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YY/T 1014-2021 English PDF

US$189.00 · In stock
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YY/T 1014-2021: Dentistry - Dental explorer
Status: Valid

YY/T 1014: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1014-2021189 Add to Cart 3 days Dentistry - Dental explorer Valid
YY/T 1014-2013639 Add to Cart 3 days Dental explorers Obsolete

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YY 1042   YY/T 0823   YY/T 0824   YY/T 1021.3   YY/T 1021.2   

Basic data

Standard ID: YY/T 1014-2021 (YY/T1014-2021)
Description (Translated English): Dentistry - Dental explorer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Word Count Estimation: 10,125
Issuing agency(ies): State Drug Administration

YY/T 1014-2021: Dentistry - Dental explorer

---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 - Dental explorer ICS 11.060.20 C33 People's Republic of China Pharmaceutical Industry Standards Replace YY/T 1014-2013 Dental Probe (ISO 7492.2019, MOD) Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 1014-2013 "Dental Probe". Compared with YY/T 1014-2013, the main technical changes of this standard as follows. ---Modified the content of the scope (see Chapter 1, Chapter 1 of the.2013 edition); ---Added normative reference documents GB/T 230.1, YY/T 0802 (see Chapter 2); ---Deleted the normative reference document YY/T 0149-2006 (see Chapter 2 of the.2013 edition); ---Modified the normative reference document GB/T 9937.3-2008 to GB/T 9937 (see Chapter 2, Chapter 2 of the.2013 edition); ---Added the content of terms and definitions (see Chapter 3); ---Modified the outline picture of the dental probe (see Figure 1~Figure 9, Figure 1 of the.2013 edition); ---Added the size diagram and shape picture of the dental probe (see Figure 1~Figure 9); --- Modify the material requirements (see Chapter 4, Chapter 4 of the.2013 edition); ---Modified the description of the measurement position of the dental probe size (see Table 1, Table 1 of the.2013 edition); ---Recommended the total length of dental probes (see 5.2, Chapter 6 of the.2013 edition); ---Modified the size of the dental probe (see Table 2, Table 2 of the.2013 edition); ---Modified the requirements for the hardness of the working tip (see 5.3, 5.2 in the.2013 edition); --- Deleted corrosion resistance and heat resistance (see 5.3, 5.4 and 7.2 of the.2013 edition); --- Modify the surface requirements (see 5.5, 5.1 in the.2013 edition); --- Increased repeated treatment tolerance (see 5.6 and 6.5); ---Modified the connection performance of the working end and the handle (see 6.4, 7.3 of the.2013 edition); ---Modified the labeling and marking (see Chapter 7, 5.6 of the.2013 edition); --- Deleted all appendices (see Appendix A, Appendix B, Appendix C, Appendix D and Appendix E in the.2013 edition). This standard uses the redrafting method to amend and adopt ISO 7492.2019 "Dental Probes". The technical differences between this standard and ISO 7492.2019 and the reasons are as follows. ---Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and facilitate this standard The implementation of the standards and adjustments are collectively reflected in Chapter 2 "Normative Reference Documents". The specific adjustments are as follows. ● Replace ISO 1942 (see 3.1) with GB/T 9937 modified to adopt international standards; ● Replace ISO 7153-1 (see 4.1) with YY/T 0294.1 which is modified to adopt international standards; ● Replace ISO 6508-1 (see 6.3) with GB/T 230.1 modified to adopt international standards; ● Replace ISO 6507-1 (see 6.3) with GB/T 4340.1 modified to adopt international standards; ● Replace ISO 17664 (see 6.5) with YY/T 0802 modified to adopt international standards; --- Delete 4.2 "should meet the relevant requirements of 4.5, 4.6 and 4.7", 4.5, 4.6 and 4.7 are routine inspections, no need to reiterate in 4.2 Re-statement; --- Deleted the "UDI code (Unique Medical Device Identification) in 7.1 and 7.2, if required by relevant laws and regulations", the UDI code must comply with the national The relevant laws and regulations in the country do not need to be listed in the standard clauses; --- Deleted "UDI codes are not allowed for devices with a diameter less than 8mm" in 7.2, UDI codes must comply with relevant domestic laws Regulatory requirements, do not need to be listed in the standard clauses; ---Modified the "measurement position of the dental probe as shown in Figure 1" in 5.1 to "the measurement position of the dental probe as shown in Figure 1~Figure 9", and Figure 1 is the dental probe Figure 2~Figure 9 contains the measurement positions of various types of dental probe sizes. This standard has made the following editorial changes. --- Deleted row 7 of Table 2, ISO editorial error; ---Modified 4.1 as Chapter 4, 4.1 materials belong to the category of raw materials, and are listed separately as a chapter, and the numbers of other chapters are extended. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is organized by the National Dental Materials and Equipment Standardization Technical Committee Dental Equipment and Equipment Sub-Technical Committee (SAC/TC99/SC1) Centralized. Drafting organizations of this standard. Guangdong Medical Device Quality Supervision and Inspection Institute, Ningbo Lanye Medical Devices Co., Ltd., Zhejiang Xinya Medical Division Technology Co., Ltd. The main drafters of this standard. Li Jiyan, Huang Minju, Zhang Yang, Zhou Liangbin, Huang Yuzhe, Zhang Min, Chen Xianming. The previous versions of the standard replaced by this standard are as follows. ---GB 5666-1985, YY 91014-1999, YY/T 1014-2013. Dental Probe

1 Scope

This standard specifies the size, performance requirements, labeling and identification of dental probes. This standard applies to dental probes. This standard does not apply to root canal probes.

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 230.1 Rockwell hardness test of metallic materials Part 1.Test method (GB/T 230.1-2018, ISO 6508-1. 2016, MOD) GB/T 4340.1 Vickers hardness test of metallic materials Part 1.Test method (GB/T 4340.1-2009, ISO 6507- 1.2005, MOD) GB/T 9937 Dental Terminology (GB/T 9937-2020, ISO 1942.2009, MOD) YY/T 0294.1 Metallic materials for surgical instruments Part 1.Stainless steel (YY/T 0294.1-2016, ISO 7153-1.1991, MOD) YY/T 0802 Handling of medical devices Information provided by medical device manufacturers (YY/T 0802-2020, ISO 17664. 2017, MOD) 3 Terms, definitions and symbols 3.1 Terms and definitions The following terms and definitions defined in GB/T 9937 apply to this document. 3.1.1 Dental probe dentalexplorer The tip is designed as a handheld dental instrument for tactile inspection of the tooth surface. Note 1.As shown in Figure 1. Note 2.Dental probes are used for the inspection of tooth decay, calculus, and root bifurcation lesions.
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