2014 02 28 Item 2 AERB IBA Radiation Safety Aspects

AERB : Radiation Safety Aspects
IBA Proteus-235 NOC Application: Anne-Sophie Grell – Frédéric Stichelbaut

AGENDA
1. Technical and clinical aspects of the Proteus-235 proton therapy facility
2. Radiation Safety Aspects (e.g. operational safety, handling of activated components and
decommissioning procedures)
3. Dosimetry aspects
4. Computational methodology adopted for Radiation Shielding of Proteus-235 Proton Accelerator Facility , proposed
project for Apollo Hospitals, Chennai
5. Site selection criteria for Proteus-235 Proton Accelerator Facility
2 Protons are possible

Radiation Safety Aspects
1. Operational safety.
2. Handling of activated components.
3. Decommissioning procedures.
1 - Operational Safety
« General Risk Analysis for Proton Therapy » following ISO 14971 standard
1. Cyclotron + related eqpt « Radiation doses around the C230 Cyclotron ».
2. Building « Interface Building Document ».
3. Interface b/ Equipt & Building TSS (Therapy Safety System), interlocks, detectors, warnings,
search button, crash button, …
« General Risk Analysis for Proton Therapy ». Appendix C Q6

« The purpose of this document is to present the risk analysis and the safety decisions that are part of the requirements
of the Proteus 235 product at the system level-PTS GRA. »
191 pages covering and listing every potential hazards.
From Mechanical - Electrical – Energy – Radiation – Hazardous – Biological – Environmental – Use of the
device – from any Failure – Data Integrity/errors Hazards.
MAIN INTERNATIONAL REFERENCE STANDARDS USED TO MITIGATE HAZARD DETECTED DURING THE RISK ANALYSIS
The main international reference standards used to perform this analysis are: IEC 60601-1
Medical electrical equipment -- Part 1: General requirements for safety IEC 60601-1
Medical electrical equipment -- Part 1: General requirements for safety -- 1. Collateral standard: Safety
requirements for medical electrical systems IEC 60601-1 -2
Equipment parts 1 section 2: Electromagnetic compatibility requirements and tests IEC 60601-1-4
Medical electrical equipment - General requirements for safety IEC 60601-2-38
Medical electrical equipment - part 2: Particular requirements for the Safety .of electrically operated Hospital Beds
IEC 60812
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) ISO 13849-1
and ISO 13849-2:
Safety of machinery- safety category design and safety category validation EN 982
Safety of machinery - Safety requirements for fluid power systems and their components - hydraulic.IEC 60204-1
Building « Interface Building Document ».Appendix CQ5

Facility description & Requirements
Installation & removal of equipements
Technical Requirements
Source of radiations and shielding
TSS (Therapy Safety System) + interlocks
TSS Appendix CQ4b

TSS Requirement Document
SRCU Safety Functions
SRCU Gantry Treatment room Safety Functions
Control access to areas
Safety signages and indicators
o At Treatment Room entrance
o At Cyclotron vault entrance
Automatic door closers
Crash button in various locations in the building
Security fences ESS/BTS
-8-
Crash buttons
Safety signage
-9-
1 - Operational Safety : summary of safety checks
Scanning Generator Redundant Unit Functional Red. Unit

X_CURRENT_TARGET_SP MIN_CHARGE_SEC MIN_CHARGE_TER
Y_CURRENT_TARGET_SP MAX_CHARGE_SEC MAX_CHARGE_TER
DURATION X_CURRENT_MIN_SEC_FB MIN_DOSE_RATE_TER
TARGET_CHARGE Y_CURRENT_MIN_SEC_FB MAX_DOSE_RATE_TER
BEAM_CURRENT_SP X_CURRENT_MAX_SEC_FB X_MIN_WIDTH
• E.g. 20.000 elements / trajectory (1 layer)
MIN_BEAM_CURRENT_FB Y_CURRENT_MAX_SEC_FB X_MAX_WIDTH
• >MAX_BEAM_CURRENT_FB
40 checks performed every 250 µs
X_VOLT_MIN_SEC_FB Y_MIN_WIDTH
MIN_CHARGE_PRIM Y_VOLT_MIN_SEC_FB Y_MAX_WIDTH
• In a 10 seconds layer
MAX_CHARGE_PRIM
160.000 checks
X_VOLT_MAX_SEC_FB X_POS_LOW
X_CURRENT_MIN_PRIM_FB Y_VOLT_MAX_SEC_FB X_POS_HIGH
• On a 20 layers irradiation X_MIN_FIELD

Y_CURRENT_MIN_PRIM_FB 3.200.000 checks Y_POS_LOW
X_CURRENT_MAX_PRIM_FB Y_MIN_FIELD Y_POS_HIGH
Y_CURRENT_MAX_PRIM_FB X_MAX_FIELD DURATION
X_VOLT_MIN_PRIM_FB Y_MAX_FIELD
Y_VOLT_MIN_PRIM_FB Safety with usability
MIN_DOSE_RATE_SEC
X_VOLT_MAX_PRIM_FB MAX_DOSE_RATE_SEC
Y_VOLT_MAX_PRIM_FB DURATION
MIN_DOSE_RATE_PRIM
MAX_DOSE_RATE_PRIM
2 – Handling of activated components
! According to National + Regional + Local + Hospital regulations/rules !
To be managed by RSO (Radiation Safety Officer).
To be ruled by Procedures : ex : « Handling of activated parts procedures ».
To be operated by certified staff + certified subcontractors.
To be located in designated locations for activated parts (shielding, …).

Radiation Safety Aspects Jeff Rexford
Site Manager
2 – Handling of activated components University of Florida Proton Therapy Institute
Proton System :
Low beam intensity (few hundreds of nA)
Not many areas in the system are activated
Activated area are well known and documented
Measurements are taken
Strict precautions for the personnel
Protective shielding
Personnel monitoring
Controlled stay times in the vault
Those areas are shielded during interventions
Site Manager
Role of the Radiation Safety Officer (RSO)

RSO has juridiction on the whole facility for safety issues
IBA personnel MUST comply with RSO and his program (follow all applicable
rules)
IBA can add safety requirements
Proton System Activated parts:

Activated parts removed out of the System
Cooling area in the vault (concrete shielded area)
Maintenance waste is also stored
Shipped or disposed when activity is low enough (background radiation level)
Site Manager
Personnel follow-up :
Every person is monitored
Every event is monitored
If a person ‘s exposure level becomes high: he is removed from the vault
and from the event
Cyclotron maintenance: (example of Florida PT Institute)
Twice a year
No personnel has ever received more than ½ of the maximum yearly
dose
3 – Decommissioning procedures
Building Decommissioning :
o « Concrete Activation in Proteus Plus » (appendix C Q7).
o « Decommissioning of a Proton Therapy Center » (appendix CQ12).
o « Environmental Impact of a Proton Therapy Center » (appendix CQ12).
Equipment Decommissioning :
o Decommissioning of active components/equipment :
To be managed according to Procedures of « Handeling of Activated parts »
o Decommissioning of non-active equipments :

To be dissambled as ordinary equipment (as mechanic, electric, electronic eqpt, …)
Building Decommissioning :
o « Concrete Activation in Proteus Plus » (appendix C Q7).
o « Decommissioning of a Proton Therapy Center » (appendix CQ12).
o « Environmental Impact of a Proton Therapy Center » (appendix CQ12).
Equipment and shielding concrete activation
Other long-lived isotopes such as Na22 (T1/2 = 2.33 years) can also be produced
from higher energy neutrons (energy threshold = 20-30 MeV)
For concrete activation, study of Cyclone 235 vault using MCNPX 2.7.0.
Use concentrations of stable Europium, Cesium and Cobalt in concrete
from a previous study on concrete activation around a PET cyclotron:
‘Predicting Long-Lived, Neutron-Induced Activation of Concrete in a
Cyclotron Vault’ by L.R. Carrol:
natEU (47.8% 151Eu + 52.2% 153Eu) = 0.29 ppm
59Co = 2.5 ppm
133Cs = 1.5 ppm
Compute specific activities (Bq/g) of all isotopes produced in concrete
after 20 years of operation and compare these activities to Clearance
Levels (CL) defined by IAEA: ‘Application of Concepts of Exclusion,
Exemption and Clearance’ IAEA safety guide RS-G-1.7
RESULTS: SOUTH WALL (FROM M-ID 39132)
A/CL < 0.2

(a) (b)
(b)
(a)
X = 0 corresponds to the centre of C230
RESULTS: WEST WALL
(a) A/CL < 0.8 (b)
(a)
(b)
Y = 0 corresponds to the centre of C230

RESULTS: EAST WALL
(a) A/CL < 0.4 (b)

(a)
(b)
RESULTS: ROOF (1)
X
A/CL > 1 over a small area < 10 m²
RESULTS: ROOF (2)
After ~10 years, the maximal A/CL Only the first 2 layers (depth < 20 cm)
value becomes < 1. remains with A/CL > 1 after a few years.
CONCRETE ACTIVATION: SUMMARY
• Potential concrete activation above clearance levels at very localized area

close to the energy degrader.
• Mixture of long-lived isotopes (Eu152) and middle-lived isotopes (Na22).
• This activation comes back below the clearance levels after some cooling
period < 10 years no need to foresee storage of nuclear waste for a very
long period.
• If needed, could foresee at these hot spots a 20-40 cm concrete layer

separated from the main walls to ease decommissioning.
European Commission report

2014 02 28 Item 2 AERB IBA Radiation Safety Aspects

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AERB : Radiation Safety Aspects

IBA Proteus-235 NOC Application: Anne-Sophie Grell – Frédéric Stichelbaut

1. Technical and clinical aspects of the Proteus-235 proton therapy facility

5. Site selection criteria for Proteus-235 Proton Accelerator Facility

2 Protons are possible

2. Handling of activated components.

1. Cyclotron + related eqpt « Radiation doses around the C230 Cyclotron ».

2. Building « Interface Building Document ».

« General Risk Analysis for Proton Therapy ». Appendix C Q6

of the Proteus 235 product at the system level-PTS GRA. »

191 pages covering and listing every potential hazards.

Medical electrical equipment - General requirements for safety IEC 60601-2-38

Building « Interface Building Document ».Appendix CQ5

TSS Appendix CQ4b

Control access to areas

Safety signages and indicators

o At Treatment Room entrance

o At Cyclotron vault entrance

Automatic door closers

Crash button in various locations in the building

Security fences ESS/BTS

Scanning Generator Redundant Unit Functional Red. Unit

• On a 20 layers irradiation X_MIN_FIELD

! According to National + Regional + Local + Hospital regulations/rules !

To be managed by RSO (Radiation Safety Officer).

To be ruled by Procedures : ex : « Handling of activated parts procedures ».

To be operated by certified staff + certified subcontractors.

To be located in designated locations for activated parts (shielding, …).

Role of the Radiation Safety Officer (RSO)

Proton System Activated parts:

o Decommissioning of non-active equipments :

A/CL < 0.2

(a) A/CL < 0.8 (b)

Y = 0 corresponds to the centre of C230

(a) A/CL < 0.4 (b)

• Potential concrete activation above clearance levels at very localized area

• Mixture of long-lived isotopes (Eu152) and middle-lived isotopes (Na22).

• If needed, could foresee at these hot spots a 20-40 cm concrete layer

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