YY/T 0965-2014
Active
Industry standards-Medicine
YY/T 0965-2014 Implants for surgery—Artificial ligaments
YY/T 0965-2014 Implants for surgery—Artificial ligaments
Basic Information
Standard Code:
YY/T 0965-2014
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2014-06-17
Implement Date:
2015-07-01
Pages:
20 pages
Scope
This standard specifies the special requirements for textile-based artificial ligament implants (also known as ligament implants or ligament implant bodies, hereinafter referred to as implants) intended for clinical use.
This standard specifies the technical requirements and testing methods for textile-based artificial ligaments. It provides detailed descriptions of the product's intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information provided by the manufacturer.
This standard does not apply to non-textile-based artificial ligaments, but the test methods for these types of artificial ligaments can be appropriately referenced in this standard.
Development Information
Referenced Standards
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances
YY/T 0640-2008 Non-active surgical implants—General requirements
中华人民共和国药典(2010年版)
ISO 14155(所有部分)
Related Standards
GB 12264-1990
Replaced
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