YY/T 0071-2018 English PDFUS$139.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0071-2018: Sigmoidoscopy and rectoscopy set Status: Valid YY/T 0071: Historical versions
Basic dataStandard ID: YY/T 0071-2018 (YY/T0071-2018)Description (Translated English): Sigmoidoscopy and rectoscopy set Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C40 Classification of International Standard: 11.040.99 Word Count Estimation: 7,783 Date of Issue: 2018-09-21 Date of Implementation: 2019-09-26 Older Standard (superseded by this standard): YY 0071-2008 Issuing agency(ies): State Drug Administration YY/T 0071-2018: Sigmoidoscopy and rectoscopy set---This is a DRAFT version for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.Sigmoidoscopy and rectoscopy set ICS 11.040.99 C40 People's Republic of China Pharmaceutical Industry Standard Replacing YY 0071-2008 Rectal, sigmoid colonoscope Published on.2018-09-21 Implementation of.2019-09-26 State Drug Administration issued ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 0071-2008 "rectal, sigmoid colonoscope", compared with YY 0071-2008, the main technical changes are as follows. --- Revised dimensional requirements, biocompatibility requirements (see 5.7.3,.2008 version 4.9), corrosion resistance (see 5.8,.2008 edition) 4.7); --- Added surface material (see 5.7.1), material requirements (see 5.7.2), dissolved precipitates (see 5.7.4), over temperature (see 5.9), Luer connection Head (see 5.10) requirements; --- Removed security requirements (see.2008 version 4.8), inspection rules (see Chapter 6 of the.2008 edition), signs (see.2008 edition) Chapter 7), Instructions for Use (see Chapter 8 of the.2008 edition), packaging (see Chapter 9 of the.2008 edition), transportation and storage (See Chapter 9 of the.2008 edition) and Appendix A (see Appendix A of the.2008 edition). Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Optics and Instruments (SAC/TC103/SC1). This standard was drafted. Zhejiang Medical Device Inspection Institute, Zhejiang Tiansong Medical Devices Co., Ltd. The main drafters of this standard. Zhang Yiyuan, Jia Xiaohang, Yan Qinglai, Liu Ping, Shu Mingquan, Xu Binfeng. The previous versions of the standards replaced by this standard are. ---WSZ-244-1977; ---YY 0071-1992; ---YY 0071-2008. Rectal, sigmoid colonoscope1 ScopeThis standard specifies the terms and definitions, composition and specifications, requirements and test methods for rectal and sigmoid colonoscopes. This standard is applicable to rectal and sigmoid colonoscopy (hereinafter referred to as speculum) for clinical use in medical institutions. Speculum is mainly used for anorectal examination. Check and diagnose.2 Normative referencesThe following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 1962 6% (Ruhr) conical joint for syringes, needles and other medical devices GB/T 14233.1-2008 Medical infusions, blood transfusions, injecting machines - Test methods - Part 1 GB/T 16886 (all parts) Biological evaluation of medical devices YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical instruments3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 The rectal and sigmoid colonoscope is a direct-view tube that can be inserted into the human anorectum for examination and diagnosis without an optical imaging structure.4 Composition and specifications4.1 Composition The speculum is mainly composed of a mirror body, a obturator, a handle, an illumination fiber, and an optical cable interface. The outline structure is shown in Figure 1. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0071-2018_English be delivered?Answer: Upon your order, we will start to translate YY/T 0071-2018_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 0071-2018_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0071-2018_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+ countriesQuestion 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.Question 5: Should I purchase the latest version YY/T 0071-2018?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0071-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
