Фильтр :
Стандарт и/или проект находящийся в компетенции ISO/TC 194 Секретариата Этап ICS
Cleanliness of medical devices — Process design and test methods
20.20
Biological evaluation of medical devices — Part 1: Guidance on selection of tests
95.99
Biological evaluation of medical devices — Part 1: Guidance on selection of tests — Technical Corrigendum 1
95.99
Biological evaluation of medical devices — Part 1: Evaluation and testing
95.99
Biological evaluation of medical devices — Part 1: Evaluation and testing
95.99
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
95.99
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1
95.99
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
90.92
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
20.20
Biological evaluation of medical devices — Part 2: Animal welfare requirements
95.99
Biological evaluation of medical devices — Part 2: Animal welfare requirements
90.92
Biological evaluation of medical devices — Part 2: Animal welfare requirements
50.20
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
95.99
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
95.99
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
90.92
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive and developmental toxicity
30.00
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
95.99
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
95.99
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
95.99
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
90.60
Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
95.99
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
95.99
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
90.93
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
20.60
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
95.99
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
95.99
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
90.92
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
95.99
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
90.92
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants
60.60
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1
60.60
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
20.00
Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests
95.99
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
95.99
Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing
95.99
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
95.99
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
60.60
Biological evaluation of medical devices — Part 10: Tests for irritation and sensitization
95.99
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity
95.99
Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity — Amendment 1
95.99
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
95.99
Biological evaluation of medical devices — Part 10: Tests for skin sensitization
60.60
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
95.99
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
95.99
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
90.20
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
95.99
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
60.60
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
95.99
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
90.93
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
90.93
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
95.99
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys
60.60
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
95.99
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
95.99
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
90.93
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
90.92
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
50.00
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
95.99
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
60.60
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
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
95.99
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
60.60
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
30.00
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
90.92
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
60.60
Biological evaluation of medical devices — Part 23: Tests for irritation
60.60
Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3
60.60
Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
50.00
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
Medical products containing viable human cells — Application of risk management and requirements for processing practices
90.93
Clinical investigation of medical devices for human subjects — Part 1: General requirements
95.99
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
95.99
Clinical investigation of medical devices
95.99
Clinical investigation of medical devices for human subjects — Good clinical practice
95.99
Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1
95.99
Clinical investigation of medical devices for human subjects — Good clinical practice
60.60
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
95.99
Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process
95.99
Biological evaluation of medical devices — Guidance on a risk-management process
95.99
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
60.60
Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
90.93
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
95.99
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
95.99
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
60.60
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
95.99
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
95.99
Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
60.60
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
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
Biological evaluation of absorbable medical devices — Part 1: General requirements
60.60
Biological evaluation of absorbable medical devices — Part 2: Standard guide for absorbable metals
30.60
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
90.92

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