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YY/T 1486-2016: Dentistry--General requirements for instruments and related accessories used in dental implant placement and treatment
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| YY/T 1486-2016 | English | 344 |
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Dentistry--General requirements for instruments and related accessories used in dental implant placement and treatment
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YY/T 1486-2016
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Basic data | Standard ID | YY/T 1486-2016 (YY/T1486-2016) | | Description (Translated English) | Dentistry--General requirements for instruments and related accessories used in dental implant placement and treatment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Word Count Estimation | 18,166 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1486-2016: Dentistry--General requirements for instruments and related accessories used in dental implant placement and treatment
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ICS 11.060.25
C33
Pharmaceutical Industry Standard of the People's Republic of China
Dentistry Dental Implant Instruments and Related Auxiliaries
General requirements for devices
1 Scope
This standard specifies the general requirements for the manufacture of instruments and related auxiliary instruments for the placement of dental implants and further therapeutic operations in the maxillofacial area.
This standard applies to single-use or reusable devices, whether they are manual or driven by a power system.
This standard does not apply to the drive system itself, nor does it apply to dental implants or components connected to implants.
In terms of safety, this standard specifies its classification, expected performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and manufacturer's recommendations.
Request for information.
3 Terms and Definitions
The terms and definitions defined in ISO 1942 and the following apply to this document.
3.1
short-term use of transientusage
In any clinical operation, the continuous use time of each component does not exceed 60min.
3.2 Devices
3.2.1
Invasive surgical instruments surgicalyinvasivedevice
In surgery, an instrument that penetrates the human body through the body surface.
3.2.2
Dental implant instrumentation instrumentusedindentalimplantplacementandtreatment
Invasive surgical instrument for short-term use in the preparation of bone tissue and maxillofacial tissue in the maxillofacial area for dental implant placement and subsequent related treatments.
3.2.3
Dental implant with auxiliary equipment accessoryusedindentalimplantplacementandtreatment
Non-invasive surgical instruments that are used for short-term direct or indirect contact with the human body for dental implant placement and subsequent related treatments.
3.3 stainless steel
3.3.1
stainless steel
Steel, the main alloying element is Cr, the Cr content is not less than 10.5% (mass fraction), the C content is not more than 1.2% (mass fraction), and its
The most important characteristic is corrosion resistance.
3.3.2
Austenitic stainless steel austeniticstainlesssteel
Corrosion-resistant steel, the C content is not more than 0.2% (mass fraction), the Cr content is not less than 16% (mass fraction), the typical composition is 18%
(mass fraction) of Cr and more than 8% (mass fraction) of Ni cannot be hardened by heat treatment.
3.3.3
Martensitic stainless steel martensiticstainlesssteel
Low and medium carbon corrosion-resistant steel, C content not less than 0.1% (mass fraction), Cr content 12%~19% (mass fraction), can be hardened by quenching and tempering process.
3.3.4
Precipitation hardening stainless steel precipitation-hardening stainless steel
Precipitates (very fine intermetallic compounds, carbides, or Laves phases) can be precipitated by aging treatment at lower temperatures, while
The resulting high-strength corrosion-resistant steel.
4 categories
4.1 Intended use
This standard classifies devices for dental implants according to the intended use specified by the manufacturer as follows.
--- Type 1.power-driven equipment;
--- Type 2.manual instruments.
4.2 Organizational contacts
This standard classifies dental implant devices as follows according to the main organizations expected to be in contact with in the working environment.
---1 category. hard tissue;
---2 categories. soft tissue;
--- Category 3.Unorganized contact.
4.3 Reuse
According to the expected number of uses, this standard classifies dental implant devices as follows.
--- Group 1.Multiple use;
---Group 2.Single use.
5 Expected performance
The expected performance of devices for dental implants is described and documented as follows.
a) functional characteristics;
b) Comply with the intended conditions of use specified in Chapter 4.
Note. The following points must also be considered.
--- Published standards;
--- Published clinical and scientific literature;
--- Verified test results.
The extent to which the intended performance of the device can be achieved shall be determined (see Clause 8).
6 Performance attributes
When designing the performance characteristics of devices for dental implants, the following items should be considered in order to meet the manufacturer's expected performance.
a) physical, mechanical and metallurgical properties of the device material (see Clauses 7 and 8);
b) the degree of microbial and particulate contamination (see Chapters 8, 10 and 11);
c) ease of use, cleanability and maintainability (see Clauses 8 and 10);
d) possible deterioration of material properties due to sterilization and storage (see Chapters 7, 8 and 9);
e) effects of contact between the device and the human body, implants and other devices (see Clause 8);
f) the shape and size of the device, including possible effects on the human body (see Clause 8);
g) wear characteristics of the material, the effects of wear and wear products on the device or the human body (see Chapters 7 and 8);
h) insertion, removal and interconnection of components (see Clause 8);
i) the extent to which liquids escape and/or substances diffuse into and out of the device (see Clauses 7 and 8).
Dimensional tolerances for instruments used in dental implants shall be specified. In the absence of specific tolerances, general design tolerances shall be in accordance with ISO 2768-1.
7 Material selection
Materials for the manufacture of instruments for dental implants should be selected in accordance with the characteristics of the intended purpose of use, taking into account the impact of manufacturing, handling, sterilization and storage (see Chapter 8).
The suitability of the material for a particular use shall be demonstrated by either.
a) conduct design assessments in accordance with Clause 8;
b) Select materials specified in Appendix A which have demonstrated their suitability through similar clinical use.
NOTE. For more information, see Appendix A Introduction.
If other materials are used, biological evaluation shall be carried out on the final product or a representative sample of the final product in accordance with ISO 7405 and ISO 10993-1.
8 Performance Evaluation
8.1 General
The device should be evaluated in conjunction with the design purpose of the implant system to demonstrate that it achieves its intended performance (see Clause 5). clinical
Pre-assessment and risk analysis according to ISO 14971 to demonstrate safety.
If devices are to be reused, the suitability of these devices for sterilization should be assessed.
NOTE. In some cases, a clinical evaluation is also required.
8.2 Preclinical evaluation
If preclinical testing of the device is required, the conditions of intended use should be simulated.
8.3 Clinical evaluation
If a clinical investigation is carried out, it shall be conducted in accordance with the requirements of ISO 14155.
9 production
9.1 General
Devices shall be manufactured in accordance with specifications for the required performance characteristics (see Clause 6).
Note. The application of the quality management system should be described in ISO 13485.
9.2 Technical Documentation
The manufacturer's technical documentation shall at least include the information required in Chapters 4 to 8, Chapters 10 and 11.
10 reuse
10.1 Sterile products
Devices marked with "STERILE" should comply with the relevant regional or national regulations.
The sterilization process should be validated and routinely controlled.
10.2 Non-sterile products
For non-sterile devices, the manufacturer shall specify at least one suitable sterilization method that will not affect the functional safety of the product. if not
Multiple sterilizations are allowed, and a statement should be given (see Chapter 11, 11.4c).
10.3 Reuse of information
For devices that are not sterile or that are claimed to be resterilizable, the manufacturer shall provide information on the processing of these devices in accordance with ISO 17664.
11 Information provided by the manufacturer
11.1 General
All packages must have a label stating their full contents. If the label does not list all the contents of the package, all
List of contents. If symbols are used, they shall comply with the requirements of ISO 15223-1.
11.2 Device identification
Dental implant devices and related auxiliary devices shall be marked with the following information.
a) The name or registered trademark of the manufacturer;
b) batch number (batch number) or serial number, if applicable;
c) reference number (catalogue/entry number), if applicable;
d) specification instructions required for safe selection or use;
e) depth marking, where applicable;
f) Color code, where applicable.
If the marking would affect the expected performance, or the device is too small to be legible, this information should be indicated on the label.
Note. "Easy to recognize" means visible without magnification.
11.3 Packaging labeling
The label on the package should at least contain the following information.
a) the name and address of the manufacturer;
b) batch number (batch number) or serial number, as applicable;
c) reference number (catalogue/entry number), where applicable;
d) Devices intended for single use shall be marked with the words "single use" or a symbol label consistent with ISO 15223-1.
In addition, if the device provided by the manufacturer is sterile, the following information should be given on its packaging label.
a) Sterilization validity period;
b) "STERILE" symbol consistent with ISO 15223-1;
c) Symbols for the sterilization process used in accordance with ISO 15223-1.
11.4 Instructions for use
Instructions for use shall be provided if the device cannot be used safely without them.
If the manufacturer provides instructions for the use of devices for implant implantation and treatment, the instructions for use shall contain at least the following information.
a) the name and address of the manufacturer;
b) the date of issue of the instruction manual;
c) if the device is specified for single use only, information on the known properties of the device for repeated use and technical reasons known to the manufacturer;
elements may pose risks.
It is at the discretion of the manufacturer whether to provide other information to users in electronic form (such as web pages, DVDs).
Appendix A
(Normative appendix)
Acceptable Materials for Device Manufacturing
A.1 Materials
When selecting materials for implant devices, the nature of their direct or indirect contact with the human body should be considered.
The materials specified in Annex A are suitable for the manufacture of devices.
A.2 stainless steel
Specifications for the chemical composition of stainless steel shall comply with the requirements of ISO 15510, where applicable. The design of stainless steel shall comply with the requirements of ISO 15510, where applicable.
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