ISO/TR 10993-22:2017 - $209.00   BUY NOW

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

ISO/TR 10993-22:2017 Publication Description:

ISO/TR 10993-22:2017 describes considerations for the biological evaluation of medical devices that are composed of or contain nanomaterials. In addition, this guidance can also be used for the evaluation of nano-objects generated as products of degradation, wear, or from mechanical treatment processes (e.g. in situ grinding, polishing of medical devices) from (components of) medical devices that are manufactured not using nanomaterials.

ISO/TR 10993-22:2017 includes considerations on the:

- characterization of nanomaterials;

- sample preparation for testing of nanomaterials;

- release of nano-objects from medical devices;

- toxicokinetics of nano-objects;

- biological evaluation of nanomaterials;

- presentation of results;

- risk assessment of nanomaterials in the context of medical device evaluation;

- biological evaluation report;

- nanostructures on the surface of a medical device, intentionally generated during the engineering, manufacturing or processing of a medical device.

The following are excluded from this document:

- natural and biological nanomaterials, as long as they have not been engineered, manufactured or processed for use in a medical device;

- intrinsic nanostructures in a bulk material;

- nanostructures on the surface of a medical device, generated as an unintentional by-product during the engineering, manufacturing or processing of a medical device.

NOTE Examples of unintentional nanostructures on the surface of a medical device are extrusion draw lines and machining/tool marks.

ISO/TR 10993-22:2017 is intended to provide a general framework and highlights important aspects which need to be considered when assessing the safety of medical devices composed of, containing and/or generating nano-objects. Additionally, the document identifies several common pitfalls and obstacles which have been identified when testing nanomaterials compared to bulk materials or small molecule chemical species. As a technical report (TR), this document represents the current technical knowledge related to nanomaterials. No detailed testing protocols are outlined or provided. This document can serve as a basis for future documents containing detailed protocols with a focus on nanomaterial testing.

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
$138.00 ISO 22442-3:2007 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
$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 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