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Dentistry--Coiled springs for use in orthodontics
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YY/T 1703-2020
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Basic data | Standard ID | YY/T 1703-2020 (YY/T1703-2020) | | Description (Translated English) | Dentistry--Coiled springs for use in orthodontics | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 8,833 | | Date of Issue | 2020 | | Date of Implementation | 2021-01-01 | | Issuing agency(ies) | State Drug Administration | | Summary | This standard specifies detailed methods for matching the physical and mechanical properties of coil springs, as well as test methods for testing these properties, and specifies requirements for packaging and labelling. This standard applies to coil springs for orthodontic devices. |
YY/T 1703-2020: Dentistry--Coiled springs for use in orthodontics---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--Coiled springs for use in orthodontics
ICS 11.060.10
C33
People's Republic of China Pharmaceutical Industry Standard
Coil spring for orthodontics
(ISO 17254.2016, IDT)
2020-02-21 released
2021-01-01 implementation
Issued by the State Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
The translation method used in this standard is equivalent to ISO 17254.2016 "Spiral Springs for Orthodontics in Dentistry".
The Chinese documents that have consistent correspondence with the normatively cited international documents in this standard are as follows.
---GB/T 9937 (all parts) Dental terminology [ISO 1942 (all parts), IDT].
Please note that certain 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 under the jurisdiction of the National Standardization Technical Committee for Dental Materials and Devices (SAC/TC99).
Drafting organizations of this standard. Peking University School of Stomatology Dental Medical Device Inspection Center, Youyan Medical Devices (Beijing) Co., Ltd.,
Minnesota Mining Manufacturing (Shanghai) International Trade Co., Ltd., Beijing St. Mart Technology Co., Ltd.
The main drafters of this standard. Bai Wei, Lin Hong, Xu Yongxiang, Wu Yang, Huang Bingmin, Gong Tao, Zhang Hengjin.
Introduction
This standard does not include qualitative and quantitative requirements for possible unacceptable biological hazards, but it is recommended to evaluate possible biological hazards.
When harming, refer to ISO 10993-1 and ISO 7405.
Coil spring for orthodontics
1 Scope
This standard specifies detailed methods for matching the physical and mechanical properties of coil springs, as well as test methods for testing these properties.
Established packaging and labeling requirements.
This standard applies to spiral springs for dental orthodontic devices.
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 references, the latest version (including all amendments) applies to this document.
ISO 1942 (all parts) oral vocabulary
3 Terms and definitions
The following terms and definitions defined by ISO 1942 apply to this document.
3.1
Inner diameter (spring inner diameter)
di
The maximum outer diameter of the tube that can be accommodated in the coil spring.
3.2
Outer diameter
The smallest inner diameter of a tube that can accommodate a coil spring.
3.3
Sectional size of wire
The cross-sectional size of the wire used to make the spring.
3.4
Unloaded spring length
3.5
Unloaded spring length
< tension spring> The maximum size including hooks, holes or connectors in the unloaded state.
3.6
Spring length
For springs with attachments, in the unloaded state, the maximum size including hooks, holes or connectors.
3.7
Maximum compression rate
The percentage of the length of the spring when fully compressed to the length of the unloaded spring.
3.8
Maximum elongation
When 1% permanent deformation occurs, the percentage of the extension of the spring to the length of the unloaded spring.
3.9
Spring force
After the spring is loaded to the specified maximum tension or compression deformation, it reaches the maximum extension or compression during the return process (during unloading)
The force generated by the spring at 80%, 60%, 40% and 20% of the rate.
4 requirements
4.1 General requirements
The manufacturer shall declare the following properties, when tested in accordance with the test methods in Chapter 5, the measured results shall be within the range claimed by the manufacturer.
4.2 Dimensions
4.2.1 The following dimensions should be declared and accurate to 0.01mm. According to the test in Chapter 5, the following dimensions of the product should meet the manufacturer's claim
range.
a) Inner diameter di;
b) outer diameter do;
c) Unloaded spring length luc or lue;
d) The total length of the spring is lt.
4.3 Mechanical properties
Measuring the elastic performance during unloading.
a) Maximum elongation εmax;
b) The maximum compression rate cmax;
4.4 Harmful elements
In this standard, cadmium, beryllium, lead and nickel are considered hazardous elements, and manufacturers must declare their content, expressed in mass fraction.
5 Test method
5.1 Sampling
Each test shall take 6 samples from the same batch of the same product.
5.2 Dimensions
Measure each size of each sample.
5.2.1 Appliances
Use calipers, micrometers, optical measuring instruments or other instruments with an accuracy of 0.005mm.
5.2.2 Measurement procedure
According to their respective definitions, measure the following items and should be accurate to 0.01mm. inner diameter di, outer diameter do, full length lt and unloaded spring
Length luc or lue.
5.3 Mechanical properties
5.3.1 Appliances
A testing machine with a crosshead speed of 0.5mm/min~10.0mm/min and calibrated for force and displacement should be used for measurement.
5.3.2 Test procedure
5.3.2.1 The test shall be carried out at (23±2)℃, and the temperature-sensitive spring shall be tested at (36±1)℃.
5.3.2.2 The crosshead speed should be 0.5mm/min~10.0mm/min.
5.3.2.3 (20 ± 0.2) mm should be taken as the sample length, or the length of the unloaded spring should be taken when the length is less than 20 mm.
5.3.2.4 Measure the following mechanical properties of the spring.
a) Maximum elongation, εmax;
b) Maximum compression rate, cmax;
5.4 Results processing
The test results of each sample are within the range specified by the manufacturer, and the material meets the requirements.
6 Packaging and labeling information
6.1 General requirements
The following information should be clearly indicated by the manufacturer in the catalog, package insert, label, or in other easily accessible ways.
a) Chemical composition. The composition range of the alloy should include all elements with a content greater than or equal to 0.1% (mass fraction), and 4.4
The quality score of any harmful elements
b) The range of each size should meet the requirements of 5.2;
c) The design of the spring, that is, compression rate (push spring) or elongation (tension spring);
d) The range of various mechanical properties should meet the requirements of 5.3.2.4.
6.2 Packaging
During transportation and storage, appropriate packaging and pollution protection should be provided in accordance with acceptable business practices.
6.3 Identification
At least the following information should be marked on each package.
a) The name and address of the manufacturer, if applicable, the name and address of the distributor;
b) The name of the spring;
c) The design of the spring;
d) Lot number;
e) The number of springs in the package;
f) Warning of harmful elements contained in the product (if applicable, the information should be expressed in symbolic form).
references
[1] GB/T 16886.1 Biological Evaluation of Medical Devices Part 1.Evaluation and Testing in the Process of Risk Management (GB/T 16886.1-
2011, ISO 10993-1.2009, IDT)
[2] YY/T 0268-2008 Biological Evaluation of Dental Oral Medical Devices Unit 1.Evaluation and Testing (YY/T 0268-
2008, ISO /FDIS7405.2008, NEQ)
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