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YY 0484-2004Implants for surgery - Two-part addition-cure silicone elastomers (English PDF)

外科植入物双组分加成型硫化硅橡胶

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

July 16, 2004

Implementation date

August 1, 2005

Scope

YY 0484-2004 is the English-translated version of 外科植入物双组分加成型硫化硅橡胶.

YY 0484-2004 is the Chinese standard "Implants for surgery - Two-part addition-cure silicone elastomers".

Its scope clause reads: 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.

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Document preview — YY 0484-2004

National Standard of the People's Republic of China

Issued by: National Medical Products Administration of the People's Republic of China

Foreword3
Introduction4
1 Scope5
2 Normative references5
3 Terms and definitions6
4 Formulation9
5 Biocompatibility10
6 Characterization and testing10
7 Documentation13
Annex A (Normative) Determination of substances soluble in hexane15
Annex B (Normative) Determination of volatile matter20
Bibliography23

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

YY 0469-2023 | YY/T 0471.5-2017 | YY/T 0487-2010 | YY/T 0471.4-2004 | YY/T 0866-2024 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 527-2:1993

Cited by

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