Document Center List of Standards on Biological Evaluation Of Medical Devices Medical Microbiology, See 07.100.10
ICS Code 11.100.20
Return to ICS Index.Up to Level 2:
The following documents are a part of this series:
ASTM:
- ASTM-E2805 - Standard Practice for Measurement of the Biological Activity of Ricin
- ASTM-E3060 - Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
- ASTM-E3152 - Standard Guide for Standard Test Methods and Practices Available for Determining Antifungal Activity on Natural or Synthetic Substrates Treated with Antimicrobial Agents
- ASTM-F2567 - Standard Practice for Testing for Classical Pathway Complement Activation in Serum by Solid Materials (Withdrawn 2016)
BSI:
- BIP-0113 - Guide to European medical device trials and BS EN ISO 14155
- BS-EN-12442-1 - Animal tissues and their derivatives utilized in the manufacture of medical devices. Analysis and management of risk
- BS-EN-12442-2 - Animal tissues and their derivatives utilized in the manufacture of medical devices
- BS-EN-30993-3 - Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
- BS-EN-ISO-10993-1 - Biological evaluation of medical devices
- BS-EN-ISO-10993-10 - Biological evaluation of medical devices
- BS-EN-ISO-10993-11 - Biological evaluation of medical devices
- BS-EN-ISO-10993-12 - Biological evaluation of medical devices
- BS-EN-ISO-10993-12-TC - Tracked Changes. Biological evaluation of medical devices
- BS-EN-ISO-10993-13 - Biological evaluation of medical devices
- BS-EN-ISO-10993-14 - Biological evaluation of medical devices
- BS-EN-ISO-10993-15 - Biological evaluation of medical devices
- BS-EN-ISO-10993-15-TC - Tracked Changes. Biological evaluation of medical devices
- BS-EN-ISO-10993-16 - Biological evaluation of medical devices
- BS-EN-ISO-10993-17 - Biological evaluation of medical devices
- BS-EN-ISO-10993-17-TC - Tracked Changes. Biological evaluation of medical devices
- BS-EN-ISO-10993-18 - Biological evaluation of medical devices
- BS-EN-ISO-10993-1-TC - Tracked Changes. Biological evaluation of medical devices
- BS-EN-ISO-10993-23 - Biological evaluation of medical devices
- BS-EN-ISO-10993-3 - Biological evaluation of medical devices
- BS-EN-ISO-10993-4 - Biological evaluation of medical devices
- BS-EN-ISO-10993-5 - Biological evaluation of medical devices
- BS-EN-ISO-10993-6 - Biological evaluation of medical devices
- BS-EN-ISO-10993-6-TC - Tracked Changes. Biological evaluation of medical devices
- BS-EN-ISO-10993-7 - Biological evaluation of medical devices
- BS-EN-ISO-10993-7-TC - Tracked Changes. Biological evaluation of medical devices
- BS-EN-ISO-10993-9 - Biological evaluation of medical devices
- BS-EN-ISO-10993-9-TC - Tracked Changes. Biological evaluation of medical devices
- BS-EN-ISO-14155-1 - Clinical investigation of medical devices for human subjects
- BS-EN-ISO-14155-2 - Clinical investigation of medical devices for human subjects
- BS-EN-ISO-14155-TC - Tracked Changes. Clinical investigation of medical devices for human subjects. Good clinical practice
- BS-EN-ISO-20776-2 - Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices
- BS-EN-ISO-20776-2-TC - Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices
- BS-EN-ISO-22442-1 - Medical devices utilizing animal tissues and their derivatives
- BS-EN-ISO-22442-2 - Medical devices utilizing animal tissues and their derivatives
- BS-EN-ISO-22442-3 - Medical devices utilizing animal tissues and their derivatives
- BS-EN-ISO-7405 - Dentistry. Evaluation of biocompatibility of medical devices used in dentistry
- BS-ISO-17593-TC - Tracked Changes. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
- PD-ISO-10993-19 - Biological evaluation of medical devices
- PD-ISO-10993-22 - Biological evaluation of medical devices
- PD-ISO-10993-33 - Biological evaluation of medical devices
- PD-ISO-11796 - 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
- PD-ISO-15499 - Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
- PD-ISO-15499-TC - Tracked Changes. Biological evaluation of medical devices. Guidance on the conduct of biological evaluation within a risk management process
- PD-ISO-21582 - Pyrogenicity. Principles and methods for pyrogen testing of medical devices
- PD-ISO-21726 - Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
ISO:
- ISO-10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO-10993-10 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO-10993-10-1 - Amendment 1: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation
- ISO-10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO-10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO-10993-13 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
- ISO-10993-14 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
- ISO-10993-15 - Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
- ISO-10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
- ISO-10993-17 - Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
- ISO-10993-18 - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
- ISO-10993-18-AM1 - - Amendment 1: 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
- ISO-10993-19 - Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
- ISO-10993-2 - Biological evaluation of medical devices - Part 2: Animal welfare requirements
- ISO-10993-20 - Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
- ISO-10993-22 - Biological evaluation of medical devices - Part 22: Guidance on nanomaterials
- ISO-10993-23 - Biological evaluation of medical devices - Part 23: Tests for irritation
- ISO-10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO-10993-33 - Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
- ISO-10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- ISO-10993-4-1 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1
- ISO-10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO-10993-55 - Biological evaluation of medical devices - Part 55: Interlaboratory study on cytotoxicity
- ISO-10993-6 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- ISO-10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO-10993-7-1 - Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals Amendment 1: Applicability of allowable limits for neonates and infants
- ISO-10993-9 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
- ISO-11796 - 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
- ISO-13022 - Medical products containing viable human cells - Application of risk management and requirements for processing practices
- ISO-14155 - Clinical investigation of medical devices for human subjects - Good clinical practice
- ISO-14155-RL - Clinical investigation of medical devices for human subjects - Good clinical practice
- ISO-15499 - Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
- ISO-16782 - Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
- ISO-17593 - Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
- ISO-20776-1 - 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
- ISO-20776-2 - 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
- ISO-20993 - Biological evaluation of medical devices - Guidance on a risk-management process
- ISO-21582 - Pyrogenicity - Principles and methods for pyrogen testing of medical devices
- ISO-21726 - Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
- ISO-22442-1 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- ISO-22442-2 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- ISO-22442-3 - 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
- ISO-22442-4 - 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
- ISO/DIS-10993-2 - Biological evaluation of medical devices - Part 2: Animal welfare requirements
- ISO/DIS-14155 - Clinical Investigation of Medical Devices for Human Subject - Good Clinical Practice
- ISO/FDIS-14155 - Clinical investigation of medical devices for human subjects - Good clinical practice
Other SDOs:
- AAMI/ISO-14155 - Clinical investigation of medical devices for human subjects
- AAMI/ISO-TIR22442-4 - 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
- ANSI/AAMI/ISO-13022 - Medical products containing viable human cells - Application of risk management and requirements for processing practices (ANSI/AAMI/ISO 13022:2012)
- DIN-EN-ISO-10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- DIN-EN-ISO-10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006); German version EN ISO 10993-11:2009
- DIN-EN-ISO-10993-18 - Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005); German version EN ISO 10993-18:2009
- DIN-EN-ISO-10993-2 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006); German version EN ISO 10993-2:2006
- DIN-EN-ISO-10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006); German version EN ISO 10993-4:2009
- DIN-EN-ISO-22442-1 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- DIN-EN-ISO-22442-2 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- DIN-EN-ISO-22442-3 - 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 (ISO 22442-3:2007); German version EN ISO 22442-3:2007
- EN-12442-1 - Part 1: Analysis & Management of Risk, Animal Tissues & Their Derivatives Utilized In
- EN-ISO-10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- EN-ISO-10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
- EN-ISO-10993-11 - Part 11: Tests for Systemic Toxicity, Biological Evaluation of Medical Devices
- EN-ISO-10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
- EN-ISO-10993-13 - Biological Evaluation of Medical Devices, Identification & Quantification of Degradati
- EN-ISO-10993-14 - Part 14: Identification & Quantification of Degradation Products From Ceramics, Biolog
- EN-ISO-10993-15 - Part 15: Identification & Quantification of Degradation Products From Metals & Alloys,
- EN-ISO-10993-16 - Part 16: Toxicokinetic Study Design for Degradation Products & Leachables, Biological
- EN-ISO-10993-17 - Part 17: Establishment of Allowable Limits for Leachable Substances, Biological Evalua
- EN-ISO-10993-18 - Part 18: Chemical Characterization of Materials, Biological Evaluation of Medical Dev
- EN-ISO-10993-2 - Part 2: Animal Welfare Requirements, Biological Evaluation of Medical Devices
- EN-ISO-10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- EN-ISO-10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
- EN-ISO-10993-5 - Part 5: Tests for in Vitro Cytotoxicity, Biological Evaluation of Medical Devices
- EN-ISO-10993-6 - Part 6: Tests for Local Effects After Implantation, Biological Evaluation of Medical D
- EN-ISO-10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- EN-ISO-10993-9 - Part 9: Framework for Identification & Quantification of Potential Degradation Product
- EN-ISO-14155 - Clinical investigation of medical devices for human subjects - Good clinical practice
- EN-ISO-14155-1 - Part 1: General Requirements, Clinical Investigation of Medical Devices for Human Subj
- EN-ISO-14155-2 - Part 2: Clinical Investigation Plans, Clinical Investigation of Medical Devices for Hu
- EN-ISO-20776-2 - Clinical Laboratory Testing & in Vitro Diagnostic Test Systems, Susceptibility Testing
- EN-ISO-22442-1 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- EN-ISO-22442-2 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
- EN-ISO-22442-3 - Medical Devices Utilizing Animal Tissues and Their Derivatives, Validation of the Elimin
- JIS-T-0993-1 - Part 1: Evaluation & Testing, Biological Evaluation of Medical Devices (Japanese)
- SIS-EN-ISO-10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
- SIS-ISO/TS-21726 - Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of extractable substances from medical devices (ISO/TS 21726:2019)
- SS-EN-ISO-10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)
- SS-EN-ISO-10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
- SS-EN-ISO-10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
- SS-EN-ISO-10993-13 - Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
- SS-EN-ISO-10993-14 - Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
- SS-EN-ISO-10993-15 - Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
- SS-EN-ISO-10993-16 - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
- SS-EN-ISO-10993-17 - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
- SS-EN-ISO-10993-18 - Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)
- SS-EN-ISO-10993-18-AM1 - 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 (ISO 10993-18:2020/Amd 1:2022)
- SS-EN-ISO-10993-2 - Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
- SS-EN-ISO-10993-23 - Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
- SS-EN-ISO-10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
- SS-EN-ISO-10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
- SS-EN-ISO-10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
- SS-EN-ISO-10993-6 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
- SS-EN-ISO-10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
- SS-EN-ISO-10993-7-AM1 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)
- SS-EN-ISO-10993-9 - Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
- SS-EN-ISO-14155 - Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)
- SS-EN-ISO-14155-1 - Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
- SS-EN-ISO-14155-2 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
- SS-EN-ISO-20776-1 - 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 (ISO 20776-1:2019, including Corrected version 2019-12)
- SS-EN-ISO-20776-2 - 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 (ISO 20776-2:2021)
- SS-EN-ISO-22442-1 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)
- SS-EN-ISO-22442-2 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020)
- SS-EN-ISO-22442-3 - 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 (ISO 22442-3:2007)
- SS-EN-ISO/IEC-30111 - Information technology - Security techniques - Vulnerability handling processes (ISO/IEC 30111:2019)
- SS-ISO-10993-17 - Biological evaluation of medical devices Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023, IDT)
- SS-ISO-17593 - Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy (ISO 17593:2022, IDT)
- UNE-EN-ISO-22442-1 - Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
- UNE-EN-ISO-22442-2 - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling