Medical microbiology, see 07.100.10
Items to be displayed:
| Standard and/or project | Stage | TC |
|---|---|---|
| ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | 60.60 | ISO/TC 194 |
| ISO 10993-1:2009/Cor 1:2010 | 60.60 | ISO/TC 194 |
| ISO 10993-2:2006 Biological evaluation of medical devices -- Part 2: Animal welfare requirements | 90.60 | ISO/TC 194 |
| ISO/DIS 10993-3.2 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | 40.60 | ISO/TC 194 |
| ISO 10993-3:2003 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | 90.92 | ISO/TC 194 |
| ISO 10993-4:2002 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood | 90.92 | ISO/TC 194 |
| ISO 10993-4:2002/Amd 1:2006 | 60.60 | ISO/TC 194 |
| ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | 90.92 | ISO/TC 194 |
| ISO/AWI 10993-6 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | 20.00 | ISO/TC 194 |
| ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation | 90.92 | ISO/TC 194 |
| ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | 90.60 | ISO/TC 194 |
| ISO 10993-7:2008/Cor 1:2009 | 60.60 | ISO/TC 194 |
| ISO 10993-9:2009 Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | 60.60 | ISO/TC 194 |
| ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | 60.60 | ISO/TC 194 |
| ISO 10993-11:2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | 90.60 | ISO/TC 194 |
| ISO 10993-12:2012 Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | 60.60 | ISO/TC 194 |
| ISO 10993-13:2010 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices | 60.60 | ISO/TC 194 |
| ISO 10993-14:2001 Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics | 90.60 | ISO/TC 194 |
| ISO 10993-15:2000 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | 90.60 | ISO/TC 194 |
| ISO 10993-16:2010 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 | 90.60 | ISO/TC 194 |
| ISO 10993-18:2005 Biological evaluation of medical devices -- Part 18: Chemical characterization of materials | 90.60 | ISO/TC 194 |
| ISO/TS 10993-19:2006 Biological evaluation of medical devices -- Part 19: Physico-chemical, morphological and topographical characterization of materials | 90.60 | ISO/TC 194 |
| ISO/TS 10993-20:2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices | 90.60 | ISO/TC 194 |
| ISO 13022:2012 Medical products containing viable human cells -- Application of risk management and requirements for processing practices | 60.60 | ISO/TC 194/SC 1 |
| ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice | 60.60 | ISO/TC 194 |
| ISO 14155:2011/Cor 1:2011 | 60.60 | ISO/TC 194 |
| ISO/TR 15499:2012 Biological evaluation of medical devices -- Guidance on the conduct of biological evaluation within a risk management process | 60.60 | ISO/TC 194 |
| ISO/CD 16782 Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing | 30.20 | 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 | 90.93 | 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 | 90.60 | 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 | 90.60 | ISO/TC 212 |
| ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management | 90.60 | 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 | 90.60 | 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 | 90.60 | 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 | 60.60 | ISO/TC 194/SC 1 |
