Medical microbiology, see 07.100.10
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Standard and/or project Stage TC
ISO 10993-10:2002
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity
95.99 ISO/TC 194
ISO 10993-10:2002/Amd 1:2006
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity — Amendment 1
95.99 ISO/TC 194
ISO 10993-10:2010
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
90.92 ISO/TC 194
ISO 10993-11:1993
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
95.99 ISO/TC 194
ISO 10993-11:2006
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
95.99 ISO/TC 194
ISO 10993-11:2017
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
60.60 ISO/TC 194
ISO 10993-12:2002
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99 ISO/TC 194
ISO 10993-12:2007
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99 ISO/TC 194
ISO 10993-12:2012
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
90.92 ISO/TC 194
ISO 10993-13:1998
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
95.99 ISO/TC 194
ISO 10993-13:2010
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
90.93 ISO/TC 194
ISO 10993-14:2001
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
90.93 ISO/TC 194
ISO 10993-15
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
60.00 ISO/TC 194
ISO 10993-15:2000
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
90.92 ISO/TC 194
ISO 10993-16:1997
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
95.99 ISO/TC 194
ISO 10993-16:2010
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
95.99 ISO/TC 194
ISO 10993-16:2017
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
60.60 ISO/TC 194
ISO 10993-17:2002
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
90.92 ISO/TC 194
ISO 10993-18
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
60.00 ISO/TC 194
ISO 10993-18:2005
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
90.92 ISO/TC 194
ISO 10993-1:2003
Biological evaluation of medical devices — Part 1: Evaluation and testing
95.99 ISO/TC 194
ISO 10993-1:2009
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
95.99 ISO/TC 194
ISO 10993-1:2009/Cor 1:2010
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1
95.99 ISO/TC 194
ISO 10993-1:2018
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
60.60 ISO/TC 194
ISO 10993-2:1992
Biological evaluation of medical devices — Part 2: Animal welfare requirements
95.99 ISO/TC 194
ISO 10993-2:2006
Biological evaluation of medical devices — Part 2: Animal welfare requirements
90.92 ISO/TC 194
ISO 10993-3:2003
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
95.99 ISO/TC 194
ISO 10993-3:2014
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
90.20 ISO/TC 194
ISO 10993-4:2002
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
95.99 ISO/TC 194
ISO 10993-4:2002/Amd 1:2006
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
95.99 ISO/TC 194
ISO 10993-4:2017
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
60.60 ISO/TC 194
ISO 10993-5:1999
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
95.99 ISO/TC 194
ISO 10993-5:2009
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
90.93 ISO/TC 194
ISO 10993-6:1994
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
95.99 ISO/TC 194
ISO 10993-6:2007
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
95.99 ISO/TC 194
ISO 10993-6:2016
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
60.60 ISO/TC 194
ISO 10993-7:1995
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
95.99 ISO/TC 194
ISO 10993-7:2008
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
90.93 ISO/TC 194
ISO 10993-7:2008/Amd 1
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
60.00 ISO/TC 194
ISO 10993-7:2008/Cor 1:2009
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
60.60 ISO/TC 194
ISO 10993-8:2000
Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests
95.99 ISO/TC 194
ISO 10993-9
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
60.00 ISO/TC 194
ISO 10993-9:1999
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
95.99 ISO/TC 194
ISO 10993-9:2009
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
90.92 ISO/TC 194
ISO/AWI 10993-17
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
20.00 ISO/TC 194
ISO/CD 10993-10
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
30.60 ISO/TC 194
ISO/CD 10993-2
Biological evaluation of medical devices — Part 2: Animal welfare requirements
30.60 ISO/TC 194
ISO/DIS 10993-12
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
40.60 ISO/TC 194
ISO/DIS 10993-23
Biological evaluation of medical devices — Part 23: Tests for irritation
40.60 ISO/TC 194
ISO/PRF TS 10993-19
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
50.00 ISO/TC 194
ISO/TR 10993-22:2017
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
60.60 ISO/TC 194
ISO/TR 10993-33:2015
Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
60.60 ISO/TC 194
ISO/TS 10993-19:2006
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
90.92 ISO/TC 194
ISO/TS 10993-20:2006
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
90.92 ISO/TC 194
ISO 13022:2012
Medical products containing viable human cells — Application of risk management and requirements for processing practices
90.93 ISO/TC 194/SC 1
ISO 14155-1:2003
Clinical investigation of medical devices for human subjects — Part 1: General requirements
95.99 ISO/TC 194
ISO 14155-2:2003
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
95.99 ISO/TC 194
ISO 14155:2011
Clinical investigation of medical devices for human subjects — Good clinical practice
90.92 ISO/TC 194
ISO 14155:2011/Cor 1:2011
Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1
60.60 ISO/TC 194
ISO/FDIS 14155
Clinical investigation of medical devices for human subjects — Good clinical practice
50.00 ISO/TC 194
ISO/TR 15499:2012
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
95.99 ISO/TC 194
ISO/TR 15499:2016
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
95.99 ISO/TC 194
ISO/TS 16782:2016
Clinical laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
90.20 ISO/TC 212
ISO 17593:2007
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
90.92 ISO/TC 212
ISO/CD 17593
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
30.60 ISO/TC 212
ISO 20776-1:2006
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
ISO 20776-1:2019
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
ISO 20776-2:2007
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
90.92 ISO/TC 212
ISO/NP 20776-2
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
10.99 ISO/TC 212
ISO/TS 20993:2006
Biological evaluation of medical devices — Guidance on a risk-management process
95.99 ISO/TC 194
ISO/DTR 21582
Pyrogenicity — Principle and method for pyrogen testing of medical devices
30.60 ISO/TC 194
ISO/TS 21726:2019
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
60.60 ISO/TC 194
ISO 22442-1:2007
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
95.99 ISO/TC 194/SC 1
ISO 22442-1:2015
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
90.92 ISO/TC 194/SC 1
ISO 22442-2:2007
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
95.99 ISO/TC 194/SC 1
ISO 22442-2:2015
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
90.92 ISO/TC 194/SC 1
ISO 22442-3:2007
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/SC 1
ISO/DIS 22442-1
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
40.60 ISO/TC 194/SC 1
ISO/DIS 22442-2
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
40.60 ISO/TC 194/SC 1
ISO/TR 22442-4:2010
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/SC 1

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