YY 0484-2004 English PDF (YY0484-2004)

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YY 0484-2004: Implants for surgery. Two-part addition-cure silicone elastomers
YY 0484-2004
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 48
YY 0484-2004 / ISO 14949.2001
Implants for surgery -
Two-part addition-cure silicone elastomers
(ISO 14949.2001, IDT)
ISSUED ON. JULY 16, 2004
IMPLEMENTED ON. AUGUST 01, 2005
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 Formulation ... 9 
5 Biocompatibility ... 10 
6 Characterization and testing ... 10 
7 Documentation ... 13 
Annex A (Normative) Determination of substances soluble in hexane ... 15 
Annex B (Normative) Determination of volatile matter ... 20 
Bibliography ... 23 
Implants for surgery -
Two-part addition-cure silicone elastomers
1 Scope
This Standard specifies the characteristics of, and corresponding test methods
for, the two-part addition-cure high consistency or liquid silicone elastomer for
use in the manufacture (partially or totally) of surgical implants.
2 Normative references
The following documents contain provisions which, through reference in this
Standard, constitute provisions of this Standard. For the dated references, their
subsequent amendments (excluding corrections) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest editions of these
documents are applicable. For undated reference documents, the latest
editions apply to this Standard.
GB/T 529-1999 Rubber, vulcanized or thermoplastic - Determination of tear
strength (Trouser, angle and crescent test pieces) (eqv ISO 34-1.1994)
GB/T 6031-1998 Rubber, vulcanized or thermoplastic - Determination of
hardness (hardness between 10 IRHD and 100 IRHD) (idt ISO 48.1994)
GB/T 9869-1997 Rubber - Measurement of vulcanization characteristics with
the oscillating disc curemeter (idt ISO 3417.1991)
GB/T 16584-1996 Rubber - Measurement of vulcanization characteristics
with rotorless curemeters (eqv ISO 6502.1991)
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1.
Evaluation and testing (idt ISO 10993-1.1997)
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. Test
for in vitro cytotoxicity (ISO 10993-5.1999, IDT)
ISO 527-2.1993 Plastics - Determination of tensile properties - Part 2. Test
conditions for moulding and extrusion plastics