Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
1product 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.
Stakeholders
2Entity responsible for submitting NDINs
Provides specifications and recommendations for annual calibration
Regulatory Context
Regulatory Activities
2testing performed on the production line and audit
Submission to CDRH for review before implementation
Document Types
4sample documentation form for recording calibration data; record kept for every survey instrument for compliance testing; Appendix 3, record of daily instrument verification
record kept on the reference field instruments; Appendix 5 documentation for tracking long-term system constancy.
log maintained for each instrument used in production or audit; Appendix 7, record for every instrument on production line; Log for recording polarization ellipticity readings and instrument details.
Appendix 8, monitors calibration data constancy; Record for tracking instrument readings since last calibration.
Attributes
7determining whether an instrument's calibration is changing with time
Unique identifier for instruments and probes.
Material requirement for the probe-holding fixture to minimize field perturbations.
Determined by the quality and size of the anechoic environment.
field setting of approximately 1.0 mW/cm2
measurement of polarization response error
Checked to ensure instrument accuracy and constancy
Technical Details
Testing Methods
4calibration against absolute standards traceable to NBS
Checking the polarization ellipse of the LCR and compliance meters.
checking for gross shifts in response indicating instrument damage
Appendix 3 record for monitoring polarization ellipticity readings.
Processes
4testing programs to assure compliance with performance standards
Annual calibration of the Laboratory Compliance Reference instrument.
system used for establishing and maintaining calibration constancy
Performed annually for LCR and periodically for other instruments
Identified Hazards
Hazards
1safeguards against radiation exposure
Standards & References
External Standards
1standards for absolute calibration traceability
Specifications
7Criteria for accepting or rejecting instrument performance based on ellipticity error.
Each instrument must meet the limit specified by the manufacturer.
A/B ratio must be less than 1.59 (2 dB) since last calibration.
Nonreference readings must be verified to be within 10 percent of each other.
percentage error limit specified by the instrument manufacturer
Constancy limit for mean readings of compliance instruments
Maximum disagreement allowed between most and least sensitive instruments
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 →