YY/T 1158-2009 English PDF

US$259.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1158-2009: Prothrombin time reagent (Kit)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1158-2009	259	Add to Cart	3 days	Prothrombin time reagent (Kit)	Valid

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Basic data

Standard ID: YY/T 1158-2009 (YY/T1158-2009)
Description (Translated English): Prothrombin time reagent (Kit)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 11,133
Date of Issue: 2009-12-30
Date of Implementation: 2011-06-01
Quoted Standard: GB/T 191; GB 6682; YY 0466
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the prothrombin time assay (box) quality inspection and testing of common technical requirements, including terms and definitions, requirements, test methods, marking, labeling and instructions, packaging, transportation and storage. This standard applies to routine clinical laboratory testing using Quick- stage method of prothrombin time assay (box) Products (hereinafter referred to as PT reagent), including freeze- dried product and liquid reagent products. This standard does not apply to the bedside rapid test (POCT) prothrombin time assay (box).

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