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YY/T 0342-2020 English PDF

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US$209.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 0342-2020: Implants for surgery - Determination of bending strength and stiffness of bone plates
Status: Valid

YY/T 0342: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0342-2020	209	Add to Cart	3 days	Implants for surgery - Determination of bending strength and stiffness of bone plates	Valid
YY/T 0342-2002	319	Add to Cart	3 days	Implants for surgery. Determination of bending strength and stiffness of bone plates	Obsolete

Similar standards

YY/T 0346 YY/T 0345.1 YY 0341.2

Basic data

Standard ID: YY/T 0342-2020 (YY/T0342-2020)
Description (Translated English): Implants for surgery - Determination of bending strength and stiffness of bone plates
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 11,153
Date of Issue: 2020-09-27
Date of Implementation: 2021-09-01
Older Standard (superseded by this standard): YY/T 0342-2002
Regulation (derived from): Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies): State Drug Administration

YY/T 0342-2020: Implants for surgery - Determination of bending strength and stiffness of bone plates

---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.
(Surgical implants Determination of bending strength and stiffness of bone plates) ICS 11:040:40 C35 People's Republic of China Pharmaceutical Industry Standard Replace YY/T 0342-2002 Surgical implants Determination of Bending Strength and Rigidity of Bone Plate (ISO 9585:1990, MOD) 2020-09-27 release 2021-09-01 implementation Issued by the State Drug Administration

Preface Ⅲ 1 Scope 1 2 Terms and definitions 1 3 Method 2 4 Test report 8

Foreword

This standard was drafted in accordance with the rules given in GB/T 1:1-2009: This standard replaces YY/T 0342-2002 "Determination of Bending Strength and Rigidity of Bone Plates for Surgical Implants": With YY/T 0342- Compared with:2002, the main technical differences are as follows: ---Modified the scope of application (see Chapter 1 and Chapter 1 of the:2002 edition); ---Modified the roller diameter range in the standard (see 3:1:1:2, 3:2 in the:2002 edition); --- Added a new displacement method for determining the bending strength and stiffness of the bone plate (see 3:2) and the corresponding term definitions (see 2:6 and 2:7); ---Modified the standard structure, due to the addition of a measurement method (see 3:2), the overall structure of the standard has been adjusted: This standard uses the redrafting method to modify and adopt ISO 9585:1990 "Determination of Bending Strength and Rigidity of Bone Plates for Surgical Implants:" The technical differences between this standard and ISO 9585:1990 and the reasons are as follows: ---Modified the scope of application, revised according to the actual situation of the product, in the scope of ISO 9585:1990, "not applicable to length less than 50mm Bone plates", some bone plates smaller than 50mm can be tested, and some plates are longer than 50mm, but still does not meet the test conditions, so according to the actual situation, it is modified to "not suitable for bones with a hole distance less than 8mm board": ---The diameter range of the roller shaft in the standard is revised, according to YY/T 1503-2016 "Surgical implant metal bone plate bending fatigue According to the requirements in the Performance Test Method, the diameter of the roller shaft is unified as "6mm~13mm": --- Added a new displacement method for determining the bending strength and stiffness of the bone plate (see 3:2) and the corresponding term definitions (see 2:6 and 2:7); ---Modified the standard structure, due to the addition of a measurement method "displacement method" (see 3:2), the overall structure of the standard has been adjusted, For the content of Chapter 3 to Chapter 5 in ISO 9585:1990, see 3:1 "Deflection Method": 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 organized by the Orthopedic Implants Sub-Technical Committee of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110/ SC1) Centralized: Drafting organizations of this standard: Tianjin Medical Device Quality Supervision and Inspection Center, Medical Device Technology Review under the State Drug Administration Xin, Shandong Weigao Orthopedic Materials Co:, Ltd:, Beijing Fule Technology Development Co:, Ltd: The main drafters of this standard: Zhang Lu, Wang Tao, Sun Jiayi, Wu Jing, Lu Chenglin, Huang Wenxiang, Qiu Wanyu, Li Hongyan: The previous versions of the standard replaced by this standard are as follows: ---YY/T 0342-2002: Surgical implants Determination of Bending Strength and Rigidity of Bone Plate

1 Scope

This standard specifies the method for determining the bending strength and stiffness of straight bone plates, including terms and definitions, equipment, test procedures, and results Calculation, test report: This standard applies to straight bone plates, and also to straight plate parts with a certain angle A preloaded bone plate with a small initial bend: This standard does not apply to bone plates with a pitch of less than 8mm, nor does it apply to plates designed to be used with intramedullary devices or become intramedullary devices: Set part of the bone plate:

2 Terms and definitions

The following terms and definitions apply to this document: 2:1 Moment The mathematical expression of the rotation effect of a force around an axis is the product of F and the vertical distance h from the axis to the line of action of the force: Note: The unit is Newton Meter (N·m): 2:2 Bending moment Mb The moment acts along an axis perpendicular to the long axis of the object and usually produces lateral displacement: Note: The unit is Newton Meter (N·m): 2:3 Deflection The linear distance perpendicular to the initial axis of the bone plate due to bending: Note: The unit is meter (m): 2:4 Bending strength The smaller of the bending moment values at the breaking point or a specified yield point: Note: The unit is Newton Meter (N·m): 2:5 Equivalentbendingstiffness Bone plate calculated according to the external dimensions of the specimen and the slope S of the linear part of the load-deflection curve determined by the mechanical test method Stiffness: Note 1: The unit is cattle square meters (N·m2): Note 2: The equivalent bending stiffness takes into account the holes and grooves of the bone plate: 2:6 Bendingstructuralstiffness Consider the bending stiffness of the bone plate when testing the loading device: Response through the bone plate and loading device in the bending test ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 0342-2020_English be delivered?

Answer: Upon your order, we will start to translate YY/T 0342-2020_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 0342-2020_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 0342-2020_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.

Question 5: Should I purchase the latest version YY/T 0342-2020?

Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0342-2020 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.