The technical regulation of the legislatively regulated means of measuring equipment was approved by the Resolution of the Cabinet of Ministers of Ukraine dated January 13, 2016, No. 94.
2017/05/10 on the products of concern Dräger Safety AG & Co. KGaA:
A type certificate Module B UA.TR.001 101-17 Rev.0 was issued.
Requirements for putting into operation:
The manufacturer or his authorized representative must provide a copy of the first page of the Type Verification Certificate under Module UA.TR.001 101-17 Rev.0 dated 05.10.2017 and a copy of the Declaration of Conformity drawn up in accordance with the requirements of the applicable legislation.
The marking must be in accordance with the requirements specified in the Type Verification Certificate under Module UA.TR.001 101-17 Rev.0 dated 05.10.2017.
The gas analyzer must be sealed in accordance with the Type Verification Certificate according to Module B UA.TR.001 101-17 Rev.0 dated 05.10.2017.
The software be in accordance with the requirements specified in the Type-Certificate Verification by Module UA.TR.001 101-17 Rev.0 dated 05.10.2017.
The operation of gas analyzers must be carried out in accordance with the manufacturer's operating instructions.
Means of protection: a security element "SDI" (seal-label), which collapses when attempting to remove an element from the object of protection.
Markings and inscriptions: The mark of conformity and additional metrological marking in accordance with the Technical Regulations should be placed on the service-guarantee books of gas analyzers, as well as in battery compartments (in the Handset unit under the protective cover for Interlock alcohol blockers). The Service Guaranty must also have a Type Verification Certificate number.
Alkotesters (gas-analyzers) Dräger Alcotest® are responsible to the requirements of the Technical Regulation on medical products
European standard EN 15964: 2011 (DSTU EN 15964: 2014) is valid in Ukraine