3660 Microwave Oven Product Report

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OMB No. 0910-0025; Exp. May 31, 2010
Section: eRadHealth Menu

Role

What is your role?
Note:

[L]
If you are acting as an agent of the actual manufacturer, please select your role, for example, Importer or Consultant. Later in
the report, under Manufacturer Data, you will be prompted to enter both manufacturer and submitter information.

Submission Information

FDA or State Inspector

Abbreviated Report Applicability

OEM Laser Applicability

Section: Manufacturer Data

Introduction

Electronic Product Radiation Safety Reporting
Form
This software application is intended to automate the hard copy product reporting forms in the effort of
the Center for Devices and Radiological Health (CDRH) to become capable of accepting electronic
submissions from industry and to improve our review process. This FDA Electronic Submission
(eSub) software is the next version of the application developed to allow us to accept all Radiological
Health reports and other submissions electronically and improve the ability of CDRH to accomplish its
mandated product and industry evaluations in a timely and efficient manner.
All electronic reports and correspondence can either be transferred to CD and mailed to the address
below, or can be sent via the FDA Electronic Submissions Gateway to CDRH. If you follow
instructions to set up an account with the FDA Gateway, when you submit through it you will receive
your acknowledgement email message with Accession Number within minutes!

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Information about the FDA Electronic Submissions Gateway can be found at www.fda.gov/esg. Please
contact the Gateway Helpdesk with your questions about that system.
Electronic submissions on CD should be mailed directly to the Document Control Center at:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Submissions received in the mail on CD will be processed within a few days of receipt.
You should be familiar with the regulatory requirements for radiological products at
www.fda.gov/cdrh/radhealth/ and medical devices available at www.fda.gov/cdrh/devadvice/. If
you have specific questions about the regulations, please contact us at: [email protected].
If you have specific questions regarding this software, please contact the eSub team by email at:
[email protected].
Thank you for using our electronic product reporting software. Please communicate your comments
and suggestions to the eSub team as often as you like.
Thank you for your continued support of the FDA Electronic Submission Program (eSub).
General Information

General Information for Radiological Health
Products
Manufacturers of products subject to performance standards under the Federal Food, Drug, and
Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control are required
to furnish various reports to the Center for Devices and Radiological Health (CDRH).
The Radiological Health staff, CDRH developed this software application for the Product and Annual
reports. This application will assist manufacturers of electronic products that emit radiation in
providing adequate reporting of radiation safety testing and compliance with federal performance
standards. Title 21 of the Code of Federal Regulations (CFR), Parts 1002 and 1003 specify Reporting
and Notification requirements 1,2,3.
Reports submitted on radiation safety of electronic products must follow the appropriate form (21 CFR
1002.7). This software application serves the same report responsibility, so long as the submitter or
manufacturer prints out the cover letter and sends it in along with the CD containing the report files.
The submitter of the report will receive an acknowledgment letter (or email message) with the

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accession number that CDRH assigns to the report. Please reference this accession number in the
future when providing additional information about this model family in either a supplement or the
annual report. If a report is incomplete or inadequate CDRH may reject it and return it for completion.
CDRH will not enter a rejected report into our database.
CDRH DOES NOT APPROVE THESE REPORTS OR THE PRODUCTS BEING REPORTED.
It is the manufacturer's responsibility to certify that their products comply with all applicable standards
(21 CFR 1010 - 1050), based on a testing program in accordance with good manufacturing practices.
Prior to the shipment of products in interstate commerce, 21 CFR 1002 requires the manufacturer to
submit the product and Annual Reports and to comply with all applicable importation requirements
(21CFR 1005). If there are deficiencies, CDRH may disapprove the firm's quality control and testing
program, determine that the product contains a radiation defect, or determine that the product fails to
comply with a standard. CDRH will notify the manufacturer if we make such a determination. CDRH
may require the manufacturer to cease introduction into U.S. commerce until deficiencies are
corrected, and to initiate a corrective action program (21CFR 1003 - 1004) for products already
introduced into commerce.
CDRH can now accept and process 'CeSub' electronic submissions at this time, if all attachments are
PDF files only, and the cover letter is printed out and included with a real signature. Translate any text
that appears in a language other than English into English in a complete and accurate manner. Keep a
copy (save a copy to your hard drive) of the completed report in your records.
We are providing our new software applications for the old reporting forms upon request during this
beta testing period of development in Spring, 2005. Other regulatory information is still available on
the Internet under www.fda.gov/cdrh/radhealth/. No copyright exists for these forms.
Reproduce these forms as needed. If you would like to comment on the reporting forms, website, or
future electronic submissions, you may direct the comments to [email protected].
A complete Product Report is required for each product model or model family. Product Reports are
now more generally referred to as Radiation Safety Reports to distinguish the Radiological Health
submissions from medical device submissions. CDRH suggests that a complete report on one model of
a family be submitted, with a separate Supplemental Report for each of the other models in the family.
The Supplemental Report should respond in detail to the parts of the form where there are differences
to report, referencing the number of the affected item. Items that are unchanged will still appear in the
supplement from the original report.
When new models of a product are introduced, if the models satisfy the criteria for an established
reporting exemption or if the new models do not involve changes in radiation emission or performance
requirements, then the manufacturer need not report the models prior to introduction into commerce.
Rather, the manufacturer is only required to identify them in the annual report, or in quarterly updates
to the annual report. Quarterly updates to annual reports may be submitted using the Annual Report
software included in this application. [See 21 CFR 1002.13(c).]
All symbols, units, and unusual terms in the report must be adequately defined and consistently used.
Please use the terms as defined in Section 1040.10(b) and in the IEEE Standard Dictionary of
Electrical and Electronic Terms (IEEE Std. 1001972 and ANSI C42.1001972).
Definitions

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Definitions for Rad Health Products
Manufacturers
Manufacturer is any person or organization engaged in the business of manufacturing, assembling, or
importing of electronic products (21 CFR1000.3(n)). Manufacturers of electronic products subject to
21CFR1000-1050 must:
z

z
z
z

z

z
z
z

Design and manufacture their products to be in compliance with applicable performance
standards;
Test their products to assure compliance;
Certify compliance of their products;
Maintain test and distribution records and a file of correspondence concerning radiation safety,
safety complaints, and inquiries;
Use the published reporting forms or electronic software application to submit reports to CDRH,
including Product reports describing the manner of compliance of the product design and testing
program and Annual Reports summarizing their compliance testing;
Report accidental radiation occurrences (i.e., possible, suspected,or known exposures);
Report any radiation defects or noncompliances; and
Recall (i.e., repair, replace, or refund the purchase price of) defective or noncompliant products.

Accidental Radiation Occurrences
An accidental radiation occurrence means a single event or series of events that has/have resulted in
injurious or potentially injurious exposure of any person to electronic product radiation as a result of
the manufacturing, testing, or use of an electronic product.

Importers
Importer is any person of organization engaged in the business of importing electronic products. An
importer is considered to be a manufacturer. The requirements for Manufacturers given above also
apply to importers if the requirements have not been done by the foreign manufacturer.

United States Agent for Foreign Manufacturers
Every manufacturer of electronic products, prior to offering such product for importation into the
United States, shall designate a permanent resident of the United States as the manufacturer`s agent
upon whom service of all processes, notices, orders, decisions, and requirements may be made for and
on behalf of the manufacturer as provided in section 536(d) of the Radiation Control for Health and
Safety Act of 1968 (21U.S.C. 360mm(d)) and this section. The agent maybe an individual, a firm, or a
domestic corporation. For purposes of this section, any number of manufacturers may designate the
same agent.

From The Federal Food, Drug, and Cosmetic ActSec 536 [21 U.S.C. 360mm](d)
Designation of agent for purposes of service
It shall be the duty of every manufacturer offering an electronic product for importation into the United

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States to designate in writing an agent upon whom service of all administrative and judicial processes,
notices, orders, decisions, and requirements may be made for and on behalf of said manufacturer, and
to file such designation with the Secretary, which designation may from time to time be changed by
like writing, similarly filed. Service of all administrative and judicial processes, notices, orders,
decisions, and requirements may be made upon said manufacturer by service upon such designated
agent at his office or usual place of residence with like effect as if made personally upon said
manufacturer, and in default of such designation of such agent, service of process, notice, order,
requirement, or decision in any proceeding before the Secretary or in any judicial proceeding for
enforcement of this part or any standards prescribed pursuant to this part may be made by posting such
process, notice, order, requirement, or decision in the Office of the Secretary or in a place designated
by him by regulation.
Sec. 531 [21 U.S.C. 360hh] (1) the term ''electronic product radiation''means:
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the
result of the operation of an electronic circuit in such product.
Sec. 531 [21 U.S.C. 360hh](2) the term ''electronic product''means:
(A) any manufactured or assembled product which, when in operation,(i) contains or acts as part of
an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would
emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component, part, or
accessory of a product described in clause (A) and which when in operation emits (or in the absence
of effective shielding or other controls would emit) such radiation.
Burden to Industry

Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 26 hours per
response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, completing, and reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of this collection of information, including
suggestions for reducing this burden to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number."

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Manufacturer and Report Information

Information:

This general report requests names, addresses, phone numbers, etc. for your firm, various officials of your firm, consultants
who may assist in preparing the report, parent firm (if any), importer and designated agent (for foreign firms). Some of this
information is mandatory and its absence will prevent you from completing the report submission. You can check for missing
data using the "Missing Data" report from the "Output" menu.
If you are acting as an agent or consultant for another firm who is certifying the product (or laser light show), please enter the
certifying manufacturer and list yourself as the report submitter, below.

Information:

Attention: Variance Applicants
If you are acting as an agent or consultant for, or on behalf of, or filing for, a company that will be manufacturing or producing
a Class IIIb or IV projector or laser light show or both which require an approved variance, the following explanations may
provide further clarification.
Manufacturer: This is the firm or company who is requesting the variance, will certify the product or show, and will be the
holder and owner of the variance. This is not the agent or consultant who may be filing this report or Variance request for the
manufacturer; that agent may be the submitter, identified in a later screen.
Responsible Individual: This person works for the Manufacturer and is responsible for compliance of the projector and/or
show. In the case of laser light shows, he or she may be the company president, CEO, or the laser light show head operator
or a manager who oversees the shows.
Reporting Official: This person works for the Manufacturer and is responsible for reports, recordkeeping, and submitting FDA
required documents and correspondence.

Manufacturer Responsible for Product Compliance

Note:

This is the firm that takes responsibility for certification that the product meets the performance standard. This firm develops
and maintains the quality control and testing program that is the basis for the certification of this product. Additionally, this firm
usually is the owner of the product design and manufacturing process design.

Select the Manufacturer's address from the Establishment Address book:
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Responsible Individual

Note:

The responsible individual is the highest level and most responsible individual affiliated with this establishment.

Select the Responsible Individual from the Contact Address book:

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Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Manufacturer's Reporting Official

Note:

This is the person at the manufacturing facility that is knowledgeable and responsible for addressing all aspects of the testing
and quality control procedures for certification as reported to FDA in the product report. Documentation of changes intesting
and quality control procedures submitted to FDA must be signed by this individual.

Select the Reporting Official from Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Report Submitter

Note:

The submitter maybe a consulting individual or firm providing assistance in report preparation and maintenance. All
documents prepared by the submitter must have the manufacturer's reporting official signature for authenticity of submitted

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documentation.
Select the Submitter from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Comments:

Internal Reference Number:

Parent Establishment

Is there a parent establishment?

[L]

Select the Parent Establishment and Contact from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:

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Address

Manufacturer Designated United States Agent

Note:

Manufacturers exporting to the U.S. must designate a U.S. agent, see 21 CFR 1005.25.

Is there a United States agent that has been designated by the manufacturer?

[L]

Written Agreement

Item: 1 (could contain up to 10 items with none required)

Note:

If any of the required responses below do not apply to your designated agent, enter 'NOT APPLICABLE' or 'NA.'

Select the Designated Agent from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address
Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
Attach a copy of written agreement with the designated U.S. agent:
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Importer

Item: 1 (could contain up to 10 items with none required)

Select the Importer from the Contact Address book:
Contact Information:
Contact Name
Occupation Title
Email Address

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Establishment Information:
Establishment Name
Division Name
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address

Additional Manufacturing Locations

Item: 1 (could contain up to 100 items with none required)

Note:

If any of the products certified in this report are manufactured at locations other than listed in the Manufacturer Responsiblefor
Product Compliance section, then the names, addresses, and FDA registration numbers should be provided. In addition any
codes used on labels to identify a manufacturing location must be provided. Each factory location must assure all production
procedures are followed identically step by step as provided in this report.If the procedures are not the same then separate
reports should be filed.

Select the Manufacturer Address from the Establishment Address book:
Establishment Information:
Establishment Name
Division Name
Home Page
Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Comments:

Code used on identification labels:

Section: Product Data

Product and Model Identification

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At this time we are only accepting electronic versions of reporting guides contained within this software. Other reporting
guides that are not yet electronic are available for downloading from http://www.fda.gov/cdrh/comp/eprc.html.

Product Type Reported

Report Information

Is this submission a supplement to an Annual Report submitted previously for the same reporting year?

[L]

Provide the Accession Number of the original report for which this is a supplement:
(Note: Do not enter any Device Premarket Application or Notification document number here, such as PMAs, 510(k)s, IDEs,
etc.)

Please verify that your accession number matches the report type that is being filed. The third
character of your accession number must correspond with its associated report type as shown in
the table below:
Report Type Description:

Third Character:

Initial Product Report

1

Model Change Product Report

2

Annual Report

3

Abbreviated Report

8

Variance Request

A

Laser OEM Registration and Listing Report R
Are you requesting a new variance, a renewal, extension or amendment to a previous variance?

[L]

If you are requesting a renewal, extension, or amendment, please provide the variance number that was issued by
CDRH.
Stop:

If you are requesting a new variance, renewal, extension, or amendment, you must file a Variance Request separate from this
report. To do this, open a new report (File > New) and select either "Laser Light Show Variance Request" or "Variance
Request, Other" as your Type of Submission in the Submission Information Screen. If you select "Variance Request, Other"
you must select the product for which you are requesting a variance at the end of the screen.

Special Considerations

Note:

Check all items in this section that may apply to this submission.

Noncompliances or Defects

Does this document or any of its attachments contain:
A self-declaration or notification of noncompliance or defect?

[L]

Provide an explanation:

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[Multi-Line Plain Text]

Responses to Noncompliances or Defects

Does this document or any of its attachments contain and of these responses concerning noncompliances?
A refutation of noncompliances?

[L]

A request for an exemption from notification?

[L]

Corrective action plans you may be conducting?

[L]

A description of any design changes that correct noncompliances for future production?

[L]

Provide an explanation:
[Multi-Line Plain Text]

Exemption Requests

Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (1010.5)?

[L]

Exemption for products for government use from reporting and recordkeeping (1002.51)?

[L]

Special exemption of products from reporting and/or recordkeeping (1002.50)?

[L]

Request for approval of alternate labeling?

[L]

Application for alternate test procedures (1010.13)?

[L]

Provide an explanation:
[Multi-Line Plain Text]
Attach any necessary files.
[Multi-Line Plain Text]
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Variance Requests

Message:

Click the plus sign to list the requirements from which you are requesting a variance.

This submission includes an application for a variance from certain requirements.
Item 1
Item 2
Item 3
Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details

[HTML Text]

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File Attachment
Stop:

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[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]
For all Variance requests, two submissions must be made to the FDA.
The electronic version should be submitted following the Packaging Files for Submission instructions located under Output in
the Menu bar, and explained in subsection 4.3 of the User Manual. If sending a CD & submittal letter, please mail to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Attn: eSubmitter Team
Document Mail Center - WO66-0609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Additionally, a paper version (hard-copy) of the signed Variance request document should be submitted to:
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20857

Responses to Communications from FDA

Does this document or any of its attachments contain:
A response to an inspection?

[L]

What was the date of the inspection?

[Date]

A response to a warning letter from the Food and Drug Administration (FDA)?

[L]

What was the date of the Warning Letter?

[Date]

A response to a report review inquiry from the Center for Devices and Radiological Health (CDRH) (the inquiry may have

[L]

been in the form of a letter, email, or phone call)?
What was the date of the inquiry?

[Date]

A response to any other communication from FDA?

[L]

What was the date of the communication?

[Date]

Provide an explanation:
[Multi-Line Plain Text]

Additional Information
Is there any other relevant information or additional comments that would help expedite the review of this submission? Click the plus sign below to
attach any supporting files.
File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

Private Labeling

Is the product sold by other companies under different brand names?

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[L]

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Private Labeling-Table

Item: 1 (could contain up to 20 items with 1 required)

Give the name and address of the manufacturer:
Establishment Information:
Establishment Name
Division Name
Email Address
Address
Address
Telephone Number
Fax Number
Give the firm establishment registration number of the manufacturer listed above (if known):

Enter brand names and/or model designations in the following table by clicking on the Add button. If you prefer to attach a file, please click on the
Add button and enter the text "See File Attachment" as the first table entry.
Item 1
Item 2
Item 3
List of Brand Names and/or Model Designations
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

The Original Equipment Manufacturer (OEM) accession number (if known):

Explain how the brand names and model designations correspond with your own brand names and model designations:
[Multi-Line Plain Text]

Medical Devices
Provide the premarket 510(k), IDE, HDE, PDP, or PMA filing numbers related to this medical product, if one of these numbers has been assigned by
FDA yet.
[Multi-Line Plain Text]

If it has not been assigned yet, provide an explanation and submit it as soon as you receive such a filing number.
[Multi-Line Plain Text]

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See www.fda.gov/cdrh for more information onmedical device premarket clearance procedures.

Document Key: Specialized Response content is defined within straight brackets [ ]; Special code: [L] List of Values.

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Section: Microwave Oven Product

Part 1.0 Model Designation and Specifications

1.1 Identification of Model Family
Provide an identification of a Model Family (Identify by numbers, letters, symbols, or any generic family name that would represent the models to be
listed).

Enter Model designation.
Item 1
Item 2
Item 3
If you use code for the brand name, please attach a list providing the complete address for each importer or distributor of each brand and identify the
codes used.
File Attachment

[Single File Attachment (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

1.2 Magnetron and Waveguide

Please provide photographs and/or engineering diagrams of the waveguide.
File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

1.3 Mode Stirrer or Equivalent Devices

Item: 1 (could contain up to 15 items with 1 required)

Model Designation
Speed of Stirrer (in RPM)
Speed of Turntable (in RPM)
Number of Blades
Method of Drive
Please provide photographs and/or engineering diagrams of mode stirrer. If your oven does not have a mode stirrer, please explain in the Details
space below:

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File Attachment

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Details

[HTML Text]

1.4 Insertion
Can an insulated wire be inserted through any opening in the external surface of the oven into the cavity, waveguide, or other microwave
energy containing spaces while the door is closed, provided the wire, when inserted, would consist of two straight segments forming an

[L]

obtuse angle of not less than 170 degrees?
Warning:

If you answered yes, your product does not comply with the wire insertion requirement. Please review the requirement in 21
CFR 1030.10(c)(2)(iv).

Attach clearly labeled photographs or engineering diagrams which show all external surfaces of a fully assembled oven. Adequate illustrations
should demonstrate that it is not possible to insert an insulated wire through any opening in the external surface into the cavity, waveguide, or other
microwave energy containing spaces.
File Attachment

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Details

[HTML Text]

1.5 Exposed Welds or Seams of the Cavity

Are there any exposed welds or seams of the cavity on the fully assembled oven (such as bottom of oven)?

[L]

Attach clearly labeled photographs or engineering diagrams which show the entire surface of the fully assembled oven (including underneath).
File Attachment

[Multiple File Attachments (.pdf, .jpg, .gif, .tif, .avi, .wmv, .xpt, .xml, .dtd, .sgml, .mol, .xls, .csv, .zip)]

Details

[HTML Text]

1.6 Oven Door

Item: 1 (could contain up to 20 items with 1 required)

Model Designation
The oven door is attached to the main frame by:

[L]

Give a description of your other means by which the oven door is attached to the main frame.
[HTML Text]
Further adjustment or loosening is prevented by (explain):
[HTML Text]
If the door sealing system includes a gasket, which kind is it?

[L]

The type of door latches are:

[L]

If a viewing window is provided, describe its construction and size and the techniques used to control RF emission through it:
[HTML Text]
Attach photographs or engineering diagrams of microwave emission control door features, hinges, gasket, viewing screen, choke, door sealing
system, door latches, etc.

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1.7 Safety Interlocks and Monitor System

Item: 1 (could contain up to 10 items with 3 required)

Note:

Answer the following questions for one safety interlock or monitor system at a time.

Which safety interlock or monitor system are you describing?

[L]

(Location) - Indicate the location of the safety interlock or monitor system
(Concealment) - Is the interlock or actuator hidden from view (is it concealed)?

[L]

(Wire Insertion) - Can a straight wire or other small thin straight object (10 cm in length or less) operate the interlock?

[L]

(Finger Insertion) - Can a small child's finger operate the interlock or actuator?

[L]

(Interlock adjustment) - Can the switch (or bracket on which the switch is mounted) be adjusted to allow the interlock to remain in a "closed"

[L]

position or the monitor to remain open?
(Actuation distance) - How far can the door be opened before the interlock switch actuates (fill in
number and unit, example, 2 mm )
(Monitored) - Is the safety interlock in the monitoring or crowbar circuit?

[L]

(Door Motion) - Is door motion required to operate this interlock?

[L]

(Sequential Operation) - With the door just opening, number the order of interlock actuation, for example, primary interlock = first, secondary
interlock = second, monitor = third, or primary interlock = first, secondary interlock = same time as primary, monitor = second.

1.8 Other Requirements
Can a failure of any single mechanical or electrical component of the microwave oven cause all safety interlocks to be inoperative? [ 21

[L]

CFR 1030.10(c)(2)(ii)]
is there any additional component in the monitor circuit, such as a relay which can disrupt or prevent the function of the monitor system?

[L]

[ 21 CFR 1030.10(c)(2)(v)]
Can interlock failures distrupt the monitoring functions? [ 21 CFR 1030.10(c)(2)(v)]

[L]

Attach schematic and wiring diagram for each model or Model Family. Be sure the required safety interlocks and monitor are clearly labeled or
identified in the schematic or wiring diagram.
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Attach an explanation of how the monitor system works when the safety interlock(s) fail(s) to perform its (their) required function(s). Be sure to
explain the sequence of operation when safety interlock(s) fail(s).
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1.9 Attachments

Attach photographs or engineering diagrams of safety interlocks, monitor and support brackets.
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Attach photographs or engineering diagram of latches (external and internal) in relation to the safety interlocks and monitor. Be sure to show
dimensions of access areas where the latches enter to actuate the safety intelocks and monitor.
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Attach photographs or engineering diagrams of concealed safety interlock(s) to show how it (they) cannot be activated by a small child's finger or a
straight wire (10 cm in length). Please include dimensions.
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Part 2.0 Labeling Requirements

Information:

21 CFR 1010.2 requires that a legible certification label or tag be permanently affixed and accessible to view on a fully
assembled oven. The following statements are given as examples which satisfy the requirements of 21 CFR 1010.2:
1. "This oven complies with DHHS Radiation Performance Standards, 21 Subchapter J," or
2. "This product complies with applicable sections of DHHS Federal Performance Standard 21 CFR 1030.10"
21 CFR 1010.3 requires that a legible identification label be permanently affixed and accessible to view on a fully assembled
oven. The identification label should contain the full name and address of the manufacturer; and the date (month and year) of
manufacture must be spelled out completely without abbreviation. The place of manufacture may be expressed in code
provided the manufacturer has supplied the key to such code to CDRH (as a supplement to the annual report).
21 CFR 1030.10(c)(6)(i) requires that a legible user warning label be permanently affixed and be readily viewable during
normal oven use. This label must also have the title emphasized, and be so located as to elecit the attention of the user. The
exact wording of the user warning label is specified in 21 CFR 1030.10(c)(6)(i).
21 CFR 1030.10(c)(6)(ii) requires that a legible service caution label be permanently affixed and be readily viewable during
servicing. This label must also have the title "CAUTION" emphasized and be so located as to elecit the attention of the service
personnel. More than one service warning label may be needed if there is more than one access entry to the internal
mechanism of the oven. The exact working of the service caution label is specified in 21 CFR 1030.10(c)(6)(ii)
21 CFR 1030.10(c)(4) - User instructions or manual - For each model family, submit a representative draft or final sample of
user instructions which will contain adequate instructions for safe use. These instructions must include the required clear
warnings of the "PRECAUTIONS TO AVOID POSSIBLE EXPOSURE TO MICROWAVE ENERGY ..." statements specified in
21 CFR 1030.10(c)(4).
21 CFR 1030.10(c)(5) - Service Instructions or manual - For each model family, submit a representative draft or final sample
of the service manual. The service manual must contain adequate instructions for service adjustments and service
procedures. These instructions must include the required clear warnings of the "PRECAUTIONS TO BE OBSERVED
BEFORE AND DURING SERVICING TO AVOID POSSIBLE EXPOSURE TO EXCESSIVE MICROWAVE ENERGY ..."
statements as specified in 21 CFR 1030.10(c)(5).

2.1 Labels and Radiation Warnings

Certification label [ 21 CFR 1010.2]: Describe location of the certification label on the product
[HTML Text]

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Is the label permanent and legible?

[L]

Identification label [ 21 CFR 1010.3 ] : Describe location of the identification label on the product
[HTML Text]
Is the label permanent and legible?

[L]

Is the place of manufacture expressed in code?

[L]

Provide addresses for each code.
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User Warning label [ 21 CFR 1030.10(c)(6)(i) : Describe location of the User Warning label on the product
[HTML Text]
Is the label permanent and legible?

[L]

Service Caution label [ 21 CFR 1030.10(c)(6)(ii) ] : Describe location of the Service Caution label on the product
[HTML Text]
Is the label permanent and legible?

[L]

2.2 Label Attachments
Attach a copy of each of the following labels:
a. Certification label
b. Identification label
c. User warning label
d. Service caution label
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2.3 Attach User and Service manuals

Attach a copy of the draft or final user manual and service manual.
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Section: Technical Data

Part 3.0 Special Tests on Pre-Production Ovens

Information:

For each model family, provide the results of any special or unique tests performed on preproduction ovens to assure

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compliance of subsequent production ovens with the Federal performance standard. The attachment of results of tests on the
preproduction ovens should include the following:
1. Testing performed to evaluate effects of the environment (heat, humidity, etc.), sensitivity to cavity temperature, effects of
abuse, and the effects of shipping and transporting the oven.
2. Testing to evaluate performance of safety interlocks and monitor switches, door-sealing system, door choke, and other
radiation safety components through life and endurance testing.
3. Testing to evaluate microwave emission characteristics on the external surfaces ( vents, door-sealing system, door choke,
underneath the oven, etc.) prior to actuation of safety interlocks and monitor switches in both normal mode and worse case
mode; microwave emission sensitivity to load placement; and stirrer modulation effects on microwave emission.
The special test should also include results of testing performed on the monitor system ( or crowbar circuit). The summary of
the results should include the conditions of the safety interlocks and monitor system before and after the tests and description
of how the monitored safety interlock(s) was (were) defeated. The monitor system should render the oven inoperable (such as
fuse blowing) and servicing is required.

3.1Special Tests on Pre-Production Ovens
Attach the results of special or unique tests necessary to evaluate the performance of the safety interlocks, monitor, microwave emission at all
surfaces, transportation testing, life and endurance testing of radiation safety components.
File Attachment

[Multiple File Attachments (pdf)]

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3.2 Testing of the Monitor System

Attach a description of how the monitor system works when one or both safety interlocks failed, and how the oven is rendered inoperable.
File Attachment

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Details

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Section: Quality Control

Part 4.0 Incoming Inspection and Subassembly Testing

Message:

Part 4.0 must be completed in its entirety for the Quality Control Report only. Any addenda or changes to this Part should be
reported as a supplement to the Quality Control Report using appropriate Part D - Supplement to Product Reports. Quality
Control Report or Annual Report.
Part 4.0 addresses all applicable quality control and testing procedures for incoming inspection and subassembly testing of
critical radiation safety components which you consider to be a vital and necessary part of your testing program to ensure
compliance of your finished products with the Federal performance standard 21 CFR 1030.10. This shall include (but not be
limited to) incoming inspection andlor subassembly testing of such items as safety interlocks and monitor switches, wire
harnesses, magnetron gasket, waveguide and cavity assemblies, door and door assemblies, door sealing system, door
viewing screen and noncertified microwave oven modules.
4.1 - For each critical safety component listed on the corresponding form, use as many of the keys to test parameters
identified below as necessary to describe the parameters of each test conducted during incoming inspection or subassembly
testing. In addition, use the notation (100) or (S) to describe whether the tests are done on a "100 percent basis" or "sampling
basis." If no tests are done to the component, use the notation (NT) for "no test."
Keys to Test Parameters:
D = dimension check
E =electrical continuity or performance
F = function test
RF = microwave emission measurement
V = visual inspection

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W = weld integrity (destructive or non-destructive)
Example:
Cavities and waveguides: VIS, W/S, DIS
Wire harnesses:NT
Magnetron gasket: V/l00
Microwave oven modules: E/l00, RF/S, F/l00

4.1 Incoming Inspection and Component Tests

Item: 1 (could contain up to 16 items with 8 required)

Select the next component to be described
Message:

[L]

For each test parameters, select the type of test plan used

Dimension check

[L]

Electrical continuity or performance

[L]

4.2 Control of components
Are the incoming components adequately controlled to prevent their use until quality control tests are completed and lot acceptability is

[L]

determined?
Are the rejected lots of components adequately marked or secured so the rejected parts are not used in production unless reworked?

[L]

Part 5.0 Production Line and Final Tests
5.1 General Tests and Microwave Emission Tests

When are the following tests performed?
Door installation and adjustment checks

[L]

Safety interlocks and monitor continuity function checks

[L]

Microwave emission hazard test over waveguide, cavity seams and magnetron area prior to installing cabinent

[L]

Amount of door travel before secondary safety interlock actuation

[L]

Open door (shut off) operation tests

[L]

Presence and content of required labels ( such as certification, identification, service and user caution labels)

[L]

Microwave emission test of door viewing screen

[L]

Microwave emission test of door perimeter

[L]

Microwave emission test of door perimeter with door pullled out and all safety interlocks operating

[L]

Microwave emission test of door perimeter with door pulled out and only secondary safety interlocks operating

[L]

Microwave emission test of door hinge, control panel, vents and louvers

[L]

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Microwave emission test of underneath the oven (if there is exposed cavity under the oven)

[L]

Microwave emission tests performed by an automated microwave oven scanner

[L]

5.2 Description of Quality Control Checks

Are the written procedures or diagrams available or posted in the working area for the individual performing the quality control checks?

[L]

Are repaired or adjusted ovens returned to the assembly line at a point prior to the test that caused their rejection?

[L]

Are all repaired or adjusted ovens, regardless of the nature of the repair, returned to the assembly line for the open door operation test and

[L]

final microwave emission tests?

5.3 Test Procedures
Section 5.3.1. Attach written quality control test procedures for testing continuity of safety interlocks and monitor switches. You may attach the entire
quality control and testing procedures but please indicate where the specific test procedures are located.
These procedures should include the following:
A) A brief outline of the procedures for function tests of each safety interlock switch (primary and secondary) and monitor. Also describe electrical
continuity checks of each switch along with as much related wiring as possible.
B) A sample schematci with test points identified.
C) A list of instruments and test equipment and description of preoperational checks. Describe any special testing apparatus or devices.
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Section 5.3.2. Attach written quality control test procedures for performing open door restart operation. You may attach the entire quality control and
testing procedures but please indicate where the specific test procedures are located.
This open door restart operation test procedure must be performed on every fully assembled oven. An open door operation test procedure is an
excellent quality control test to prevent any oven that will operate with the door open from being introduced into commerce. The test should incude a
check that operation ceases when the door is opened and an attempt to restart the oven while the door is unlatched. Any signs of microwave power
can be monitored by either an ammeter or RF emission. The restart check should be done with the oven both programmed, and not programmed, for
operation for electronic controller ovens; with and without time on the timer for electromechnanical timer ovens.
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Section 5.3.3. Attach written quality control test procedures for assesing the performance of the secondary safety interlock. You may attach the
entire quality control and testing procedures but please indicate where the specific test procedures are located.
This section requests written quality control procedures for assessing the performance of secondary interlock design that interrupt power to the oven
(interlock actuates) after the door starts to move. These quality control tests assure that this secondary safety interlock will prevent "microwave
radiation in excess of 5 milliwatts per square centimeter at any point 5 centimeters or more from the external surface of the oven," as stated in 21
CFR 1030.10(c)(2)(v). If the oven design employs a latch actuated secondary safety interlock that interrupts power to the oven before there is
outward door movement, this part is not required.
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Section 5.3.4. Attach written quality control test procedures for repair and retesting of defective ovens found on the production line. You can attached
the entire quality control and testing procedures but please indicate where the specific test procedures are located.
You should describe the following information:
A) A description of all quality control checks done on the repaired or adjusted ovens, such as hazard RF emission, electrical continuity of safety

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interlocks and monitor, and tests of any other radiation safety components required to confirm proper operation.
B) A description of how all ovens set aside for repair and or adjustment re-enter the production line.
C) A sample of the record or form used to retain the model, serial number, nature of defect and repair, and the results of all retesting conducted.
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5.4 Final RF Emission Testing of Fully Assembled Ovens

Information:

Attach written quality control test procedures for testing continuity of safety interlocks and monitor switches. You may attach
the entire quality control and testing procedures but please indicate where the specific test procedures are located.

Section 5.4.1 (A) - Physical and electrical conditions under which tests are made (such as line voltage, test load, test load placement, test load
temperature, turntable rotation, power on/off, full power setting, door open, door pulled, door closed, secondary interlock only RF emission test.
Section 5.4.1 (B) - Adjustment, if any, made during the test and specific procedures and criteria for making adjustments.
Section 5.4.1 (C) - Instruments and test equipment used to make each test, including preoperational instrument checks and descriptions of any
special testing apparatus or devices such as door shims or door pull devices.
Section 5.4.1 (D) - Description of microwave emission measurement procedures, including survery meter scanning procedures, surface and areas
surveyed for RF leakage, scanning speed, and type of spacer probes used to maintain constatn distance from oven surface.
Section 5.4.1 (E) - RF reject limit and its basis, such as instrument manufacturer's assessment of calibration error, stirrer modulation effects,
turntable modulation effects, scan speed.
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Section 5.4.2 Provide a sample copy of the record used to retain the results of final emission tests. If an automated microwave oven scanner
(AMOS) is used, inlcude samples for both hand-held testing and AMOS testing.
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Section 5.4.3 Attach a flowchart diagram of the production lines describing the quality control stations, final test areas, repair bays and audit testing
stations.
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Part 6.0 Quality Audit
For each quality control procedures listed, fill in the appropriate sampling rate, or use the notation, "NP" to indicate that this procedure is
not performed in audit. Your sampling rate answer can be similar to any of the following examples: (ovens per lot), e.g., "20/1000";
(percentage of today's production), e.g. "10%"; (ovens per quarter), e.g., "5/quarter"; (ovens per year), e.g., "4/year"; or (not performed),
e.g., "NP".
Safety interlocks and monitor continuity function checks
Microwave emission hazard test over waveguide, cavity seams and magnetron area prior to installing
cabinet
Microwave emission hazard test over waveguide, cavity seams and magnetron area prior to installing
cabinet
Amount of door travel before secondary safety interlock actuation.

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Open door (shut off) operation tests.
Insertion test by finger or wire into concealed safety interlock(s) and cavity
Presence and content of required labels (such as certification, identification, service and user caution
labels)
Check for required precaution statements in user and service manuals

RF EMISSION TESTS
Microwave emission test of door viewing screen
Microwave emission test of door perimeter
Microwave emission test of door perimeter with door pullled out and all safety interlocks operating
Microwave emission test of door perimeter with door pulled out and only secondary safety interlocks
operating
Microwave emission test of door hinge, control panel, vents and louvers
Microwave emission test of underneath the oven (if there is exposed cavity under the oven)
Microwave emission tests performed by an automated microwave oven scanner

Part 6.1 Quality Control Procedures Conducted in Audit

Attach a copy of the written quality control test procedures for testing continuity of safety interlocks and monitor switches and their related wiring.
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Attach copy of written quality control test procedures for performing open door restart operation.
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Attach copy of written quality control procedures for assessing the performance of the secondary safety interlock.
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Are the written procedures or diagrams available or posted in the working area for the individuals performing the quality control checks?

[L]

Please explain how the firm can ensure that the proper quality control testing procedures are being followed.
[Multi-Line Plain Text]
Attach a sample copy of the record used to retain the results of the quality control checks in audit.
File Attachment

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Part 6.2 Audit Program

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Attach a sample copy of the audit record used to retain the results of the quallity control checks in audit, including the reject limit value for RF
emission.
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Attach an internal quality control audit document that contains all oven audit procedures. Include all the equivalent information requested in Part 5.4.
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Attach a copy of the internal quality control document that contains the audit corrective action plan that would be followed should any ovens selected
for audit testing fail to meet the audit test criteria. The description of the audit plan should include at least the following information:
A. Classification of radisation safety and compliance defects such as excessive RF emission, safety interlocks and monitor not performing their
intended functions, failure of the open door operation check, absence of the required labels, etc, and their rejection criteria.
B. Plan of action following audit failure, including any resampling.
C. Sample of document or record used to retain test results from corrective action plan including: type of compliance related defect, sample size,
selection, and corrective action or decision taken by responsible or supervisory audit personnel.
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Part 7.0 Life and Endurance Testing
This Part relates to all applicable life and endurance test procedures to determine the ability of the oven and its subsequent model family to comply
with the Federal performance standard throughout its normal life. Attach the internal quality control document and a sample of the test results
including the following information:
A. Frequency of life testing (weekly, monthly, or quarterly).
B. Test length (short term and long term).
C. Rf leakage tests (start of test, every fixed cycles, and end of test).
D. Rf emission reject limit.
E. Safety interlocks and monitor continuity checks (start of test, every fixed cycles, and end of test).
F. Active Monitor check at end of endurance test.
G. Sample of actual record used to retain the results of life and endurance test.
File Attachment

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Part 8.0 Instrumentation and Calibration Checks

Manufacturers must use properly calibrated microwave leakage measurement instruments in their
production and audit testing and quality control programs to assure compliance with the Federal
Performance Standard for Microwave Ovens, 21 CFR 1030.10. This Part is divided into 5 major
segments. 1. Type of microwave survey instruments aand their measurement errors ( total polarization
ellipticity allowed) 2. Daily Checks and recordkeeping. 3. Thirty-Day calibration constancy checks and
recordkeeping. 4. Repair of survey instruments and calibration instruments. 5. Annual calibration and
periodic calibration.

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8.1 Identification of Compliance Test Instruments
Attach document which provides the name of the compliance survey instrument, model number, and how many are used in the production
department, engineering department and audit department. You can attach a copy of an operation manual of the compliance survey instrument.
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8.2 Daily Check

Is a preoperational check made on each microwave survey instrument in accordance with the instrument manufacturer's recommendation?

[L]

Is a polarization ellipse check performed on each instrument each day the instrument is used for compliance instrument?

[L]

Is the following formula used to calculate the percent of polarization ellipticity of each instrument?

[L]

( MAXIMUM - MINIMUM) / MEAN x 100 = _______(%) TOTAL
What formula is used (type in formula below)? If you prefer, you may attach a file showing the formula for calculating the percentage of polarization
ellipticity of each instrument.
File Attachment

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Is each instrument that is found to exceed the maximum polarization ellipticity limit rejected until the instrument is repaired and

[L]

recalibrated?
During the daily check, is the spacer cone checked on each survey meter and replaced if it is worn or dirty?

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What type of microwave source instrument is used for performing the daily check?
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Is the probe holding fixture on the daily check instrument designed to prevent any horizontal, vertical and transverse motion while the probe

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is being rotated during ellipticity check?
Is a daily record used to retain the model number, serial number, probe serial number, date of check, percent of polarization ellipticity, entry

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for accept/reject criteria, and any other information on the corrective action to to any instrument that exceeds the limit?
Attach a sample copy of the sample daily check record for the daily check
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8.3 Thirty Day Constancy Check
Please provide the manufacturer name and model number of the instrument intercomparison system that is used to perform the thirty-day constancy
check. Please attach a copy of the user operating manual.
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Is a preoperational check made on the LCR in accordance with the instrument manufacturer's recommendation?

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Is the initial reference RF field set by adjusting the RF power level (with the LCR probe positioned at the mean of its polarization ellipse)

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until the LCR is reading 1 mW/cm^2 ?

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Which of the following is used to establish the initial reference field (1 mW/cm^2 ) within the 30 day constancy check system?

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Which of the following is used to re-establish the reference field (1 mW/cm^2) for subsequent constancy checks?

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After the initial reference field (1 mW/cm^2 ) is established, does the technician perform the polarization ellipticity of the LCR to determine

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that it does not exceed the maximum polarization limit specified by the instrument manufacturer?
Is a thirty-day operational log record used to retain the date of the check, LCR polarization ellipticity (minimum, maximum, mean, and

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percentage deviation from mean) and RPM net power readings (RPM difference readings)?
Please attach a sample copy of the thirty-day operational log record with data filled out.
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For whichever instrument is used (LCR or RPM) to re-establish the reference field, are the previous readings for the other instrument
compared with the present readings to ensure that they do not differ more than 10 percent (highest to lowest readings between annual LCR

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calibration)?
After the reference field is reset, is the polarization ellipticity of each compliance instrument including the LCR shown not to exceed the

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maximum polarization ellipticity limit specificed by the instrument manufacturer?
After all the compliance instruments have been checked, does the calibration technician perform a self-comparison check for all similar
compliance instruments including the LCR by reviewing or plotting on a graph all of the minimum and maximum polarization readings since
the last annual LCR calibration to ensure that the LOWEST mimimum reading does not differ from the HIGHEST maximum reading by

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more than 2 dB?
Is a 30-day check record maintained including the model number, probe serial number, date of check, LCR and RPM readings, instrument

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polarization readings, accept/reject criteria, and repair history for each compliance survey instrument?
Please provide a copy of the 30-day record, with data filled out.
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Does the technician maintain a graph plotting the historical mean average values of each compliance instruments (including the LCR ) to

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ensure that the instrument's mean values will be within +/- 5 percent of its historical mean average values?
Please provide a sample graph or table used to record the instrument's historical mean average values.
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8.4 Repair and Calibration of Compliance Test Instruments

Repair and re-calibration of the microwave survey compliance instruments are performed by the following firm(s):
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Please provide a copy of the written procedures for having instruments repaired and re-calibrated.
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Repair and re-calibration of the LCR, RPM, and any other 30-day calibration instruments are performed by the following firm(s):
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Each time the LCR or RPM is sent out for calibration or repair, do you begin all of your instrumentation records again?

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8.5 Annual Calibration and Periodic Calibration

Are the LCR and RPM instruments returned to the instrument manufacturer or other qualified calibration facility for annual calibration?

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How often are the compliance survey instruments returned to the instrument manufacturer or other qualified calibration facility for periodic calibration
( at least once every year ) unless they have been sent out for repair and re-calibration?
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Part 9.0 Recordkeeping

Information:

This part requests confirmation that the manufacturer is maintaining records as required by 21 CFR 1002.30 These records
basically consist of:
A - Written quality control procedures
B - Quality control test results
C - Life and Endurance test results
D - Copies of written communication between the manufacturer and dealers, distributors and purchases concerning radiation
safety
E - Dealer, distributor, purchaser shipment records.

Are records maintained for the results of tests for the electronic product radiation safety, including control of unnecessatry secondary or
product leakage radiation, the methods, devices and procedures used in such tests, and the basis for selecting such methods, devices and

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procedures?
Are the records maintained of tests for durability and stability of the product?

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Are the results of quality control tests conducted on the production line kept for a minimum of one year after filing the annual report for

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these records?
Are the quality control audit records, documentation of defective ovens found in audit and the results of audit reaction plan kept for

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minimum of five years?
Is a file maintained of all written communications between manufacturer, dealers, distributors, and purchasers concerning radiation safety
including complaints, investigations, instructions, or explanations affecting the use, repair, adjustment, maintainence or testing of the

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microwave oven manufactured by your company?
Where is the file located?

Is a file maintained of records necessary for tracing of microwave ovens to distributors, dealers and purchasers?

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Have all the dealers and distributors been informed of their obligations or requirements to obtain the information required by 21 cfr 1002.4

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(b) (purchaser information) in order to permit tracing of specific products to specific purchasers?
Manufacturer can trace shipment to dealers/distributors or purchasers by:

[
[
[
[

] Model number
] Serial number
] Date of manufacture
] Other:

Please specify other methods

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