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Basic data Standard ID | YY 1045.2-2010 (YY1045.2-2010) | Description (Translated English) | Dental handpieces. Part 2: Straight and geared angle handpieces | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | Classification of Chinese Standard | C33 | Classification of International Standard | 11.060.25 | Word Count Estimation | 11,184 | Date of Issue | 2010-12-27 | Date of Implementation | 2012-06-01 | Quoted Standard | GB/T 4340.1-2009; GB/T 6682-2008; GB 9706.1-2007; GB/T 9937.3-2008; YY/T 0628-2008; YY 1012-2004; YY 1045.1-2009; ISO 1797-1-1992/AMD 1-1997; ISO 1797-2-1992 | Adopted Standard | ISO 7785-2-1995, MOD | Regulation (derived from) | State Food and Drug Administration Notice 2010 No. 97 | Issuing agency(ies) | State Food and Drug Administration | Summary | This standard provides for the patient's direct phone and turn mobile phone performance requirements and test methods, but also the manufacturer's instructions, marking and packaging. In addition to these specific requirements, there are many other ways, such as mobile phones materials, structures and integrated design can not be objective requirements or evaluation. If you meet the above objective, verifiable requirements, is considered to meet the requirements. These phones are powered electric or pneumatic motor. |
YY 1045.2-2010: Dental handpieces. Part 2: Straight and geared angle handpieces---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.
Dental handpieces.Part 2. Straight and geared angle handpieces
ICS 11.060.25
C33
People's Republic of China pharmaceutical industry standards
Dental handpieces - Part 2. Direct phone and handpieces
(ISO 7785-2.1995, MOD)
Issued on. 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
YY 1045 handpiece standard is divided into two parts.
--- Part 1. High-speed air turbine hand;
--- Part 2. Direct phone and handpieces.
This is Part 2 YY 1045 of.
The partial modification of the use of ISO 7785-2.1995 "Handpiece Part 2. Straight and curved handset phone." The main modifications are as follows.
--- Delete ISO 7785-2.1995 in clause 5.2.2;
--- Delete ISO 7785-2.1995 "Normative references" in the IEC 651. 1979 Standard;
--- ISO 7785-2.1995 "Normative references" cited ISO 6507-2. 1983 by the ISO 6507-1.1997 substituted,
GB/T 4340.1-1999 modify using ISO 6507-1.1997. Here replaced by GB/T 4340.1-2009
ISO 6507-1.2005.
For ease of use, this section also made the following editorial changes.
--- The term "international standard ISO 7785 in this section" to "this Part of this standard";
--- Delete foreword international standards;
--- For other international standards cited in this section, if it has converted to our standards, replace the International Standard In this section, references to
The corresponding number of national or industry standards, and in Chapter 2 marked on relationships.
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, Xianyang Northwest Medical Devices
(Group) Co., Ltd., Yu Yao Ruixin Medical Devices Co., Ltd., Foshan City Razor surplus medical equipment Limited.
The main drafters of this standard. Zhao Lijun, Pengcan Guang, Li Danrong, Chen Wen Jun, Zeng Wenbin.
Introduction
Because the phone structure is complex, it is impossible to require all the details, although these details are important. Sometimes only likely to make the appropriate general specification
Regulations, manufacturers have a responsibility to make decisions, to ensure product safety and reliability.
Individual terms listed in this section take precedence GB 9706.1-2007 standard.
Only terms set out in this section is applicable.
This section refers to GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety." Where there is a reference to the place are marked
Understand the terms of the standard GB 9706.1-2007 number.
Dental handpieces - Part 2. Direct phone and handpieces
1 Scope
YY 1045 This section specifies performance requirements and test methods for patients with straight and curved handset phones, including manufacturers make
With brochures, signs and packaging. In addition to these specific requirements, there are many other aspects, such as mobile phones materials, structures and integrated design without
Law provisions or objective evaluation. If you meet the above objective, verifiable requirements, is considered to meet the requirements.
These phones are powered by electric or pneumatic motor.
2 Normative references
The following documents contain provisions which, through reference YY 1045 present, constitute provisions of this section. For dated references,
All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section
Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section.
Test Method. GB/T 4340.1-2009 Vickers hardness test - Part 1 (ISO 6507-1.1997, MOD)
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 9937.3-2008 Oral Vocabulary - Part 3. dental instruments (ISO 1942-3. 1989, IDT)
YY/T 0628-2008 dental equipment Graphical symbols (ISO 9687.1993, IDT)
YY 1012-2004 handpiece coupling dimensions (ISO 3964. 1982, IDT)
YY 1045.1-2009 Dental handpieces - Part 1. High-speed air turbine handpiece (ISO 7785-1.1997, IDT)
ISO 1797-1.1992/Amd1.1997 Dental rotary instruments - Part 1 lever. metal rod
ISO 1797-2.1992 Dental rotary instruments lever Part 2. plastic rod
3 Terms and Definitions
GB/T 9937.3 and established in the following terms and definitions apply to this part YY 1045.
Category 4
Direct phone and dental handpieces by low voltage electric motor or a pneumatic motor driven dental handpiece.
Direct phone and handpieces YY 1045.1-2009 prescribed in Table 1 classification.
5 Requirements
5.1 Integrated Design
5.1.1 Overview
Phone should be appropriate for the operator to use and easy to operate. The outer surface should be easy to clean, and pay special attention to the availability of safe gripping surface for operation
On the operation.
Meets these requirements in the objective can not be directly evaluated.
If you meet the requirements 5.1.2,5.1.3 and 5.2 to 5.8, it is considered to meet the requirements of 5.1.1.
Testing should be required to be 7.1.
5.1.2 Materials
All materials used in the structure of the mobile phone should be suitable for its intended use, and able to withstand the manufacturer's recommended cleaning, disinfection and sterilization methods.
Meets these requirements in the objective can not be directly evaluated.
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