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GB/T 43277.2-2023: Clamps and flow regulators for medical infusion and transfusion equipment - Part 2: Graduated flow regulators with fluid contact
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 43277.2-2023 | English | 249 |
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Clamps and flow regulators for medical infusion and transfusion equipment - Part 2: Graduated flow regulators with fluid contact
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GB/T 43277.2-2023
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Basic data | Standard ID | GB/T 43277.2-2023 (GB/T43277.2-2023) | | Description (Translated English) | Clamps and flow regulators for medical infusion and transfusion equipment - Part 2: Graduated flow regulators with fluid contact | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 12,112 | | Date of Issue | 2023-11-27 | | Date of Implementation | 2024-12-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 43277.2-2023: Clamps and flow regulators for medical infusion and transfusion equipment - Part 2: Graduated flow regulators with fluid contact
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11:040:20
CCSC31
National Standards of People's Republic of China
Flow-stop clamps and flow regulators for medical infusion (blood transfusion) equipment
Part 2: Liquid Contact Scale Flow Regulators
Published on 2023-11-27
Implemented on 2024-12-01
State Administration for Market Regulation
Released by the National Standardization Administration Committee
Foreword
This document complies with the provisions of GB/T 1:1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents"
Drafting:
This document is Part 2 of GB/T 43277 "Clamps and flow regulators for medical infusion (blood transfusion) equipment": GB/T 43277
The following sections have been published:
---Part 1: Non-liquid contact stop clamps and flow regulators;
---Part 2: Liquid contact scale flow regulator:
This document is modified to adopt ISO 8536-13:2016 "Medical infusion equipment - Part 13: Liquid contact disposable scale flow rate"
Regulator":
Compared with ISO 8536-13:2016, this document has made the following structural adjustments:
---6:5:1 and 6:5:2 correspond to 6:5 in ISO 8536-13:2016;
---Appendix B corresponds to A:4 in the ISO 8536-13:2016 appendix:
The technical differences between this document and ISO 8536-13:2016 and their reasons are as follows:
---Replaced ISO 8536-4 with GB 8368 (see Chapter 7 and Chapter 8) for ease of use;
---Replaced ISO 10993-1 (see Chapter 5) with GB/T 16886:1 for ease of use;
---Added normative appendix B, supplemented the test content on flow rate in A:4 of ISO 8536-13:2016, and added instrument
instruments, test procedures and calculation formulas to increase the operability of the standard:
The following editorial changes have been made to this document:
---In order to coordinate with my country's technical standard system, the standard name is changed to "Clamps and Flow Regulators for Medical Infusion (Blood Transfusion) Apparatus"
Part 2: Liquid Contact Scale Flow Regulators";
---Added notes to 6:5:1 and Chapter 7:
Please note that some content in this document may be subject to patents: The publisher of this document assumes no responsibility for identifying patents:
This document is proposed by the National Medical Products Administration:
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Equipment (SAC/TC106):
This document was drafted by: Shandong Medical Device and Drug Packaging Inspection Institute, Shandong Ande Medical Supplies Co:, Ltd:, Shandong
Weigao Group Medical Polymer Products Co:, Ltd:, Shandong Zhongbaokang Medical Equipment Co:, Ltd:
The main drafters of this document: Wang Xiuxiu, Wang Cihai, Liu Xinglin, Tang Xiumei, Zhang Lei and Guo Linlin:
Introduction
Flow-stop clamps and flow regulators for medical infusion (blood transfusion) equipment, also known as pipe clamps, flow-stop clamps, hose flow adjustment clamps, etc:, are used as infusion sets
Product components of the equipment, usually assembled into the pipeline part of the infusion equipment, are used to regulate and control the flow of liquid in the pipeline: Divided into liquid contacts
There are two categories: contact with liquid and non-contact with liquid:
GB/T 43277 "Clamps and flow regulators for medical infusion (blood transfusion) equipment" is a component product standard: GB/T 43277 is intended to regulate
Determines the performance requirements for stop clamps and flow regulators used in medical infusion (blood transfusion) equipment, and is intended to consist of two parts:
---Part 1: Non-liquid contact stop clamps and flow regulators: The purpose is to specify non-liquid contact stop clamps and flow regulators:
Controller performance requirements:
---Part 2: Liquid contact scale flow regulator: The purpose is to specify performance requirements for liquid contact graduated flow regulators:
Flow-stop clamps and flow regulators for medical infusion (blood transfusion) equipment
Part 2: Liquid Contact Scale Flow Regulators
1 Scope
This document specifies the design, materials, physical requirements, and chemical requirements of liquid contact scale flow regulators for medical infusion and blood transfusion equipment:
and biological requirements:
This document applies to liquid contact scale flow regulators for medical infusion and blood transfusion equipment:
2 Normative reference documents
The contents of the following documents constitute essential provisions of this document through normative references in the text: Among them, the dated quotations
For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to
this document:
GB 8368 Disposable infusion set gravity infusion type (GB 8368-2018, ISO 8536-4:2010, MOD)
GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing during risk management process (GB/T 16886:1-
2022,ISO 10993-1:2018,IDT)
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
A component with a scale mark and in contact with the chemical liquid, used to set a specific flow rate:
3:2
flowflowrate
The volume of liquid flowing through the pipeline per unit time:
3:3
scalescale
A series of identifiers and corresponding identification numbers associated with the observed indicator position:
4 design
Scale flow regulators should be designed for constant flow regulation: Graduated flow regulators should be designed to be used safely to avoid inadvertent flow
external changes, and the "OPEN" and "OFF" positions should be clearly indicated:
A typical design of a graduated flow regulator is shown in Figure 1:
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