YY/T 1579-2018: In vitro diagnostic medical devices--Evaluation of stability of in vitro diagnostic reagents

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Scope

This standard applies to in vitro diagnostic medical devices (including reagents, calibrators, controls, diluents, buffers, and kits, hereinafter referred to as
Stability evaluation of "in vitro diagnostic reagents"). This standard also applies to substances containing sample storage or to initiate reactions to further process samples.
A sample collection device for the substance.
This standard specifies the general requirements for stability evaluation when generating data from the following processes, as well as for real-time stability and acceleration stability.
Specific requirements for sex.
--- Establish the shelf life of in vitro diagnostic reagents, including the determination of the transport conditions to ensure product performance;
--- Establish the stability of the use of in vitro diagnostic reagents after initial opening of the initial packaging, for example, in machine stability, reconstitution stability, opening
stability;
---Monitor the stability of in vitro diagnostic reagents that have been placed on the market;
--- Verification of the stability of the improved reagent. After the reagent is improved, it may affect the stability and the stability needs to be verified.
This standard does not apply to instruments, devices, equipment, systems, specimen containers, and test samples.

Basic Data

Standard ID	YY/T 1579-2018 (YY/T1579-2018)
Description (Translated English)	In vitro diagnostic medical devices--Evaluation of stability of in vitro diagnostic reagents
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	9,960
Date of Issue	2018-02-24
Date of Implementation	2019-03-01
Quoted Standard	GB/T 29791.1-2013; ISO 14971
Adopted Standard	ISO 23640-2011��IDT
Regulation (derived from)	China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard applies to the evaluation of the stability of in vitro diagnostic medical devices (including reagents, calibrators, controls, diluents, buffers, and kits, hereinafter referred to as "in vitro diagnostic reagents"). This standard also applies to sample collection devices that contain substances for sample storage or start reactions for further processing of sample substances. This standard specifies the general requirements for stability evaluation when generating data from the following processes, as well as specific requirements for real-time stability and accelerated stability: Establishment of shelf life of in vitro diagnostic reagents, including determination of transport conditions to ensure product performance Establish the stability of the use of in vitro diagnostic reagents after opening the initial packaging for the first time, for example, on-board stability, re-dissolve stability, bottle opening stability; monitor the stability of the in-vitro diagnostic reagents that have been placed on the market; Verification