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www.ChineseStandard.net Database: 189760 (18 Oct 2025)

YY 0484-2004 PDF English

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YY 0484-2004: Implants for surgery. Two-part addition-cure silicone elastomers
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Status: Obsolete
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YY 0484-2004English145 Add to Cart 0-9 seconds. Auto-delivery Implants for surgery. Two-part addition-cure silicone elastomers Obsolete

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YY 0484-2004: Implants for surgery. Two-part addition-cure silicone elastomers

---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/YY0484-2004
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 ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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