ISO 22442-3:2007 - $138.00   BUY NOW

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 Publication Description:

ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Biological Evaluation-Medical Devices (11.100.20)

ICS Related Standards

Cart Document Number Document Title
$138.00 ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
$209.00 ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
$138.00 ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
$138.00 ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
$103.00 ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
$68.00 ISO 10993-14:2001 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
$68.00 ISO 10993-15:2000 Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys
$68.00 ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
$138.00 ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
$103.00 ISO 10993-18:2005 Biological evaluation of medical devices - Part 18: Chemical characterization of materials
$103.00 ISO/TS 10993-19:2006 Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
$103.00 ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
$103.00 ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
$162.00 ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
$185.00 ISO/TR 10993-33:2015 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
$162.00 ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
$19.00 ISO 10993-4/Amd1:2006 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood - Amendment 1
$162.00 ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
$162.00 ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
$149.00 ISO 10993-6:2007 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
$232.00 ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
$68.00 ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
$185.00 ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
$209.00 ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
$103.00 ISO/TR 15499:2016 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
$123.00 ISO/TR 15499:2012 Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
$138.00 ISO/TS 16782:2016 Clinical laboratory testing - Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
$209.00 ISO 17593:2007 Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
$138.00 ISO 20776-1:2006 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
$68.00 ISO 20776-2:2007 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
$162.00 ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
$149.00 ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
$103.00 ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
$123.00 ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
$103.00 ISO/TR 22442-4:2010 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
$103.00 ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
$209.00 ISO/TR 10993-22:2017 Biological evaluation of medical devices - Part 22: Guidance on nanomaterials
$209.00 ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
$162.00 ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity