YY/T 1532-2017 Active Industry standards-Medicine

YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test

YY/T 1532-2017 Biological evaluation of medical devices—Nanomaterials—Hemolysis test

Publish Date: 2017-03-28 Implement Date: 2018-04-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1532-2017

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2017-03-28

Implement Date: 2018-04-01

Pages: 11 pages

Scope

This standard specifies the test methods for the hemolytic performance of nanomaterials and their combinations that directly/indirectly come into contact with blood, as well as nanomaterials in medical devices.
This standard applies to the evaluation of the hemolytic performance of nanomaterials and their combinations that directly/indirectly come into contact with blood, as well as nanomaterials that are free or released in medical devices.

Development Information

Word Count: 20 Thousand words Pages: 11 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 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood 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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