T/CAS 886-2024 Active

Scope: This document specifies the general requirements for the detection performance verification (hereinafter referred to as "performance verification") of blood transfusion compatibility testing equipment, the timing of performance verification, preparations before performance verification, and the requirements for performance verification. This document applies to the detection performance verification of blood transfusion compatibility testing equipment used in laboratories of all levels and types of medical institutions and by manufacturers. Note: The blood transfusion compatibility testing equipment described in this document is limited to fully automatic equipment. Semi-automatic equipment can be used for reference. Main technical content: 1. Scope This document specifies the general requirements for the detection performance verification (hereinafter referred to as "performance verification") of blood transfusion compatibility testing equipment, the timing of performance verification, preparations before performance verification, and the requirements for performance verification. This document applies to the detection performance verification of blood transfusion compatibility testing equipment used in laboratories of all levels and types of medical institutions and by manufacturers. Note: The blood transfusion compatibility testing equipment described in this document is limited to fully automatic equipment. Semi-automatic equipment can be used for reference. 2. Normative references The content of the following documents is an essential part of this document through normative references in the text. Among them, the referenced documents with a specified date apply only to the version corresponding to that date; the referenced documents without a specified date apply to the latest version (including all amendment sheets) of the document. GB/T 22576.1—2018 Medical Laboratories—Requirements for Quality and Capability Part 1: General Requirement