YY/T 1715-2020Implants for surgery—Ceramic materials based on yttria-stabilized tetragonal zirconia(Y-TZP) (English PDF)

Foreword

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

This standard uses the redrafting method to modify and adopt ISO 13356:2015 "Surgical Implant Yttrium Oxide Stabilized Tetragonal Zirconia (Y-TZP) Ceramic Material".

This standard has made editorial changes to the structure of Chapter 3 in accordance with the rules of GB/T 1.1-2009, adding the article number "3.1 General".

Compared with ISO 13356:2015, this standard has the following technical differences.

--- "Scope" (see Chapter 1) added "This standard applies to yttria stabilized tetragonal zirconia (Y-TZP) ceramic materials for surgical implants";

--- 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 3310-1 with GB/T 6003.1 modified to adopt international standards;

- Replace ISO 14704 with GB/T 6569 modified to adopt international standards;

- Replace ISO 14705 with GB/T 16534 modified to adopt international standards;

- Replace ISO 7500-1:2004 with GB/T 16825.1-2008 which is equivalent to the international standard;

- Replace ISO 18754 with GB/T 25995 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 standard specifies the biocompatible and biostable yttria-stabilized tetragonal zirconia for surgical implants Crystal, Y-TZP) ceramic bone substitute material requirements and corresponding test methods.

This standard applies to yttria stabilized tetragonal zirconia (Y-TZP) ceramic materials for surgical implants.

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.

GB/T 6003.1 Test sieve technical requirements and inspection Part 1: Metal wire woven mesh test sieve (GB/T 6003.1-2012, ISO 3310-1.:2000, MOD)

GB/T 6569 Test method for bending strength of fine ceramics (GB/T 6569-2006, ISO 14704:2000, MOD)

GB/T 16534 Room temperature hardness test method for fine ceramics (GB/T 16534-2009, ISO 14705:2008, MOD)

GB/T 16825.1-2008 Inspection of static uniaxial testing machine Part 1: Inspection and calibration of force measuring system of tensile and (or) compression testing machine (ISO 7500-1:2004, IDT)

GB/T 25995 Fine ceramic density and apparent porosity test method (GB/T 25995-2010, ISO 18754:2003, MOD)

ISO 3611 Product Geometric Technical Specification (GPS) Dimensional Measuring Equipment. External Micrometer Measurement Design and Metrological Characteristics

ISO 13383-1 Fine ceramics (advanced ceramics, high-tech ceramics) Microstructure characteristics Part 1: Determination of grain size and size distribution

ISO 17561 Fine ceramics (advanced ceramics, high-tech ceramics) Test method for measuring the elastic modulus of bulk ceramics by acoustic resonance at room temperature

ISO 20501 Weibull statistics of the strength data of fine ceramics (advanced ceramics, high-tech ceramics)

ISO 22214 Fine ceramics (advanced ceramics, high-tech ceramics) cyclic bending fatigue test method for bulk ceramics at room temperature

3 Physical and chemical properties