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Dentistry - Tissue punches
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YY/T 1972-2025
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Basic data | Standard ID | YY/T 1972-2025 (YY/T1972-2025) | | Description (Translated English) | Dentistry - Tissue punches | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.25 | | Word Count Estimation | 11,124 | | Date of Issue | 2025-06-18 | | Date of Implementation | 2026-07-01 | | Issuing agency(ies) | National Medical Products Administration | | Summary | This standard specifies the performance requirements, marking and labeling information for soft tissue circumferential cutters used with dental handpieces, and describes the corresponding test methods. This document applies to soft tissue circumferential cutters used in oral surgical implantation procedures for making incisions or circumferential cuts to remove gingival tissue. | YY/T 1972-2025: Dentistry - Tissue punches---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.
ICS 11.060.25
CCSC33
Pharmaceutical Industry Standards of the People's Republic of China
Dental soft tissue circumcision knife
(ISO 23445.2021, MOD)
Published on 2025-06-18
Implemented on July 1, 2026
National Medical Products Administration issued
Table of contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 Symbols 1
5 categories 2
6 Requirements 3
6.1 Selection of Metallic Materials 3
6.2 Surface 3
6.3 Dimensions 3
6.4 Tolerance to repeated treatments 3
6.5 Hardness 3
6.6 Radial runout 3
7 Measurement and Test Methods 3
7.1 Visual inspection 3
7.2 Dimensions 3
7.3 Tolerance to Repeated Treatments 4
7.4 Hardness 4
7.5 Radial runout 4
8.Markings, labels, and instructions for use 4
8.1 Instrument Marking 4
8.2 Packaging Labels 4
8.3 Instruction Manual 5
Foreword
This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents".
Drafting.
This document is modified to adopt ISO 23445.2021 "Dental Science - Soft Tissue Circumcision Knife".
The technical differences between this document and ISO 23445.2021, and the reasons therefor, are as follows.
---Added a description of the scope of application (see Chapter 1);
---ISO 1942 has been replaced with the normatively referenced GB/T 9937 (see Chapter 3) to adapt to my country's technical conditions and increase operability.
Actual nature;
---ISO 1797 (see Chapter 3, 6.3.4) has been replaced with the normatively referenced YY/T 0967 to adapt to my country's technical conditions, and has been improved.
Increase operability;
---ISO 16443 (see Chapter 3) has been replaced with the normatively referenced YY/T 1619 to adapt to my country's technical conditions and add [further details needed].
Operability;
---A symbol for the diameter of the central guide post has been added (see Chapter 4);
---ISO 21850-1 (see 6.1) has been replaced with the normatively referenced YY/T 1952.1 to adapt to my country's technical conditions and add [further details needed].
Operability;
---The clause "The manufacturer should confirm whether the accuracy of the measuring device is suitable" (see 7.2) has been removed to better suit actual testing conditions and improve operability.
Actual nature;
---ISO 17664 (see 7.3) has been replaced with the normatively referenced YY/T 0802 to adapt to my country's technical conditions and increase operability.
Actual nature;
---ISO 6508-1 (see 7.4) has been replaced with the normatively referenced GB/T 230.1 to adapt to my country's technical conditions and increase operability.
Actual nature;
---ISO 6507-1 (see 7.4) has been replaced with the normatively referenced GB/T 4340.1 to adapt to my country's technical conditions and increase operability.
Actual nature;
---ISO 13504 (see 8.1, 8.2, 8.3) has been replaced with the normatively referenced YY/T 1486 to adapt to my country's technical conditions, and has been improved.
Increase operability;
---The AB distance in Figure 3 has been corrected according to the description in 7.5 (see Figure 3).
The following editorial changes have been made to this document.
---The URLs referenced in the ISO and IEC terminology databases have been removed;
---Added illustrations of Figure 2D4 and the central guide post in the left view;
---Added a note to the illustration of Figure 3 in 7.5 (see 7.5) to clarify the function of Figure 3;
---Figure 3 has been changed from "AB" to "AB"; point B has been moved forward to ensure its fixed position is secure; point B has been added according to YY/T 0874.
The diagram shows a distance of 3mm from the end of the rod.
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed by the National Medical Products Administration.
This document was prepared by the National Technical Committee on Standardization of Dental Materials and Instruments, Subcommittee on Dental Equipment and Instruments (SAC/TC99)
SC1) is under the jurisdiction of the relevant authorities.
This document was drafted by. Zhejiang Xinya Medical Technology Co., Ltd., Guangdong Provincial Institute of Medical Device Quality Supervision and Inspection, and Weihai Weigao Cleaning Equipment Co., Ltd.
Likang Biomaterials Co., Ltd., and West China Hospital of Stomatology, Sichuan University.
The main drafters of this document are. Chen Xianming, Qi Ruijuan, Lu Hansheng, Zhou Liangbin, Li Xinchang, Man Yi, Su Zimei, Xiang Lixuan, and Ma Xiaxia.
Introduction
A soft tissue circumcision blade is a dental implant instrument used in conjunction with a curved handpiece for the implantation of dental implants in oral surgery.
During the process, holes are made or circumferential cuts are made in the gingival tissue and removed, etc.
This document provides guidance on quality control for this type of product.
Dental soft tissue circumcision knife
1 Scope
This document specifies the performance requirements, marking and labeling information for soft tissue circumferential excision tools used with dental handpieces, and describes the corresponding test...
Verification method.
This document applies to soft tissue circumcision knives used in oral surgical implantation procedures to make holes or circumcise and remove gingival tissue.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB/T 230.1 Metallic materials—Rockwell hardness test—Part 1.Test methods (GB/T 230.1-2018, ISO 6508-1.
2016, 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 Terminology in Dentistry (GB/T 9937-2020, ISO 1942.2009, MOD)
YY/T 0802 Handling of Medical Devices - Information provided by medical device manufacturers (YY/T 0802-2020, ISO 17664.
2017, MOD)
YY/T 0874-2013 Test methods for dental rotating instruments (ISO 8325.2004, IDT)
YY/T 0967 Rods for dental rotary and reciprocating instruments (YY/T 0967-2022, ISO 1797-2017, MOD)
YY/T 1486 General Requirements for Instruments and Related Auxiliary Instruments for Dental Implants (YY/T 1486-2016)
ISO 13504.2012, IDT
YY/T 1619 Terminology for Dental Implant Systems and Related Processes (YY/T 1619-2018, ISO 16443.2014, IDT)
YY/T 1952.1 Dental Science - Materials for Dental Instruments - Part 1.Stainless Steel (YY/T 1952.1-2024, ISO 21850-1.
2020, MOD)
3 Terms and Definitions
The terms and definitions defined in GB/T 9937, YY/T 0967, and YY/T 1619, as well as the following terms and definitions, apply to this document.
3.1
Soft tissue circumcision knife tissuepunches
An instrument used to remove a circular piece of soft tissue.
[Source. YY/T 1619-2018, 3.3.8]
4 symbols
The following symbols apply to this document.
D1.Outer diameter of the working part.
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YY/T 1972-2025: Dentistry - Tissue punches
Status: Valid
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