[ RadSafe ] Year of manufacture of radiographic exposure devices

[Maury]

Hi Miguel,

Please click on this link for the most extensive document I could find 
on the Iriditron 520, but think it does not answer your production 
question.  A search on "Iriditron 520" does produce many search hits or 
responses, but they don't seem to address your date question

http://pbadupws.nrc.gov/docs/ML0423/ML042330198.pdf

Hope something here might be helpful to you,
Maury&Dog  [MaurySiskel maurysis at peoplepc.com]










.August 20, 2004
ALL AGREEMENT STATES, MINNESOTA, PENNSYLVANIA
REQUEST FOR SEALED SOURCE & DEVICE APPROVAL FROM FOREIGN (MEXICAN)
RADIOGRAPHY COMPANIES - (STP-04-061)
The United States Nuclear Regulatory Commission (NRC), as well as 
several Agreement
States, was contacted by Mr. Carlos Martinez of Naumex, S.A. de C.V., 
representing four
industrial radiography companies in Mexico. The purpose of these 
contacts was to request
NRC or Agreement State "Approval or Certification" of a refurbished 
exposure device (Model
Iriditron 520).
Enclosed for your information is an email to Mr. Martinez providing our 
response. He was
informed that consistent with our guidance, neither the NRC nor the 
Agreement States issue
registration certificates to companies located outside the United 
States. Mr. Martinez was
advised to contact the Mexican regulatory authority, directly and 
request that they contact the
NRC should they desire NRC advice or technical assistance.
We appreciate the prompt notice provided to us by several Agreement 
States. If you have any
questions on this correspondence, please contact me or the individual 
named below.
POINT OF CONTACT: Lloyd Bolling INTERNET: LAB at NRC.GOV
TELEPHONE: (301) 415-2327 FAX: (301) 415-3502
/RA By Dennis M. Sollenberger Acting for/
Paul H. Lohaus, Director
Office of State and Tribal Programs
Enclosure:
As stated
STP-04-061 August 20, 2004
Distribution:
DIR RF DCD (SP03)
BUsilton PDR (YES
)
JJankovich, NMSS
KHenderson, OIP
DOCUMENT NAME: G:\LAB\Rad-Mex\520.wpd *See previous concurrence.
To receive a copy of this document, indicate in the box: "C" = Copy 
without attachment/enclosure "E" = Copy with attachment/enclosure "N" = 
No copy
OFFICE STP STP:DD STP:D
NAME LABolling:gd JMPiccone
(DMSollenberger for)
PHLohaus
(DMSollenberger for)
DATE 8/18/04* 8/19/04* 8/20/04*
OFFICIAL RECORD COPY
From: John Jankovich
To: CONTROL DE CALIDAD, TECNICA RN, MEXICANA DE RADIOGRAFIAS & NAUMEX
Date: 8/11/04 12:58PM
Subject: Re: EVALUATION AMENDED AI 520 DEVICE
Mr. Martinez,
This is a response to your e-mails, dated July 29, and August 3, 2004 
(attached below),
regarding the registration of the Model Iriditron 520 radiography 
camera. You indicated that
your company modified 76 units by replacing the original lock box with 
an automatic lock box
and, thereby, you intended to meet the requirements in 10 CFR 
34.20(c)(2) of the U.S. Nuclear
Regulatory Commission (NRC) and you requested an NRC registration 
certificate as a
"reference" for the use of the devices in Mexico.
Please note that the U.S. performance requirements for industrial 
radiography equipment are
described in 10 CFR 34.20, 34.21, and 34.24. The requirements specify 
that the equipment
must be tested in accordance with the provisions of ANSI Standard 
N432-1980. We are not
familiar with the requirements in ISO Standard 3999-1-2000 that you 
quoted in your e-mail.
One obvious difference between the ANSI Standard and the tests conducted 
on your cameras
is the endurance test: ANSI requires 20,000 cycles, your locks were 
tested for 600 cycles.
Please also note that the NRC conducted, under contract, extensive 
testing of three models of
radiography equipment that are in wide use in the U.S. The test methods, 
test durations and
the test results were published in the NRC Technical Report No. 
NUREG/CR-6652, "Safety
Testing of Industrial Radiography Devices." You may want to consult the 
report for reference.
The responses to your specific questions in your e-mail dated July 29, 
2004, are below.
Question 1. "What kind of certificates can be issued by you for AI 520 
to be used in Mexico by
a Mexican Licensee?"
Response: The U.S. Nuclear Regulatory Commission does not issue 
registration certificates to
companies located outside the U.S. When a U.S. company wishes to 
register and distribute a
product within the U.S. for use by U.S. licensees, the product must be 
registered by the NRC or
an Agreement State. The NRC or the Agreement States issue the 
registration certificate on the
basis of a safety evaluation of the device which is conducted in 
accordance with the applicable
guidance. The guidance used by the NRC is our technical report entitled 
"Consolidated
Guidance About Materials Licenses: Applications for Sealed Source and 
Device Evaluation and
Registration," NUREG-1556, Vol. 3, Rev.1. The document is accessible at 
the following
web-site: 
http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v3/r1/. Section 
10
in the document lists the technical areas that the NRC staff uses for 
conducting the safety
evaluation. The Agreement States use similar procedures.
Since the Model Iriditron 520 device was modified, a new safety 
evaluation would be needed in
the U.S. for the updated Model Iriditron 520 radiography cameras. The 
registration issued for
the original design would not be acceptable. A safety evaluation would 
be conducted in
response to an application from a distributor, such as yourself, if your 
business was located in
the U.S. However, in your specific case the NRC or the Agreement States 
cannot conduct such
an evaluation because our authority does not extend beyond the U.S.
Question 2. "In the U.S.A. do you have to issue certificates for each 
exposure device or only
for the prototype?"
Response: In the U.S., the registration certificate is issued to the 
distributor on the basis of a
safety evaluation of the prototype tests as well as the other areas 
subject to safety evaluation
that are listed in Section 10 of the guidance document referred to 
above. The registration
certificate is issued for the model in general, not for individual 
units. Once the registration
certificate is issued, the manufacturer is free to distribute as many 
units as they wish on the
commercial market.
Question 3. "If the AI 520 approved prototype was accepted regarding the 
above authorized
cited modification, does Naumex as the Manufacturer/Distributor 
responsible for the
modification made in México, can issue the certificates of compliance 
for the 76 modified
devices if they are going to be used only by three Mexican licensees 
exclusively in México?"
Response: We are not familiar with the requirements in Mexico and, 
therefore, unable to
answer your question. We recommend that you contact the nuclear 
regulatory authorities in
Mexico directly.
Question 4. "Do you know if the original U.S. manufacturer of the 
radiographic exposure
devices AI Model Iriditron 520 manufactured before 1992 named Automation 
Industries, Inc.
Sperry Products Division, still exists?"
Response: As far as we can determine, this camera was built originally 
by Automation
Industries, and later was registered in the U.S. by Amersham 
Corporation, and the registration
certificate (NR-628-D-807-S) was inactivated in 1992. Amersham has 
changed the name since
the time when the inactive registration was issued; their current name 
is: AEA Technology,
QSA, Inc. The address is the same: 40 North Avenue, Burlington, MA 01803.
In summary, the NRC conducts safety evaluations and device registrations 
only for U.S.
licensees and for devices that are used in the U.S. We suggest that you 
contact the Mexican
regulatory authority, Comisión Nacional de Seguridad Nuclear y 
Salvaguardias (CNSNS),
directly and ask them to request such a review from the NRC. If CNSNS 
would like to seek
NRC's advice on the application, we will consider a request from them 
for technical support.
If you need further information regarding the requirements or the 
registration process in the
U.S., please contact me by e-mail or call at 301 415-7904.
John Jankovich, Team Leader
Sealed Source and Device Registration
CC: Josephine Piccone; Lloyd Bolling; PKH; Teh; the ; Theodore Sherr




On 1/6/2015 11:23 AM, Miguel Ticllacuri wrote:
> Group,
> I´m interested to know the year when were stopped manufacturing the following radiographic exposure devices:
>
> -          SPEC, Model 2-T
>
> -          AMERTEST/AMERSHAM (Sentinel), Model 660/660A/660B
>
> -          Automation Industries, Model Iriditron 520
> If you have any information, please contact me.
> Best regards.
>
> Miguel
>
>
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