YY/T 0647-2021 English PDF (YYT0647-2021)

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YY/T 0647-2021: Non-active surgical implants - Particular requirements of mammary implants
YY/T 0647-2021
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
CCS C 35
YY/T 0647-2021 / ISO 14607:2018
Replacing YY 0647-2008
Non-Active Surgical Implants – Particular Requirements of
Mammary Implants
(ISO 14607:2018, Non-Active Surgical Implants
– Mammary Implants – Particular Requirements, IDT)
ISSUED ON: DECEMBER 06, 2021
IMPLEMENTED ON: DECEMBER 01, 2022
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 7
2 Normative References ... 7
3 Terms and Definitions ... 8
4 Intended Performance ... 10
5 Design Attributes ... 10
6 Materials ... 10
7 Design Evaluation ... 12
8 Manufacturing ... 15
9 Sterilization ... 15
10 Packaging ... 15
11 Information Supplied by the Manufacturer ... 15
Appendix A (Normative) Determination of Octamethylcyclotetrasiloxane (D4) and
Decamethylcyclopentasiloxane (D5) in Silicone Gels ... 18
Annex B (Normative) Tests for Shell Integrity ... 22
Annex C (Normative) Mechanical Tests on a Mammary Implant in its Implantable State
... 25
Annex D (Normative) Test Method for Valve Competence and Injection Site
Competence ... 31
Annex E (Normative) Test for Silicone Gel Cohesion (Silicone Filling Materials Only)
... 34
Annex F (Normative) Test for Silicone Gel Penetration (Silicone Filling Materials Only)
... 36
Annex G (Informative) Assessment of Silicone Diffusion from Mammary Implants
Using an in Vitro Method ... 41
Annex H (Informative) Test for Surface Characteristics ... 46
Annex I (Normative) Information for the User ... 49
Annex J (Normative) Information for the Patient ... 50
Bibliography ... 52
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.
This Document was proposed by National Medical Products Administration.
This Document shall be under the jurisdiction of National Technical Committee on Implants
for Surgery and Orthopedic Devices of Standardization Administration of China (SAC/TC 110).
Drafting organizations of this Document: National Institutes for Food and Drug Control; Hebei
Research Institute of Medical Device and Drug Packaging Materials Inspection; Henan Institute
of Medical Device Inspections; and Tianjin Medical Devices Quality Supervision and Testing
Center.
Chief drafting staffs of this Document: Fu Bufang, Wang Shuo, Wang Li, Liu Dong, Li Jia,
Wang Jian, Fu Haiyang, Chen Ming, Liu Ruojin, Xu Yuyin, Han Qianqian, Li Libing, and Wang
Chunren.
The historical editions replaced by this Document are as follows:
--- YY 0647-2008 was first-time published in 2008;
Non-Active Surgical Implants – Particular Requirements of
Mammary Implants
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)
ISO 34-1:2015 Rubber, Vulcanized or Thermoplastic – Determination of Tear Strength –
Part 1: Trouser, Angle and Crescent Test Pieces
ISO 37:2017 Rubber, Vulcanized or Thermoplastic – Determination of Tensile Stress-
Strain Properties
ISO 4287 Geometrical Product Specifications (GPS) – Surface Texture: Profiled Method
– Terms, Definitions and Surface Texture Parameters
ISO 7619-1 Rubber, Vulcanized or Thermoplastic – Determination of Indentation
Hardness – Part 1: Durometer Method (Shore Hardness)
ISO 10993-1 Biological Evaluation of...