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Dentistry. Periodontal probes. Part 1: General requirements
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YY/T 1622.1-2018
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Basic data | Standard ID | YY/T 1622.1-2018 (YY/T1622.1-2018) | | Description (Translated English) | Dentistry. Periodontal probes. Part 1: General requirements | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.25 | | Word Count Estimation | 12,167 | | Date of Issue | 2018-11-07 | | Date of Implementation | 2019-11-01 | | Quoted Standard | GB/T 228.1; GB/T 4340.1; GB/T 9937.1; GB/T 9937.2; GB/T 9937.3; GB/T 9937.4; GB/T 9937.5; YY/T 0149-2006; YY/T 0294.1; YY/T 0820-2010 | | Adopted Standard | ISO 21672-1-2012, MOD | | Regulation (derived from) | Announcement No. 87 of 2018 by the State Drug Administration | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies the general requirements and test methods for periodontal probes. This standard applies to periodontal probes made of austenitic stainless steel or martensitic stainless steel. This standard does not apply to periodontal probes made entirely of plastic at the working end, nor to HAUER probes and periodontal probes with settable detection forces. |
YY/T 1622.1-2018: Dentistry. Periodontal probes. Part 1: General requirements---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.
Dentistry.Periodontal probes.Part 1. General requirements
ICS 11.060.25
C33
People's Republic of China Pharmaceutical Industry Standard
Dentistry periodontal probes - Part 1. General requirements
(ISO 21672-1.2012, MOD)
Published on.2018-11-07
2019-11-01 implementation
State Drug Administration issued
Content
Foreword III
1 Scope 1
2 Normative references 1
3 terms, definitions and symbols 1
4 Category 2
5 Requirements 5
6 Test method 7
7 labels and logos 9
Foreword
YY/T 1622 "Dental Periodontal Probe" is divided into two parts.
--- Part 1. General requirements;
--- Part 2. Identification.
This part is part 1 of YY/T 1622.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This section uses the redrafting method to modify the use of ISO 21672-1.2012 "Dental Periodontal Probes Part 1. General Requirements".
The technical differences between this part and ISO 21672-1.2012 are as follows.
--- Modified 5.1 "shape and size";
--- Removed Appendix 15 of ISO 15087-1.1999 in 5.2.4.1;
--- Revised the requirements for tensile load, torque, hardness and stiffness in 5.6 and 5.7;
--- Revised the requirements for corrosion resistance of periodontal probes in 5.7;
--- For other international standards cited in this section, if it has been converted to Chinese standards, this section replaces the referenced international standard number with
Corresponding national standard number, and indicate the adoption relationship in Chapter 2.
This section has also made the following editorial changes compared to the original.
--- Removed the preface to international standards.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is divided into the National Technical Committee for Dental Materials and Equipment Standardization Technical Committee of Dental Equipment and Devices (SAC/
TC99/SC1) is under the jurisdiction.
This section drafted by. Guangdong Medical Device Quality Supervision and Inspection Institute, Shandong Xinhua Medical Devices Co., Ltd., Ningbo Blue Wild Medical
Therapeutic Equipment Co., Ltd.
The main drafters of this section. Xu Honglei, Tian Xiaojun, Wan Yiyi, Cai Chuanwen, Xu Buguang.
Dentistry periodontal probes - Part 1. General requirements
1 Scope
This part of YY/T 1622 specifies the general requirements and test methods for periodontal probes.
This section applies to periodontal probes made of austenitic stainless steel or martensitic stainless steel.
This section does not apply to periodontal probes made entirely of plastic at the working end, nor to HAUER probes and can be set up.
A prosthetic probe for the detection force.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 228.1 tensile testing of metallic materials - Part 1. Test methods for room temperature (GB/T 228.1-2010, ISO 6892-1.
2009, MOD)
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1. Test methods (GB/T 4340.1-2009, ISO 6507-
1.2005, MOD)
GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)]
YY/T 0149-2006 Test Method for Corrosion Resistance of Stainless Steel Medical Devices (ISO 13402.1995, MOD)
YY/T 0294.1 Metal materials for surgical instruments - Part 1. Stainless steel (YY/T 0294.1-2005, ISO 7153-1.1991,
MOD)
YY/T 0820-2010 Information on the treatment of re-sterilizable medical devices provided by the sterilization manufacturer of medical devices (0802-
2010, ISO 17664.2004, IDT)
3 terms, definitions and symbols
3.1 Terms and definitions
The following terms and definitions as defined in GB/T 9937 apply to this document.
3.1.1
Periodontal probe periodontalprobe
Dental handpiece for measuring the depth of the periodontal pocket, diagnosing and evaluating the periodontal pocket environment.
3.1.2
Root fork probe furcationprobe
Periodontal probe for detecting premolars and molar root bifurcations.
3.2 symbol
The following symbols apply to this document.
R1. Rod radius.
R2. Working radius.
B1. edge thickness.
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