FDA 3659 TV (esubmitter)

Submission Report

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Submission Report
eRadHealth Menu
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, it currently may take several weeks,, but
when you submit through it you will receive your acknowledgement email message with Accession
Number within minutes! Or, in the interest of faster turn-around for a one-time urgent report of if
you submit few reports, you may simply fill out this template creating the submission and then at
'Packaging' follow the instructions to transfer the files to a CD to mail in. This method of submitting
your report will be acknowledged by an email with the Accession Number within several days.
Information about the FDA Electronic Submissions Gateway can be found at
www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. 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.
Note about eSubmitter software:
Instructions provided in this software briefly summarize the requirements of the regulations under
the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product

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Radiation Control, that applies to manufacturers of electronic products that emit radiation. The
software provides questions relevant to requirements in the performance standards and may include
explanations or clarification about the performance, labeling, and informational requirements of the
standard. It does not replace the regulations, however, and if there is any conflict between the
software and the regulations, the regulations must prevail. Throughout this application, pertinent
sections of Title 21, Code of Federal Regulations, Chapter I, Subchapter J, are cited in parentheses.
Please consult them before making design or procedural decisions.
Regulatory requirements for radiological products can be found at http://www.fda.gov/RadiationEmittingProducts/default.htm and for medical devices are located at
www.fda.gov/M/devaDvices/default.htm. 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).
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. The OMB control number for
this information collection is 0910-0025 (expires January 31, 2017).
Role
What is your role?
Information:

!* Manufacturer

The following screen provides several options for you to accurately define what type of
eSubmission you intend to create for FDA. Below are explanations of your options. Please
feel free to review this screen, advance to the next screen and view the picklists, but if you're
confused, come back to read this screen again to be certain you are selecting the correct
report or correspondence type you want to create.

Submission Information
Step 1

Use the radio buttons to identify the type of submission you are preparing.
(Supplements should be prepared using the same document type as the original
submission.)

What Type of Submission is this? (Supplements should be submitted
selecting the same document type as the original report.)

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!* (•) Radiation Safety

Report (Product) Report
(21 CFR 1002.10)
( ) Annual Report (21
CFR 1002.13)
( ) Laser Light Show
Documents (all relevant
documents) (21 CFR
1040.11(c))
( ) Correspondence

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( ) Variance Request
(General, not Laser Light
Show) (21 CFR 1010.4)
( ) Laser Original
Equipment/Component
Manufacturer Registration
(21 CFR 1040.10(a)(3)(ii))
( ) Abbreviated Report
(21 CFR 1002.12)
Step 2

After answering the Submission Type question above, one of the questions below
may become active and required (see the blue dot to the right of the question). If there
is an active question, select the appropriate product area or document type from the
question's pick list.

What Type of Product is this Radiation Safety Report about?

!*

Television Receivers, Television Projectors, Video and Computer Monitors containing Cathode Ray Tubes
(CRT)
What Type of Product is this Annual Report about?
What Laser Light Show Document are you filing?
What Type of Correspondence is this?
What Type of Product is this Variance Request about?

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Manufacturer Data
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.
Be sure to enter address information for each tab below:

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
Telephone Number
Fax Number

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:

*

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

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Mailing Location:
Address
Telephone Number
Fax Number

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
Telephone Number
Fax Number

Report Submitter
Note:

The submitter may be a consulting individual or firm providing assistance in report
preparation and maintenance. Documents or submissions such as this one that are prepared
by the submitter must have an accompanying authorization letter from the manufacturer's
reporting official for authenticity.

Select the Submitter from the Contact Address book:

*

Contact Information:
Contact Name
Occupation Title
Email Address
Establishment Information:
Establishment Name
Division Name

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Physical Location:
Address
Telephone Number
Fax Number
Mailing Location:
Address
Telephone Number
Fax Number
Comments:
Internal Reference Number:

Parent Establishment
Is there a parent establishment?

*

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:
Address
Telephone Number
Fax Number

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?

*

Importer

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Additional Manufacturing Locations

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Product Data
Product and Model Identification

Attention - Information about this section
In this section you'll be asked to identify several required or optional things which will help
FDA/CDRH staff to prioritize their reviews. You'll be asked to consider the following aspects:
(1) Identify your product's radiation type and the CDRH Product Code.
(2) Enter an Accession number if this will be a report supplment. If you are preparing a supplement,
you'll see that after entering a valid 7-digit Accession number many questions will no longer be
required (they will either be disabled or will be optional, meaning they will no longer have the blue
dot).
(3) You will also have several questions that are of high significance for FDA/CDRH - why you
might be submitting this report or correspondence. Please read these questions carefully, referring to
the 21 CFR regulations on the website www.FDA.gov if you are unsure if the question is relevant to
your firm's situation.
(4) If you find that you have more information that you want the FDA/CDRH to read but it doesn't
seem to fit under other questions, we have a final "Additional Information" question in this section
which invites you to add comments and/or attach a file that provides further information from your
firm about this submission. This is the place to add that extra information.

Product Type Reported
What is the product code?

*

To select the three letter product code,
- Click the plus sign. You will see a product code filter dialog box.
- Select the appropriate category name from the pick list. You will be provided a list of product codes
from which to choose.
- Select the best match to your product.
- The remaining fields will be filled in for you when you select your product code.
Category
Product Code
Performance
Standard
If Other, provide a category name for this specific product.

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Report Information
Is this the first time you've submitted a report on the particular type of product selected
in the Product Type Reported section?

*

Since this is not the first time you've reported on this type of product, then is this a report
supplement to a previously reported model family?
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. See Accession number description below.)
Are you requesting a new variance, a renewal, extension or amendment to a
previous variance?
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 (General, not Laser
Light Show)" as your Type of Submission in the Submission Information Screen. If you select
"Variance Request (General, not Laser Light Show)r" you must select the product for which
you are requesting a variance with the pick list in the bottom section of the screen.

Special Considerations

Information:

If this product will require a formally approved Variance from a certain performance
requirement, you will need to complete two Reports for FDA, both (1) this Radiation Safety
Report (RSR) on this product, and (2) a Variance Request report. This eSubmitter software
application package includes a general Variance Request form as well as the specific Laser
Light Show Variance Request form. Both the Product RSR file and the appropriate Variance
Request Correspondence file must be submitted to CDRH following the regular files
packaging procedures in this application. Both may be transferred to the same CD or
submitted via the FDA ESG to submit to the FDA/CDRH.
In addition, any Variance Request form must be printed out and the signed hard-copy sent to
FDA's Division of Dockets Management at:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
NOTE: There is no need to send a copy of the CD to Division of Dockets Management.

Noncompliances or Defects
Does this document or any of its attachments contain:
A notification of noncompliance or defect?

*

You may provide an explanation and/or attach a document here:
Details

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Responses to Noncompliances or Defects
Does this document or any of its attachments contain any of these responses concerning
noncompliances or defects?
A refutation of noncompliances or defects identified to your firm?

*

A request for an exemption from notification to purchasers (see 21 CFR 1003.21 and 1003.30)?

*

Corrective action plans you intend to implement to correct noncompliances or defects discovered in
past or current production?

*

Note:

If you are submitting a Corrective Action Plan (CAP) following 21 CFR 1004 and information
on design changes for future production, the design change information must be submitted in
a Radiation Safety (Product) Report or supplemental report. Both the proposed CAP and the
design changes may be submitted in one document if you prepare a product report and
choose to include the CAP in it as a file attachment. Alternatively, you may create a separate
eSubmission for the CAP using the "Correspondence" type template and selecting "Followup correspondence to FDA."

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

*

If you are submitting information on product design changes for future production due to a
discovery of noncompliances or defects in current production, you must use the Radiation
Safety (Product) Report template to create the report . Correspondence templates may be
used to submit other information such as a proposed corrective action plan pertaining to a
noncompliance or defect.

You may add an explanation and/or attach a document here:
Details

Exemption Requests
Does this document or any of its attachments contain:
Exemption of a product for government use from a standard (21 CFR 1010.5)?

*

Exemption for products for government use from reporting and recordkeeping (21 CFR 1002.51)?

*

Special exemption of products from reporting and/or recordkeeping (21 CFR 1002.50)?

*

Request for approval of alternate labeling?

*

Application for alternate test procedures (21 CFR 1010.13)?

*

You may provide an explanation and/or attach any relevant documents here:

Variance Requests
Information:

Please note: in addition to responding to these questions below, a separate General
Variance Request or Laser Light Show Variance Request form must be completed and
submitted to CDRH, with a hard copy sent to FDA's Division of Dockets Management as
instructed below for any variance request. The information requested on this screen does not
constitute the full structured content of the variance request. The 2 types of Variance forms
can be created in eSubmitter by selecting the appropriate Variance submission type under
the eRad Health Menu section of this application.

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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

No Information Provided.

Provide an explanation and attach supporting files, if necessary. Click on the plus sign below to attach files.
Details
Stop:

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 FDA inspection?

*

What was the date of the inspection?
A response to a Warning letter or a Notification of Noncompliance or Defect from the
FDA?

*

What was the date of the Warning Letter or other notification letter?
A response to a report review inquiry from the CDRH (the inquiry may have been in the
form of a letter, email, or phone call)?

*

What was the date of the inquiry?
A response to any other communication from FDA?

*

What was the date of the communication?
Provide an explanation:

Additional Information
Here's your opportunity to add anything else to this submission that you want to tell the FDA!

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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.
Details

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

*

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.

If it has not been submitted yet, or if your device is exempt from premarket clearance or approval, please
provide an explanation. The device regulations can be found in 21 CFR 807 - device manufacturer
registration and device listing.

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Television Data
Model Designation
Model Designation:
Specify which Product Type this TV Product Report is for.

*

Explain:
Specify the Product Display of the Product Type selected above.

*

Product Labeling and Special Information
Labels, Radiation Warnings and Instructions:
What label(s) are you providing information for?

* [ ] Certification Label (21

CFR 1010.2)
[ ] Identification Label (21
CFR 1010.3(a)(l))
[ ] Date of Manufacture
(21 CFR 1010.3(a)(2))
[ ] Critical Component
Warning Label (21 CFR
1020.10(~)(4))

Provide a copy of the exact text of labels that are silk-screened onto or molded into the cabinet or those for
which an actual label is not available. Include an example of the date of manufacture such as "February
1995." Identify the location of each label.
Details
The place of manufacture may be expressed in code provided the manufacturer has supplied the CDRH
with the address(es) corresponding to each code. Please provide CDRH with the address(es) corresponding
to each code for the attached Identification label.
Details

Engineering and Technical Information
Service Instructions, Schematics and Parts List
Service Instructions, Schematics and Parts List:
Which of the following will you be providing?

* [ ] Service Instructions and Schematics
[ ] Complete Service Manual

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Attach copies of the above documents here.

*

Final versions of the service manual will be submitted by (MM/YYYY):

Chassis Family Power Curves and CRT Isoexposure Rate Mimit Curve (IRLC)
Chasis Family Power Curves and CRT Isoexposure Rate Limit Curve (IRLC):
Submit a copy of the CRT manufactureer's 0.5 mR/hr isoexposure rate limit curves (IRLC) for all CRT's
used with the chassis family or selling models being reported.

*

It must also include a graph of: (a) the worst-tolerance chassis power curve, obtained with the worsttolerance components and the worst component failure, and (b) the design-center chassis power curve,
obtained with design-center components and the worst component failure. These two curves (a and b)
must be plotted (with an appropriate scale) on the same graph as the CRT isoexposure curve(s).
Graphical plots should be necessary only when the product employs several different CRT's or is
designed to operate at several different horizontal scan frequencies or input voltages. Clearly label each
curve, including identification of the chassis and failed component.
Details
Are the above mentioned CRT's registered?

*

Provide the EIA or other curve number for the CRT's.
Item

No Information Provided.

Special Radiation Shielding
Special Radiation Shielding:
Does this product include special shielding in addition to the inherent CRT shielding and anode cap
shieldng?

*

Provide the description and specification for the special radiation shielding other than the anode cap. Indicate
components shielded, shielding material and thickness, shielding attenuation characteristics, and
specifications.
Details

Hold-down Saftety Circuits
Hold-down and Safety Circuits:
Does the product have a hold-down or other safety circuit?

*

How many safety circuits does the product contain?

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For each safety circuit, describe the circuit's operation accurately and concisely. Identify the high voltage, B
plus, or beam current at which the circuit operates, and whether it is intended to limit or shut down the unit if
these limits are exceeded.
Details

Engineering Analysis
Note:

This engineering analysis is used to determine whether a given product design has a
sufficient margin of safety with respect to the CRT x-radiation isoexposure rate limit curve,
and thus with respect to the 0.5 mRlhr x-radiation emission limit. The data submitted in
Attachments J-1 through J-6 are important in establishing that the manufacturer has
identified the proper test conditions for each television chassis and is conveying to CDRH the
margin of x-radiation safety of the chassis design. In Attachment J-1 through 5-6, CDRH
requires an engineering analysis of the following:
1. Worst-Tolerance Chassis. A chassis fitted with the worst-tolerance components.
2. Design-Center Chassis. A chassis with design or nominal value components. A preproduction television
product can be used as a design-center chassis.
3. Worst-Comvonent Failure. That single component failure which is determined, by the
engineering analysis, to be most likely to cause the greatest increase in x-radiation emission.
Such analysis must, of course, be confirmed by subsequent measurements.
4. Phase 111 Test Conditions. Those conditions at which the potential to emit x-radiation is
maximized. This includes the Worst-Component Failure and adjustment of all controls and
input voltage to the point or region of the power curve at which x-radiation is maximized, i.e.
the point at which the power curve most closely approaches or most exceeds the IRLC.

Component Failure Data Sheets (Tables J1-J6)

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Quality Control
Quality Control and Testing
Note:

In order to ensure that critical components affecting the radiation safety remain within
specified tolerance limits, components should be sampled to check appropriate parameters.
These components can be checked by the television manufacturer or by the component
vendor. Incoming test procedures or test data provided by the component suppliers must be
sufficient to satisfy the television manufacturer that the components meet design
specifications. Remember, vou, not the component manufacturers, are responsible for the
compliance of your product.

Critical Component Incoming Inspection
Production Inspection and Testing
High Voltage Circuit
High Voltage Circuit:
Specify which type of circuit this product contains

*

Define the type:
Has this circuit been tested on a 100% basis?

*

Provide an explanation for the deviation of 100% testing

*

Details
Percentage of production tested or checked:

*

How has the circuit been tested or checked?

*

Details

Sealed Controls
Sampling Plan and Rejection Procedures
Sampling Plan and Rejection Procedures:
This manufacturer/program is related to:

*

Is this program applicable to all production plants?

*

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Explain and identify programs to applicable production plants in an attachment.
Details
What are the minimum number of units sampled from each
production line each day (or shift)?

*

Samples for x-radiation testing are taken from (check all that apply):
[
[
[
[

*

] Each lot
] Each selling model being manufactured
] A selling model representative of each chassisICRT-size combination within a chassis family
] None of the above

Explain (may include attachment):
Details
Provide the unit rejection limit (mR/hr).

*

What is the action taken if the unit rejection limit is exceeded?

*

Details
Provide the lot rejection limit (mR/hr).

*

What action is taken if the lot rejection limit is exceeded?

*

Details

X-Radiation Testing of Production Sets
X-Radiation Testing of Production Sets:
Provide detailed step-by-step procedures for production x-radiation testing.

*

Details
Do the production test procedures employ a critical component failure or simulation that is different from the
worst component failure determined for the engineering analysis?
Provide information regarding alternate failure selection and justification.
Details

X-Radiation Testing Instruments
Note:

The standard method for detecting x-radiation from TV products is to use a large-area, fastresponse, qualitative survey instrument (such as the Johnson TVX-1 or 1B) for locating
areas of radiation emission and approximating emission levels. A precisely calibrated
instrument (such as the Victoreen 440 RFIC or D) with the proper performance specifications

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(21 CFR 1020.10(~)(2)) should then be used for quantitative results. The CDFW does not
endorse these specific instruments, but rather, uses them as typical examples. Instruments
other than those described here must be identified in Item 6.15 of the guide and fully
described in Attachment L. The maufacturer must assure CDFW that they have a proper
compliance radiation instrument because it must be specifically designed to measure low
energy x-rays and meet the measurement requirements of the Federal Performance
Standard for Television Receivers. 21 CFR 1020.1 O(c)(2).
The quantitative x-radiation survey meter must be appropriate for measuring low energy
x-rays down to 20 keV, which is the approximate energy level that may be emitted by
television products. If not, large correction factors will have to be applied to compensate for
the instrument's inability to respond accurately at the low energy level. It is also important
that the quantitative survey meter comply with the cross-sectional area requirements
specified in the Federal Performance Standard for Television Receivers, 21 CFR 1020.10(~)
(2), as follows:
"compliance with the erposilre rate limit defined in paragraph (c)(l) of this section shall be
determined by measurements made with an instrument, the radiation sensitive volume of
which shall have a cross section parallel to the external surface of the receiver with an area
of ten (10) square centimeters and no dimensions larger than five (5) centimeters."
Measurements with instruments having other areas must be corrected for spatial nonuniformity of the radiation field to obtain the exposure rate averaged over a ten square
centimeter area. The quantitative survey instrument must also be able to operate properly in
the vicinity of electronics equipment which may have large electrostatic, magnetic, andlor
electromagnetic (RF) fields associated with it. The instrument must also have the ability to be
checked daily using some check source and a record of this check should be made and kept.
The quantitative survey instrument must be calibrated at least annually by exposure to an
x-ray field having an exposure rate and energy representative of those to be measured.
The Victoreen Models 440 RF/C and D Radiation Exposure Rate Survey Meters have been
specifically designed to measure low-intensity gamma or x-radiation fields and to meet the
measurement requirements of the Federal Performance Standard for Television Receivers,
specifically 21 CFR 1020.10(~)(2). Response to gamma radiation over the energy range of 6
keV to 1.2 MeV is achievable with field intensities as low as 0.1 mR/hr. The upper limit of
measurable exposure rate is 100 mRlhr. This instrument is valuable for x-ray leakage
detection, especially in the vicinity of electronics equipment which may have large
electrostatic, magnetic, and/or electromagnetic (RF) fields associated with it. The 440 RFIC
and D are entirely nonresponsive to such fields and respond only to ionizing radiation.
Proper operation of the quantitative measuring instrument, e.g., the Victoreen Model 440
RFIC, should be checked daily with its built-in check source prior to use and a record of this
check should be made and kept. The instrument must be calibrated on an annual basis by a
qualified laboratory. A certificate of calibration should be obtained from the laboratory and
the instrument should be labeled to indicate the dates of last calibration and next scheduled
calibration.
William B. Johnson TVX-1 or TVX-IB Survey Meter (Qualitative) The TVX-I and TVX-1B
survey meters detect radiation including x-radiation, that may emanate from television
products. They are sensitive to x-rays in the energy and intensity ranges encountered in
television testing. The meters are portable, easy to operate, and particularly adaptable for
field use. They are based on an original design by Stoms and Kuerze of the United States
Public Health Service.
The TVX-1 and TVX-1B survey meters consist of six Geiger-Mueller tubes spaced
equidistantly in an array to provide a search area of 18 x 4 inches. Only the tube that reads
the highest amount of radiation will activate the meter. On the TVX-1, once radiation has
been discovered, a pushbutton will energize a search tube so that the source may be
pinpointed. Sensitivity of the TVX-I extends to below 0.1 mRlhr. On the TVX-IB a light will
show which tube is reading the highest amount of radiation.

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The CST-1 or CST-2 is a check source for the TVX-1 and TVX-1B survey meters. They
consist of a sealed radioisotope source (approximately 10 microcuries of cadmium-109)
affixed inside a plastic tube. This permits positioning over a detector tube during the periodic
check.
The TVX-I and TVX-1B should be checked daily for proper operation prior to use, using the
check source. Each tube must be checked individually. A record of these daily checks should
be made. A more precise and carefully controlled periodic check of response should be
conducted every 30 to 90 days and recorded. The instrument should be labeled to indicate
the dates of last "calibration" and next scheduled calibration. All instruments used in the
x-radiation testing program must be controlled to assure that these calibrations are
conducted as scheduled.

Qualitative X-Radiation Survey Meter(s)
Quantitative X-Radiation Survey Meter(s)
Other Survey Meter(s)
AC/DC Input Voltmeter

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Model name:

*

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Model number:

*

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Name of Instrument Manufacturer:

*

-

How often is the meter calibrated?

*

Beam Current Ammeater

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Model name:

*

-

Model number:

*

-

Name of Instrument Manufacturer:

*

-

How often is the meter calibrated?

*

High Voltage Meter

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Model name:

*

-

Model number:

*

-

Name of Instrument Manufacturer:

*

-

How often is the meter calibrated?

*

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1/9/2017