YY/T 0647-2021Non-active surgical implants-Particular requirements of mammary implants (English PDF)

Foreword

This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for Standardization - Part 1: Rules for the Structure and Drafting of Standardizing Documents.

This Document replaced YY 0647-2008 Non-Active Surgical Implants - Mammary Implants - Particular Requirements. Compared with YY 0647-2008, the major technical changes of this Document are as follows.

--- Add the requirements and test methods for the cytotoxicity test of raw materials (see 6.2 of this Edition);

--- Add the requirements and test methods for residual low molecular weight oligomers in silica gel (see 6.3 of this Edition);

--- Add the limit requirements for trace elements of raw materials (see 6.4 of this Edition);

--- Add test methods for physical and mechanical properties and characterization of raw materials (see 6.5 of this Edition);

--- Modify the requirements and test methods for fatigue tests (see 7.2.2.2.1 of this Edition;

7.2.2.5.2 of 2008 Edition);

--- Delete the tear resistance of the shell (see 7.2.2.2.3 of 2008 Edition);

--- Delete the static rupture test (see 7.2.2.5.4 of 2008 Edition);

--- Add the test method for silicone gel penetration test (see 7.2.3.3.3 of this Edition);

--- Modify the test method of the diffusion test (see 7.2.3.4 of this Edition; 7.2.3.4 of 2008 Edition);

--- Modify the test method for surface properties (see 7.2.3.7 of this Edition; 7.2.2.8 of 2008 Edition);

--- Add requirements for surface particle contamination (see 7.2.3.8 of this Edition).

This Document uses translation method to equivalently adopt ISO 14607:2018 Non-Active Surgical Implants - Mammary Implants - Particular Requirements.

The Chinese documents that have a consistent correspondence with the international documents normatively cited in this Document are as follows.

--- GB/T 528-2009 Rubber, Vulcanized or Thermoplastic - Determination of Tensile Stress- Strain Properties (ISO 37:2005, IDT);

--- GB/T 529-2008 Rubber Vulcanized or Thermoplastic - Determination of Tear Strength (Trouser, Angle and Crescent Test Pieces) (ISO 34-1:2004, MOD);

--- GB/T 531.1-2008 Rubber Vulcanized or Thermoplastic - Determination of Indentation Hardness - Part 1: Durometer Method (Shore Hardness) (ISO 7619-1:2004, IDT);

--- GB/T 3505-2009 Geometrical Product Specifications (GPS) - Surface Texture. Profile Method - Terms Definitions and Surface Texture Parameters (ISO 4287:1997, IDT);

--- GB/T 16886.1-2011 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process (ISO 10993-1:2009, IDT);

--- GB/T 16886.5-2017 Biological Evaluation of Medical Devices - Part 5: Tests for in Vitro Cytotoxicity (ISO 10993-5:2009, IDT);

--- GB/T 16886.18-2011 Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials (ISO 10993-18:2005, IDT);

--- GB/T 19633.1-2015 Packaging for Terminally Sterilized Medical Devices - Part 1.

Requirements for Materials, Sterile Barrier Systems and Packaging Systems (ISO 11607- 1.2006, IDT);

--- YY/T 0297-1997 Clinical Investigation of Medical Devices (ISO 14155:1996, IDT). This Document made the minimum editorial modifications as follows.

--- In order to coordinate with the current standard, change the standard name into Non- Active Surgical Implants - Particular Requirements of Mammary Implants.

Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents.

1 Scope

This Document specifies particular requirements for mammary implants.

With regard to safety of the implants, this Document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information supplied by the manufacturer.

2 Normative References

The provisions in following documents become the essential provisions of this Document through reference in 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 Document.

YY/T 0640-2016 Non-Active Surgical Implants - General Requirements (ISO 14630:2012, IDT)

3 Terms and Definitions

For the purposes of this Document, the terms and definitions given in ISO 10993-1, ISO 14155 and YY/T 0640 and the following apply.

Volume of the material contained within the shell (3.11) or volume of the solution necessary to fill an inflatable or adjustable mammary implant (3.8).

4 Intended Performance

The requirements of YY/T 0640-2016, Clause 4, shall apply.

5 Design Attributes

The requirements of YY/T 0640-2016, Clause 5, shall apply.

6 Materials

The components of each production raw material lot shall be cured and tested for cytotoxicity in accordance with ISO 10993-5.No cytotoxic effects, as defined in ISO 10993-5, shall be induced by the material tested, or throughout the culture.

7 Design Evaluation

The pre-clinical evaluation of mammary implants shall conform to YY/T 0640-2016, 7.2, and fulfil the requirements of ISO 10993-1. The integrity of the shell shall be evaluated.

8 Manufacturing

The requirements of YY/T 0640-2016, Clause 8, shall apply.

9 Sterilization

The requirements of YY/T 0640-2016, 9.1, 9.2 and 9.4, shall apply. Implants shall be supplied sterile.

10 Packaging

The requirements of YY/T 0640-2016, Clause 10, apply. Packaging design shall be validated according to ISO 11607-1.