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YY/T 1637-2018: Dentistry - Magnetic attachments
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| YY/T 1637-2018 | English | 279 |
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Dentistry - Magnetic attachments
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YY/T 1637-2018
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PDF similar to YY/T 1637-2018
Standard similar to YY/T 1637-2018 YY/T 1691 YY/T 1692 YY/T 1702 YY/T 1284 Basic data | Standard ID | YY/T 1637-2018 (YY/T1637-2018) | | Description (Translated English) | Dentistry - Magnetic attachments | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 14,132 | | Date of Issue | 2018-12-20 | | Date of Implementation | 2019-06-01 | | Regulation (derived from) | State Drug Administration Announcement No. 97 of 2018 | | Issuing agency(ies) | State Drug Administration | YY/T 1637-2018: Dentistry - Magnetic attachments---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 magnetic attachment)
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
Dentistry magnetic attachment
(ISO 13017.2012, MOD)
Published on.2018-12-20
2019-06-01 implementation
State Drug Administration issued
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the redrafting method to modify the use of ISO 13017.2012 "Dentistry-Magneticattachments" (dental science magnetic
Sexual attachments) and ISO 13017.2012/Amd.1.2015 "Dentistry-Magneticattachments" (dental magnetic attachment)
body).
This standard is compared with ISO 13017.2012 and ISO 13017.2012/Amd.1.2015, except for editorial changes.
as follows.
---1 Scope, "This standard specifies the requirements and test methods for dental magnetic attachments, dental magnetic attachments for crowns and bridges,
Repair of partial dentures, overdentures, implant superstructures and orthodontic and maxillofacial prostheses (including occluders)
Position, support and stability. "" to "This standard specifies the requirements and test methods for dental magnetic attachments, dental magnetic attachments
For the restoration of removable partial dentures, overdentures, implant superstructures and maxillofacial prostheses (including occluders)
Position, support and stability. "The reason is that magnetic attachments have never been used in the field of "crown and bridge" and "orthodontics" in fixed restorations.
Used.
---4.1.1, the main components of the magnetic core should meet the main component requirements of the GB/T 17951 magnet classification.
A magnetic material classified as the main component of GB/T 17951 is used as a magnetic core. "The reason is not to limit the composition of the magnet, so as not to hinder
Product innovation.
---4.1.3, "The main elements of the magnetic core should comply with the provisions of GB/T 17951 [see 7a)]." "The manufacturer should declare the main magnetic core.
The elements are in accordance with GB/T 17951 [see 7a)]. "and add notes," Note. The main elements of the magnetic core are in accordance with GB/T 17951,
The elements refer to GB/T 17951 instead of content. "The reason is not to limit the composition of the magnet, so as not to hinder the innovation of the product.
---4.6.2, the breakdown voltage of the magnet or combined magnet and armature should be equal to or higher than the stainless steel processing material specified in ISO 58321
Breakdown voltage. "Change to "The breakdown voltage of the magnet or combination magnet and armature should not be lower than the claimed value of the manufacturer's instructions." "because
The breakdown voltage value of any material is not specified for ISO 58321.
--- Regarding the normative reference documents, replace the international standards with the Chinese standards modified or equivalent, and the specific adjustments are as follows.
● Replaced ISO 5832-1 with GB 4234 modified to adopt international standards;
● Replace ISO 1942 (all parts) with GB/T 9937 (all parts). The degree of consistency between the two standards is as follows.
GB/T 9937.1-2008 Oral vocabulary Part 1. Basic and clinical terms (ISO 1942-1.1989,
IDT);
◆ GB/T 9937.2-2008 Oral vocabulary Part 2. Oral materials (ISO 1942-2.1989, IDT);
◆ GB/T 9937.3-2008 Oral vocabulary Part 3. Oral devices (ISO 1942-3.1989, IDT);
GB/T 9937.4-2005 Dental terminology - Part 4. Dental equipment (ISO 1942-4.1989, IDT);
GB/T 9937.5-2008 Oral vocabulary Part 5. Terminology related to testing (ISO 1942-5-1989,
IDT).
● Replaced ISO 22674 with GB 17168, which is equivalent to the international standard;
● Replace IEC 60404-8-1 with GB/T 17951 modified to adopt international standards;
● Replace ISO /IEC 17025 with GB/T 27025 equivalent to the international standard;
● Replace ISO 14971 with YY/T 0316, which is equivalent to the international standard;
● Replace ISO 15223-1 with YY/T 0466.1 equivalent to the international standard;
● Replace ISO 10271 with YY/T 0528, which is equivalent to the international standard;
● Replace ISO 14233 with YY/T 0911, which is equivalent to the international standard;
● Replaced ISO 3585 with HG/T 3115, which is equivalent to the international standard.
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 standard was proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Devices (SAC/TC99).
This standard was drafted. Peking University School of Stomatology Dental Medical Device Testing Center, Rijin Dental Materials (Kunshan) Co., Ltd.
The main drafters of this standard. Bai Wei, Zhou Yongsheng, Zheng Gang, Shen Xizhen, Xu Zhengguo.
Dentistry magnetic attachment
1 Scope
This standard specifies the requirements and test methods for dental magnetic attachments. The removable magnetic attachments are used for removable partial dentures, overdentures,
Prostheses such as implant superstructures and maxillofacial prostheses (including occluders) provide retention, support, and stability.
This standard does not contain qualitative and quantitative requirements for possible biological hazards, but is recommended for evaluation of possible biological hazards.
GB/T 16886.1 and YY/T 0268.
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 4234 Stainless steel for surgical implants (GB 4234.2003, ISO 5832-1.1997, MOD)
GB/T 9937 (all parts) Oral vocabulary [ISO 1942 (all parts)]
GB 17168 Metal materials for dental restoration and activity restoration (GB 17168.2013, ISO 22674.2006, IDT)
GB/T 17951 General technical conditions for hard magnetic materials (GB/T 17951.2005, IEC 60404-8-1.2001, MOD)
GB/T 27025 General requirements for testing and calibration laboratory capabilities (GB/T 27025-2008, ISO /IEC 17025.2005,
IDT)
Performance of HG/T 3115 borosilicate glass 3.3 (HG/T 3115-1998, ISO 3585.1991, IDT)
YY/T 0316 Medical Device Risk Management for Medical Devices (YY/T 0316-2016, ISO 14971.2007 is more genuine)
YY/T 0466.1 Medical devices for the labeling, marking and information of medical devices - Part 1. General requirements
(YY/T 0466.1-2016, ISO 15223-1.2012, IDT)
YY/T 0528 Corrosion test method for dental metal materials (YY/T 0528-2018, ISO 10271.2011, IDT)
YY/T 0911-2014 Dentistry polymer based materials (ISO 14233.2003, IDT)
3 Terms and definitions
The following terms and definitions as defined in GB/T 9937 apply to this document.
3.1
Magnetic attachment
A device that uses magnetic force to provide a restoration of the restoration.
3.1.1
Open magnetic circuit attachment openmagneticcircuitattachment
A magnetic attachment that utilizes an open magnetic circuit between two pairs of components.
Note. In order to avoid corrosion of the magnet, the magnet will be wrapped in a casing made of corrosion-resistant metal or alloy such as pure titanium, titanium alloy or stainless steel, and
A two-component that is retracted by the attraction between two magnets or between a magnet and a ferromagnetic alloy armature. see picture 1.
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