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Accreditation for the conformity assessment scheme in the field of measuring instruments that are component of medical devices

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Accreditation for the conformity assessment scheme in the field of measuring instruments that are component of medical devices

Rulebook on Amendments to the Rulebook on measuring instrument types that are subject to legal control ("Official Gazette of RS" No. 13/18, 45/19, 93/20) has been amended and entered into force on July 9, 2020. The Rulebook has been amended in such a way that the measuring instruments that are component of medical devices (no. 35 and no. 36 of the Table in Article 2) have been added, and which, according to Article 7, are verified by designated bodies. They must be accredited according to Article 9 of the Law on metrology ("Official Gazette of RS" No. 15/16).

In "Official Gazette of RS" no. 92/2020, the following Rulebooks have been published:

  • the Rulebook on electrocardiograph verification
  • the Rulebook on verification of measuring instruments that are component of Dialyzers
  • the Rulebook on verification of measuring instruments that are component of Defibrillators
  • the Rulebook on verification of measuring instruments that are component of Anesthesia Sets
  • the Rulebook on verification of measuring instruments that are component of Infusion and Perfusion pumps
  • the Rulebook on verification of  measuring instruments that are component of multifunctional devices for patient monitoring
  • the Rulebook on verification of measuring instruments that are component of ultrasonic physiotherapy devices
  • the Rulebook on verification of measuring instruments that are component of respirators
  • the Rulebook on the verification of measuring instruments that are component of neonatal and pediatric incubators and resuscitation hot tables
  • the Rulebook on the verification of measuring instruments that are component of high-frequency surgical knives and high-frequency surgical accessories.

All the activities regarding extending the field of ​ATS operation in this field of ​​conformity assessment have been completed as well in accordance with its procedures. Also, the document ATS-PA08, Fields of ATS activity, was updated.