257-100-0010 Ignition Interlock Device Standards and Requirements (1) Any device model for use in Oregon must meet or exceed the established standards set by OSP. A device model for use in the State of Oregon is qualified by OSP based on its ability annually to meet the minimum established device and performance standards set forth by ORS 813.599, 813.600 and OAR Chapter 257, Division 100. (2) To be considered for placement on the Oregon List of Qualified Devices, a manufacturer’s representative must submit all of the following to OSP: (a) A completed Application for Ignition Interlock Device Qualification. (b) A written statement from the manufacturer on the manufacturer’s letterhead addressed to OSP that authorizes a manufacturer’s representative to act as the sole source manufacturer’s representative for the manufacturer’s device model. (c) A certificate of insurance as proof of product liability insurance as described in OAR 257-100-0015. (d) Written documentation, issued within the preceding five years prior to submission of the application, from an International Organization for Standardization (ISO) 17025 certified testing laboratory that states that the device meets or exceeds the model specifications established by NHTSA, identified as “Model Specifications for Breath Alcohol Ignition Interlock Devices (BAIIDS).” The documentation must be for the manufacturer’s specific model of ignition interlock device listed on the application. The NHTSA model specification for BAIIDs is incorporated by reference and made part of this rule as published in the 78 Fed Reg 26849-26867 (effective May 8, 2014) and 80 Fed Reg 16720-16723 (effective March 30, 2015). The documentation from the ISO 17025 certified testing laboratory must include: (A) The name, physical location, mailing address, and phone number of the testing laboratory; (B) A description of the tests performed; (C) Copies of the data and results of the testing procedures; and (D) The names of the lab employees performing the tests. (e) Written documentation of the manufacturer’s certification to the current International Organization for Standardization (ISO) 9001 Quality Management System (QMS) for aspects related to construction, production and repair of a device. Along with this certification, a copy of the manufacturer’s Quality Assurance Plan (QAP) for checking the accuracy of the calibration; All new manufacturer’s representatives applying for certification shall ensure their device manufacturer obtains an accredited ISO 9001 certification prior to application submission to OSP. (f) A functional device model being submitted for qualification; (g) Any electronic device, which reports login procedures, and allows online accessibility for OSP to review and download reports of any individual and device; (h) A written notice to OSP, illustrating an implementation plan and description of any modification to the device. Any modification in either firmware or hardware may require the applicant to resubmit their device and all documents required in OAR 257-100-0010; (i) A signed OSP Ignition Interlock Device Violation Policy form (257-0012), detailing how the validity of violations committed by the individual will be determined in accordance with ORS 813.635; and (j) The application fee described in OAR 257-100-0070(2)(b). (k) Written documentation indicating the manufacturer’s representative’s registry with the Oregon Secretary of State’s Office. Any manufacturer’s representative conducting business in the State of Oregon as an assumed business name (ABA) or doing business as (DBA), must also provide documentation indicating registry with the Oregon Secretary of State’s Office. (3) OSP shall review the application when all the materials described in subsection (2) are received. If additional documentation is required, the manufacturer’s representative must submit all required material within 60 calendar days from OSP notifying the manufacturer or manufacturer’s representative or re-submission of the application may be required. (4) When a completed application has been accepted by OSP, OSP shall conduct an ODC test, as outlined in OSP Form 257-0037 (Oregon Device Configuration Test Requirements and Procedures), of each device model submitted to determine if the device model meets standards described in ORS 813.599, 813.600 and OAR Chapter 257, Division 100. If the device fails the ODC conducted by OSP, the manufacturer or manufacturer’s representative must correct the disqualifying factors within 60 calendar days from OSP notifying the manufacturer or manufacturer’s representative or re-submission of the application may be required. (5) For an ignition interlock device to remain on the Oregon List of Qualified Devices, a manufacturer or manufacturer’s representative must: (a) Maintain valid product liability insurance as described in OAR 257-100-0015; (b) Maintain valid registry with the Oregon Secretary of State’s Office; (c) Pass an annual Oregon Device Configuration Test conducted by OSP as outlined in OSP Form 257-0037; (d) Meet or exceed the performance standards outlined in OAR 257-100-0050. (6) At any time after a device has been approved by the Department, if the firmware or hardware of the device model is modified and the modification change affects any operational aspect of the device subject to current NHTSA model specification as described in subsection (2)(d) of this rule, the manufacturer or manufacturer’s representative must notify OSP within 30 calendar days from release and, as determined by OSP, either modify OSP’s demo device or send a modified device to OSP. (7) When a firmware or hardware modification affects NHTSA specifications outlined in section (5), OSP shall conduct an ODC test of the modified device. (8) Device qualifications are valid for a period of five years. [Publications: Publications referenced are available from OSP.] Statutory/Other Authority: ORS 813.600 & ORS 813.660 Statutes/Other Implemented: ORS 813.599 – 813.680 History: OSP 3-2022, amend filed 05/20/2022, effective 05/20/2022 OSP 25-2019, amend filed 12/27/2019, effective 12/31/2019 OSP 24-2019, temporary amend filed 07/03/2019, effective 07/03/2019 through 12/29/2019 TSD 3-2019, renumbered from 737-005-0110, filed 05/30/2019, effective 07/01/2019 TSD 2-2019, adopt filed 01/17/2019, effective 01/17/2019 TSD 3-2018, temporary adopt filed 09/24/2018, effective 09/24/2018 through 03/22/2019