YY/T 0647-2021 PDF English
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| YY/T 0647-2021 | English | 590 |
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Non-active surgical implants - Particular requirements of mammary implants
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| YY 0647-2008 | English | 350 |
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Non-active surgical implants. Mammary implants. Particular requirements
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YY/T 0647-2021: Non-active surgical implants - Particular requirements of mammary implants---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0647-2021
PHARMACEUTICAL INDUSTRY STANDARD
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;
--- It is first-time revised hereby.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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