Medical electrical equipment. Lung ventilators. Technical requirements for public procurement

2Scope / Description

This standard specifies the basic technical requirements for ventilators (ventilators) in medical electrical products, intended for use by authorized personnel of national procurement agencies when developing technical specifications for competitive bidding documents to procure high-tech medical equipment for national needs. This standard applies to government procurement tenders for the provision of high-tech medical equipment (HMOs) for high-tech medical services to national needs. This standard does not apply to medical equipment not procured by the national government. This standard specifies the technical requirements for ventilators (ventilators) intended for use by professional operators for ventilator-dependent patients and for intensive care within specialized medical facilities, or for transport within specialized medical facilities. Note: Technical Specifications (TN) are developed by the procuring entity and should comply with the requirements set forth in Federal Law No. 94-FZ (Sections 22(2) and 34(2)). The product information in the technical specifications identifies the project for procuring high-tech medical equipment and dominates competitive or auction documents because they have many specific characteristics and are prepared individually for each lot. Technical specifications are the most volatile part of the document and are, in most cases, strictly personal. The procuring entity is responsible for the completeness and adequacy of the Technical Specifications (TN). To avoid errors, the Technical Specifications must be developed by experts with specific knowledge or experience in the procurement project. The expert-evaluator should be able to professionally develop the procuring entity's technical requirements for the HMO and bear personal responsibility for the reasonableness of these requirements in the Technical Specifications.