YY/T 1754.1-2020 Active Industry standards-Medicine

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

Publish Date: 2020-09-27 Implement Date: 2021-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1754.1-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2020-09-27

Implement Date: 2021-09-01

Pages: 12 pages

Scope

This part of YY/T 1754 specifies the general requirements for preclinical animal research of medical devices.
This part applies to the design of preclinical medical device animal experiments and the collection of data.
Note: This part does not replace technical documents related to the biological evaluation of medical devices, such as the GB/T 16886 series standards. For evaluating the biocompatibility of medical devices through animal experiments, please refer to technical documents related to biological evaluation, such as the GB/T 16886 series standards.

Development Information

Word Count: 14 Thousand words Pages: 12 pages

Same series standard

YY/T 1754.2-2020 Preclinical animal study of medical devices—Part 2:Model of skin defect in induced diabetic rats

Referenced Standards

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24