国际血液学标准化委员会（ICSH）止血分析仪与试剂检测系统验证实验室指南。第 2 部分：专项检测与校准测定。本文件就监管机构与认可机构所要求的性能、验证与实施流程提供指南，内容涵盖专项止血检测的规划与验证，包括凝血因子测定、D-二聚体、直接抗凝药物以及易栓症检测。
International Council for Standardization in Haematology (ICSH) laboratory guidance for the verification of haemostasis analyser-reagent test systems. Part 2: Specialist tests and calibrated assays. 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, including factor assays, D-dimers, direct anticoagulants and thrombophilia testing.