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KS ISO 10993-17:2002
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances.
Specifies a method for the determination of allowable limits for substances leachable from medical devices..
Kes 3,605.00
KS ISO 10993-2:1992
Biological evaluation of medical devices - Part 2: Animal welfare requirements.
Specifies minimum requirements for the use of animals in biological testing..
Kes 2,472.00
KS ISO 10993-4:2017
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
Provides provides general requirements for evaluating the interactions of medical devices with blood..
Kes 5,562.00
KS ISO 10993-5:1999
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
Describes test methods to assess the in vitro cytotoxicity of medical devices..
Kes 2,884.00
KS ISO 10993-6:1994
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.
Specifies test methods for the assessment of the local effects of an implant material on living tissue, at both the macroscopic and microscopic level..
Kes 3,038.00
KS ISO 10993-9:2019
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products.
Provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies..
Kes 3,038.00
KS ISO 10993-1:2018
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
Specifies the general principles governing the biological evaluation of medical devices within a risk management process..
Kes 5,562.00
KS ISO 10993-3:2014
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices..
Kes 3,862.00
KS ISO/TR 23644:2023
Blockchain and distributed ledger technologies (DLTs) Overview of trust anchors for DLT-based identity management
Describes concepts and considerations on the use of trust anchors for systems leveraging blockchain and distributed ledger technologies (DLTs) for identity management, i.e. the mechanism by which one or more entities can create, be given, modify, use..
Kes 3,605.00