YY 0341.1-2020Non-active surgical implants—Osteosynthesis and spinal implants - Part 1: Particular requirements for osteosynthesis implants (English PDF)

Foreword

All technical contents of this standard are mandatory.

The standard of YY 0341 "Non-active surgical implants - Osteosynthesis and spinal implants" is divided into the following two parts.

- Part 1: Particular requirements for osteosynthesis implants;

- Part 2: Particular requirements for spinal implants. This part is part 1 of YY 0341.

This part was drafted in accordance with the rules given in GB/T 1.1-2009. "Non-active surgical implants - Osteosynthesis and spinal implants" replace YY 0341-2009 "General technological requirements for non-active metallic surgical implants for osteosynthesis". The main technical differences between this part and YY 0341-2009 are as follows.

- SPLIT the original standard into two parts. "Osteosynthesis implant" and "spinal implant";

- MODIFY the scope of application to no longer only apply to non-active surgical implants made of metal materials. In addition, MODIFY the inapplicable scope in YY 0341.1 to "coating of osteosynthesis implant with surface coatings" (see Chapter 1; Chapter 1 of the 2009 edition);

- ADD relevant terms and definitions, such as "anodization of titanium and titanium alloys" (see 3.3);

- MODIFY the "appearance" requirements (see 4.5.3; 4.4.3 of the 2009 edition);

- ADD the "anodized surface treatment" requirements (see 4.5.4);

- ADD the "cooperating performance" requirements (see 4.7);

- ADD the requirement of "residual amount of ethylene oxide" (see 4.8);

- DELETE the original Chapter 6 "Inspection rules". MERGE the requirements on the number of test samples into Chapter 5 "Test methods".

DELETE the original Chapter 7 "Instructions for use", the original Chapter 10 "Transport and storage", the original Chapter 11 "Requirements for use";

ADD "Manufacturing" and "Information provided by the manufacturer" and other chapters.

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 0341 specifies the special requirements for non-active surgical implants for osteosynthesis (hereinafter referred to as "osteosynthesis implants"), including the terms and definitions, requirements, test methods, manufacturing, sterilization, packaging and information provided by the manufacturer, etc. of osteosynthesis implants.

This part of YY 0341 applies to osteosynthesis implants, not to the coating part of osteosynthesis implants with surface coating.

2 Normative references

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this standard.

GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1: Test method

GB/T 10610 Geometrical product specifications(GPS) - Surface texture.

Profile method - Rules and procedures for the assessment of surface texture

GB/T 14233.2 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods

GB/T 16886.7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

3 Terms and definitions

The terms and definitions as defined in YY/T 0640-2016 as well as the following terms and definitions apply to this document.

4 Requirements

5 Test method

6 Manufacturing

It shall meet the requirements of Chapter 8 in YY/T 0640-2016.

7 Sterilization

It shall meet the requirements of Chapter 9 in YY/T 0640-2016.

8 Packaging

It shall meet the requirements of Chapter 10 in YY/T 0640-2016.

9 Information provided by the manufacturer