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Standards Development
This document specifies requirements and test methods for verifying the physical properties, biological properties, chemical properties, additives and other requirements of an arterial blood specimen collection (often called “arterial blood gas collection needles ") for blood gas analysis. This document is applicable to single-use receptacles for human arterial blood specimen collection, including preset type receptacle for arterial blood specimen collection and drawout type receptacle for arterial blood specimen collection.This document does not provide requirements for venous blood specimen collection and capillary blood specimen collection.
Single-use receptacles for human arterial blood specimen collection is a device consisting of a bloodtaking needle (optional), a receptacle (containing additives) and a seal piece for the collection and storage of arterial blood specimens. The collected blood specimens are used for blood gas analysis.It can be divided into two types, which are preset type receptacle for arterial blood specimen collection and drawout type receptacle for arterial blood specimen collection. The quality of receptacles for human arterial blood specimen collection is related to the safety of clinical blood collection and the accuracy of blood gas analysis results. YY/T 0612-2022 Single-use receptacles for human arterial blood specimen collectionarterial blood gas collection needles) and its former edition has been widely used in China since their implementation and serve as specifications for receptacles for human arterial blood specimen collection. At present, the International Organization for Standardization ISO/TC76 " Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use " does not have any relevant product standards. The development of this product standard will make the international standard system in the field of medical infusion device more complete.
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