YY/T 1404-2016 English PDF

US$179.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1404-2016: Requirements and tests for copper used for IUD
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1404-2016	179	Add to Cart	3 days	Requirements and tests for copper used for IUD	Valid

Similar standards

YY/T 1704.1   YY/T 1704.2   YY/T 1470   YY/T 1921   YY/T 1405   

Basic data

Standard ID: YY/T 1404-2016 (YY/T1404-2016)
Description (Translated English): Requirements and tests for copper used for IUD
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C36
Classification of International Standard: 11.200
Word Count Estimation: 9,922
Date of Issue: 2016-03-23
Date of Implementation: 2017-01-01
Regulation (derived from): Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies): State Food and Drug Administration

YY/T 1404-2016: Requirements and tests for copper used for IUD

---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.
Requirements and tests for copper used for IUD ICS 11.200 C36 People's Republic of China Pharmaceutical Industry Standard Copper technology for copper intrauterine device Requirements and test methods 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed and centralized by the National Standardization Technical Committee for Family Planning Instruments (SAC/TC169). The standard drafting unit. Shanghai Jiaotong University School of Medicine affiliated Ninth People's Hospital, Shanghai Medical Devices Testing Institute. The main drafters of this standard. Sun Jiao, Yao Tianping, Ding Tingting, Lu Hua, Zou Fengping. Copper technology for copper intrauterine device Requirements and test methods

1 Scope

This standard specifies the chemical composition, requirements and test methods for copper containing copper intrauterine devices. This standard applies to copper and copper IUD used copper and copper raw materials.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 5121.27-2008 Methods for chemical analysis of copper and copper alloys - Part 27. Inductively coupled plasma atomic emission Spectrum method GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (GB/T 16886.12- 2005, ISO 10993-12..2002, IDT)

3 chemical composition

According to the method specified in Chapter 5, the minimum content of copper is 99.99%. Where the individual impurity metal content is not greater than that in Table 1 Regulations. Table 1 impurity metal content in micrograms per gram Maximum amount of individual metal Lead (Pb) 5 Tellurium (Te) 3 Cadmium (Cd) 1 antimony (Sb) 4 Iron (Fe) 10 arsenic (As) 5 Nickel (Ni) 10 phosphorous (P) 3 Bi (Bi) 2 silver (Ag) 25 Tin (Sn) 2

4 requirements

4.1 purity of copper 4.1.1 Copper content in copper raw materials shall comply with the provisions of Chapter 3. 4.1.2 copper raw materials impurity metal content should be consistent with the provisions of Table 1. 4.2 Surface quality 4.2.1 copper raw material surface should be clean, no sludge, oil and other pollutants. ......

Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1404-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1404-2016_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 1404-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1404-2016_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.