YY/T 1649.1-2019 Active Industry standards-Medicine

YY/T 1649.1-2019 Test method for interactions of medical devices with platelet—Part 1:In vitro platelet count assay

Publish Date: 2019-05-31 Implement Date: 2020-06-01 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 1649.1-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2019-05-31

Implement Date: 2020-06-01

Pages: 7 pages

Scope

This part of YY/T 1649 specifies the platelet count test method used to detect the interaction between medical devices/materials and platelets in vitro during blood compatibility evaluation.
This part is applicable to the evaluation of the platelet adhesion performance and activation potential on the surface of medical devices/materials.
The test system established in this part is suitable for human blood. When conducting tests with animal blood, reference can be made to this part, but its suitability should be demonstrated through verification.

Development Information

Word Count: 10 Thousand words Pages: 7 pages

Same series standard

YY/T 1649.2-2019 Test method for interactions of medical devices with platelet—Part 2:In vitro platelet activation products(β-TG,PF4 and TxB2)assay

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

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