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Information Notice No. 96-20: Demonstration of Associated Equipment Compliance with 10 CFR 34.20

UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555

April 4, 1996

NRC INFORMATION NOTICE 96-20: DEMONSTRATION OF ASSOCIATED EQUIPMENT
COMPLIANCE WITH 10 CFR 34.20

Addressees

All industrial radiography licensees and radiography equipment manufacturers.

Purpose

The U.S. Nuclear Regulatory Commission is issuing this information notice to
inform radiography licensees of acceptable methods to demonstrate that their
associated equipment used in radiographic operations meets the regulations in
10 CFR 34.20. It is expected that recipients will review the information for
applicability to their facilities and consider appropriate actions. However,
this information notice does not contain any new requirements; therefore, no
specific action nor written response is required.

Description of Circumstances

Section 34.20 of 10 CFR Part 34 specifies performance requirements for
radiography equipment. Paragraph (d) of 10 CFR 34.20 provided that all newly
manufactured radiographic exposure devices and associated equipment
(manufactured after January 10, 1992) acquired by NRC licensees must meet
Section 34.20 requirements. Paragraph (e) of 10 CFR 34.20 provides that all
radiographic exposure devices and associated equipment in use by NRC licensees
after January 10, 1996, must comply with the requirements specified in
10 CFR 34.20. NRC amended the regulations in 10 CFR 34.20 to permit licensees
to use an alternate value of torque for performance testing criteria and to
allow licensees to use engineering analysis to demonstrate that a modest
change in an already approved design is acceptable without the need to perform
prototype testing. The changes were published in the Federal Register as a
final rule on May 31, 1995.

NRC Information Notice (IN) 95-58: "10 CFR 34.20; Final Effective Date,"
issued on December 18, 1995, to all radiography licensees, reminded licensees
of the final effective date implementing the regulations in 10 CFR 34.20. IN
95-58 also reminded licensees that associated equipment used with radiography
cameras (i.e., source assemblies, drive cables, guide tubes, control tubes,
source stops, etc.) were subject to 10 CFR 34.20 requirements. IN 95-58 went
on to explain that, previously, certain associated equipment had not been
independently registered and/or evaluated by the NRC or the Agreement States
(AS). This includes drive cables, guide tubes, and source stops. Most new

9603290269. IN 96-20
April 4, 1996
Page 2 of 4

camera models and their basic associated equipment were registered as part of
the gamma radiography system as described in the American National Standard
N432-1980, "Radiological Safety for the Design and Construction of Apparatus
for Gamma Radiography." Therefore, information concerning certain associated
equipment to be used with the devices was included as part of the overall
system evaluation and registration process. Some manufacturers have also been
labeling their equipment with an identifier, such as the manufacturer�s logo,
to indicate that the equipment meets the requirements of 10 CFR 34.20.
IN 95-58 went on to remind licensees that 10 CFR 34.20 makes the licensee
responsible for ensuring that equipment meets regulatory requirements.

NRC and AS review and evaluate radiography-associated equipment (guide tubes,
exposure heads, and collimators) as well as sealed sources, radiographic
exposure devices (cameras) and source changers for compliance with 10 CFR
Part 34. On completion of this evaluation, acceptable components are
identified on a registration certificate. Information is also included in a
National Registry System maintained by NRC. Regulatory authorities use this
information in their licensing and inspection activities.

Discussion

The regulation on performance requirements for radiography equipment --
Section 34.20 -- require that the radiographic exposure device and all
associated equipment must meet the requirements of ANSI N432-1980, and other
specific requirements listed in 10 CFR 34.20. Associated equipment includes
source assemblies, drive cables, guide tubes, control tubes, cranks, "J"
tubes, collimators, exposure heads, and source stops.

In particular for guide tubes, 10 CFR 34.20(c)(5) states, "The guide tube must
have passed the crushing tests for the control tube as specified in ANSI N432
and a kinking resistance test that closely approximates the kinking forces
likely to be encountered during use." In addition, 10 CFR 34.20(c)(8)
requires that the connection between the guide tube and exposure head be able
to withstand the tensile test for control units specified in ANSI N432. Since
Section 8.9 of ANSI N432-1980 specifies that radiography systems must
withstand the endurance test described in that section, licensees must
demonstrate that guide tubes and exposure heads will withstand the endurance
test.

Recently some questions were raised concerning what constitutes an exposure
head vs. a guide tube. Exposure heads may be a separate or integral part of a
guide tube. NRC's analysis of associated equipment (i.e., collimators, guide
tubes, exposure heads) has shown that there is little risk of obstruction of
source travel for equipment that guides a source assembly a distance less than

. IN 96-20
April 4, 1996
Page 3 of 4

10 times the length of the source capsule. NRC's analysis included a review
of equipment designs and incidents involving source travel obstructions.
Based on these findings, NRC's policy is that associated equipment that guides
a source assembly a distance greater than 10 times the length of the source
capsule (i.e., exposure heads, "J" tubes, jet engine probes, source stops) is
considered a guide tube and must meet the testing requirements for guide
tubes. In addition, NRC�s policy is that only associated equipment that comes
in contact with the source (e.g., collimators that slip over the end stop)
must meet the applicable testing requirements.

The NRC has identified several ways licensees can demonstrate that their
radiography equipment meets 10 CFR 34.20 requirements. First, the most direct
method would be that the equipment has been labeled by the manufacturer
pursuant to a registration certificate. (If the label has worn off, you
should contact the manufacturer or have support information as described
below.) Alternatively, licensees can make this demonstration if they can
provide a document trail to registered associated equipment. The equipment
will be considered to meet the requirements, if the licensee has in its
possession one of the following for each piece of equipment:

(a) A purchase order(s) listing the radiography equipment that can be
tied-back to a registration certificate; or,

(b) Documentation from the manufacturer verifying that the equipment
the licensee is using was approved and registered with the NRC or
AS. The documentation must clearly identify which equipment meets
the requirements; or,

(c) A signed NRC or AS recognized checklist(s) certifying that the
licensee has evaluated its equipment, and that it meets the
specifications of the checklist. In order for the checklist to be
recognized, it must have been provided by the manufacturer of the
equipment and approved by the NRC or AS. As of this date, only
one checklist has been approved. See Attachment 1 for the
recognized checklist.

If a licensee possesses and intends to use radiography equipment that is not
labeled by the manufacturer, or that the licensee cannot demonstrate that it
meets 10 CFR 34.20 requirements, then the licensee must submit an application
for a custom evaluation. Attachment 2 includes information on how to file an
application for custom evaluation. Equipment cannot be used in radiographic
operations until it has been approved for use by NRC or an AS.

. IN 96-20
April 4, 1996
Page 4 of 4

This information notice requires no specific action nor written response. If
you have any questions about the information in this notice, please contact
the technical contact listed below or the appropriate regional office.

signed by

Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards

Attachments:
1. Recognized Checklist for Associated Equipment
2. Custom Evaluation of Associated Equipment
3. List of Recently Issued NMSS Information Notices
4. List of Recently Issued NRC Information Notices

Contact: Thomas W. Rich, NMSS
(301) 415-7893

. Attachment 1
IN 96-20
April 4, 1996
Page 1 of 2

Checklist for Amersham�s Model 591 Controls

To assure the associated equipment you are using are approved Amersham
manufactured accessories, please perform a side by side comparison against a
known (i.e., flying A is legible or Pos are available) Amersham manufactured
piece. Perform a detailed mechanical and visual inspection of your equipment
against the following checklist. If you have any questions, please call
Amersham for assistance.

Amersham Controls:

1. All controls have a yellow polyvinyl housing with a 9/16 inch outer
diameter.

2. The fittings are 3 inches long (including the hex nut).

3. The hex nut is 11/16 inch.

4. Check the fittings for swage marks, the fittings will have 3 single
swage marks � 1/8 inch wide and � 1/2 inch apart or 4 single swage marks
� 1/8 inch wide and � 1/2 inch apart.

5. The first swage mark is typically 3/8 inch from the end.

6. The thread pattern for the control connector is 5/8"-18.

7. The 661 connector assembly will have an indentation � 1/2 inch wide band
behind the jaws, for newer units this will be covered with a red stripe,
but this stripe may have worn off on the older models.

To the best of my knowledge the piece of equipment identified below (the
equipment must be uniquely identifiable, either by labeling, marking, or
tagging, or other means to signify which piece of equipment is certified as
meeting the conditions of this checklist) has been manufactured after 1964,
meets the conditions of this checklist, and is the same design as a similar
piece of equipment that has been registered and approved by the NRC.

Specify Equipment (i.e., Guide Tube) Signature
Include Identifier/Labeling

Printed or Typed Name . Attachment 1
IN 96-20
April 4, 1996
Page 2 of 2

Amersham Model 402, 489, and 676 Guide Tubes

To assure the associated equipment you are using are approved Amersham
manufactured accessories, please perform a side by side comparison against a
known (i.e., flying A is legible or POs are available) Amersham manufactured
piece. Perform a detailed mechanical and visual inspection of your equipment
against the following checklist. If you have any questions, please call
Amersham for assistance.

Amersham Guide Tubes:

1. Housing should be yellow polyvinyl with either a 5/8 inch or 3/4 inch
outer diameter.

2. The fittings are yellow iridited steel, the threaded fittings consist of
1 inch 18 thread.

3. The fittings for both the threaded fitting and the source stop fitting
will have 2 single swage marks approx 1/4 inch apart.

4. The Amersham standard source stops are made from aluminum and are 2 1/2
inches long.

Specify Equipment (i.e., Guide Tube) Signature
Include Identifier/Labeling

Printed or Typed Name . Attachment 2
IN 96-20
April 4, 1996
Page 1 of 3

CUSTOM EVALUATION OF ASSOCIATED EQUIPMENT

The information provided below applies to custom registration of associated
equipment.

Product Registration

Either the manufacturer, distributor, or user of the radiographic equipment
can submit the information outlined in 10 CFR 32.210 for evaluation.

If the applicant is located within the jurisdiction of the U.S. Nuclear
Regulatory Commission, the application should be sent to the following
address:

U.S. Nuclear Regulatory Commission
Sealed Source Safety Section
Mail Stop T-8-F-5
Washington, DC 20555

Otherwise, the applicant should submit the information to the appropriate
Agreement State.

Application Contents

General:

Licensees are required to use only radiography equipment, including exposure
heads and source guide tubes, that meets the requirements specified in 10 CFR
34.20. The regulations require that the exposure device and all associated
equipment must meet the requirements in American National Standard N432-1980,
�Radiological Safety for the Design and Construction of Apparatus for Gamma
Radiography,� and other specific requirements listed in 10 CFR 34.20. The
standard defines the requirements for the design and method of qualifying
(testing) prototypes of gamma radiography systems.

Refer to Regulatory Guide 10.10, �Guide for the Preparation of Applications
for Radiation Safety Evaluation and Registration of Devices Containing
Byproduct Material� for information on what types of information needs to be
included in your application.

Specific:

Applications for registration for the equipment must, at a minimum, include
the following documentation:
. Attachment 2
IN 96-20
April 4, 1996
Page 2 of 3

1. A demonstration, either by testing or by engineering analysis, that
prototypes of the associated equipment meets the appropriate tests
listed below;

2. A list of all radiographic exposure equipment with which the equipment
will be used, and an explanation of how the equipment is compatible with
each piece of equipment;

3. Details of how the associated equipment will be identified, such as by
labeling, marking, or tagging, as meeting the requirements of
Section 34.20;

4. Complete specifications, including materials, details of construction,
and complete dimensions of each component of the equipment; and

5. Likely environments (i.e., temperature, pressure, vibration, humidity,
impact) and conditions of use of the equipment.

Prototype Tests

Each associated equipment design (e.g., source guide tube, collimator,
exposure head) must either pass the appropriate tests listed below, or by
engineering analysis demonstrate that the designs would likely meet the test
requirements.

NRC�s policy is that associated equipment that guides a source assembly a
distance greater than 10 times the length of the source capsule (i.e.,
exposure heads, �J� tubes, jet engine probes, source stops) is considered a
guide tube and must meet the testing requirements for guide tubes.

Source Guide Tube Tests

Source guide tubes are required to meet the following:

a. The crushing test specified in Section 8.6 of ANSI N432-1980;

b. a kinking resistance test that closely approximates the kinking
forces likely to be encountered during use;

c. the endurance test specified in Section 8.9 of ANSI N432-1980; and

d. the tensile tests specified in Section 8.7 of ANSI 432-1980 for
control units.

. Attachment 2
IN 96-20
April 4, 1996
Page 3 of 3

Exposure Head and Collimator Tests

Exposure heads and collimators that are not considered guide tubes, need only
meet the tests listed in item c, and d above.

Engineering Analysis

Engineering analysis will be considered in lieu of actual testing if the
analysis is based on a similar design that has been tested in accordance with
the standard and has been approved by the NRC or Agreement State. The
engineering analysis, at a minimum, must compare the tested design against the
associated equipment you want evaluated and address the effects of the
materials of construction (i.e., wear resistance, strength, corrosion
properties), the wall thickness, the length (i.e., resistance), any bends,
bend angles and the minimum bend radii over which the bends will be produced
(curvature), and any other properties that would have an effect on the outcome
of the endurance test.

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