GB 12264-1990
Replaced
YY/T 0484-2004
Active
Industry standards-Medicine
YY/T 0484-2004 Implants for surgery—Two-part addition-cure silicone elastomers
YY/T 0484-2004 Implants for surgery—Two-part addition-cure silicone elastomers
Basic Information
Standard Code:
YY/T 0484-2004
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2004-07-16
Implement Date:
2005-08-01
Pages:
14 pages
Scope
This standard specifies the characteristics of two-component addition-molded vulcanized high-viscosity or liquid silicone rubber used in the production of (part or all) surgical implants, and the corresponding test methods
Development Information
Referenced Standards
GB/T 529-1999 Rubber,vulcanized or thermoplastic—Determination of tear strength (Trouser,angle and crescent test pieces)
GB/T 6031-1998 Rubber,vulcanized or thermoplastic—Determination of hardness (hardness between 10 IRHD and 100IRHD)
GB/T 9869-1997 Rubber—Measurement of vulcanization characteristics with the oscillating disc curemeter
GB/T 16584-1996 Rubber—Measurement of vulcanization characteristics with rotorless curemeters
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
ISO 527-2:1993
Adopt standards
ISO 14949:2001
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced