This standard specifies the general technical requirements for quality inspection and testing of activated partial thromboplastin time detection reagents (kits), including terms and definitions, requirements, test methods, signs, labels, instructions for use, packaging, transportation and storage. This standard applies to activated partial thromboplastin time detection reagents (boxes) for routine testing in clinical laboratories. This standard does not apply to activated partial thromboplastin time detection reagents for rapid point-of-care testing (POCT).
YY/T 1157-2009 history
2009YY/T 1157-2009 Actived partial thromboplastin time reagent(Kit)