwave Ovens (Status: Final)
- Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only) (Status: Final)