Standard Number: YY/T 1441-2016(YY/T1441-2016)
Chinese:体外诊断医疗器械性能评估通用要求
English:Performance evaluation of in vitro diagnostic medical devices
Effective Date:2017-01-01
ICS:11.100
Standard Applicability:This standard specifies the responsibilities and general requirements of a manufacturer in a performance evaluation study of an in vitro diagnostic medical device with respect to study planning, implementation, evaluation, and development of documentation. This standard applies to the performance evaluation of in vitro diagnostic medical devices. This standard does not apply to an evaluation program for a specific in vitro diagnostic medical device or for a specific use.
PDF Downloadable: Y
You can click the button below to purchase the PDF version, and we will send it to you via email.Click below to buy the printed version. Shipped via FedEx within 7 days. Full refund if out of stock.
If you encounter the following issues, please click here to contact us, and we will do our best to assist you.
1. You cannot find the standard document you are looking for on our website.
2. You have found the standard document, but our page indicates that PDF download is not available.
3. You need to purchase our translated version.
