GB 12264-1990
Replaced
YY/T 0988.3-2021
Active
Industry standards-Medicine
YY/T 0988.3-2021 Coatings of surgical implants—Part 3:Mussel adhesive proteins
YY/T 0988.3-2021 Coatings of surgical implants—Part 3:Mussel adhesive proteins
Basic Information
Standard Code:
YY/T 0988.3-2021
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:
2021-09-06
Implement Date:
2022-09-01
Pages:
16 pages
Scope
This document specifies the technical requirements and test methods for mussel adhesive protein materials used in the coating of surgical implants.
This document is applicable to mussel adhesive protein materials derived from mussels and used in the coating of surgical implants.
Development Information
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
中华人民共和国药典(2020年版四部)
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
YY/T 0615.2-2007 Requirements for medical devices to be designated "STERILE"—Part 2:Requirements for aseptically processed medical devices
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling
YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors
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