US$179.00 · In stock Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1273-2016: Roller pump for auxiliary blood purification Status: Valid YY/T 1273: Evolution and historical versions
Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
YY/T 1273-2016 | English | 179 |
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Roller pump for auxiliary blood purification
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YY/T 1273-2016
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YY/T 1273-2016 | English | 179 |
Add to Cart
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3 days [Need to translate]
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Roller pump for auxiliary blood purification
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YY/T 1273-2016
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Basic data Standard ID | YY/T 1273-2016 (YY/T1273-2016) | Description (Translated English) | Roller pump for auxiliary blood purification | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | Classification of Chinese Standard | C45 | Classification of International Standard | 11.040.40 | Word Count Estimation | 8,861 | Date of Issue | 2016-03-23 | Date of Implementation | 2018-01-01 | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard specifies the terms, definitions, requirements, test methods, marks, instructions for use, packaging, transportation and storage of roller pumps for auxiliary blood purification (hereinafter referred to as roller pumps). This standard applies to the blood purification auxiliary roller pump defined in 3.1. The rolling pump cannot be used independently for blood purification treatment. |
YY/T 1273-2016: Roller pump for auxiliary blood purification---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
C45
Pharmaceutical Industry Standard of the People's Republic of China
YY 1273-2016
Roller pump for auxiliary blood purification
According to the State Drug Administration medical device industry
Standard Announcement (No: 76 of 2022), this standard is from
From September 7, 2022, it will be converted into a recommended standard, no
Enforce it again:
Released on March 23,:2016
2018-01-01 Implementation
Issued by China Food and Drug Administration
foreword
All technical contents of this standard are mandatory:
This standard is drafted in accordance with the rules given in GB/T 1:1-2009:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying these patents:
This standard was proposed by China Food and Drug Administration:
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment (SAC/TC158):
This standard was drafted by: State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Guangzhou Jihua Medical Devices
Ltd:
The main drafters of this standard: He Min, Wu Shaohai, Chen Yuen, Yang Jianlong, Wang Peilian, Liu Jing:
YY 1273-2016
Roller pump for auxiliary blood purification
1 Scope
This standard specifies the terms, definitions, requirements, test methods, marks, and usage of roller pumps for auxiliary blood purification (hereinafter referred to as roller pumps):
Instructions and packaging, transportation and storage:
This standard applies to the blood purification auxiliary roller pump defined in 3:1: The rolling pump cannot be used independently for blood purification treatment:
This standard does not apply to:
---Hemoperfusion equipment;
---blood cell separation equipment;
---Continuous blood purification equipment;
--- Immunoadsorption equipment;
--- hemodialysis device;
--- Hemodiafiltration device;
---Centrifugal pump;
---Artificial heart-lung machine rolling blood pump:
2 Normative references
The following documents are indispensable for the application of this document: For dated references, only the dated version applies to this document
pieces: For undated references, the latest version (including all amendments) applies to this document:
GB/T 191 Packaging, storage and transportation icon marks
GB 9706:1 Medical Electrical Equipment Part 1: General Safety Requirements
GB/T 9969 General Rules for Instructions for Use of Industrial Products
GB/T 13074 Terminology for blood purification
GB/T 14710-2009 Environmental requirements and test methods for medical electrical appliances
YY/T 0466:1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1: General Requirements
3 Terms and Definitions
The following terms and definitions defined in GB/T 13074 apply to this document:
3:1
A power device that uses rolling to assist blood extracorporeal circulation during blood purification treatment:
4 requirements
4:1 Normal working conditions
The manufacturer's specification or the following conditions shall be met:
a) The ambient temperature is 5°C~40°C;
YY 1273-2016
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