YY/T 1649.1-2019 PDF English
US$119.00 · In stock · Download in 9 secondsYY/T 1649.1-2019: Test method for interactions of medical devices with platelet - Part 1: In vitro platelet count assay Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| YY/T 1649.1-2019 | English | 119 |
Add to Cart
|
3 days
|
Test method for interactions of medical devices with platelet - Part 1: In vitro platelet count assay
| Valid |
Excerpted PDFs (Download full copy in 9 seconds upon purchase)PDF Preview: YY/T 1649.1-2019
YY/T 1649.1-2019: Test method for interactions of medical devices with platelet - Part 1: In vitro platelet count assay
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT1649.1-2019
Test method for interactions of medical devices with platelet - Part 1. In vitro platelet count assay
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device and platelet interaction test
Part 1. In vitro platelet counting
Testmethodforinteractionsofmedicaldeviceswithplatelet-
Part 1. Invitroplateletcountassay
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
YY/T 1649 "Medical Device and Platelet Interaction Test" is divided into the following sections.
--- Part 1. In vitro platelet counting method;
--- Part 2. In vitro platelet activation test.
This part is the first part of YY/T 1649.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section is mainly drafted by. Shandong Medical Device Product Quality Inspection Center, Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Shanghai Songli
Biotechnology Co., Ltd.
The main drafters of this section. Qiao Chunxia, Wang Hong, Zong Honghai, Li Chunling.
introduction
The test methods for the blood compatibility of medical devices/materials and the selection strategies for the tests are given in GB/T 16886.4. But only given
Choose the principle. This part of YY/T 1649 is a specific test method for in vitro platelet count, which can be used as a medical device in GB/T 16886.4.
Supplement to the evaluation of the interaction of the device/material with platelets.
As an important component of blood, platelets play a key role in preventing bleeding. The decrease in the number of platelets in the blood after contact with the device is caused by
Caused by the action of platelet adsorption, aggregation or activation, it will directly affect the blood compatibility of medical devices/materials. YY/T 1649 of this
Part of the method for determining in vitro platelet counts can be used to screen medical devices with potential platelet adhesion and activation.
material.
Medical device and platelet interaction test
Part 1. In vitro platelet counting
1 Scope
This part of YY/T 1649 specifies the use of medical devices/materials for in vitro and platelet interaction in blood compatibility assessment.
Platelet count test method used.
This section applies to the evaluation of platelet adhesion properties and activation potential on medical devices/materials.
The test system established in this section is applicable to human blood. The test is carried out using animal blood. Refer to this section and its suitability should be carried out.
Argument.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood (GB/T 16886.4-2003,
ISO 10993-4.2002, IDT)
3 Terms and definitions
The terms and definitions defined in GB/T 16886.1 and GB/T 16886.4 apply to this document.
4 Overview
When medical devices/materials come into contact with human blood, platelets in the blood may adhere to the surface of the medical device/material and potential
Activation reaction. When the medical device/material is in contact with blood, the number of platelets in the blood is significantly reduced, indicating that platelet has occurred.
Adhesion and activation may be associated with induction of thrombosis in vivo.
5 reagents and materials
5.1 Reagents
5.1.1 Controls or other reference materials suitable for blood analyzer calibration.
5.1.2 Fresh healthy anticoagulant human whole blood.
Note. After the test is over, the blood and blood contact items should be disposed according to relevant regulations.
5.1.3 EDTA salt solution (analytical grade), 500 mmol/L.
5.1.4 0.9% sodium chloride injection, for selection.
5.1.5 CaCl2 solution (calcium chloride, analytical grade), 1 mol/L.
5.1.6 Heparin sodium or lithium heparin solution,.200 U/mL.
YY/T 1649.1-2019
Test method for interactions of medical devices with platelet - Part 1. In vitro platelet count assay
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device and platelet interaction test
Part 1. In vitro platelet counting
Testmethodforinteractionsofmedicaldeviceswithplatelet-
Part 1. Invitroplateletcountassay
Published on.2019-05-31
2020-06-01 implementation
State Drug Administration issued
Foreword
YY/T 1649 "Medical Device and Platelet Interaction Test" is divided into the following sections.
--- Part 1. In vitro platelet counting method;
--- Part 2. In vitro platelet activation test.
This part is the first part of YY/T 1649.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section is mainly drafted by. Shandong Medical Device Product Quality Inspection Center, Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Shanghai Songli
Biotechnology Co., Ltd.
The main drafters of this section. Qiao Chunxia, Wang Hong, Zong Honghai, Li Chunling.
introduction
The test methods for the blood compatibility of medical devices/materials and the selection strategies for the tests are given in GB/T 16886.4. But only given
Choose the principle. This part of YY/T 1649 is a specific test method for in vitro platelet count, which can be used as a medical device in GB/T 16886.4.
Supplement to the evaluation of the interaction of the device/material with platelets.
As an important component of blood, platelets play a key role in preventing bleeding. The decrease in the number of platelets in the blood after contact with the device is caused by
Caused by the action of platelet adsorption, aggregation or activation, it will directly affect the blood compatibility of medical devices/materials. YY/T 1649 of this
Part of the method for determining in vitro platelet counts can be used to screen medical devices with potential platelet adhesion and activation.
material.
Medical device and platelet interaction test
Part 1. In vitro platelet counting
1 Scope
This part of YY/T 1649 specifies the use of medical devices/materials for in vitro and platelet interaction in blood compatibility assessment.
Platelet count test method used.
This section applies to the evaluation of platelet adhesion properties and activation potential on medical devices/materials.
The test system established in this section is applicable to human blood. The test is carried out using animal blood. Refer to this section and its suitability should be carried out.
Argument.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1-
2011, ISO 10993-1..2009, IDT)
GB/T 16886.4 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood (GB/T 16886.4-2003,
ISO 10993-4.2002, IDT)
3 Terms and definitions
The terms and definitions defined in GB/T 16886.1 and GB/T 16886.4 apply to this document.
4 Overview
When medical devices/materials come into contact with human blood, platelets in the blood may adhere to the surface of the medical device/material and potential
Activation reaction. When the medical device/material is in contact with blood, the number of platelets in the blood is significantly reduced, indicating that platelet has occurred.
Adhesion and activation may be associated with induction of thrombosis in vivo.
5 reagents and materials
5.1 Reagents
5.1.1 Controls or other reference materials suitable for blood analyzer calibration.
5.1.2 Fresh healthy anticoagulant human whole blood.
Note. After the test is over, the blood and blood contact items should be disposed according to relevant regulations.
5.1.3 EDTA salt solution (analytical grade), 500 mmol/L.
5.1.4 0.9% sodium chloride injection, for selection.
5.1.5 CaCl2 solution (calcium chloride, analytical grade), 1 mol/L.
5.1.6 Heparin sodium or lithium heparin solution,.200 U/mL.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Tips & Frequently Asked QuestionsQuestion 1: How long will the true-PDF of English version of YY/T 1649.1-2019 be delivered?Answer: The full copy PDF of English version of YY/T 1649.1-2019 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice. Question 2: Can I share the purchased PDF of YY/T 1649.1-2019_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1649.1-2019_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet. Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 1649.1-2019 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds. How to buy and download a true PDF of English version of YY/T 1649.1-2019?A step-by-step guide to download PDF of YY/T 1649.1-2019_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 1649.1-2019".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3 Steps 4~6 Step 7 Step 8 Step 9
|