YY/T 1754.1-2020: Preclinical animal study of medical devices - Part 1: General considerations

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY/T 1754.1-2020 (Self-service in 1-minute)
Newer / historical versions: YY/T 1754.1-2020

Preview True-PDF

Scope

This Part of YY/T 1754 specifies the general considerations for preclinical
animal study of medical devices.
This Part applies to the design of animal test and the acquisition of data for
preclinical medical devices.
Note: This Part does not replace the technical documents, which are related to
the biological evaluation of medical devices, such as GB/T 16886 series
standards. For the biocompatibility of medical devices which is evaluated
through animal test, refer to the GB/T 16886 series standards and other
relevant technical documents related to biological evaluation.

Basic Data

Standard ID	YY/T 1754.1-2020 (YY/T1754.1-2020)
Description (Translated English)	Preclinical animal study of medical devices - Part 1: General considerations
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	8,867
Date of Issue	2020-09-27
Date of Implementation	2021-09-01
Regulation (derived from)	Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies)	State Drug Administration