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YY/T 1274: Historical versions
| Std ID | Version | USD | Buy | Deliver [PDF] in | Title (Description) |
| YY/T 1274-2025 | English | 229 |
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Peritoneal dialysis equipment
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| YY 1274-2016 | English | 359 |
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3 days [Need to translate]
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Pressure control peritoneal dialysis equipment
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| YY/T 1274-2016 | English | 199 |
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3 days [Need to translate]
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Pressure control peritoneal dialysis equipment
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Basic data
| Standard ID | YY/T 1274-2025 (YY/T1274-2025) |
| Description (Translated English) | Peritoneal dialysis equipment |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C45 |
| Classification of International Standard | 11.040.40 |
| Word Count Estimation | 11,171 |
| Date of Issue | 2025-06-18 |
| Date of Implementation | 2027-01-01 |
| Older Standard (superseded by this standard) | YY/T 1274-2016, YY/T 1493-2016 |
| Issuing agency(ies) | National Medical Products Administration |
| Summary | This standard specifies the requirements for peritoneal dialysis equipment and describes the corresponding test methods. This document applies to peritoneal dialysis equipment (hereinafter referred to as equipment). This document does not apply to: disposable consumable materials used in peritoneal dialysis (such as dialysate and dialysate tubing); continuous blood purification equipment; and hemodialysis equipment. |
YY/T 1274-2025: Peritoneal dialysis equipment
---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 11.040.40
CCSC45
Pharmaceutical Industry Standards of the People's Republic of China
Replace YY/T 1274-2016, YY/T 1493-2016
Peritoneal dialysis equipment
Published on 2025-06-18
Implemented on 2027-01-01
National Medical Products Administration issued
Table of contents
Preface III
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 Requirements 1
4.1 Normal operating conditions of the equipment 1
4.2 Dialysis fluid temperature 1
4.3 Dialysis fluid volume 2
4.4 Dialysis fluid flow rate 2
4.5 Peritoneal dialysis indwelling time 2
4.6 Weighing device 2
4.7 Dialysis fluid line pressure 2
4.8 Protection against over-perfusion of dialysate 2
4.9 Insufficient Drainage Prevention 2
4.10 Pipeline blockage protection 2
4.11 Pinch valve 3
4.12 Liquid bag height 3
4.13 Operating Noise 3
4.14 Safety Requirements 3
4.15 Appearance and Structure 3
5.Test Methods 3
5.1 Test Operating Conditions 3
5.2 Dialysis fluid temperature test 3
5.3 Dialysis fluid volume test 4
5.4 Dialysis fluid flow test 4
5.5 Peritoneal dialysis indwelling time test 4
5.6 Weighing device test 4
5.7 Dialysis fluid pipeline pressure test 4
5.8 Dialysis fluid over-perfusion protection test 4
5.9 Insufficient Drainage Protection Test 4
5.10 Pipeline Blockage Protection Test 4
5.11 Pinch valve test 5
5.12 Liquid Bag Height Test 5
5.13 Operating Noise Test 5
5.14 Safety Requirements Test 5
5.15 Appearance and Structural Tests
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 supersedes YY/T 1274-2016 "Pressure-Controlled Peritoneal Dialysis Equipment" and YY/T 1493-2016 "Gravity-Controlled Peritoneal Dialysis Equipment".
Compared with YY/T 1274-2016 and YY/T 1493-2016, the main technical changes in the "Dialysis Equipment" standard are as follows, except for structural adjustments and editorial modifications.
The following is an explanation.
---The scope has been changed (see Chapter 1, Chapter 1 of YY/T 1274-2016, and Chapter 1 of YY/T 1493-2016);
---The "Normative References" have been amended (see Chapter 2, Chapter 2 of YY/T 1274-2016, and Chapter 2 of YY/T 1493-2016);
---Terms and definitions have been revised (see Chapter 3, Chapter 3 of YY/T 1274-2016, and Chapter 3 of YY/T 1493-2016);
---The word "categorization" has been removed (see Chapter 4 of YY/T 1274-2016);
---The "Normal Operating Conditions of Equipment" have been modified (see 4.1, 5.1 of YY/T 1274-2016, and 4.1 of YY/T 1493-2016);
---The requirements and test methods for "dialysis fluid temperature" have been changed (see 4.2 and 5.2, 5.2 and 6.2 of YY/T 1274-2016).
YY/T 1493-2016, sections 4.2 and 5.2);
---The requirements and test methods for "dialysis fluid volume" have been changed (see 4.3 and 5.3, 5.3 and 6.3 of YY/T 1274-2016).
YY/T 1493-2016, sections 4.3 and 5.3);
---Added requirements and test methods for "dialysis fluid flow rate" (see 4.4 and 5.4);
---Added requirements and test methods for "peritoneal dialysis indwelling time" (see 4.5 and 5.5);
---The requirements and test methods for "weighing devices" have been changed (see 4.6 and 5.6, and 4.4 and 5.4 of YY/T 1493-2016);
---The requirements and test methods for "dialysis fluid tubing pressure" have been changed (see 4.7 and 5.7, see 5.4 of YY/T 1274-2016).
6.4);
---The requirements and test methods for "protection against air ingress" have been removed (see sections 5.7 and 6.7 of YY/T 1274-2016);
---The requirements and test methods for "Protection against Over-perfusion of Dialysis Fluid" have been revised (see 4.8 and 5.8, and 5.5 of YY/T 1274-2016).
6.5, YY/T 1493-2016 (4.5 and 5.5)
---The requirements and test methods for "insufficient drainage protection" have been revised (see 4.9 and 5.9, and 5.6 and 6.6 of YY/T 1274-2016).
YY/T 1493-2016, sections 4.6 and 5.6);
---The requirements and test methods for "pipeline blockage protection" have been changed (see 4.10 and 5.10, YY/T 1274-2016 5.8 and 5.10).
6.8 (4.7 and 5.7 of YY/T 1493-2016)
---Requirements and test methods for "pinch valves" have been added (see 4.11 and 5.11);
---Added requirements and test methods for "liquid bag height" (see 4.12 and 5.12);
---The requirements and test methods for "Operating Noise" have been revised (see 4.13 and 5.13, and 4.11 and 5.11 of YY/T 1493-2016);
---The requirements and test methods for "Safety Requirements" have been changed (see 4.14 and 5.14, 5.13 and 6.13 of YY/T 1274-2016).
YY/T 1493-2016, sections 4.14 and 5.14);
---The requirements and test methods for "environmental testing" have been deleted (see sections 5.14 and 6.14 of YY/T 1274-2016, YY/T 1493-).
(April 15th and May 15th,.2016)
---The requirement and test method for "interruption of mains power supply" have been deleted (see sections 5.9 and 6.9 of YY/T 1274-2016).
YY/T 1493-2016, sections 4.8 and 5.8);
---The requirements and test methods for "alarm sound pressure level" have been removed (see sections 5.11 and 6.11 of YY/T 1274-2016, YY/T 1493-).
(April 12 and May 12,.2016)
---The section "Marking, Instructions for Use, Packaging, Transportation, and Storage" (see Chapter 7 of YY/T 1274-2016, YY/T 1493-) has been removed.
Chapter 6 of.2016.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document is under the jurisdiction of the National Technical Committee on Standardization of Medical Extracorporeal Circulation Equipment (SAC/TC158).
This document was drafted by. Guangdong Provincial Institute of Medical Device Quality Supervision and Inspection, Fuzhou Dongze Medical Device Co., Ltd., and Shenzhen Zhili Medical Technology Co., Ltd.
Technology Co., Ltd., Suzhou Baxter Medical Supplies Co., Ltd., Fresenius Medical Research & Development (Shanghai) Co., Ltd.
The main drafters of this document are. Wu Shaohai, Cai Haiqing, Luo Jiewei, Tian Liyan, Huang Qiyu, Chen Huayan, Wang Jing, Guo Baocai, Wang Hongli, and Meng Qinghai.
Hou Chunlei and Liu Jinhuan.
The release history of this document and the document it replaces is as follows.
---YY/T 1274, first released in.2016;
---YY/T 1493, first released in.2016.
Peritoneal dialysis equipment
1 Scope
This document specifies the requirements for peritoneal dialysis equipment and describes the corresponding test methods.
This document applies to peritoneal dialysis equipment (hereinafter referred to as the equipment).
This document is not applicable to.
---Disposable consumables used in peritoneal dialysis (such as dialysate and dialysate tubing);
---Continuous blood purification equipment;
---Hemodialysis equipment.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB 9706.1 Medical electrical equipment - Part 1.General requirements for basic safety and basic performance
GB 9706.239 Medical electrical equipment – Part 2-39.Particular requirements for basic safety and basic performance of peritoneal dialysis equipment
YY 9706.108 Medical Electrical Equipment - Parts 1-8.General Requirements for Basic Safety and Basic Performance (Parallel Standard). General Requirements
Seeking testing and guidelines for alarm systems in medical electrical equipment and medical electrical systems.
3 Terms and Definitions
The terms and definitions defined in GB 9706.239 apply to this document.
4 Requirements
4.1 Normal operating conditions of the equipment
The equipment should meet the normal operating conditions specified by the manufacturer.
4.2 Dialysis fluid temperature
4.2.1 Temperature Control
The equipment should have a dialysate heating function and meet the following requirements.
a) The manufacturer should specify the control range and tolerance for the dialysate temperature in the accompanying documentation;
b) The temperature control range of the dialysate should comply with the provisions of the accompanying documents.
4.2.2 Heater surface temperature protection
When the heater surface is an accessible part, the maximum normal operating surface temperature of the heater should not exceed 56°C; otherwise, reasonableness and/or protection are required.
Protective measures should be determined through the analysis of risk management documents.
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