GB 12264-1990
Replaced
YY/T 0919-2014
Active
Industry standards-Medicine
YY/T 0919-2014 Non-active surgical implants—Joint replacement implants—Specific requirements for knee-joint replacement implants
YY/T 0919-2014 Non-active surgical implants—Joint replacement implants—Specific requirements for knee-joint replacement implants
Basic Information
Standard Code:
YY/T 0919-2014
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2014-06-17
Implement Date:
2015-07-01
Pages:
8 pages
Scope
This standard specifies the special requirements for knee joint replacement implants.
Regarding safety, this standard stipulates the expected performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer, as well as the requirements for testing methods.
Development Information
Referenced Standards
YY/T 0640-2008 Non-active surgical implants—General requirements
ISO 14243-1
ISO 14243-2
ISO 14243-3
ISO 21534:2007
YY/T 0810.1-2010 Implants for surgery—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays
YY/T 0810.1-2024 Joint replacements—Total knee-joint prostheses—Part 1:Determination of endurance properties of knee tibial trays
YY/T 0924.1-2014 Implants for surgery—Components for partial and total knee joint prostheses—Part 1:Classification, definitions and designation of dimensions
Adopt standards
ISO 21536:2007
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