Home / Подкомитет "Искусственный интеллект в здравоохранении" (ПК 01/ТК164) / Activities of the SC 01 in the National Standardization Program
Description Activities of the SC 01 in the National Standardization Program Structure of the SC 01 Документы СМИ о нас
General provisions.

Establishes the general provisions of the set of national standards on “Artificial intelligence systems in clinical medicine”, including: General purposes and objectives. Requirements. Terms and definitions

 

September 2022

Part 8: Application of quality management

Establishes the requirements for a quality management system in cases where an institution should demonstrate the ability to participate in one or more stages of artificial intelligence system life cycle and comply with the user and applicable regulatory requirements

 

September 2022

Algorithms for medical image analysis. Test methods. General requirements

A NEW TYPE OF STANDARD – INCLUDES THE DATASET

Establishes the requirements for the methods of testing the algorithms for medical image analysis in artificial intelligence systems in clinical medicine.

 

September 2022

Data analysis algorithms for clinical physiology. Test methods. General requirements

A NEW TYPE OF STANDARD – INCLUDES THE DATASET

Establishes clarifying provisions to the set of national standards on the use of intelligent digital methods of medical data processing and:
Sets the main tasks and objectives to standardize intelligent processing methods for medical data obtained by methods of clinical physiology;
Specifies activities to standardize intelligent processing methods for medical data obtained by methods of clinical physiology.

 

September 2022

ISO/IEC standard “Artificial intelligence (AI) – Software testing of AI medical devices – Part 1: clinical evaluation”

An international standard is being developed based on the national standard “Artificial intelligence systems in clinical medicine. Part 1: Clinical trials”