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 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 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: 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 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 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 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 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

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 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

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 laboratory testing — Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

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

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases

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

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 against reference broth micro-dilution

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

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

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 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes