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YY/T 0817-2010: Physical performance requirements and test methods for enteral feeding catheters with a retention balloon
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| YY/T 0817-2010 | English | 419 |
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Physical performance requirements and test methods for enteral feeding catheters with a retention balloon
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YY/T 0817-2010
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Basic data | Standard ID | YY/T 0817-2010 (YY/T0817-2010) | | Description (Translated English) | Physical performance requirements and test methods for enteral feeding catheters with a retention balloon | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.100 | | Word Count Estimation | 18,128 | | Date of Issue | 2010-12-27 | | Date of Implementation | 2012-06-01 | | Quoted Standard | YY 0483-2004 | | Adopted Standard | ASTM F2528-2006, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the one-time use of enteral feeding with positioning the balloon catheter physical performance requirements. Enteral with positioning balloon catheter through the patient's natural cavity (nasal, oral) or by surgery to provide nutrition to patients fistula and (or) administration. The product can be different materials (such as silicone rubber, polyurethane and other polymers as well as a combination of several materials above) made of various specifications, can be supplied non-sterile, sterilized prior to use, or in the form of sterile supply only one-time use. This standard does not involve the bowel with positioning the balloon catheter biological nutrient requirements, chemical requirements, packaging and labeling requirements. | YY/T 0817-2010: Physical performance requirements and test methods for enteral feeding catheters with a retention balloon
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Physical performance requirements and test methods for enteral feeding catheters with a retention balloon
ICS 11.100
C30
People's Republic of China pharmaceutical industry standards
With locating balloon catheter enteral nutrition physical properties
Requirements and test methods
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given in drafting the rules.
This revised standard adopts ASTMF2528-06 "Standard Test Method for enteral nutrition with the positioning of the balloon."
This standard gives a test method for enteral feeding nutrition catheter lumen flow measurement of YY 0483-2004 complements and provides
Performance test methods balloon positioning.
This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This section is drafted. Shandong Medical Devices Product Quality Inspection Center.
The main drafters of this section. Zhang Limei, Mupeng Tao, SHEN Yong, Wan Min.
Introduction
To ensure that the clinical use of enteral feeding catheter with a balloon positioning should have certain physical properties. The performance by the material, manufacturing processes and
Catheter geometry of.
This standard gives the test methods for important physical characteristic for enteral feeding catheter with a measurement of positioning balloon. Including nutrition flow chamber
The amount of the balloon burst volume, retention volume of the balloon, the balloon tube body size and specifications, and the integrity of the balloon after balloon in simulated gastric fluid
Integrity.
Test methods are given in this standard test method for arbitration, is not necessarily applicable to the production process quality control or manufacturer batch release
test.
With locating balloon catheter enteral nutrition physical properties
Requirements and test methods
1 Scope
This standard covers the physical performance requirements for disposable enteral feeding with locating balloon catheter. Enteral nutrition with locating a balloon catheter through
Through the patient's natural orifice (nasal, oral) or through surgical colostomy provide nutrition and (or) administration to the patient. The product is available in different materials
(Such as silicone rubber, polyurethane and other polymer compositions and more than several materials) made of a variety of specifications, can supply non-sterile form, use the Forward
Line sterilization, or in the form of a sterile supply for single use only.
This standard does not involve intestinal nutrition balloon catheter positioned with the requirements of biological, chemical requirements, packaging and labeling requirements.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
YY 0483-2004 disposable enteral feeding catheters, bowel supplies and its design and test methods for connecting member
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Burst volume burstvolume
Filled with the appropriate volume of liquid damage or balloon burst when.
3.2
Headend distalend
It refers to the end of the balloon catheter enteral nutrition.
3.3
Enteral nutrition with locating balloon catheter enteralfeedingcatheterwithretentionbaloon
Expected (or have both) to provide patients with nutrition and (or) administration of dual-chamber medical devices through a natural cavity (nose, mouth) or ostomy surgery.
Comprising a dosing chamber and filling the cavity (see Figure 1). Common specifications for balloon filling 5mL, 15mL, 20mL.
3.4
French Specification Frenchsize (Fr)
And other tubular conduit used to indicate the size of the instrument unit of measure. French tube diameter size values are in millimeters measured value
3 times, e.g., having a diameter of 18Fr i.e. a diameter of 6mm.
3.5
Filling volume inflationvolume
Test method given in this standard for enteral feeding catheter positioning the balloon be filled with a volume of liquid.
3.6
Rated volume ratedvolume
Filling volume label or manufacturer's instructions for use indicated enteral feeding catheter positioning balloon.
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