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YY/T 0872-2013

Chinese Standard: 'YY/T 0872-2013'
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YY/T 0872-2013English279 Add to Cart Days<=3 Test methods for ureteral stents Valid YY/T 0872-2013
YY/T 0872-2013Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

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Detail Information of YY/T 0872-2013; YY/T0872-2013
Description (Translated English): Test methods for ureteral stents
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C40
Classification of International Standard: 11.040.20
Word Count Estimation: 14,190
Quoted Standard: GB/T 528; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.8; GB/T 16886.9; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17;
Drafting Organization: Shandong Hengxin detection technology development center
Administrative Organization: State Food and Drug Administration, Jinan Medical Devices Product Quality Supervision and Inspection Center
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization: National Standardization Technical Committee for Medical Infusion Apparatus (SAC/TC 106)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the use of ureteral stents disposable test methods for evaluating the characteristics of arbitration fixtures at both ends, these brackets apply to short-term drainage of urine from the kidneys to the bladder hazy. Such stent diame


YY/T 0872-2013
Test methods for ureteral stents
ICS 11.040.20
C40
People's Republic of China pharmaceutical industry standards
Ureteral stent Test Method
Issued on. 2013-10-21
2014-10-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This revised standard adopts ASTMF1828-1997 "ureteral stent norms." Content include.
--- According to GB/T 1.1 provisions of editorial changes;
--- On the test apparatus made appropriate improvements, but there is no difference in technology.
This standard by the National Standardization Technical Committee medical infusion apparatus (SAC/TC106) proposed.
This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This standard was drafted. Shandong Hengxin detection technology development center.
Drafters of this standard. Song Jinzai, Zhang Limei, Xu Hui.
introduction
This standard is intended to give an implanted ureteral stent used to evaluate the safety and effectiveness of the test method. These kidney stent
Dirty side and bladder ends with retainer, through the ureter draining urine from the kidneys to the bladder.
This standard gives the evaluation of ureteral stent characteristics arbitration test methods. Note that these test methods should not be used in the production of the manufacturer
Quality control and batch release.
Ureteral stent Test Method
1 Scope
Disposable ureteral stent test method for evaluating the characteristics of arbitration ends with fixing device according to the standards, and these stents
Short-term urine drainage from the kidney to the bladder. The diameter of these stents have generally 3.7Fr ~ 14.0Fr, a length of 8cm ~ 30cm, the
Silicone rubber, polyurethane and other polymers, and in the form of non-sterile and sterile disposable form of supply.
The product will have a long-term retention (more than 30d) situation, but not common, so this standard does not cover this situation. Also, the standard
Nor does it include non-ureteral applications (such as kidney colostomy and ileostomy) ureteral stents. Because the hospital's sterilization equipment, sterilization processes
Presence and stent characteristics produce differences, so this standard does not apply to non-sterile ureteral stent.
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.
GB/T 528 Determination of vulcanized rubber or thermoplastic rubber tensile stress-strain properties
Biological evaluation of GB/T 16886 (all parts) Medical Devices
YY/T 0586 Medical Polymer Co. X-ray opaque Test Method
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Artificial urine artificialurine
An organic and inorganic compound solution, its physical and chemical properties close to normal human urine. Artificial urine instead of human urine to
Effects of simulated human urine ureteral stent.
3.2
Bladder fixtures bladderretentionmeans
Prevent the physical structure of the stent from the bladder off the end of the stent bladder.
3.3
Breaking strength breakstrength
The stent required to break the maximum tensile load.
3.4
Cross section crosssection
Vertical section view of the bracket in the longitudinal direction of the stent.
3.5
The distal end of distal
End remote from the starting point, the distal end of the stent is indwelling in the bladder, also known as bladder end.
Related standard:   YY/T 0871-2013  YY/T 0719.8-2019
Related PDF sample:   YY/T 0864-2011  YY/T 0619-2017
   
 
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