Characterization of residuals relevant to the biological evaluation of medical devices

Biological evaluation of medical devices — Part 1: Guidance on selection of tests

Biological evaluation of medical devices — Part 1: Guidance on selection of tests — Technical Corrigendum 1

Biological evaluation of medical devices — Part 1: Evaluation and testing

Biological evaluation of medical devices — Part 1: Evaluation and testing

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

Biological evaluation of medical devices — Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

Biological evaluation of medical devices — Part 2: Animal welfare requirements

Biological evaluation of medical devices — Part 2: Animal welfare requirements

Biological evaluation of medical devices — Part 2: Animal welfare requirements

Biological evaluation of medical devices — Part 2: Animal welfare requirements

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Biological evaluation of medical devices — Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1

Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood

Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Biological evaluation of medical devices — Part 6: Tests for local effects after implantation

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Technical Corrigendum 1

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Biological evaluation of medical devices — Part 8: Selection and qualification of reference materials for biological tests

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products

Biological evaluation of medical devices — Part 10: Tests for irritation and sensitization

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity

Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity — Amendment 1

Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization

Biological evaluation of medical devices — Part 10: Tests for skin sensitization

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — Amendment 1

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

Biological evaluation of medical devices — Part 16: Toxicokinetic evaluation for degradation products and leachables

Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents

Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents — Amendment 1

Biological evaluation of medical devices — Part 18: Chemical characterization of materials

Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

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

Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

Biological evaluation of medical devices — Part 22: Guidance on nanomaterials

Biological evaluation of medical devices — Part 23: Tests for irritation

Biological evaluation of medical devices — Part 23: Tests for irritation — Amendment 1: Additional in vitro reconstructed human epidermis models

Biological evaluation of medical devices — Part 33: Guidance on tests to evaluate genotoxicity — Supplement to ISO 10993-3

Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity

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

Biological evaluation of medical devices — Guidance on commissioning scientifically robust chemical characterization testing in accordance with ISO 10993-18

Medical products containing viable human cells — Application of risk management and requirements for processing practices

Clinical investigation of medical devices for human subjects — Part 1: General requirements

Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans

Clinical investigation of medical devices

Clinical investigation of medical devices for human subjects — Good clinical practice

Clinical investigation of medical devices for human subjects — Good clinical practice — Technical Corrigendum 1

Clinical investigation of medical devices for human subjects — Good clinical practice

Clinical investigation of medical devices for human subjects — Good clinical practice

Clinical investigation of medical devices for human subjects — Good clinical practice

Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

Biological evaluation of medical devices — Guidance on the conduct of biological evaluation within a risk management process

Clinical evaluation of medical devices

Generation of medical device extracts for chemical analysis to support toxicological risk assessment

Biological evaluation of medical devices — Guidance on a risk-management process

Pyrogenicity — Principles and methods for pyrogen testing of medical devices

Pyrogenicity — Principles and methods for pyrogen testing of medical devices

Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

Medical devices utilizing non-viable human materials — Risk management

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

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

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

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

Sources of hazard information for medical device constituents

Chemical characterization of medical devices — Part 1: Identification of organic extractables in Non-Targeted Analysis (NTA)

Analytical chemistry matters associated with ISO 10993-18 — Part 2: Quantification of medical device extractables and leachables using Non-Targeted Analysis (NTA)

Analytical chemistry matters associated with ISO 10993-18 — Part 3: Instrumental and human requirements for evaluating organic medical device extractables and leachables via Non-Targeted Analysis (NTA)

Analytical chemistry matters associated with ISO 10993-18 — Part 4: Critical aspects of extract viability in extractables and leachables testing using non-targeted analysis (NTA)

Medical devices utilizing bioengineered biological substances — Application of risk management

Biological evaluation of medical devices – Guidance on risk estimation in the application of ISO 10993-1

Biological evaluation of medical devices — Guidance on the impact of bioaccumulation and intermittent contact in the application of ISO 10993-1

Biological evaluation of absorbable medical devices — Part 1: General requirements

Biological evaluation for absorbable medical devices — Part 2: Evaluation and testing of medical devices for soft tissue repair

Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants