YY 0647-2008 English PDF (YY0647-2008)

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YY 0647-2008: Non-active surgical implants. Mammary implants. Particular requirements
YY 0647-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
YY 0647-2008 / ISO 14607:2007
Non-active surgical implants - Mammary implants -
Particular requirements
(ISO 14607:2007, IDT)
ISSUED ON: APRIL 25, 2008
IMPLEMENTED ON: DECEMBER 01, 2009
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 4 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 6 
4 Intended performance ... 7 
5 Design attributes ... 7 
6 Materials ... 7 
7 Design evaluation ... 7 
8 Manufacturing ... 13 
9 Sterilization ... 13 
10 Packaging ... 13 
11 Information supplied by the manufacturer ... 13 
Annex A (normative) Test for surface characteristics ... 17 
Annex B (normative) Tests for shell integrity ... 18 
Annex C (normative) Test method for valve competence and injection site
competence ... 20 
Annex D (normative) Test for silicone gel cohesion (silicone filling materials only)
... 22 
Annex E (normative) Mechanical tests on a mammary implant in its implantable
state ... 24 
Annex F (normative) Information for the patient ... 29 
Annex G (normative) Information for the user ... 31 
Annex H (informative) Silicone release assessment from mammary implants by
an in vitro method ... 32 
Bibliography ... 36 
Foreword
This Standard is mandatory.
This Standard identically adopts ISO 14607:2007 "Non-active surgical implants
- Mammary implants - Particular requirements". In this Standard, "Pre-clinical
evaluation (7.2)" and "Sterilization (9)" shall be interpreted as items for product
technical requirements. The technical requirements and inspection methods of
these items are included in the normative appendix.
This Standard was proposed by China Food and Drug Administration.
Annex A, Annex B, Annex C, Annex D, Annex E, Annex F, and Annex G of this
Standard are normative. Annex H is informative.
This Standard shall be under the jurisdiction of National Standardization
Technical Committee for Surgical Implants and Orthopaedic Devices.
The drafting organizations of this Standard: Medical Device Inspection Center,
National Institute for the Control of Pharmaceutical and Biological Products.
This Standard is interpreted by the China Pharmaceutical, Biological Products
and Medical Devices Inspection Center.
Main drafters of this Standard: Feng Xiaoming, Wang Wen, Fang Yu, Wang
Zhaoxu, Wang Chunren, Xi Tingfei.
Non-active surgical implants - Mammary implants -
Particular requirements
1 Scope
This Standard specifies particular requirements for mammary implants (or
called breast prosthesis, breast implants and artificial breasts, hereinafter
referred to as the implants) for clinical practice.
With regard to safety, this Standard specifies requirements for intended
performance, design attributes, materials, design evaluation, manufacturing,
sterilization, packaging and information supplied by the manufacturer.
2 Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For dated references, the subsequent
amendments (excluding corrigendum) or revisions do not apply to this Standard,
however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
GB/T 528-1998, Rubber, vulcanized or thermoplastic - Determination of
tensile stress-strain properties (mod ISO 37:1996)
GB/T 529-1999, Rubber, vulcanized or thermoplastic - Determination of tear
strength (Trouser, angle and crescent test pieces) (Mod ISO 34-1:1996)
YY/T 0640-2008, Non-active surgical implants. General requirements (ISO
14630-2005, IDT)
ISO 10993-1:2003, Biological evaluation of medical devices - Part 1:
Evaluation and testing
ISO 14155-1, Clinical investigation of medical devices for human subjects -
Part 1: General requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects -
Part 2: Clinical investigation plans
NF S99-401-1994, Medical devices. Silicone elastometer of medical grade