YY/T 0993-2015 Active Industry standards-Medicine

YY/T 0993-2015 Biological evaluation of medical devices—Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)

YY/T 0993-2015 Biological evaluation of medical devices—Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)

Publish Date: 2015-03-02 Implement Date: 2016-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0993-2015

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2015-03-02

Implement Date: 2016-01-01

Pages: 14 pages

Scope

This standard specifies the in vitro cytotoxicity test methods, sample preparation, operating procedures, and evaluation for nanomaterials and nanomaterial combinations in medical devices.
This standard applies to the in vitro cytotoxicity evaluation of nanomaterials and nanomaterial combinations in medical devices (except for particles or fibers that are encapsulated or combined in a non-releasable or non-free state), including the MTT test and LDH test using L929 cells as the test cells. This standard is a supplement to GB/T 16886.5.

Development Information

Word Count: 22 Thousand words Pages: 14 pages

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 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity 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

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