YY/T 1579-2018 in English

VALID

In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents

Issued on:2018-02-24
Implemented on:2019-03-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $140.00
$136.00

Standard No:	YY/T 1579-2018
Document status:	VALID
Title in English:	In vitro diagnostic medical devices—Evaluation of stability of in vitro diagnostic reagents
Title in Chinese:	体外诊断医疗器械体外诊断试剂稳定性评价
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-02-24
Implemented on:	2019-03-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	vitro diagnostic medical devices evaluation diagnostic reagents diagnostic reagents introductionthis standard medical devices stability evaluation process
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本标准适用于体外诊断医疗器械（包括试剂、校准物、质控物、稀释液、缓冲液和试剂盒）的稳定性评价。
本标准也适用于含有保存样品用物质或启动反应以进一步处理样品用物质的样品收集装置。
本标准规定了从下述过程产生数据时，对稳定性评价的通用要求，以及对实时稳定性和加速稳定性的具体要求：
（1）建立体外诊断试剂保存期，包括保证产品性能的运输条件的确定；
（2）建立首次打开初始包装后的体外诊断试剂的使用稳定性，例如在机稳定性、复溶稳定性、开瓶稳定性；
（3）监测已投放市场的体外诊断试剂的稳定性；
（4）试剂改进后稳定性的验证。试剂改进后，可能会影响稳定性，需要对稳定性进行验证。本标准不适用于仪器、装置、设备、系统、标本容器、检验样品。

Introduction

This standard provides guidelines for assessing the stability of in vitro diagnostic reagents used in medical devices. It outlines the methods and procedures for evaluating the performance and shelf life of these reagents under various storage conditions. The document covers aspects such as testing protocols, data analysis, and reporting requirements to ensure consistency and reliability in the stability evaluation process. It is intended to support manufacturers, testing laboratories, and regulatory authorities in the development and quality control of in vitro diagnostic products. The standard includes detailed information on the factors that may influence the stability of reagents, as well as recommendations for conducting long-term and accelerated stability studies. It also addresses the documentation and validation of stability data to facilitate regulatory submissions and product approvals.

*** Please note: This description may not be accurate, please refer to the official documentation.

More samples: JJG 21-2008 GB 18306-2015 DL/T 5154-2012

Sample only — not a preview of YY/T 1579-2018

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