YY/T 1274-2025 English PDF

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1274-2025	RFQ	ASK	3 days	(Peritoneal dialysis equipment)	Valid
YY 1274-2016	359	Add to Cart	3 days	Pressure control peritoneal dialysis equipment	Obsolete
YY/T 1274-2016	199	Add to Cart	3 days	Pressure control peritoneal dialysis equipment	Valid

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
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Older Standard (superseded by this standard): YY/T 1274-2016, YY/T 1493-2016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

YY 1274-2016: Pressure control 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.
Pressure control peritoneal dialysis equipment ICS 11.040.40 C45 People's Republic of China Pharmaceutical Industry Standard Pressure - controlled peritoneal dialysis equipment 2016-03-23 release 2018-01-01 implementation State Food and Drug Administration issued

Foreword

The technical content of this standard is mandatory. This standard 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 release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Extracorporeal Circulation Equipment Standardization Technical Committee (SAC/TC158) centralized. The drafting unit. the State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Baxter medical supplies trade (Shanghai) Co., Ltd. The main drafters of this standard. Li Shi, Tu Rong, Chen Yuen, Gao Yuan, Wang Peilian. Pressure - controlled peritoneal dialysis equipment

1 Scope

This standard specifies the terminology and definitions, classification, requirements, test methods, logos, instructions and instructions for pressure-controlled peritoneal dialysis equipment Packaging, transportation, storage. This standard applies to pressure-controlled peritoneal dialysis equipment (hereinafter referred to as equipment). This standard does not apply to. Peritoneal dialysis in the process of disposable materials (such as dialysis solution, dialysis fluid line); Plan to use only continuous ambulatory peritoneal dialysis equipment; - equipment intended for continuous mobile peritoneal dialysis; --- gravity control type peritoneal dialysis equipment.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 packaging and storage icon Medical electrical equipment - Part 1. General requirements for safety GB 9706.1 GB 9706.39 Medical electrical equipment - Part 2-39. Particular requirements for safety of peritoneal dialysis equipment General rules for the use of industrial products GB/T 9969 Glacier for blood purification GB/T 13074 Environmental requirements and test methods for medical appliances GB/T 14710-2009 YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 terms and definitions

GB 9706.39 and GB/T 13074 and the following terms and definitions apply to this document. 3.1 Gravity control type gravitycontroltype The use of gravity to achieve irrigation and drainage equipment. 3.2 Pressure control type pressurecontroltype The use of changes in pressure to achieve irrigation and drainage equipment. 3.3 Stay belly dwel Dialysis fluid remains in the abdominal cavity stage.

4 classification

Equipment according to the realization of irrigation and drainage into the way. ......

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