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YY/T 0870.8-2024 Active Industry standards-Medicine

YY/T 0870.8-2024 Test for genotoxicity of medical devices—Part 8:Unscheduled DNA synthesis test with mammalian liver cells in vivo

YY/T 0870.8-2024 Test for genotoxicity of medical devices—Part 8:Unscheduled DNA synthesis test with mammalian liver cells in vivo

Publish Date: 2024-07-08 Implement Date: 2025-07-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: YY/T 0870.8-2024
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical devices
ICS Name: Integrated medical equipment
Publish Date: 2024-07-08
Implement Date: 2025-07-20
Pages: 12 pages

Scope

This document describes the experimental method for extracellular DNA synthesis in mammalian liver cells in vivo for medical devices.
This document is applicable to evaluating whether medical devices have potential genotoxic effects by measuring extracellular DNA damage in mammalian liver cells caused by medical devices.
Note: The experimental method for extracellular DNA synthesis in mammalian liver cells in vivo for nanomaterials may require specific modifications to the methods described in this document, but these modifications are not described in this document.

Development Information

Word Count: 15 Thousand words Pages: 12 pages

Referenced Standards

GB 14925-2001 Laboratory animal—Requirements of environment and housing facilities GB 14925-2010 Laboratory animal—Requirements of environment and housing facilities GB 14925-2023 Laboratory animal—Environment and housing facilities 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 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials 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
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