YY/T 1755-2021Dentistry—Powder jet handpieces and powders (English PDF)
牙科学 喷砂手机和喷砂粉
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1755-2021 is the English-translated version of 牙科学 喷砂手机和喷砂粉.
YY/T 1755-2021 is the Chinese standard "Dentistry—Powder jet handpieces and powders". Its scope clause reads: This standard specifies the general requirements, test methods, manufacturer's information, signs and packaging for sandblasting mobile phones.
This independently designed sandblasting hand The machine is shown in Figure 1. This standard applies to sandblasting handpieces and sandblasting powders in the dental field.
They can be used to remove patients' tartar, stains and dental plaque. Used for cleaning When cleaning and polishing teeth, abrasion is a side effect.
This standard is also applicable to sandblasting handpieces and sandblasting powders that use air-driven abrasion in the dental field, such as the preparation of minimally invasive cavities, adhesion The surface treatment and the removal of the cement before the mixture is used.
In this case, abrasion is part of the expected result. This standard does not apply to dental units that provide power for sandblasting handpieces. This standard does not apply to dental polishing handpieces (contra-angle handpieces), or electric plaque cleaners (scaler) or multi-function handpieces (spray guns).
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Document preview — YY/T 1755-2021
National Standard of the People's Republic of China
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Mobile phone classification
- 5 Requirements
- 6 Sampling
- 7 Measurement and test methods
- 8 Instructions for use, maintenance and service
- 9 Technical Specification
- 10 Signs and labels
- 11 Packaging
1 Scope
This standard specifies the general requirements, test methods, manufacturer's information, signs and packaging for sandblasting mobile phones. This independently designed sandblasting hand
The machine is shown in Figure 1.
This standard applies to sandblasting handpieces and sandblasting powders in the dental field. They can be used to remove patients' tartar, stains and dental plaque. Used for cleaning
When cleaning and polishing teeth, abrasion is a side effect.
This standard is also applicable to sandblasting handpieces and sandblasting powders that use air-driven abrasion in the dental field, such as the preparation of minimally invasive cavities, adhesion
The surface treatment and the removal of the cement before the mixture is used. In this case, abrasion is part of the expected result.
This standard does not apply to dental units that provide power for sandblasting handpieces.
This standard does not apply to dental polishing handpieces (contra-angle handpieces), or electric plaque cleaners (scaler) or multi-function handpieces (spray guns).
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 3785.1 Electroacoustic Sound Level Meter Part 1.Specifications (GB/T 3785.1-2010, IEC 61672-1.2002, IDT)
GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1.
2012, MOD)
GB 9706.260-2020 Medical electrical equipment Part 2-60.Specific requirements for basic safety and basic performance of dental equipment (IEC 80601-2-60.2012,MOD)
GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD)
GB/T 16483 Chemical safety technical specification content and item sequence
GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction
Version, IDT)
YY/T 0466.1 Medical devices are used for medical device labeling, marking and providing information symbols. Part 1.General requirements (YY/T 0466.1-2016,ISO 15223-1.2012,IDT)
YY/T 0514 Dental hose connector for pneumatic dental handpiece (YY/T 0514-2018, ISO 9168.2009, MOD)
YY/T 0628 Graphical symbols for dentistry dental equipment (YY/T 0628-2020, ISO 9687.2015 A1.2018, IDT)
YY/T 0802 Handling of medical devices Information provided by medical device manufacturers (YY/T 0802-2020, ISO 17664.
2017, MOD)
YY/T 1043.1 Dental treatment machine Part 1.General requirements and test methods (YY/T 1043.1-2016,
ISO 7494-1.2011, MOD)
YY/T 1474 Application of medical device usability engineering to medical devices (YY/T 1474-2016, IEC 62366.2007,
IDT)
YY/T 1501 Graphical symbols for dental instruments (YY/T 1501-2016, ISO 21531.2009, IDT) […]
......
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/T 3785.1Electroacoustics - Sound level meters - Part 1: Specifications
- GB 9706.1-2020Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- GB 9706.260-2020Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
- GB/T 9937Dentistry - Vocabulary
- GB/T 16483Safety data sheet for chemical products content and order of sections
- GB/T 16886.1Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 7494-1:2011
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB 9706.260-2020 — Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
GB/T 16483-2008 — Safety data sheet for chemical products content and order of sections
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