YY/T 1631.1-2018Compatibility determination of the transfusion sets with blood components - Part 1: Assessment of blood component depletion (English PDF)
输血器与血液成分相容性测定 第1部分：血液成分残留评定
This is a limited preview
Buy now to download the full PDF (20 pages)
Need quotation for your management?
Get a formal quotation for YY/T 1631.1-2018 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 1631.1-2018 is the English-translated version of 输血器与血液成分相容性测定 第1部分：血液成分残留评定.
YY/T 1631.1-2018 is the Chinese pharmaceutical industry standard that gives the method for measuring what the blood components left behind in a transfusion set - red cells, platelets and fresh frozen plasma - amount to after the blood has passed through it.
It is the first part of the YY/T 1631 series on the compatibility of transfusion equipment with blood components and sets out the components and their preparation, the flow through the device and the way the residue in the set is recovered and measured. Issued on 20 December 2018, it has applied since 1 January 2020.
Found what you need?
Document preview — YY/T 1631.1-2018
National Standard of the People's Republic of China
- ICS
- 11.040.20
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Component blood collection and storage
Foreword
YY/T 1631 "Determination of the compatibility of blood transfusion and blood components" is divided into the following two parts.
--- Part 1. Assessment of blood component residues;
--- Part 2. Assessment of blood component damage. This part is the first part of YY/T 1631.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Introduction
GB 8369 requires that the blood transfusion device be rated for the recommended range of blood components to ensure that the blood transfusion device is relevant to each blood component.
The residue of the component does not exceed 5% of an adult therapeutic dose. Only specific requirements are given in the standard, but no specific test methods are specified.
The purpose of this section of YY/T 1631 is to design a protocol to assess the loss of blood components after passing through the blood transfusion device. can be used as A supplement to GB 8369 for evaluating the residual of blood components as they flow through a blood transfusion device.
The blood transfusion device can be used for the infusion of blood cell components and blood plasma components. Possible factors affecting the function of the blood transfusion include long liquid lines Degree, flow rate and characteristics, void volume and selected materials. The design and processing of the filter in the drip bucket is particularly important.
Significant sources of variation include material source, surface area and characteristics, wire diameter, mesh size and homogeneity. This section of YY/T 1631 The method for assessing blood component residues can be used to evaluate the compatibility of blood transfusion devices with blood components.
1 Scope
This part of YY/T 1631 specifies the blood components (red fines) used in the blood donor biocompatibility evaluation to detect the flow through the blood transfusion device.
Method for assessing residues in cells, platelets, and fresh frozen plasma in a blood transfusion device.
This section applies to the evaluation of the compatibility of blood transfusion devices with blood components.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 18469 Whole blood and component blood quality requirements Pharmacopoeia of the People's Republic of China (four)
3 Component blood collection and storage
3.1 General
This section recommends the use of component blood within the shelf life but close to the end of the shelf life, should meet the requirements of GB 18469. Red blood cell component blood, The collection and storage of platelet concentrate and fresh frozen plasma should be carried out according to 3.2~3.4.
3.2 Red blood cell component blood
Red blood cell components (redcelscomponents, RCC) are stored in the red blood cell maintenance solution. An adult therapeutic dose of red blood cells Component blood refers to suspended red blood cells prepared from 2 units of whole blood [(400 ± 40) mL, without anticoagulant]. For before flowing through the blood transfusion device The red blood cell component usually requires a hemoglobin value of >18 g/unit.
3.3 Platelet concentrate
Platelet concentrates (PCs) were stored at 22 ° C with shaking. An adult therapeutic dose of platelet concentrate Refers to 1 unit of apheresis platelets or 10 units of mixed concentrated platelet suspension (concentrated platelets prepared from 10 units of whole blood). Correct The platelet component blood before flowing through the blood transfusion device usually requires a platelet count of > 2.4 x 10^11 cells per unit.
3.4 Fresh frozen plasma
Fresh frozen plasma (frsefrozenplasma, FFP) was thawed in a constant temperature water bath at 37 °C. An adult treatment dose FFP refers to Fresh frozen plasma prepared in 2 units of whole blood [(400 ± 40) mL, without anticoagulant]. Fresh frozen before flowing through the blood transfusion device Plasma typically requires a Factor VIII (FVIII) concentration of >0.7 IU/mL.
Note. "An adult therapeutic dose" is derived from GB 8369. It can also be used to separate red fines from 1 unit of whole blood [(200±20) mL, without anticoagulant]. Cell suspension or fresh frozen plasma.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
Normative references
Similar standards
How to Download YY/T 1631.1-2018
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB 18469-2012 — Quality requirements for whole blood and blood components
YY/T 1631.2-2020 — Compatibility determination of the transfusion sets with blood component - Part 2: Assessment of damage to blood component
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 1631.1-2018
$105.00