Appendix A_QG1.pdf

Special Notice

70T04026SN7573N001

Air Cargo Screening Qualification Test

Qualification Group One Visual Imaging

White Paper Submission

Appendix A: ACSQT White Paper Requirements & Templates initiator:blake.muzny@irtc-hq.com;wfState:distributed;wfType:email;workflowId:1a540ea0798f734dbac09183e042d718

Manufacturer: _______________________________ Date: ______________________________

Model: _____________________________________

I. VENDOR INFORMATION

What is the vendor’s legal business name?

What is the type of business entity? U.S. Business Foreign Business Foreign Government

Does the vendor have a (SAM.gov) Unique Entity Identifier (UEI) number?

Yes No

If yes, what is the vendor’s UEI number?

What is the physical address the SAM.gov has on file for the vendor?

Is the vendor currently registered with the System for Award Management (SAM)?

Yes No

If yes, what is the vendor’s Commercial and Government Entity (CAGE) code?

What is the vendor’s web address?

What is the vendor’s Point of Contact (POC) name for this submission?

What is the POC’s phone number?

What is the POC’s email address?

Provide city & state location(s) of the candidate device final point of production.

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine the vendor’s ability to meet Security Sensitive Information (SSI) vetting requirements and that the vendor is an established business.

II. DEVICE OVERVIEW AND TECHNICAL SPECIFICATION

Describe the candidate device to include a technical summary of the screening/detection technology

What are the dimensions of the largest object (width x height x length) that can be screened by the candidate device in metric and English units?

What is the dimensions of the candidate device in metric and English units?

What are the following electrical requirements for the candidate device?

Voltage Alternating Current?

Hertz

Amperage

Yes No

How many views does the candidate device have? (The device must display at least two complimentary views)

For the views that are the most separated, what is the angle differentiating them. T he angle should be defined by two lines drawn from the center of the x-ray tubes’ focal point to the geometric center of the detectors.

Does the candidate device have dual-energy capabilities?

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the device meets the qualification group criteria and assess the candidate device general screening capabilities.

III. COMMERCIAL AVAILABILITY

Is the candidate device currently available for purchase Yes No

If available for purchase, what is the production lead time for the candidate device?

What is the current production rate of the candidate device?

What is the current commercial pricing of the candidate device?

Is the candidate device rebranded? Yes No

If rebranded, who is the original Equipment Manufacturer (OEM)?

Is the candidate device product information available online? Yes No

If yes, what is the web address?

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the candidate device is commercially available and a representative unit can be made available for further evaluation upon acceptance into the ACSQT program.

IV. IMAGE QUALITY PERFORMANCE

For devices that are capacity A or B, please provide the ASTM F792-08 scores for the two primary views of the device. Devices are considered capacity A or B if the largest item screenable has any dimension less than 48” wide x 60.2” high x 48” long (122 cm x 153 cm x 122 cm) or if the loading weight is less than 2,205 lbs (1000 kg).

View Name:

Test #1

Test #2

Test #3

Test #4

Test #5

Test #6

Test #7

Test #8

Test #9

Devices larger than Capacity A or B are considered Capacity C. For Capacity C devices, provide image quality results relating to penetration, spatial resolution, wire detection, and contrast sensitivity for the two primary views of the device (ANSI N42.46-2008 is the preferred test method)

View Name

Useful Penetration

Spatial Resolution

Wire Detection

Contrast Sensitivity

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the image quality results are consistent with TSA performance requirements.

V. SAFETY

Yes No

Yes No

Yes No

Yes No

General Safety

Does the candidate device comply with any recognized industrial or commercial standards which ensure the device does not pose any safety hazards to an operator or to transient personnel?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with UL 61010-1?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with IEEE C95.1?

Safety (Ionizing Radiation)

Does the device comply with any recognized government standards which limit external emissions of ionizing radiation with respect to human exposure?

If yes, can the vendor provide evidence the candidate device is compliant with FDA Title, 21, C FR 1020.40?

Can the vendor provide evidence the device meets the certification requirements specified by FDA Title, 21, C FR 1010.2, and the labeling requirements specified by FDA Title, 21, C FR 1010.3?

Yes No

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the candidate device is safe and does not represent an ionizing radiation hazard. Note – compliance with the listed standards is required and evidence will be requested during later stages of the qualification process.

VI. ELECTROMAGNETIC COMPATIBILITY (EMC)

EM Immunity

Yes No

Yes No

Yes No

Yes No

Yes No

Does the candidate device comply with any recognized industrial or commercial standards which ensure the normal operation of the device is not susceptible to electromagnetic disturbances typical of an air cargo screening environment?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with IEC 61326-1?

EM Emissions

Does the candidate device comply with any recognized government, industrial, or commercial standards which ensure the device does not emit conduc ted or radiated electromagnetic fields at a level which may disrupt the operation of electronic equipment in the vicinity of the device?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with IEC 61326-1?

Radio Frequency Interference

Does the candidate device comply with any recognized industrial or commercial standards which ensure the device does not emit radiated RF electromagnetic fields at a level which may disrupt the operations of electronic equipment in the vicinity of the device?

If yes, can the vendor provide evidence from an independent testing organization that the candidate device is compliant with FCC Title 47, CFR Part 15?

Yes No

Evaluation considerations: The TRP will evaluate the vendor’s responses to determine if the candidate device is immune to EM disturbances and does not emit EM fields that may affect the operation of equipment in the vicinity of the device. Note – compliance with the listed standards is required and evidence will be requested during later stages of the qualification process.

Yes No

VII. QUALITY MANAGEMENT

Does the vendor comply with any recognized industrial or commercial quality management standards?

Yes No

If yes, can the vendor provide third-party certification evidence of compliance with the most current version of ISO 9001.

Yes No

Does the vendor agree to provide the TSA access to technical records, personnel, and facilities pertaining to manufacturing, processing, inspection, and testing to assure continued compliance with all performance specification requirements?

Yes No

Evaluation considerations: The TRP will evaluate the vendor’s responses to ensure the product and services are consistent and continually improved upon.

VIII. CONFIGURATION MANAGEMENT

Does the vendor identify, control, maintain status records, and conduct periodic audits of your product configuration baselines in accordance with ISO 10007 or an equivalent?

Yes No

Does the vendor identify and control each delivered system configuration using a unique vendor-assigned serial number?

Yes No

Will the vendor be willing to provide a document package that fully defines the design baseline of your product upon request for TSA review as part of the qualification process?

Yes No

An emulator is a standalone component of an X-ray device that displays stored X-ray image data files. This will be required to verify some proposed changes to the detection system. Is an emulator available for the candidate system?

Yes No

Evaluation consideration: The TRP will evaluate the vendor’s responses to ensure the vendor utilizes a standardized configuration management process to identify and control the functional and physical characteristics of the device.

IX. SUPPORTING INFORMATION

Does the candidate device have any current certifications or qualifications, either foreign or domestic, sponsored by a government agency?

Yes No

List current certifications or qualifications for the candidate device and the sponsoring agency.

Does the device have a completed User Manual? Yes No

Does the device have a completed user training package? Yes No

Evaluation consideration: The TRP will evaluate the vendor’s responses to assess the candidate device’s level of test readiness.

X. SIMILARITY QUESTIONNAIRE

Does the vendor wish to have the candidate device assessed under Evaluation Method #1?

Yes No

For which Air Cargo Screening Technology List (ACSTL) Qualified device is the vendor claiming similarity?

List the three dimensions of the largest object that can be screened by the qualified device (width x height x length). Report metric and English units.

List the three dimensions of the largest object that can be screened by the candidate device (width x height x length). Report metric and English units.

How many generators are utilized by the qualified device?

How many generators are utilized by the candidate device?

List the type of X-ray generator(s) used in the Qualified device (e.g.

– make and model)

List the type of X-ray generator(s) used in the candidate device (e.g.

– make and model)

How many projection views does the Qualified device provide an operator?

How many projection views does the candidate device provide an operator?

What is the voltage across the X-ray tubes of the Qualified device?

What is the current?

What is the voltage across the X-ray tubes of the candidate device?

What is the current?

Evaluation consideration: The TRP will evaluate the vendor’s responses to ascertain whether the submitted device is an acceptable variant of a previously-qualified device listed on the ACSTL.

XI. ATTACHMENTS

Include candidate device specification sheet. Yes No

Include block diagram of candidate device major components. Yes No

Include no-proprietary screen shot files for the two primary views in which image quality performance was furnished.

Yes No