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YY 0715-2009 English PDF

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US$359.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0715-2009: Dentistry. Amalgam capsules
Status: Obsolete

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY 0715-2009	359	Add to Cart	3 days	Dentistry. Amalgam capsules	Obsolete

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Basic data

Standard ID: YY 0715-2009 (YY0715-2009)
Description (Translated English): Dentistry. Amalgam capsules
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 9,940
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 6387-1986; GB/T 7408-2005; YY/T 0273-1995; ISO 24234-2004
Adopted Standard: ISO 13897-2003, IDT
Regulation (derived from): Industry standard filing Notice 2009 No. 9
Issuing agency(ies): State Food and Drug Administration
Summary: This standard provides for mixing silver alloy powder and mercury preloaded reusable capsules capsules and the requirements and test methods.

YY 0715-2009: Dentistry. Amalgam capsules

---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.
Dentistry.Amalgam capsules ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards YY 0715-2009/ISO 13897.2003 Dentistry amalgam capsules (ISO 13897.2003, IDT) Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

Foreword

All technical contents of this standard is mandatory. This standard is identical with ISO 13897.2003 "Dentistry Amalgam Capsule" and Technical Corrigendum. This standard is based on ISO 13897.2003 redrafted. This standard relates to silver amalgam capsules suitable for dental clinical treatment. This standard does not include the possible biological hazards qualitative and quantitative requirements, but it is recommended in the evaluation of possible biological hazards, the use of YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing." This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment. This standard was drafted. North State Food and Drug Administration Medical Device Quality Supervision and Inspection Center. The main drafters of this standard. Zheng Gang, Yuan Shen slope, Sun Zhihui, Zhang Dianyun, Ho Ming Ming. YY 0715-2009/ISO 13897.2003

Introduction

For the production of dental amalgam, dental amalgam reconcile electric device YY/T 0273-1995 described mainly used for mixing dental silver alloy Powder and dental mercury. Many dental amalgam to reconcile the use of a removable capsule-contained dental dental silver alloy powder and mercury. Although the use and When testing the capsule should be considered as dental amalgam reconcile the parts, but in the YY/T 0273-1995 did not relate to the capsule begging. These requirements are the subject of this standard. YY 0715-2009/ISO 13897.2003 Dentistry amalgam capsules

1 Scope

This standard specifies the pre capsule for mixing silver alloy powder and mercury and requirements and test methods for reusable capsules.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 6387-1986 Dental Materials Terminology GB/T 7408-2005 data elements and interchange formats - Information interchange dates and times (ISO 8601.2000, IDT) YY/T 0273-1995 dental amalgam harmonic filter (eqv ISO 7488.1991) ISO 24234.2004 Dentistry - Dental amalgam alloy powder of silver and mercury

3 Terms and Definitions

GB/T 6387, YY/T 0273-1995 and ISO 24234.2004 and established the following terms and definitions apply to this standard. 3.1 Single-use capsule, containing a weighed silver alloy powder and mercury, which can prevent the contact of the two components prior to mixing. 3.2 Amalgamation process mercury-silver alloy powder and automatic pre-capsule contact occurs. 3.3 Capsule of mercury silver alloy powder and mixing process.

4 Products

This standard amalgam mixing capsule according to whether reusable, divided into the following types. --- Type 1. single-use capsule; --- Type 2. reusable capsules.

5 Requirements

5.1 Packaging and capsules pollution Test in accordance with 7.1, type 1 capsule packaging container and capsule surface should be mercury and/or silver alloy powder contamination. 5.2 Dimensions 5.2.1 Length Tolerance 7.2 according to the test, the length of the activated type 1 and 2, the length of the capsule-capsule manufacturer should be within a predetermined range of values ± 1mm. 5.2.2 Diameter Tolerance Experiment 7.2 in accordance with the maximum outer diameter, type 1 and 2, the capsule-capsule should be specified by the manufacturer within a range of values ± 0.5mm. YY 0715-2009/ISO 13897.2003 ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY 0715-2009_English be delivered?

Answer: Upon your order, we will start to translate YY 0715-2009_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 0715-2009_English with my colleagues?

Answer: Yes. The purchased PDF of YY 0715-2009_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.