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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: 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. ...