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GB/T 43277.1-2023: Clamps and flow regulators for medical infusion and transfusion equipment - Part 1: Clamps and flow regulators without fluid contact
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 43277.1-2023 | English | 209 |
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Clamps and flow regulators for medical infusion and transfusion equipment - Part 1: Clamps and flow regulators without fluid contact
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GB/T 43277.1-2023
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Basic data | Standard ID | GB/T 43277.1-2023 (GB/T43277.1-2023) | | Description (Translated English) | Clamps and flow regulators for medical infusion and transfusion equipment - Part 1: Clamps and flow regulators without fluid contact | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.040.20 | | Word Count Estimation | 10,146 | | 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 43277.1-2023: Clamps and flow regulators for medical infusion and transfusion equipment - Part 1: Clamps and flow regulators without 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
Regulators Part 1: Non-liquid contact stop clamps and
flow regulator
Published on 2023-11-27 and 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 1 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 8536-14:2016 "Medical infusion equipment - Part 14: Non-liquid contact medical infusion (blood transfusion) equipment"
Equipped with flow stop clamp and flow regulator:
Compared with ISO 8536-14:2016, this document adds A:1:5 to the structure:
The technical differences between this document and ISO 8536-14:2016 and their reasons are as follows:
---Deleted "In addition, the materials of the stop clamp and flow regulator described in all clauses shall be in accordance with ISO 10993-1" in the "Materials" chapter
"Evaluation of the requirements" (see Chapter 5 of ISO 8536-14:2016), this document relates to the non-contact of the stop clamp and the flow regulator
Liquids whose materials do not require biological evaluation;
--- Added the content of test methods to prevent liquid leakage (see A:1:5), because the requirement in 6:3 "should be able to prevent the flow of liquids and gases"
"Motion", while ISO 8536-14:2016 only describes the test method to prevent gas leakage;
---The test steps of the physical test have been changed and the calculation formula has been added (see A:2:4 and A:2:5) to improve the operability of the test:
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 1: Non-liquid contact stop clamps and flow regulators";
---Added note A:2:5:
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 Institute of Medical Device and Drug Packaging Inspection, Shandong Zhongbaokang Medical Equipment Co:, Ltd:, Jiangxi San
Xin Medical Technology Co:, Ltd:, Shandong Weigao Group Medical Polymer Products Co:, Ltd:, Nanjing Sunway Biomedical Technology Co:, Ltd:
Division, Henan Tuoren Medical Equipment Group Co:, Ltd:, Shandong Ande Medical Supplies Co:, Ltd:, Fresenius Kabi (China) Investment Co:, Ltd:
company:
The main drafters of this document: Zhang Limei, Sun Jianjun, Qi Wei, Tong Minghua, Liu Xinglin, Li Zheng, Zhang Jing, An Chuantao, Hong Mei, Fang Yuan, Huang Liping:
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
Regulators Part 1: Non-liquid contact stop clamps and
flow regulator
1 Scope
This document specifies the design, material and physical requirements for non-liquid contact stop clamps and flow regulators used in medical infusion and blood transfusion equipment:
This document applies to the design, production and testing of non-liquid contact stop clamps and flow regulators for medical infusion and blood transfusion equipment:
2 Normative reference documents
This document has no normative references:
3 Terms and definitions
The following terms and definitions apply to this document:
3:1
Stop clamp
Parts that act on infusion/blood transfusion equipment from the outside in a non-liquid contact manner and have an "on/off" function for stopping or starting the flow of blood:
Liquid flow through the pipeline:
3:2
flowregulator flowregulator
Parts of infusion/blood transfusion equipment acting externally in a non-liquid contact manner, with or without graduations, used to control liquids through lines
flow:
3:3
flowflowrate
The volume of liquid flowing through the pipeline per unit time:
4 design
Non-liquid contact flow stop clamps and flow regulators should be designed to control the delivery of fluids in infusion and blood transfusion devices: non-liquid contact
Stop clamps and flow regulators should be designed to be safe to use, avoid accidental operation, and should not puncture or damage the hose during operation:
Typical designs of non-liquid contact stop clamps and flow regulators are shown in Figures 1 to 3:
Figure 1 Design example of a compression flow stop clamp
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