RFI Attachment 1 PRD Requirements Matrix.xlsx

XLSX spreadsheet 35 KB Posted

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Personal Radiation Detector (PRD)
Solicitation number
70FA4027I00000002
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This is a Requirements Matrix attachment to a Request for Information (RFI) for Personal Radiation Detectors (PRDs) issued by the Department of Homeland Security's Federal Emergency Management Agency (FEMA), Office of Chemical, Biological, Radiological, and Nuclear (CBRN) Defense. The matrix establishes technical specifications and performance requirements for commercially available, gamma-detecting PRDs with wireless communication capabilities.

The document outlines 43 operational requirements (ORs) and 12 functional requirements (FRs) organized across six Key Performance Parameters (KPPs). KPP 1 addresses radiation detection capability with gamma-only or gamma/neutron detection (with disabling capability), with probability of detection thresholds at 90% and objectives at 95%. KPP 2 specifies three alarm types (visual, audible, and vibration) with provisions for vibrate-only mode that disables lighted indicators. KPP 3 establishes detection performance metrics including false alarm rates (≤0.25 per hour threshold; ≤0.125 per hour objective), time-to-alarm within 2 seconds at threshold/1 second objective, over-range thresholds of 100 mR/h minimum, and display formats (digital or unit-less). The matrix includes environmental operating specifications spanning -20°C to +50°C temperature ranges, 40-93% relative humidity at threshold/25-99% at objective, IP53 ingress protection at threshold/IP67 at objective, and electromagnetic resilience testing for electrostatic discharge (6 kV), radio frequency fields (80 MHz to 2.5 GHz at 40 V/m threshold/50 V/m objective), and magnetic field exposure (100 A/m). Battery requirements mandate 24-hour operation in non-alarm state at threshold and 168-hour at objective, with 30-minute alarm operation at threshold and 60-minute objective. KPPs 4 and 5 specify physical dimensions (12 cm x 8 cm x 4 cm threshold; 10 cm x 6.5 cm x 3.5 cm objective) and maximum mass of 400 grams at threshold and 240 grams at objective. KPP 6 requires data transmission capability including manufacturer name, instrument model, serial number, software version, detector type, measurement date/time, radiation levels, alarm indication, and operating hours, with mobile application support for both Android and iOS platforms. Cybersecurity requirements mandate Bluetooth 4.2 or higher with FIPS-approved algorithms at threshold and Bluetooth 5.0 at objective, unique logical and physical identifiers, authenticated software updates, operational availability of 98% at threshold and 99.5% at objective, and mean time between failure of 43,800 hours at threshold and 87,600 hours at objective. Mechanical durability testing includes drop tests from 1.5 meters at threshold and 2.44 meters at objective, vibration resilience testing, and impact resistance. The matrix includes vendor response columns for capability assessment (Meets Objective, Meets Threshold Only, Partially Meets Threshold, Does Not Meet Threshold, Not Applicable), basis of response documentation (manufacturer testing, independent testing, product specification, certification/declaration, operational use, analysis, or other), test status and dates, and optional vendor comments.

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Instructions

ColumnTitleInstruction
FVendor Capability Relative to Threshold and ObjectiveSelect one: Meets Objective; Meets Threshold Only; Partially Meets Threshold; Does Not Meet Threshold; Not Applicable.
GBasis of Response / Supporting Evidence AvailableSelect one or more: Manufacturer testing; Independent testing; Product specification; Certification/declaration; Operational use; Analysis; Other.
State whether supporting documentation is available upon Government request. (Yes/No)
Do not attach test data or reports to the RFI response.
HTest Status, Most Recent Test Date, and Vendor CommentsEnter: Tested / Not Tested / N/A;
If tested, provide the most recent relevant test date or date range (MM/YYYY or MM/YYYY–MM/YYYY)
IOptional CommentsExplain any “Partially Meets Threshold” or “Does Not Meet Threshold” Responses from Column G, as desired.
Provide concise material comments, conditions, limitations, or assumptions, as desired.

RTM

Requirement ID KPP Requirement Description Threshold Objective Vendor Capability Relative to Threshold and Objective (Select one:

Meets Objective;

Meets Threshold Only;

Partially Meets Threshold;

Does Not Meet Threshold;

Not Applicable.) Basis of Response / Supporting Evidence (Identify the basis:

Manufacturer testing;

Independent testing;

Product specification;

Certification/declaration;

Operational use;

Analysis;

Other. ) Test Status, Most Recent Test Date (Enter: Tested / Not Tested / N/A)

(Date: MM/YYYY or MM/YYYY–MM/YYYY)Optional Vendor Comments
OR 1KPP 1The System shall have T/O radiation detection capability.

Amplifying Information: Systems with neutron detectors may be submitted for evaluation. If the device does come with neutron capabilities, it must have the ability of disabling that component.

FR-01Gamma onlySame as Threshold
OR 2The system shall have T/O radiation detection capability.
Amplifying Information: Systems with neutron detectors may be submitted for evaluation. If the device does come with neutron capabilities, it must have the ability of disabling that component.≥90%≥95%
OR 3KPP 2The system shall have T/O alarm types.

Amplifying Information: At least one type of alarm must be operational under any configuration of the system. In other words, it shall not be possible to deactivate all alarms at the same time.

See FR-02 and FR-03.Visual, Audible and Vibration (tactile)Same as Threshold
OR 4While in “Vibrate Only” mode, all system T/O shall be automatically disabled.
Amplifying Information: The system shall have a minimum of two alarm modes: one in which all three types of detection alarms are annunciated (visual, audible, and vibrate) are fully functional, and one in which only the vibration alarm is active. The display shall still be visible and readable without the requirement of a backlight. The requirement that at least one type of alarm must be operational under any configuration of the system (OR-03) still applies.Lighted indicators (e.g., LED, display backlight, etc.)Same as Threshold
OR 5False alarm rate for gamma radiation shall be T/O.

Amplifying Information: IAW ANSI N42.32-2016, Section 6.1. [14] The T/O values assume the system is operated in a stable background environment. A false alarm is defined as either a false positive or a false negative. A false positive is a situation in which the system alarms indicate the presence of ionizing radiation when no radiation source exists. A false negative is that the system fails to alarm

when in the presence of an ionizing radiation source. Test data should provide context to the results in case one or more devices do not meet this requirement.≤ 0.25 per hour≤ 0.125 per hour
OR 6The system shall alarm in T/O after reaching a distance of closest approach

to a gamma source for 19 out of 20 trials.

Amplifying Information: IAW ANSI N42.32-2016, Section 6.2. [14] Increase exposure rate to 50 μR/h above background at a distance of closest approach of 1.5 m and a speed of 1.2 m/s. Test data should provide context to the results in case one or more devices do not meet this requirement.

See FR-04.≤ 2 s≤ 1 s
OR 7The system Time to Alarm threshold (OR-06) shall not be affected by slowly increasing radiation levels when approaching a radiation source at a speed of T/O for 10 out of 10 trials.

Amplifying Information: Per ANSI N42.32-2016, Section 6.4 [14] (gamma only), start at the background. Move the source at the speed indicated by the threshold or objective values to produce an exposure rate of 50 μR/h at the distance of closest approach (1.5m). Test data should provide context to the results in case one or more devices do not meet this requirement.

See FR-05.0.25 m/sSame as Threshold
OR 8KPP 3The system shall have an over-range threshold of at least T/O.

Amplifying Information: When an exposure rate is two times the maximum dose rate/exposure rate (OR-38) or higher, the system shall alarm. The alarm shall remain active, and an over-range indication shall be displayed for the duration of the over-range exposure. Systems with an overload threshold of less than two times the maximum dose rate/exposure rate (OR-38) threshold may not be submitted for evaluation. Test data should provide context to the results in case one or more devices do not meet this KPP requirement.

See FR-06 and FR-07.100mR/h1 R/h
OR 9The system shall display radiation levels in one or both of the T/O formats.

Amplifying Information: IAW ANSI N42.32-2016, Section 5.8, [14] the system only needs to have one of the two display formats and the display may be backlit, except as indicated in (OR-04). The system itself shall have a display in addition to the user interface of a mobile device if a mobile application is used. Test data should provide context to the results in case one or more devices do not meet this requirement.

See FR-08. Digital display: System directly displays the measured exposure rate, dose rate, ambient dose equivalent rate, or count rate (e.g., µR/h or cps).

Unit-less display: The system displays a numerical value (e.g., 1 to 9) that may be proportional to the radiation field but is not explicitly reported as the exposure, dose or ambient dose-equivalent rate, or

count rate.Same as Threshold except the system has both types of displays and the operator can choose which display to view.
OR 10The system shall provide cybersecurity protection to Bluetooth (BT) communications using T/O.

Amplifying Information: The vendor shall provide a detailed description of the Bluetooth protocols used, to include but not limited to:

•The level of security.
•Method of pairing.
•Type of encryption used.

In accordance with DHS Policy Directive 4300A Handbook Attachment 6, [15] the BT connection shall be configured such that:

•Bluetooth functionality shall be disabled when the system is not in use.
•The system only allows manual pairing and prompts the user to authorize any incoming connection requests; auto pairing may not be implemented.
•The system shall be in non-discoverable mode, except during device pairing.
•Devices shall use Bluetooth low energy option to minimize the range of communication.BT 4.2
specification or higher with FIPS approved algorithm & Wi-Fi WPA2 with FIPS approved encryption (NIST SP 800-121 REV. 2)BT 5.0

specification or higher with FIPS approved algorithm (NIST SP 800-

121 REV. 2)

OR 11 The system shall have unique T/O identifiers.

Amplifying Information: Consistent with DHS Policy Directive 4300A, V13.3 2023, Information Technology System Security Program, Sensitive Systems: [15]

•Unique logical identifiers shall not be reused.
•Unique logical identifiers shall be included on all communication interfaces (e.g., Media Access Control address on network connections, System ID on BT connections) in accordance with industry standards.
•Unique physical identifier (e.g., serial number bar code) will be provided by the government.Logical and physicalSame as Threshold
OR 12If applicable, any future changes made to the system device software shall require T/O authentication.

Amplifying Information: There is no requirement for the system to have software that FEMA CBRN Operations or the end-user can update; however, if the system does have software that FEMA CBRN Operations or the end-user can update, this requirement applies. Consistent with DHS Policy Directive 4300A, V13.3 2023, Information Technology System Security Program, Sensitive Systems: [15]

•A group authenticator shall be considered a single authenticator (e.g., password, passcode) used per device. An individual authenticator shall be considered a discrete authenticator [e.g., personal identification number (PIN)] per individual user, normally associated with a user identifier.
•Authentication may be made at the system level or as part of the setup software.
•Software updates can use certificates to validate the authenticity of the update.
•If applicable, the vendor shall provide design documentation that describes the security features of the system.
•The manufacturer shall notify FEMA CBRN Operations what modifications are made during each update.GroupIndividual
OR 13The system shall have an operational availability (Ao) of T/O.
Amplifying Information: Ao = Mean uptime/(mean uptime + mean downtime). Uptime is defined as the amount of time that the system is operating or capable of operating. Downtime is defined as the amount of time that the system is not capable of being operated for any reason, such as breakage, being out for repair, or the logistics associated with the repair.≥ 98%≥ 99.5%
OR 14The system shall have both T/O low battery indicators.

Amplifying Information: IAW ANSI N42.32-2016, Section 5.13, [14] the batteries that are used shall be widely available, shall not be unique to the system, and shall be replaceable in the field with tools that are easily obtained

or are commercially available (e.g., screwdriver, coin).Visible and audibleSame as Threshold
OR 15The system’s batteries shall be capable of powering the system in a non-alarm state for T/O.

Amplifying Information: IAW ANSI N42.32-2016, Section 5.13, [14] the batteries that are used shall be widely available, shall not be unique to the system, and shall be replaceable in the field with tools that are easily obtained or are

commercially available (e.g., screwdriver, coin).≥ 24 hours≥ 168 hours
OR 16The system’s batteries shall be capable of powering the system’s audible, visual, and vibration alarms for T/O while continuously alarming.

Amplifying Information: IAW ANSI N42.32-2016, Section 5.13, [14] the batteries that are used shall be widely available, shall not be unique to the system, and shall be replaceable in the field with tools that are easily obtained or are

commercially available (e.g., screwdriver, coin).≥ 30 min≥ 60 min
OR 17The system shall have a mean time between failure of T/O.

Amplifying Information: A failure is a severe degradation or total loss of a mission essential function. Mission essential functions may include detecting, analyzing, alarming, displaying, and communicating. The MTBF threshold

of 43,800 hours equates to 1,825 days or 5 years. This is intended to be an aggregate metric.≥ 43,800 hrs≥ 87,600 hrs
OR 18The system shall operate as intended over the T/O range of relative humidity (RH).

Amplifying Information: IAW ANSI N42.32-2016, Section 7.3, [14] the

temperature at which testing is performed shall be 35°C (± 2°C). No alarms or spurious indications shall occur due to the changes in humidity.40% to 93%25% to 99%
OR 19The system shall operate as intended at temperatures from T/O.

Amplifying Information: IAW ANSI N42.32-2016, Section 7.1, [14] if the manufacturer specifies a narrower operating temperature range, testing shall not be performed, and the system fails the test. If the manufacturer specifies a broader operating range, the instrument shall be tested at the broader temperature range specified by the manufacturer. Relative humidity shall be less than 75%. –20°C (-4°F) to +50°C (122°F)

The system response is acceptable if no alarms or spurious indications occur due to temperature changes, the system continues to alarm when exposed to the test source at all temperatures, and the display is readable at all temperatures. –20°C (-4°F) to +50°C (122°F)

The system response is acceptable if it meets the Threshold, and the post-test measurements are within the values described in ANSI N42.34-2021, Section 4.8.

OR 20 The system shall be able to operate as intended when switched on at the low temperature limit of -20°C and at the high temperature limit of 50°C within T/O.

Amplifying Information: IAW ANSI N42.32-2016, Section 7.5, [14] if the

manufacturer specifies a narrower operating temperature range, testing shall not be performed, and the system fails the test.5 min2 min
OR 21The system shall withstand exposure to random vibrations at T/O spectral density at frequencies associated with the operation of body-worn equipment.

Amplifying Information: IAW ANSI N42.32-2016, Section 9.1, [14] the frequency endpoints associated with the operation of body-worn equipment are 5 Hz and 500 Hz. The physical condition and functionality of the system shall not be affected by the vibration (e.g., solder joints shall hold, nuts and bolts shall not come loose). The test method described in Section 9.1 of ANSI N42.32-2016 describes a duration of one hour.

No alarms or spurious indications shall occur as a result of the vibrations alone.0.01 g2/HzSame as Threshold
OR 22The system shall have a MTAT of T/O.

Amplifying Information: The system shall operate without the need for scheduled maintenance. Scheduled maintenance includes any maintenance of the system except for:

•Charging and changing of batteries.
•Non-invasive cleaning.
•System operational checks (these functions shall require no special training or tools).

The formula for MTAT is: MTAT = (MTTR + Waiting Time) where:

•MTTR – the actual time a technician spends repairing the device.
•Waiting Time – any time the device spends in a queue or idle state as the manufacturer awaits spare parts, ships the device to another repair facility,
finds time to repair the device, spends time conducting a quality control review of the device, etc.≤ 30 days≤ 20 days
OR 23The PRD will have a source-based response check to validate detector performance
Amplifying Information: The PRD shall conduct a source-based performance verification that evaluates detector response, energy peak stability, and sensitivity against stored calibration reference values to ensure continued operational accuracy.PRD confirms source from factory calibrated reference valueSame as threshold
OR 24The system case design shall meet the requirements stated for ingress protection (IP) code T/O.

Amplifying Information: IAW ANSI N42.32-2016, Section 7.4, [14] the International Electrotechnical Commission (IEC), IP53 refers to protection from the ingress of dust and spraying water. For IP53, the ingress of dust is not totally prevented, but dust shall not penetrate in a quantity to interfere with satisfactory operation of the system or to impair safety. For IP53 water sprayed at angles up to 60°F on either side of the vertical shall have no harmful effects. For IP67, the device is dust tight (no ingress of dust) and the ingress of water in quantities causing harmful effects shall not be possible when the enclosure is temporarily immersed in water

under standard conditions of pressure and time. More specifically, the device can be immersed in water with a depth of up to 1m for up to 30 minutes.IP53IP67
OR 25The system shall not be affected by exposure to electrostatic discharges at voltages of up to T/O.

Amplifying Information: IAW ANSI N42.32-2016, Section 8.1, [14] the method of testing shall be the contact discharge technique. When exposed to these electrostatic discharges, the system shall function correctly. No alarms or spurious

indications shall occur as a result of the electrostatic discharges alone.± 6 kVSame as Threshold
OR 26The system shall not be affected by radio frequency (RF) fields over the frequency range of 80 MHz to 2.5 GHz at an intensity of T/O.

Amplifying Information: IAW ANSI N42.32-2016, Section 8.2, [14] when

exposed to these RF fields, the system shall function correctly. No alarms or spurious indications shall occur as a result of the RF radiation alone.40 V/m50 V/m
OR 27The system shall operate as intended when exposed to a T/O magnetic field in all three mutually orthogonal orientations.

Amplifying Information: IAW ANSI N42.32-2016, Section 8.3, [14] no alarms or spurious indications shall occur as a result of the magnetic field alone.

The gauss is a unit of measurement of magnetic induction, also known

as magnetic flux density and essentially refers to the intensity of a magnetic field. Amperes per meter (A/m) is an indication of the magnetic field strength.100 A/m (1.3 Gauss)
60 Hz ACSame as Threshold
OR 28The system shall be fully operational within T/O of exposure to rapid temperature changes.

Amplifying Information: IAW ANSI N42.32-2016, Section 7.2, [14] the rapid temperature changes shall be from 22°C to –20°C, –20°C to 22°C, 22°C to 50°C, and 50°C to 22°C, with each change being made in less than five minutes. If the manufacturer specifies a narrower operating temperature range, testing shall not be performed, and the system fails the test.

See FR-06.2 min1 min
OR 29The system shall alarm as intended after being subjected to drops on each of its six surfaces from a height of T/O onto a concrete floor.

Amplifying Information: IAW ANSI N42.32-2016, Section 9.2, [14] there shall be no visible external damage to the system, except for minor scratches or nicks on the case, and all control functions shall be verified to be operating

correctly.1.5m (» 5ft)2.44m (» 8ft)
OR 30The system response shall be unaffected by T/O impacts, such as those that may occur from low intensity impacts from sharp contact with hard surfaces.
Amplifying Information: IAW ANSI N42.32-2016, Section 9.3, [14] the objective of this test is to ensure the system’s response shall be unaffected by from low intensity impacts from sharp contact with hard surfaces. The test shall be performed on each side of the system case, and there shall be three impacts on each side of the system. The 0.2 J impact is equivalent to a mass of 0.2 kg moving at 1.4 m/s over a distance of 0.1m. The performance is acceptable if no alarms or spurious indications occur as a result of the impacts alone.0.2 Joules
( 0.15 ft/lbs)0.27 Joules

( 0.2 ft/lbs) OR 31 The system shall be provided with PC supporting software that runs on a T/O operating system.

Amplifying Information: The intent of the vendor-provided software is to perform software updates, configuration changes, calibrations, and some level of troubleshooting.

See FR-07, FR-08, FR-09, and FR-12.Windows 11 or newerSame as Threshold
OR 32The system shall demonstrate cyber resilience such that the system will continue to perform designed T/O operations throughout all incidents.

Amplifying Information: Reference DHS Policy Directive 4300A, V13.3 2023, Information Technology System Security Program, Sensitive Systems. [15] Upon re-establishment of communications following any communication failures, the system shall transmit all information collected during the time frame of the communications failure.

See FR-10, FR-11, and FR-12.R/N detectionSame as Threshold
OR 33KPP 4The system shall have dimensions of T/O.
Amplifying Information: These dimensions exclude any holster or carrying case. Length is 20cm, width is 10cm, and height or thickness is 5cm.≤ 12 cm x 8 cm x 4 cm≤ 10cm x 6.5cm x 3.5cm
OR 34KPP 5The system shall have a maximum mass of T/O.
Amplifying Information: IAW ANSI N42.32-2016, Section 5.3. [14] The system as it is worn during use, including the battery and holster or clip, shall be weighed.≤ 400g≤ 240g
OR 35Powering on the system shall require either T/O.
Amplifying Information: Upon startup, the PRD shall perform automatic self-calibration, including energy stabilization and internal system checks, without requiring operator input.Self-CalibrationSame as Threshold
OR 36Powering off the system shall require either T/O.

Amplifying Information: None (1) A two-step process

— or —

(2) A sustained hold of the power button for a minimum of 10 seconds (1) A two-step process

— or —

(2) A sustained hold of the power button for a minimum of 5 seconds OR 37 The PRD kit shall include a carrying accessory (clip or holster/case) that enables secure, hands-free wear on a duty belt or uniform. (1) A two-step process

— or —

(2)A sustained hold of the power button for a
minimum of 10 secondsSame as Threshold
OR 38The system shall physically accommodate the 5th to 95th percentile of operators when conducting T/O activities.

Amplifying Information: The system must physically accommodate most operators and minimize the potential for fatigue or injury over the course of short-and long-term use. Fifth to 95th was based on MIL-STD-1472H. [16] Per this standard, “the multivariate central 90 percent of suitably clothed and equipped males of the target user population and the multivariate central 90 percent of suitably clothed and equipped females of the target user population will be able to use and fit the system to accomplish required physical tasks under consideration. The distribution of the 10 percent not accommodated by the design, including range of adjustment of system features, should be evenly split between the smaller and larger portions of the population.”

Note: The PM and Sponsor may pursue a waiver/exemption to this 508-compliance requirement given that the majority of end-users are law enforcement officers and first responders.Primary screening and routine maintenanceSame as Threshold
OR 39The system shall provide a unique visible, audible, and vibration notification to the operator when the dose rate/exposure rate exceeds T/O.

Amplifying Information: Exposure rate is a measure of the amount of radiation present in the environment and is usually expressed in units such as milliRoentgens per hour (mR/h). Dose rate is a measure of the amount of radiation that is absorbed by a person (or object) and is usually expressed in units such as millirems per hour (mrem/h). In reality, for gamma rays there is approximately a one-to-one ratio between exposure rate and dose rate. While not a requirement,

the preferred unit of measurement is (mR/h).2 mR/hAn operator adjustable dose rate setting
OR 40The radiated emission limits for the system shall be less than the T/O values when measured at 3 m.

Amplifying Information: IAW ANSI N42.32-2016, Section 8.4 [14] and as described in the FCC/CFR15.109 rules for unintentional radiators Class A digital devices. Emission frequency Range (MHz) 30-88 88-216 216-960 above 960

Field Strength (microvolts/meter)

500Same as Threshold
OR 41The system shall have the capability to connect with and transmit data to T/O devices.
Amplifying Information: At a minimum, the desired connection between the system and smart phone/tablet shall be made via Bluetooth. The PRD shall be capable of connecting to and sharing data with situational awareness software platformsWireless communication equipment, such as a smart phone or tablet, that utilizes the operating system currently fielded to system stakeholders.Same as Threshold
OR 42KPP 6The system shall be capable of transmitting data containing the T/O information.
Amplifying Information: IAW ANSI N42.32-2016, Section 5.14, [14] the data format shall meet the ANSI requirements. The transfer protocol shall be fully described in the manufacturer’s technical manual. No data shall be lost due to changing or recharging batteries. Data shall have the ability to be uploaded to the cloud.• Manufacturer name

• Instrument model

• Serial number

• Software version

• Gamma detector type (e.g., CsI (Tl), NaI (Tl), GMT)

• Date and time of measurement

• Measured radiation levels (e.g., exposure rate, dose rate, or level)

• Gamma-ray alarm indication

• Track total operating hoursSame as Threshold with the additional data field of “operating hours”
OR 43The PRD shall support connection to a mobile application on both Android and iOS devices for data access.Connected mobile application will work both on Android and iOS devices for data accessSame as Threshold
FUNCTIONAL REQUIREMENTS
FR #OR #Functional RequirementThresholdObjectiveVendor Capability Relative to Threshold and Objective

(Select one:

Meets Objective;

Meets Threshold Only;

Partially Meets Threshold;

Does Not Meet Threshold;

Not Applicable.) Basis of Response / Supporting Evidence (Identify the basis:

Manufacturer testing;

Independent testing;

Product specification;

Certification/declaration;

Operational use;

Analysis;

Other. ) Test Status, Most Recent Test Date (Enter: Tested / Not Tested / N/A)

(Date: MM/YYYY or MM/YYYY–MM/YYYY)Optional Vendor Comments
FR-01OR-02The system shall demonstrate the Probability of Detection (Pd) listed in OR- 02 when exposed for T/O.≥.90 confidence level≥.95 confidence level
Amplifying Information: In this context, the probability of detection (Pd) is a statistical measure of the likelihood that the system clearly detects the presence of ionizing radiation it is intended to monitor for. Include multiple points for Pd assessment. Test data should provide context to the results in case one or more devices do not meet this requirement.
FR-02OR-03The system shall have an audible alarm with a T/O.A-weighted sound level between 85 dB(A) and 100 dB(A)A-weighted sound level between 70dB(A) and 100 dB(A)
Amplifying Information: IAW ANSI N42.32, 2016 Section 5.10.1. [16], the audible alarm of the system shall be activated with the appropriate radiation sources (137Cs) and the A-weighted sound level measured at a distance of 30 cm from the source. Test data should provide context to the results in case one or more devices do not meet this requirement.
Note: Volumes of approximately 50 dB are generally considered pleasant for human hearing; however, may not be loud enough for an operator to hear over ambient noise levels. Volumes above 70 dB over a prolonged period of time may damage a person’s hearing. Discomfort levels start around 100 dB and volumes above 120 dB can cause immediate harm to a human being’s hearing.
FR-03OR-03The system audible alarm shall have a frequency within the range of T/O.1000 Hz to 4000 Hz.Same as Threshold
Amplifying Information: IAW ANSI N42.32, 2016 Section 5.10.1. [16], the audible alarm of the system shall be activated with the appropriate radiation sources (137Cs) and the frequency measured at a distance of 30 cm from the source. Test data should provide context to the results in case one or more devices do not meet this requirement.
FR-04OR-06The system shall alarm in ≤2 s after exposure to an increase in the background radiation level of 50 μR/h above background while moving at a speed of T/O.1.2 m/s (+/-10%)0.6 m/s (+/-10%)
Amplifying Information: IAW ANSI N42.32, 2016 [16], Section 6.2, the system shall alarm in ≤2 s after exposure to an increase in the ambient radiation level of 50 μR/h above background for 241 Am, 137Cs, and 60Co sources when moving at a speed of 1.2 m/s at a distance of closest approach of 1.5 m.
FR-05OR-07The system Time to Alarm threshold (OR-06) shall not be affected by slowly increasing radiation levels when approaching a radiation source at a speed of T/O.≤0.5 m/sSame as Threshold
Amplifying Information: IAW ANSI N42.32, 2016 [16], Section 6.4 (gamma only), the 137Cs source shall produce an exposure rate of 50 μR/h (± 20%) above background at the reference point of the system at the distance of closest approach of 1.5 m.
FR-06OR-08 OR-28The system shall operate as intended when exposed to rapid temperature changes within T/O.30 minutesSame as Threshold
Amplifying Information: IAW ANSI N42.32, 2016 [16], Section 7.2, each temperature change shall be made in less than 5 minutes. The temperature ranges are:

· (22 °C to –20 °C),

· (–20 °C to 22 °C),

· (22 °C to 50 °C), and

· (50 °C to 22 °C)

FR-07OR-08 OR-31The system shall require T/O software updates to be authenticated.AllSame as Threshold
Amplifying Information:

• Applicable in all cases where the device requires updates to be made by FEMA CBRN OPERATIONS.

• Software updates can use certificates to validate the authenticity of the update.

• The vendor shall provide design documentation that describes the operation of the authentication features.

FR-08OR-09 OR-31The system shall require all changes made to the device detection settings to be authenticated T/O.Group authenticationIndividual authentication
Amplifying Information:

• Changes to detection settings should not be permitted without authentication either by group or individual user.

• A group authenticator shall be considered a single authenticator (e.g., password, passcode) used per device. • An individual authenticator shall be considered a discrete authenticator (e.g., personal identification number [PIN]) per individual user, normally associated with a user identifier.

• Authentication may be made at the system level or as part of the setup software FR-09 OR-31 The supporting software shall collect T/O audit information of all changes made to system software and detection settings. a. What type of event occurred.

b. When the event occurred.

c. Where the event occurred.

d. Source of the event;

e. Outcome of the event.

f. Identity of any individuals, subjects, or objects/entities associated with the event.

Audit information shall be protected from changes (to include deletion) by all users.Same as Threshold
Amplifying Information: None
FR-10OR-32The system shall provide a T/O alert to the operator of any communication anomalies that prevents data from being transmitted from the system to the mobile device.Audible and visualSame as Threshold
Amplifying Information: Any alerts should be clear to the operator that they are in response to communication issues.
FR-11OR-32The system shall continue to T/O regardless of the state of the communications interface (BT).Detect and alarmSame as Threshold
Amplifying Information: None
FR-12OR-32Upon re-establishment of Bluetooth communications, the system shall transmit all data collected during the time frame of the communications failure.Yes/No (Pass/Fail)Same as Threshold
Amplifying Information: The data referenced in the requirement statement is the same Threshold and Objective data listed in OR-40/KPP-6.

File details come from the government source that posted it. Updated .