Medical microbiology, see 07.100.10
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Standard and/or project Stage TC
Biological evaluation of medical devices — Part 1: Evaluation and testing
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
90.92 ISO/TC 194
Biological evaluation of medical devices — Part 2: Animal welfare requirements
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 2: Animal welfare requirements
90.92 ISO/TC 194
Biological evaluation of medical devices — Part 2: Animal welfare requirements
60.00 ISO/TC 194
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
90.92 ISO/TC 194
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive and developmental toxicity
30.00 ISO/TC 194
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
90.60 ISO/TC 194
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
90.93 ISO/TC 194
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
90.92 ISO/TC 194
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
90.92 ISO/TC 194
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity — Amendment 1
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
90.20 ISO/TC 194
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
90.93 ISO/TC 194
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
90.93 ISO/TC 194
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
90.93 ISO/TC 194
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
90.92 ISO/TC 194
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
50.00 ISO/TC 194
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process — Amendment 1: Determination of the uncertainty factor
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
95.99 ISO/TC 194
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
90.92 ISO/TC 194
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 23: Tests for irritation
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
60.60 ISO/TC 194
Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
50.00 ISO/TC 194
Biological evaluation of medical devices — Guidance for interlaboratory studies to demonstrate the applicability of validated in-vitro methods to assess the skin sensitization of medical devices
30.99 ISO/TC 194
Medical products containing viable human cells — Application of risk management and requirements for processing practices
90.93 ISO/TC 194
Clinical investigation of medical devices for human subjects — Part 1: General requirements
95.99 ISO/TC 194
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
95.99 ISO/TC 194
Clinical investigation of medical devices for human subjects — Good clinical practice
95.99 ISO/TC 194
Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1
95.99 ISO/TC 194
Clinical investigation of medical devices for human subjects — Good clinical practice
60.60 ISO/TC 194
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
95.99 ISO/TC 194
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
95.99 ISO/TC 194
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
90.93 ISO/TC 212
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
95.99 ISO/TC 212
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
60.60 ISO/TC 212
Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
95.99 ISO/TC 212
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
60.60 ISO/TC 212
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
95.99 ISO/TC 212
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 against reference broth micro-dilution
60.60 ISO/TC 212
Biological evaluation of medical devices — Guidance on a risk-management process
95.99 ISO/TC 194
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
60.60 ISO/TC 194
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
90.93 ISO/TC 194
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
95.99 ISO/TC 194
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
95.99 ISO/TC 194
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
60.60 ISO/TC 194
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
95.99 ISO/TC 194
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
95.99 ISO/TC 194
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
60.60 ISO/TC 194
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
90.93 ISO/TC 194
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
90.93 ISO/TC 194

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