"STANDARTINFORM" took part in the preparation of the Prospective Program of Standardization in the field of medical devices for the period 2020-2025.
The document was approved by a joint decision of the Russian Ministry of Industry and Trade, Rosstandart and Roszdravnadzor on November 19, 2020.
The program goals are to ensure the safety of medical devices, promote import substitution and improve the quality and competitiveness of domestic products in domestic and foreign markets, as well as harmonization of requirements of Russian regulatory and technical documents with the best international practices.
The prospective program consists of 10 directions:
- Safety and quality of medical devices in general;
- medical materials, means and clothing;
- medical instruments;
- implants;
- medical instruments and devices;
- medical equipment;
- artificial intelligence systems in medicine;
- digital medicine;
- clinical laboratory researches and diagnostic test-systems in-vitro;
- optics.
Collection and systematization of proposals for the development of projects of interstate and national standards to ensure the implementation of the program directions, as well as timely and high-quality examination of these proposals were carried out by "STANDARTINFORM" together with specialized technical committees on standardization:
- with TC 011 "Medical devices, apparatus and equipment" and TC 453 "Implants in surgery" - on medical devices, apparatus and equipment, implants in surgery;
- with TC 422 "Evaluation of biological effect of medical devices" - in the field of safety and quality of medical devices;
- with TC 468 "Health Information" - in the field of digital medicine and artificial intelligence systems in medicine.
In total, more than 10 technical committees on standardization, which are supervised by "STANDARTINFORM", participate in the implementation of the program activities.
The Prospective Program for 2025 provides for approval and/or revision of 525 interstate and national standardization documents. At the same time, work on a number of documents has started this year. Some documents have already been approved. For example, GOST ISO/TR 10993-22-2020, Biological evaluation of medical devices. Part 22: Guidance on nanomaterials, developed by "STANDARTINFORM" in collaboration with ANO "IMBIIT".