YY/T 1044-2018Transportable Dental Units (English PDF)
可移动式牙科治疗机
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 1044-2018 is the English-translated version of 可移动式牙科治疗机.
YY/T 1044-2018 is the Chinese pharmaceutical industry standard for the transportable dental unit, the portable treatment unit taken to the patient.
It gives the classification, the requirements, the test methods, the instructions for use and the packaging, covering the air and water supplies and their pressures, the handpiece connections, the suction, the operating light where fitted, the stability and the mechanical strength of the assembly, the noise and the electrical safety. Issued on 20 December 2018, it has applied since 1 January 2020.
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Document preview — YY/T 1044-2018
National Standard of the People's Republic of China
- ICS
- 11.060.20
- Classification
- C 33
- Replacing
- YY 91044-1999
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Classification and composition
- 5 Requirements
- 6 Test method
- 7 User Manual
- 8 Packing
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 91044-1999 "High Speed Turbine Drilling Rig".
Compared with YY 91044-1999 "High Speed Turbine Drilling Rig", the main technical changes are as follows.
--- The standard name was changed to "Removable Dental Therapy Machine";
--- Added terms and definitions (see 3);
--- Increased requirements for water storage and water supply devices (see 5.3);
--- Increased the requirements for suction and three-purpose spray guns (see 5.4, 5.6);
--- Added requirements in accordance with YY/T 1043.1-2016 and YY/T 1043.2-2018 (see 5.8);
--- Revised the technical requirements for noise (see 5.7, 4.10 of the 1999 edition);
--- Removed the requirements for plating parts, paint parts, etc. and Chapter 6 inspection rules (see 4.12, 4.13, 6 of 1999 edition).
1 Scope
This standard specifies the classification, requirements, test methods, instructions for use and packaging of mobile dental treatment machines.
This standard applies to mobile dental treatment machines.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 9706.1 Medical electrical equipment - Part 1. General requirements for safety (GB 9706.1-2007, IEC 60601-1:1988, IDT)
GB/T 9937 oral vocabulary (all parts) [ISO 1942 (all parts)]
YY/T 1043.1-2016 Dental surgery machines - Part 1. General requirements and test methods (ISO 7494-1:2011, MOD)
YY/T 1043.2-2018 Dental surgery machines - Part 2. Gas, water, suction and waste water systems (ISO 7494-2. 2015, IDT)
YY 1057 medical foot switch general technical conditions
3 Terms and definitions
The following terms and definitions as defined in GB 9706.1 and GB/T 9937 apply to this document.
3.1 Portable dental treatment machine
A portable dental device consists of at least a box, an air compressor, a foot switch, a water storage device, and a waste water collection device.
4 Classification and composition
4.1 Classification
Mobile dental treatment machines are generally classified into mobile and portable.
4.2 Composition
Portable dental treatment machine with dental high-speed gas turbine mobile phone, suction device, three-purpose spray gun, dental air motor or electric motor, straight mobile phone / Bend mobile phones, light curing machines, etc.
5 Requirements
5.1 Air compressor
5.1.1 Gas flow
When the air pressure is 0.4 MPa, the compressor gas flow rate should not be lower than 32 L/min.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 19 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.1Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB/T 9937Dentistry - Vocabulary
- YY/T 1043.1-2016Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
- YY/T 1043.2-2018Dentistry. Dental units - Part 2: Air, water, suction and wastewater systems
- YY 1057General specifications for medical foot switches
Similar standards
Editions of YY/T 1044
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 1044-2018 | Transportable Dental Units | current edition | Current |
| YY 91044-1999 | Transportable Dental Units | previous edition | Superseded |
This page sells the current edition, YY/T 1044-2018. Earlier editions are listed for reference only.
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB/T 9937.2-2008 — Dental vocabulary -- Part 2: Dental materials
GB/T 9937-2020 — Dentistry - Vocabulary
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