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YY 0006-2013 English PDF

Q: How long will the true-PDF of English version of YY 0006-2013 be delivered?

Upon your order, we will start to translate YY 0006-2013_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.

Q: Can I share the purchased PDF of YY 0006-2013_English with my colleagues?

Yes. The purchased PDF of YY 0006-2013_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

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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). Avoidance of Double Taxation Agreements (DTAs) between Singapore and 100+ Countries: https://www.iras.gov.sg/taxes/international-tax

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Q: Should I purchase the latest version YY 0006-2013?

Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0006-2013 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.

US$279.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0006-2013: Metal double-wing vagina dilator
Status: Valid

YY 0006: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0006-2013	279	Add to Cart	3 days	Metal double-wing vagina dilator	Valid
YY 0006-1990	399	Add to Cart	3 days	Double-Wing Vagina Dilator	Obsolete

Similar standards

YY/T 0979 YY/T 1470 YY 0091 YY/T 1921 YY/T 0079 YY/T 0090

Basic data

Standard ID: YY 0006-2013 (YY0006-2013)
Description (Translated English): Metal double-wing vagina dilator
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C36
Classification of International Standard: 11.040.30
Word Count Estimation: 12,127
Older Standard (superseded by this standard): YY 0006-1990
Quoted Standard: GB/T 2040; GB/T 2828.1; GB/T 2829; GB/T 3280; GB/T 6463; GB/T 10610; GB/T 16886.1; GB/T 16886.5; GB/T 16886.10; YY 0076; YY/T 0149-2006; YY/T 0171; YY/T 1052
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 metal wings vaginal dilator structure type, requirements, test methods, inspection rules, marking, packaging, transport and storage. This standard applies to metal wings vaginal dilator (hereinafter referred to as dilator), the

YY 0006-2013: Metal double-wing vagina dilator

---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.
Metal double-wing vagina dilator ICS 11.040.30 C36 People's Republic of China pharmaceutical industry standards Replacing YY 0006-1990 Metal wings vaginal dilator Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Foreword

Drafted in accordance with the standard GB/T 1.1-2009 given rules. This standard replaces YY 0006-1990 "wings vaginal dilator." The main technical differences between this standard and YY 0006-1990 follows. --- Modify the reference standards and reference standards year; --- Canceled a standard icon to use parts of the Central African dimension; --- Modify the "deflection" to "deformation"; --- Modify the surface roughness; --- Increase the corrosion resistance of the product performance requirements and test methods; --- Increased biological evaluation requirements and test methods for products. Please note that some of the content of this standard may involve patents. The standard release mechanism does not assume the responsibility to identify these patents. This standard by the national family planning equipment Standardization Technical Committee (SAC/TC169) and focal points. This standard was drafted. Tait Zhejiang Medical Devices Co., Ltd., the State Food and Drug Administration of Quality Supervision, Inspection Shanghai Medical Devices Inspection center, Shanghai 40 Link instrumentarija. The main drafters of this standard. Zhu Jianjun, Yaotian Ping, music Weimin, Xia Jiming, Wengbing Hao, Sun Hongzhi. The standard standard replaces the previous editions. --- WS2-45-1974; --- WS2-35-1974; --- YY 0006-1990. Metal wings vaginal dilator

1 Scope

This standard specifies the structure type metal wings vaginal dilator, requirements, test methods, inspection rules, marking, packaging, transport and Storage. This standard applies to the metal wings vaginal dilator (hereinafter referred to as dilator), expansion of the product for obstetrics and gynecology vagina, cervix examination, Douching and general surgery. This standard does not apply to single-use vaginal dilators.

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 2040 copper and copper alloy sheet GB/T 2828.1 Sampling procedures for inspection, Part 1. batch inspection sampling plan according to accepted quality limit (AQL) retrieval GB/T 2829 periodic inspection Sampling procedures and sample forms (suitable for process stability test) GB/T 3280 stainless steel cold-rolled steel sheet and strip Reviews on the cover layer thickness measurement GB/T 6463 Metallic and other inorganic GB/T 10610 Geometrical product specifications (GPS) Surface texture Profile method - Rules and procedures for evaluation of the surface structure GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and test GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test YY 0076 metal parts coating technology classification conditions YY/T 0149-2006 stainless steel medical equipment corrosion test methods YY/T 0171 surgical instruments, packaging and marking and instructions for use YY/T 1052 surgical instruments logo

3 structure type

3.1 dilator wings should be copper or GB GB/T 2040 stipulated/T 3280 specified in stainless steel. 3.2 dilator type specified in Table 1 and Figures 1, 2 and 3. Table 1 dilator types and specifications in millimeters Type specifications Check the type adjustable 118 × 37 100 × 30 90 × 22 Surgery type Stationary Adjustable 90 × 34 85 × 32 90 × 34 85 × 32 ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0006-2013_English be delivered?

Answer: Upon your order, we will start to translate YY 0006-2013_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 0006-2013_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0006-2013_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.

Question 5: Should I purchase the latest version YY 0006-2013?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0006-2013 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.