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YY 0837-2011: Dental handpieces. Dental air-motors
Status: Obsolete
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0837-2011 | English | 519 |
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Dental handpieces. Dental air-motors
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YY 0837-2011
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Basic data | Standard ID | YY 0837-2011 (YY0837-2011) | | Description (Translated English) | Dental handpieces. Dental air-motors | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.20 | | Word Count Estimation | 13,138 | | 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/T 0514-2009; YY/T 0628-2008; YY 1012-2004; YY/T 1043-2004; YY 1045.2-2010; ISO 4211-1979 | | Adopted Standard | ISO 13294-1997, 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 machine control by the dental treatment with dental straight angle handpiece connected mobile phones and for the patient's dental air motor performance requirements and test methods. This standard also regulates the manufacturer's instructions, marking and packaging. This standard refers to GB 9706. 1-2007 (basic medical electrical equipment safety standards). Where references are to the marked GB 9706. 1-2007 standard in terms of numbers. The terms stipulated in this standard take precedence over GB 9706. 1-2007 standard. Only in this standard is set out in the applicable provisions. | YY 0837-2011: Dental handpieces. Dental air-motors---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 air-motors
ICS 11.060.20
C33
People's Republic of China pharmaceutical industry standards
Dental Handpiece Air Motor
(ISO 13294.1997, 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 13294.1997 "Dental Handpiece Air Motor" (in English).
This standard and ISO 13294.1997 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 "of the two criteria;
--- 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 "Handpiece Part 2. Straight and curved handset phone";
--- 4.3 will be "2.2.2" to "5.5";
--- 5.2.1 will be "at a water pressure of 250kPa (2.5bar) when" read "the water pressure is 200kPa (2.0bar) when";
--- 5.2.2 will be "in the pressure of 250kPa (2.5bar) when" replaced by "pressure 200kPa (2.0bar) is";
--- Remove the ISO 13294.1997 Annex A (informative). ISO 3964 This informative appendix lists. 1982 standard
Referenced in 5.2.4, it should be included in this standard Chapter 2, "Normative references" on.
For ease of use, this standard also made the following editorial changes.
--- "This International Standard" be replaced by "this standard";
--- Delete ISO 13294.1997 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
Corresponding national or industry standard number, and indicate the degree of consistency in Chapter 2 of this standard.
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, Xianyang Northwest Medical Devices
(Group) Co., Ltd.
The main drafters of this standard. Fan Xiang, Zhao Lijun, Li Danrong, Wei Ni powder, Cenqiu Hui.
Dental Handpiece Air Motor
1 Scope
This standard specifies the control of dental treatment, dental straight and curved phone handset connected to a patient of dental air motor
Test methods and performance requirements.
This standard also regulates the manufacturer's instructions, signs and packaging.
This standard refers to GB 9706.1-2007 (basic safety standards for medical electrical equipment). Where there is a reference to the office were marked
GB 9706.1-2007 standard in terms of numbers.
Specified in this standard take precedence over the terms of GB 9706.1-2007 standard.
Only the terms of this standard is set out in the applicable.
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/T 0514-2009 handpiece hose connector (ISO 9168.1991, 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 appliance cryogenic liquid
3 Terms and Definitions
GB/T 9937.3-2008 and GB 9706.1-2007 terms and definitions defined in Chapter 2 apply to this document.
Category 4
4.1 No-load speed range
Dental air motors are classified according to its no-load speed range (Table 1), or with air motor can be unworthy of the dental 5.2.7
Phone.
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