YY 0836-2011Dental handpieces—Dental low-voltage electrical motor (English PDF)
牙科手机 牙科低压电动马达
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY 0836-2011 is the English-translated version of 牙科手机 牙科低压电动马达.
YY 0836-2011 is the Chinese pharmaceutical industry standard for the dental low-voltage electrical motor, the motor to which a dental handpiece is connected, whether controlled by the dental unit or supplied as a separate mobile device.
It specifies the performance requirements and the test methods for the motor and the system it forms with the handpiece, together with the requirements for the manufacturer's instructions, the packaging and the marking, covering the speed and the torque and their control, the heat and noise produced and the coupling to the handpiece.
All the tests it describes are type tests, and its provisions take precedence over GB 9706.1-2007. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY 0836-2011
National Standard of the People's Republic of China
- ICS
- 11.060.20
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
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
--- 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".
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).
5.2.1 Spray water flow
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 ";
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 6682-2008Water for analytical laboratory use - Specification and test methods
- GB 9706.1-2007Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- YY/T 0149-2006Medical instruments of stainless steel - Test methods of corrosion resistance
- YY 0505-2005Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- YY/T 0628-2008Dentistry—Graphical symbols for dental equipment
- YY 1012-2004Dental handpieces - Coupling dimensions
GB/T 9937.3-2008 · ISO 4211
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Related Standards
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
YY 0505-2005 — Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
YY 1012-2004 — Dental handpieces - Coupling dimensions
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