Description
The purpose of this document is to establish procedures for laboratory testing of microwave ovens that are certified by the manufacturer as being in compliance with the OHHS Performance Standard for Microwave Ovens published in 21 CFR 1010 and 21 CFR 1030.10.
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.
Requires 100,000 cycles of operation for endurance testing
Requires 200,000 cycles of operation for endurance testing
Stakeholders
2Entity responsible for submitting NDINs
Personnel assigned to ensure compliance by individuals with the requirements of part 121
Regulatory Context
Attributes
8Minimum endurance requirement for household ovens
setting required for the oven during the survey
Measurement unit for microwave radiation
Electrical characteristic of the microwave oven.; Electrical characteristic of the oven; voltage level set using a Variac during testing
Minimum endurance requirement for commercial ovens
A required characteristic for user precaution, service caution, and certification labels.
labels must remain legible under normal conditions of use
Measured using specific instruments during tests
Identified Hazards
Hazards
2Safety hazard inherent in testing microwave ovens.; Safety concern if emissions exceed 5 mW/cm²
Cautionary note regarding presence of hazards during testing
Related CFR Sections (3)
- 21CFR1010.3§ 1010.3 Identification.
(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such prRead full regulation →
- 21CFR1010.2§ 1010.2 Certification.
(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.Read full regulation →
- 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 (8)
- Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products (Laser Notice 42) (Status: Final)
- Quality Control Guide for Sunlamp Products (FDA 88-8234) (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Compliance Guide for Cabinet X-Ray Systems (Status: Final)
- Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 398.600 Certification and Identification of X-ray Components - Sections 1010.2 and 1020.30(e) (Status: Final)
- Quality Control Practices for Compliance with the Federal Laser Performance Standard (Status: Final)