GB/T 16886.11-1997
Replaced
YY/T 0879.1-2013
Active
Industry standards-Medicine
YY/T 0879.1-2013 Test for sensitization of medical devices—Part 1:Murine local lymph node assay (LLNA):Radioisotope incorporation method
YY/T 0879.1-2013 Test for sensitization of medical devices—Part 1:Murine local lymph node assay (LLNA):Radioisotope incorporation method
Basic Information
Standard Code:
YY/T 0879.1-2013
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2013-10-21
Implement Date:
2014-10-01
Pages:
8 pages
Scope
This part of YY/T 0879 provides a detection method for allergy testing of medical devices/materials.
This part is intended to provide an alternative method for guinea pig allergy testing, especially for medical devices/materials that only come into contact with intact skin. However, when evaluating the allergy response of metal materials or medical device products/materials used in deep tissues or damaged surfaces, it is still recommended to use guinea pig allergy testing.
This part is only applicable to low-molecular-weight chemicals that can penetrate the skin. The absorbed chemicals or metabolites can bind to macromolecular substances such as proteins to form immunogenic complexes.
Development Information
Referenced Standards
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
GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization
GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity
GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization
GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization
GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced