YY/T 0342-2020Implants for surgery—Determination of bending strength and stiffness of bone plates (English PDF)

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".

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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.