YY/T 1512-2017: Translated English of Chinese Standard. YY/T1512-2017: Biological Evaluation of Medical Devices - Guidance on the Conduct of Biological Evaluation within a Risk Management Process

Copertina anteriore
https://www.chinesestandard.net, 10 ago 2018 - 26 pagine
0 Recensioni
Google non verifica le recensioni, ma controlla e rimuove i contenuti falsi quando vengono identificati
This Standard is applicable to the biological evaluation of medical devices in accordance with the requirements in GB/T 16886.1-2011. This Standard does not add or modify the requirements in GB/T 16886.1-2011. This Standard does not include requirements of regulatory inspection or certification and assessment activities. This Standard is applicable to all the biological evaluation of various types of medical devices, including active, passive, implantable and non-implantable medical devices.
 

Cosa dicono le persone - Scrivi una recensione

Nessuna recensione trovata nei soliti posti.

Sommario

Foreword
3
Biological Evaluation is a Risk Management Activity
9
Guidance of Biological Evaluation in Specific Aspects
17
References
25

Parole e frasi comuni

Informazioni sull'autore (2018)

https://www.chinesestandard.net specializes in providing translation services of all Chinese Standards.

Informazioni bibliografiche