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YY 0836-2011: Dental handpieces. Dental low-voltage electrical motor
Status: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0836-2011 | English | 559 |
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Dental handpieces. Dental low-voltage electrical motor
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YY 0836-2011
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Basic data | Standard ID | YY 0836-2011 (YY0836-2011) | | Description (Translated English) | Dental handpieces. Dental low-voltage electrical motor | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 14,146 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 6682-2008; GB 9706.1-2007; GB/T 9937.3-2008; YY/T 0149-2006; YY 0505-2005; YY/T 0628-2008; YY 1012-2004; YY/T 1043-2004; YY 1045.2-2010; ISO 4211-1979 | | Adopted Standard | ISO 11498-1997, 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 connection with dental handpieces for dental patients with low-voltage electric motor performance requirements and test methods, but also the manufacturer's instructions, packaging and marking. All tests in this standard are type tests. Dental low electric motors controlled by the dental unit or as a stand-alone mobile devices. They are straight with dental handpieces and supporting the use of mobile phones. This standard outlined in the terms of the priority GB 9706. 1-2007 standard. Only in this standard is set out in the applicable provisions. | YY 0836-2011: Dental handpieces. Dental low-voltage electrical motor---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.Dental low-voltage electrical motor
ICS 11.060.20
C33
People's Republic of China pharmaceutical industry standards
Dental handpiece low voltage electric motors
(ISO 11498.1997, MOD)
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This revised standard adopts ISO 11498.1997 "dental handpieces and low voltage electric motor" (in English).
This standard and ISO 11498.1997 The main differences are as follows.
--- Delete references to IEC 651 normative documents and text referenced. 1979 "Sound Level Meter" and ISO 554. 1976 "standard atmosphere
Conditioning and/or testing - technical requirements ";
--- With GB/T 6682-2008 "analytical laboratory use specifications and test methods" (ISO 3696. 1987, MOD) instead of
ISO 3696. 1987 "Laboratory analysis of water specifications and test methods";
--- With YY/T 0149-2006 "stainless steel medical equipment corrosion test methods" (ISO 13402.1995, MOD) on behalf of the
For ISO 13402.1995 "surgical and dental instruments handheld anti - autoclaving, corrosion and thermal radiation determination";
--- With YY 1045.2-2010 instead of "handpieces - Part 2.. straight and curved handset phone" (1995, MOD ISO 7785-2)
ISO 7785-2.1995 "handpieces - Part 2. Direct phone and handpieces"
--- Since the spray water corresponding to 7.3.3 5.2.1 Test methods and specified in this standard in line with the use of electric motors
YY 1045.2-2010 handpiece cooling water volume is measured in the water pressure was adjusted to 200kPa (2.0bar), thus making the
5.2.1 Spray water "in water pressure 250kPa (2.5bar), the maximum water flow should not be less than 50mL/min" replaced by "
Water pressure is 200kPa (2.0bar), the maximum water flow should not be less than 50mL/min ";
--- According to the provisions of GB 9706.1-2007 and 5.3.8 Continuous leakage currents and patient auxiliary current maximum allowable continuous leakage in Table 2
Patient flow and patient auxiliary current increases the leakage current (dc) requirements.
For ease of use, this standard also made the following editorial changes.
--- According to GB/T 1.1-2009 some formatting has been modified;
--- Delete ISO introduction;
--- For other international standards referenced in this standard, if it has converted to our standards, the replacement of the International Standard for the standard references
The corresponding number of national or industry standards, and this standard in Chapter 2 marked on relationships.
--- According to usage, the unit 5.2.8 torque by the "N · m" to "N · cm".
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, Xianyang Northwest Medical Devices
(Group) Co., Ltd.
The main drafters of this standard. Wu Ming lean, Xu Yu Chun, Zhao Lijun, Wei Ni powder.
Dental handpiece low voltage electric motors
1 Scope
This standard specifies performance requirements and test methods for dental patients with low-voltage electric motor and handpiece connected, the system further comprising
Manufacturer's instructions, packaging and marking. All tests in this standard are type tests.
Dental low voltage electric motors controlled by the dental unit or as a separate mobile device. They dental handpieces and direct phone support
use.
The provisions of this standard are listed in priority to GB 9706.1-2007 standard.
Only the terms of this standard is set out in the applicable.
This standard refers to GB 9706.1-2007. Where there is a reference to the office were marked GB 9706.1-2007 standard in terms of numbers.
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 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. 1982, IDT))
YY/T 0149-2006 stainless steel medical equipment corrosion test methods (ISO 13402.1995, MOD)
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
(IEC 60601-1-2.2001, IDT)
YY/T 0628-2008 dental equipment Graphical symbols (ISO 9687.1993, IDT)
YY 1012-2004 handpiece coupling dimensions (ISO 3964. 1982, IDT)
YY/T 1043-2004 dental unit (ISO 7494.1996, IDT)
YY 1045.2-2010 Dental handpieces - Part 2. Direct phone and handpieces (ISO 7785-2.1995, MOD)
ISO 4211. 1979 assessment of surface impedance utensils cryogenic liquid
3 Terms and Definitions
GB/T 9937.3-2008 and GB 9706.1-2007 defined in the terms and definitions apply to this document.
Category 4
4.1 No-load speed range
Dental low voltage electric motors are classified according to its no-load speed range (see Table 1).
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