YY/T 1274: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1274-2025 | English | RFQ |
ASK
|
3 days [Need to translate]
|
(Peritoneal dialysis equipment)
| Valid |
YY/T 1274-2025
|
| YY 1274-2016 | English | 359 |
Add to Cart
|
3 days [Need to translate]
|
Pressure control peritoneal dialysis equipment
| Obsolete |
YY 1274-2016
|
| YY/T 1274-2016 | English | 199 |
Add to Cart
|
3 days [Need to translate]
|
Pressure control peritoneal dialysis equipment
| Valid |
YY/T 1274-2016
|
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Standard | 11.040.40 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2027-01-01 | | Older Standard (superseded by this standard) | YY/T 1274-2016, YY/T 1493-2016 | | Issuing agency(ies) | National Medical Products Administration | YY 1274-2016: Pressure control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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