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Standard and/or project under the direct responsibility of ISO/TC 194 Secretariat | Stage | ICS |
---|---|---|
Cleanliness of medical devices — Process design and test methods
|
20.00 |
|
Cleanliness of medical devices — Process design and test methods
|
30.98 | |
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: Requirements and general principles for the evaluation of biological safety within a risk management process
|
40.60 | |
Biological evaluation of medical devices — Part 2: Animal welfare requirements
|
95.99 | |
Biological evaluation of medical devices — Part 2: Animal welfare requirements
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95.99 | |
Biological evaluation of medical devices — Part 2: Animal welfare requirements
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90.92 | |
Biological evaluation of medical devices — Part 2: Animal welfare requirements
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40.20 | |
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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95.99 | |
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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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: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity
|
30.60 |
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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
|
90.92 | |
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
|
50.20 | |
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
|
10.99 |
|
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
|
40.60 | |
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
|
40.99 | |
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
|
90.20 | |
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
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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
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95.99 | |
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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90.92 | |
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
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30.60 |
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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
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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
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95.99 | |
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
|
60.60 | |
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1
|
40.60 | |
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
|
90.92 | |
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
|
10.99 |
|
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
|
90.92 | |
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
|
10.99 |
|
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
|
90.20 | |
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
|
90.92 | |
Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables
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20.99 |
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Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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95.99 | |
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
|
60.60 | |
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1
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40.60 | |
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
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95.99 | |
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
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90.93 | |
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
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90.20 | |
Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
|
60.60 | |
Biological evaluation of medical devices — Part 23: Tests for irritation
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60.60 | |
Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models
|
40.20 | |
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
|
60.60 | |
Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
|
60.60 | |
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
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95.99 | |
Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
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95.99 | |
Clinical investigation of medical devices
|
95.99 | |
Clinical investigation of medical devices for human subjects — Good clinical practice
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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
|
90.92 | |
Clinical investigation of medical devices for human subjects — Good clinical practice
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40.60 | |
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 | |
Clinical evaluation of medical devices
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20.60 |
|
Biological evaluation of medical devices — Guidance on a risk-management process
|
95.99 | |
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
|
90.92 | |
Pyrogenicity — Principles and methods for pyrogen testing of medical devices
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10.99 |
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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 non-viable human materials - Risk management
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20.60 |
|
Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management
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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
|
90.92 | |
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
|
10.99 |
|
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 | |
Sources of hazard information for medical device constituents
|
10.99 |
|
Analytical chemistry matters associated with 10993-18 — Part 1: Identification of organic medical device extractables and leachables via Non-Target Analysis (NTA)
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20.00 |
|
Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA)
|
20.00 |
|
Analytical chemistry matters associated with ISO 10993-18 — Part 3: Instrumental and human requirements for performing Non-Targeted Analysis (NTA) for organic medical device extractables and leachables
|
20.00 |
|
Discovery, Identification and Quantification of Medical Device Extractables and Leachables via Non-Target Analysis (NTA) — Analytical Chemistry Matters Associated with ISO 10993-18
|
20.98 |
|
Biological evaluation of absorbable medical devices — Part 1: General requirements
|
90.93 | |
Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
|
60.60 |
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