YY/T 0771.2-2020: Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling

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Scope

This Part of YY/T 0771 specifies the control requirements for the sourcing, collection
and handling (including storage and transportation) of animals and tissues used to
manufacture medical devices made from animal-derived materials, excluding in vitro
diagnostic medical devices. The risk management process requirements given in YY/T
0771.1-2020 apply.
Note 1: The selection of animal sources is particularly important for the risk
management of transmissible spongiform encephalopathy (TSE).
This Part of YY/T 0771 does not cover medical devices using human tissues.
This Part of YY/T 0771 does not specify a quality management system for controlling
the whole process of medical device production.
YY/T 0771 does not cover the overall quality management system for production, but
specifies requirements for certain elements of the quality management system.
Attention is drawn to the standards for quality management systems for controlling the
whole process of production or reprocessing of medical devices (see YY/T 0287). The
quality management system elements required by this Part may form part of a quality
management system conforming to YY/T 0287.
Note 2: The basic principle for the application of YY/T 0771 is to give appropriate
consideration to the requirements and recommendations in all three Parts of
the standard.

Basic Data

Standard ID	YY/T 0771.2-2020 (YY/T0771.2-2020)
Description (Translated English)	Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	17,156
Date of Issue	2020
Date of Implementation	2021-04-01
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the control requirements for the source, collection and disposal (including storage and transportation) of animals and tissues for medical devices manufactured from materials of animal origin, excluding in vitro diagnostic medical devices. The risk management process requirements given in YY/T 0771.1-2020 apply. This standard does not cover medical devices using human tissue. This standard does not specify a quality management system that controls the entire process of medical device production. YY/T 0771 does not deal with the overall quality management system in production, but specifies the requirements for certain elements of the quality management system, paying attention to the quality management system standards for controlling the entire process of medical device production or reprocessing (see YY/T 0287). The elements of the quality management system required by this standard can form a quality management system that conforms to YY/T 0287