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YY 0835-2011 English PDF

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YY 0835-2011: Dentistry. Amalgam separators
Status: Obsolete
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YY 0835-2011English1039 Add to Cart 5 days [Need to translate] Dentistry. Amalgam separators Obsolete YY 0835-2011

PDF similar to YY 0835-2011


Standard similar to YY 0835-2011

YY 1042   YY/T 0823   YY/T 0824   YY 0271.2   YY/T 0826   YY/T 0825   

Basic data

Standard ID YY 0835-2011 (YY0835-2011)
Description (Translated English) Dentistry. Amalgam separators
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C33
Classification of International Standard 11.060.20
Word Count Estimation 26,239
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard GB 4793.1-2007; GB/T 6682-2008; GB 9706.1-2007; HG/T 3115; YY/T 0628; YY 1026-2009; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5
Adopted Standard ISO 11143-2008, MOD
Regulation (derived from) State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements and test methods for dental treatment centers and dental equipment connected to the amalgam separator, the provisions of the amalgam separator based on laboratory tests to be trapped amalgam is based on the level of efficiency and to determine the efficiency of the test procedure, and provides for the safety of amalgam separators operational requirements, marking requirements, use requirements, operation and maintenance requirements. All tests are type tests described in this standard.

YY 0835-2011: Dentistry. Amalgam separators

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Dentistry.Amalgam separators ICS 11.060.20 C33 People's Republic of China pharmaceutical industry standards Dentistry amalgam separator (ISO 11143.2008, MOD) Issued on. 2011-12-31 2013-06-01 implementation State Food and Drug Administration issued

Table of Contents

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Category 2 5 requires 3 Sampling 4 6 7 test device 4 8 Test Sample 6 9 Test methods 8 10 12 Test Report 11 manufacturer's installation, use, maintenance and Maintenance Manual 13 12 mark 14 Appendix A (informative) amalgam preparation of the test sample 15 Annex B (informative) grinding hardened amalgam program 17 Annex C (informative) using X-ray absorption sedimentation assay particle group 318 Annex D (informative) dental amalgam waste water particle size distribution of 20 References 21

Foreword

This standard GB/T 1.1-2009 given rule drafting. This revised standard adopts ISO 11143.2008 "dentistry amalgam separator" (in English). This standard and ISO 11143.2008 The main differences are as follows. --- Join the introduction of standard amalgam separator is used in conjunction with the dental unit in the form of instructions; --- With GB 9706.1-2007 "Medical Electrical Equipment Part 1. General Requirements for Safety" (IEC 60601-1. 1988, IDT) on behalf of the For IEC 60601-1.2005 "Medical Electrical Equipment Part 1. General requirements for safety"; --- With GB/T 6682-2008 "analytical laboratory use specifications and test methods" (ISO 3696. 1987, MOD) instead of ISO 3696. 1987 "analytical laboratory use specifications and test methods"; --- On normative references, this standard has been adjusted technical differences, in order to adapt our technical conditions, the adjusted situation Focus is reflected in the status of Chapter 2, "Normative references", the specific adjustment is GB/T 9937 (all parts) instead of the ISO 1942 (All parts), the degree of consistency between the various parts of the following two criteria. GB/T 9937.1-2008 Oral Vocabulary - Part 1. Basic and Clinical Terminology (ISO 1942-1. 1989, IDT); GB/T 9937.2-2008 Oral Vocabulary - Part 2. Oral Vocabulary (ISO 1942-2. 1989, IDT); GB/T 9937.3-2008 Oral Vocabulary - Part 3. dental instruments (ISO 1942-3. 1989, IDT); GB/T 9937.4-2005 Dental Terminology - Part 4. Dental equipment (ISO 1942-4. 1989, IDT); GB/T 9937.5-2008 Oral Vocabulary - Part 5. Testing and related terms (ISO 1942-5. 1989, IDT). --- For ease of use, the terms and definitions listed in Chapter repeat GB/T 9937 part of the terms and definitions (see 3.4 to 3.6); --- This standard was added to the constant quality note (see 9.3.2.2). For ease of use, this standard also made the following editorial changes. --- Deleted international standard preamble. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the State Food and Drug Administration. This standard by the National Dental Materials and Devices Equipment Standardization Technical Committee dental equipment and instruments Technical Committee (SAC/TC99 SC1) centralized. This standard was drafted. State Food and Drug Administration Guangzhou Medical Device Quality Supervision and Inspection Center, Ningbo has a blue field of medical devices Ltd., Suzhou Winbond Dental Medical Devices Co., Ltd. The main drafters of this standard. Li Shining, Lu Wenjuan, leaning Wu Ming, Yang Qi, Liu Maolin.

Introduction

Amalgam separator is a dental device for dental treatment centers from the trapped effluents carried amalgam particles, Thereby reducing the content of amalgam into the sewer system. Separated amalgam particles can be used centrifugation, precipitation, filtration, or any combination of these methods. Evaluation samples for testing the efficiency of the amalgam separator should be able to reflect the size of the dental treatment centers actual emissions of fine particles of silver amalgam Distribution. The standard test sample is based on the size of dental treatment center has been discharged wastewater amalgam particles Distribution Survey (see Appendix D) determined. Test principle this standard amalgam separator efficiency. the discharge from the amalgam separator water collected in a container. Then these contain amalgam separator does not live in the amalgam particles trapped water through a filter of known weight. Then close Set silver amalgam particulate filter placed in a desiccator dried at room temperature to a constant quality. So as to arrive amalgam separator collected The total weight of the microparticles to determine the collection efficiency. This standard aims to standardize amalgam separator requirements and test methods for use with its form and not dental unit Specified. The separator can be equipped on the dental unit as a member, but also as a stand-alone device and dental waste water treatment center Exhaust system connection to use. This standard amalgam separator that is YY/T 1043-2004 in amalgam separation device. Dentistry amalgam separator

1 Scope

This standard specifies the requirements and test methods for dental equipment and dental treatment centers connected amalgam separator, provides Based on laboratory tests to be trapped amalgam level-based amalgam separator efficiency, as well as determining the efficiency of the test step Step, and provides dental amalgam separator safe operation requirements, marking requirements, requirements for use, operation and maintenance requirements. All tests are type tests described in this standard.

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 4793.1-2007 measurement, control and laboratory safety requirements for electrical equipment Part 1. General requirements (IEC 61010- 1.2001, IDT) GB/T 6682-2008 analytical laboratory use specifications and test methods (ISO 3696. 1987, MOD) GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) GB/T 9937 (all parts) oral vocabulary [ISO 1942 (all parts)] HG/T 3115 performance borosilicate glass 3.3 (HG/T 3115-1998, ISO 3585.1991, IDT) YY/T 0628 Graphical symbols for dental equipment (YY/T 0628-2008, ISO 9687.1993, IDT) YY 1026-2009 dentistry mercury and silver alloy powder (ISO 24234.2004, IDT)

3 Terms and Definitions

GB/T 9937 (all parts) and YY 1026 defined and the following terms and definitions apply to this document. For ease of use, to By repeating a list of GB/T 9937 in some of the terminology and definitions. 3.1 Amalgam separator amalgamseparator A dental device for dental treatment centers interception discharged wastewater amalgam particles to reduce the number of dental amalgam particles Amount, thereby reducing the sewer system into the amalgam content (number). 3.2 Collector colectingcontainer Part of the amalgam separator for collecting the separated amalgam waste to facilitate recycling. 3.3 Dental treatment center dentaltreatmentcentre Combination of dental treatment unit, comprising at least enable the dentist to treat patients with the dental unit and a dental chair. 3.4 Dental equipment dentalequipment It specializes in the production and (or) to provide qualified personnel in dentistry clinical and (or) its various devices related to the procedure used, machine , Instruments and accessories.

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