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Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
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Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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Medical devices utilizing animal tissues and their derivatives - Part 3:Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy(TSE) agents
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Biological evaluation of medical devices - Part 22: Guidance on nanomaterials
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Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
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Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy(TSE) agents and validation assays for those processes
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Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
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Clinical laboratory testing в”Ђ Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
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