YY 0803.1-2010Dentistry - Root canal instruments - Part 1: General requirements and test methods (English PDF)
牙科学 根管器械 第1部分：通用要求和试验方法
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 27, 2010
Implementation date
June 1, 2012
Scope
YY 0803.1-2010 is the English-translated version of 牙科学 根管器械 第1部分：通用要求和试验方法.
YY 0803.1-2010 is the Chinese standard "Dentistry - Root canal instruments - Part 1: General requirements and test methods".
Its scope clause reads: This part of YY 0803 specifies general requirements and test methods for root-canal instruments used for endodontic purposes, e.g. enlargers, shaping and cleaning instruments, condensers, and accessory instruments.
In addition it covers general size designations, colour coding, packaging and identification symbols.
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Document preview — YY 0803.1-2010
National Standard of the People's Republic of China
Issued by: National Medical Products Administration
Contents
- Foreword4
- Introduction5
- 1 Scope6
- 2 Normative references6
- 3 Terms, definitions and symbols7
- 3.1 Terms and definitions7
- 3.2 Symbols9
- 4 Classification9
- 5 Requirements9
- 5.1 General9
- 5.2 Type 1.standard-sized instruments10
- 5.3 Type 2.taper-sized instruments11
- 5.4 Type 3.shape-sized instruments13
- 5.5 Type 4.non-taper-sized instruments13
- 5.6 Type 5.non-uniform taper-sized instruments14
- 5.7 Materials15
- 5.8 Dimensions16
- 5.9 Mechanical requirements16
- 5.10 Chemical requirements17
- 6 Sampling17
- 7 Test methods18
- 7.1 Visual inspection18
- 7.2 Test conditions18
- 7.3 Measurement of dimensions18
- 7.4 Resistance to fracture by twisting and angular deflection19
- 7.5 Stiffness21
- 7.6 Handle and shank security22
- 7.7 Corrosion test23
- 7.8 Heat effects of sterilization23
- 8 Designation, marking and identification24
- 8.1 General24
- 8.2 Identification symbols24
- 9 Packaging25
- 10 Manufacturer's instructions for use25
- 11 Labelling25
- References27
1 Scope
This part of YY 0803 specifies general requirements and test methods for root-canal instruments used for endodontic purposes, e.g. enlargers, shaping and cleaning instruments, condensers, and accessory instruments. In addition it covers general size designations, colour coding, packaging and identification symbols.
2 Normative references
The following documents, referenced by YY 0803, are indispensable for the application of this document. For dated references, all subsequent amendments (not including errata content) or revisions do not apply to this Part. However, parties to agreements that are based on this Part are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest edition applies to this Part.
GB/T 7408, Data elements and interchange formats - Information interchange -
Representation of dates and times (GB/T 7408-2005, ISO 8601.2000, IDT)
GB/T 9937, Dentistry - Vocabulary (all parts) (GB/T 9937-2008, ISO 1942, IDT)
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1.General requirements (YY/T 0466.1-2009, ISO 15223.2007, IDT)
YY 0803.2-2010, Dental root-canal instruments - Part 2.Enlargers (ISO 3630-
2.2000, IDT)
ISO 554, Standard atmospheres for conditioning and/or testing - Specifications
ISO 1797-1.1992, Dental rotary instruments - Shanks - Part 1.Shanks made of metals
ISO 1797-2.1992, Dental rotary instruments - Shanks - Part 2.Shanks made of plastics
ISO 3696.1987, Water for analytical laboratory use - Specification and test methods
ISO 6360-2, Dentistry - Number coding system for rotary instruments - Part 2.
Shapes
YY 1042-2023 | YY/T 0823-2020 | YY/T 0824-2011 | YY/T 0520-2009 | YY/T 0803.1-2022 | […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 31 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 7408-2005Date and time - Representations for information interchange - Part 1: Basic rules
- GB/T 9937-2008Dentistry - Vocabulary
- YY/T 0466.1-2009Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- YY 1042-2023Dentistry - Polymer-based restorative materials
- YY/T 0803.1-2022Dentistry-Endodontic instrument - Part 1: General requirements
YY 0803 · ISO 8601.2000 · ISO 1942 · ISO 15223.2007 · YY 0803.2-2010 · ISO 3630 · ISO 554 · ISO 1797 · ISO 3696.1987 · YY1042-2023
Cited by
- YY/T 0803.4-2026Dentistry - Root-canal instruments - Part 4: Auxiliary instruments
- YY/T 0803.2-2020Dentistry—Endodontic instruments - Part 2: Enlargers
- YY/T 1684-2020Dentistry—Apex locator
- YY 0803.3-2016Dentistry - Root-canal instruments - Part 3: Condensers
- YY/T 0803.3-2016Dentistry-Root-canal instruments --Part 3: Codensers
- YY/T 0803.5-2016Dentistry-Endodontic instruments - Part 5: Shaping and cleaning instruments
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Related Standards
GB/T 7408-2005 — Date and time - Representations for information interchange - Part 1: Basic rules
YY 0803.3-2016 — Dentistry - Root-canal instruments - Part 3: Condensers
YY 1042-2023 — Dentistry - Polymer-based restorative materials
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YY 0803.1-2010
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