YY 0803.1-2010 English PDF (YY0803.1-2010)

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YY 0803.1-2010: Dentistry. Root-canal instruments. Part 1: General requirements and test methods
YY 0803.1-2010
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.20
C 33
YY 0803.1-2010 / ISO 3630-1:2008
Dentistry - Root-canal instruments - Part 1: General
requirements and test methods
(ISO 3630-1:2008, IDT)
ISSUED ON: DECEMBER 27, 2010
IMPLEMENTED ON: JUNE 01, 2012
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 4
Introduction ... 5
1 Scope ... 6
2 Normative references ... 6
3 Terms, definitions and symbols ... 7
3.1 Terms and definitions ... 7
3.2 Symbols ... 9
4 Classification ... 9
5 Requirements ... 9
5.1 General ... 9
5.2 Type 1: standard-sized instruments ... 10
5.3 Type 2: taper-sized instruments ... 11
5.4 Type 3: shape-sized instruments ... 13
5.5 Type 4: non-taper-sized instruments ... 13
5.6 Type 5: non-uniform taper-sized instruments ... 14
5.7 Materials ... 15
5.8 Dimensions ... 16
5.9 Mechanical requirements ... 16
5.10 Chemical requirements ... 17
6 Sampling ... 17
7 Test methods ... 18
7.1 Visual inspection ... 18
7.2 Test conditions ... 18
7.3 Measurement of dimensions ... 18
7.4 Resistance to fracture by twisting and angular deflection ... 19
7.5 Stiffness ... 21
7.6 Handle and shank security ... 22
7.7 Corrosion test ... 23
7.8 Heat effects of sterilization ... 23
8 Designation, marking and identification ... 24
8.1 General ... 24
8.2 Identification symbols ... 24
9 Packaging ... 25
10 Manufacturer’s instructions for use ... 25
11 Labelling ... 25
References ... 27
Foreword
All technical contents of this Part are mandatory.
YY 0803 consists of the following parts, under the general title Dentistry - Root-canal
instruments:
-- Part 1: General requirements and test methods;
-- Part 2: Enlargers;
-- Part 3: Condensers;
-- Part 4: Auxiliary instruments.
This Part is Part 1 of YY 0803.
This Part is identical to ISO 3630-1:2008 Dentistry - Root-canal instruments - Part 1:
General requirements and test methods (English version). The main differences
between this Part and ISO 3630-1:2008 are as follows:
-- Make some editorial modifications in accordance with the requirements of GB/T
1.1;
-- Delete the foreword of the international standard;
-- For other international standards cited in this Part, if they have been converted into
Chinese standards, replace the referenced international standard number with the
corresponding national or industry standard number, and indicate the adoption
relationship in Chapter 2 of this Part.
This Part shall be under the jurisdiction of Subcommittee 1 on Dental Equipment and
Devices of National Technical Committee 99 on Dental Materials and Equipment of
Standardization Administration of China (SAC/TC 99/SC 1).
Drafting organization of this Part: Guangzhou Medical Device Quality Supervision and
Test Institute of the China Food and Drug Administration, Shenzhen Superline
Technology Co., Ltd.
Chief drafting staffs of this Part: Lu Wenjuan, Wu Yiming, Peng Canguang, Wang
Zhong.
Dentistry - Root-canal instruments - Part 1: General
requirements and test methods
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