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YY/T 0872-2013 English PDF

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US$329.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0872-2013: Test methods for ureteral stents
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0872-2013	329	Add to Cart	3 days	Test methods for ureteral stents	Valid

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Basic data

Standard ID: 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: 14,196
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;
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
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

---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.
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. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0872-2013_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0872-2013_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0872-2013_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0872-2013_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.