YY/T 0651.2-2020Implants for surgery—Wear of total hip-joint prostheses - Part 2: Methods of measurement (English PDF)

Foreword

YY/T 0651 "Abrasion of Total Hip Joint Prosthesis of Surgical Implants" is divided into the following 3 parts.

---Part 1. Load and displacement parameters of the wear tester and related test environmental conditions;

---Part 2. Measurement methods;

---Part 3. Load and displacement parameters of track bearing type wear testing machine and related test environment conditions. This part is part 2 of YY/T 0651.

This section was drafted in accordance with the rules given in GB/T 1.1-2009.

This part replaces YY/T 0651.2-2008 "Surgical implants and total hip joint prosthesis wear Part 2. Measurement methods".

Compared with YY/T 0651.2-2008, the main technical changes in this part are as follows:

---The scope of application is increased by YY/T 0651.3 "Surgical implants and total hip joint prostheses wear track bearing type wear testing machine Load and displacement parameters and related test environmental conditions".

This part uses the redrafting method to modify and adopt ISO 14242-2:2016 ``Surgical implants and total hip joint prosthesis wear and tear Part 2 Points. Measurement Methods. Compared with ISO 14242-2:2016, this standard has the following technical differences.

---The scope (Chapter 1) adds "This standard applies to total hip prostheses:" --- Regarding normative references, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.

The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows:

- Replace ISO 14242-1 with YY/T 0651.1 which is equivalent to the international standard;

- Replace ISO 14242-3 with YY/T 0651.3 modified to adopt international standards.

Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.

1 Scope

This part of YY/T 0651 specifies the use of total hip joint prosthesis wear test according to YY/T 0651.1 or YY/T 0651.3 The mass method and volume method are used to assess the wear of acetabular components.

This standard applies to total hip prostheses.

Note: Some researchers have encountered the problem of organic matter deposition that obviously affects the results of this test, especially when the hard surface and the hard surface are combined, this problem is more serious. Headquarters The points did not give specific preventive measures, but if the cleaning techniques listed in this section can be used, the impact of such impurities can be reduced.

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 document. For undated references, the latest version (including all amendments) applies to this document.

YY/T 0651.1 Surgical implants. Wear of total hip joint prostheses. Part 1. Load and displacement parameters of wear testing machine and Relevant test environmental conditions (YY/T 0651.1-2016, ISO 14242-1:2012, IDT)

YY/T 0651.3 Surgical implants. Wear of total hip joint prostheses. Part 3. Load and load of orbital bearing type wear tester Displacement parameters and related test environmental conditions (YY/T 0651.3-2020, ISO 14242-3:2009, MOD)

3 Terms and definitions

The following terms and definitions apply to this document.

4 Quality method