Title: Products to X-ray People for Security
1Products to X-ray People for Security
- Presented to the
- Technical Electronic Product Radiation Safety
Standards Committee - May 22, 2002
2ANSI N43.17 Radiation Safety for Personnel
Security Screening Systems Using X-rays
3Secure 1000
Manufactured by Rapiscan Products Inc.
4Bodysearch
Manufactured by American Science and Engineering,
Inc.
5Chronology
- Sep. 1998 TEPRSSC Recommends a
- Mandatory Standard
- Apr. 1999 FDA Proposes New Project to
- ANSI/HPS N43
- Nov. 1999 N43.17 TG Convenes
- June 2001 Draft Standard Submitted to
- N43 Committee
- Apr. 2002 Final ANSI Approval
6Summary of Main Requirements
- Subject dose limits
- 0.1?Sv (10 µrem) Effective Dose per Scan
- 250 ?Sv (25 mrem) per Year
- Benefit vs. Risk Negligible Individual
- Dose (lt 10 µSv/y)
- Subject Informed of the X-Ray Exposure
- and Associated Risk
7Summary of Main Requirements
- Radiation Leakage
- 2.5 ?Sv/h (0.25 mrem/h) _at_ 30 cm from Surface
- Bystander Protection
- Inspection Zone 20 ?Sv/h (2 mrem/h)
- Safety Interlocks
- Labeling Indicators
8Summary of Main Requirements
- Operator Training
- Manufacturer Records
- User Facility Records
9Informative Annexes
- Risks and Rationale
- Measurement Protocol and Estimation
- of Effective Dose
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15Transmission X-Ray Products
16Transmission X-Ray(Conpass Body Scanner)
Manufactured by MMC International
17Transmission X-Ray
18Specifications(Conpass Body Scanner)
- Scanning Time 10 Seconds
- Anode Voltage 70 - 200 KvP with 10 kV Step
- Tube Current 1- 3 mA with 0.5 mA Step
- Dose to a Subject 0.5 mrem per Inspection
- Dose to Operator lt 0.5 mrem per hour
- Note Other Systems Exist
19Mfrs Proposed Uses
- Passenger Control
- Diamond Mines
- Prisons
- Public Offices
- Banks
- Etc.
20Issue
- Non-medical Exposure to Ionizing Radiation
- Linear no threshold model
- Societal benefit from increased security
21Principles
- 1 mrem Negligible Individual Dose
- 100 mrem Annual Public Effective Dose Limit
- Individual or Society Receives a Clear and
Compelling Benefit that Outweighs Risk - Dose as Low as Reasonably Achievable
22Negligible Individual Dose
- NCRP Recommends An Annual Effective Dose Of 1000
µRem Be Considered A Negligible Individual Dose
Per Source Or Practice - Magnitude of the dose
- Difficulty in detection and measurement of dose
and health effects - Estimated risk for the mean and variance of
natural background radiation exposure levels
23Transmission vs. Backscatter
- X-Ray Transmitted Through the Subject
- Image Interpretation Significantly More Complex
- Adjustable Technique Factors (More Complex)
- 100x More Dose to Subject
24Regulatory Status
- They are Not Medical Devices
- They are Electronic Products that Emit Radiation
- Currently No Federal Performance Standard Applies
to these Products (21 CFR 1010 through 1050)
25FDAs Proposed Response
- Guidance Document
- Radiation Safety Recommendation
- Mandatory Performance Standard
- New Instruments
- Suggested State Regulations
26Proposed Mandatory Standard
- Based on ANSI N43.17
- Dose Limit
- Interlocks
- Labeling Indicators
- Controls
- Product Performance Only
- Use Covered in a Radiation Safety Recommendation
27Discussion
- Societal Benefit vs. Risk
- Appropriate Use?
- Scope of Standard
- What Products?
- Alternatives Based on Intended Use?
- Controls Fixed or Automatic?