Standards catalogue

11.100.20 - Biological evaluation of medical devices

Medical microbiology, see 07.100.10
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Standard and/or project Stage TC
ISO 10993-1:2003 [Withdrawn]
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
90.92 ISO/TC 194
60.60 ISO/TC 194
ISO/DIS 10993-1 [Under development]
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
40.99 ISO/TC 194
ISO 10993-2:1992 [Withdrawn]
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
90.60 ISO/TC 194
ISO 10993-3:2003 [Withdrawn]
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
60.60 ISO/TC 194
ISO 10993-4:2002 [Withdrawn]
Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
95.99 ISO/TC 194
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ISO 10993-5:1999 [Withdrawn]
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/CD 10993-5 [Deleted]
Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
30.98 ISO/TC 194
ISO 10993-6:1994 [Withdrawn]
Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
95.99 ISO/TC 194
ISO 10993-6:2007 [Withdrawn]
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ISO 10993-7:1995 [Withdrawn]
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/CD Amd 1 [Under development]
30.99 ISO/TC 194
60.60 ISO/TC 194
ISO/WD 10993-7 [Deleted]
Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals
20.98 ISO/TC 194
ISO 10993-8:2000 [Withdrawn]
Biological evaluation of medical devices -- Part 8: Selection and qualification of reference materials for biological tests
95.99 ISO/TC 194
ISO 10993-9:1999 [Withdrawn]
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
90.93 ISO/TC 194
ISO/CD 10993-9 [Under development]
Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
30.99 ISO/TC 194
ISO 10993-10:2002 [Withdrawn]
Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity
95.99 ISO/TC 194
95.99 ISO/TC 194
ISO 10993-10:2010
Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
90.93 ISO/TC 194
ISO 10993-11:1993 [Withdrawn]
Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
95.99 ISO/TC 194
ISO 10993-11:2006 [Withdrawn]
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 [Withdrawn]
Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
95.99 ISO/TC 194
ISO 10993-12:2007 [Withdrawn]
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
90.60 ISO/TC 194
ISO 10993-13:1998 [Withdrawn]
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 10993-15:2000
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
90.92 ISO/TC 194
ISO/CD 10993-15 [Under development]
Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
30.99 ISO/TC 194
ISO 10993-16:1997 [Withdrawn]
Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
95.99 ISO/TC 194
ISO 10993-16:2010 [Withdrawn]
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
90.93 ISO/TC 194
ISO 10993-18:2005
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
90.93 ISO/TC 194
ISO/CD 10993-18 [Under development]
Biological evaluation of medical devices -- Part 18: Chemical characterization of materials
30.99 ISO/TC 194
ISO/NP TS 10993-19 [Under development]
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
10.99 ISO/TC 194
ISO/TS 10993-19:2006
Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials
90.93 ISO/TC 194
ISO/NP TS 10993-20 [Under development]
Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
10.99 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/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 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 14155:2011
Clinical investigation of medical devices for human subjects -- Good clinical practice
90.92 ISO/TC 194
60.60 ISO/TC 194
ISO/CD 14155 [Under development]
Clinical investigation of medical devices for human subjects -- Good clinical practice
30.99 ISO/TC 194
ISO 14155-1:2003 [Withdrawn]
Clinical investigation of medical devices for human subjects -- Part 1: General requirements
95.99 ISO/TC 194
ISO 14155-2:2003 [Withdrawn]
Clinical investigation of medical devices for human subjects -- Part 2: Clinical investigation plans
95.99 ISO/TC 194
ISO/TR 15499:2012 [Withdrawn]
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
60.60 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
60.60 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
90.60 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
90.92 ISO/TC 212
ISO/NP 20776-1 [Under development]
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
10.99 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
90.60 ISO/TC 212
ISO/TS 20993:2006 [Withdrawn]
Biological evaluation of medical devices -- Guidance on a risk-management process
95.99 ISO/TC 194
ISO/DTR 21582 [Under development]
Pyrogenicity -- Principle and method for pyrogen testing of medical devices
30.60 ISO/TC 194
ISO 22442-1:2007 [Withdrawn]
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/NP 22442-1 [Under development]
Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
10.99 ISO/TC 194/SC 1
ISO 22442-2:2007 [Withdrawn]
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/NP 22442-2 [Under development]
Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
10.99 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/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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