国际血液学标准化理事会(ICSH)关于血凝分析仪-试剂检测系统确认的实验室指南。第1部分:仪器特异性问题与常用凝血筛查试验。本文件就监管机构与认可机构所要求的性能、确认与实施流程提供指南,内容涉及专业血凝检测与易栓症检测的规划与确认。
International Council for Standardization in Haematology (ICSH) laboratory guidance for the verification of haemostasis analyser-reagent test systems. Part 1: Instrument-specific issues and commonly used coagulation screening tests. This document gives guidance for the performance, verification and implementation processes required by regulatory and accreditation bodies. It covers the planning and verification of specialist haemostatic tests and thrombophilia testing.