The Updated ISO 10993-18 In January 2020, the International Organization for Standardization (ISO) released their updated guidance ISO 10993 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process .
ISO 10993-18 (2005): 17 pages Chemical Characterization 10993-18 . 15 •The whole procedure is described on at the beginning of FDIS ISO 10993-18 (2019) ISO 10993 -1 • Provides guidance for establishing limits for compounds related to materials ISO 10993-17 •Outlines the test options for device materials ISO 10993-18 Standards for E&L testing • Provides guidance for the extraction conditions and solvents to select ISO 10993 -12 56 The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993 -1, "Biological evaluation of medical devices - Part 1 Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant. biological evaluation of medical devices - part 10: tests for irritation and skin sensitization (iso 10993-10:2010) i.s. en iso 10993-18:2009 : biological evaluation of medical devices - part 18: chemical characterization of materials (iso 10993-18:2005) en iso 10993-18 : 2009 ISO 10993-18:2018 specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization.
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials DIN EN ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 10993-2, ISO 10993-12, ISO 10993-16 and the following apply. 3.1 degradation decomposition of a material EN ISO 10993-10:2013 EN ISO 10993-10:2010 1 August, 2010 This document was published under the authority of the NSAI and comes into effect on: 1 Swift Square, Northwood, Santry Dublin 9 T +353 1 807 3800 F +353 1 807 3838 E standards@nsai.ie Údarás um Chaighdeáin Náisiúnta na hÉireann W 19 September, 2013 T +353 1 857 6730 F +353 1 857 6729 BS EN ISO 10993 series. Biological evaluation of medical devices BS EN ISO 10993 are being revised to contain informative annexes that identify the sections of the standard that conform to the Medical Devices Directives 93/42/EEC and 90/385/EEC, for medical devices and active implantable medical devices. ISO 10993-7:2008 4.4.3.1 Product sampling Samples to be used for residual analysis shall be selected in such a manner as to be truly representative of the product. When selecting samples, attention shall be given to the many factors described in Annex D.
This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources. The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1). ISO 10993-18:2005 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment. ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference materials ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials DIN EN ISO 10993-18 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 10993-2, ISO 10993-12, ISO 10993-16 and the following apply. 3.1 degradation decomposition of a material EN ISO 10993-10:2013 EN ISO 10993-10:2010 1 August, 2010 This document was published under the authority of the NSAI and comes into effect on: 1 Swift Square, Northwood, Santry Dublin 9 T +353 1 807 3800 F +353 1 807 3838 E standards@nsai.ie Údarás um Chaighdeáin Náisiúnta na hÉireann W 19 September, 2013 T +353 1 857 6730 F +353 1 857 6729 BS EN ISO 10993 series. Biological evaluation of medical devices BS EN ISO 10993 are being revised to contain informative annexes that identify the sections of the standard that conform to the Medical Devices Directives 93/42/EEC and 90/385/EEC, for medical devices and active implantable medical devices.
Hamburg, 15.01.2020, Dr. Silvia Georges. ISO published second edition of the ISO 10993-18 on chemical characterization of medical device materials. The ISO 11 Feb 2020 The final draft of the ISO 10993-18 standard (ISO / FDIS 10993-18: 2019, Biological evaluation of medical devices - Part 18: Chemical Download the exclusive whitepaper. be performed and documented [EN ISO 10993-18]. Measurement of the level of a leachable substance in a medical device is important in order to allow the. 10 Feb 2020 Highlights major changes to ISO 10993-18 and explains chemical risk assessment workflow, including extractables and leachables analysis. 25 Sep 2020 ISO 10993-18:2020; partial recognition. 2. Common questions about chemical analysis approaches when screening for extractables. a) General
This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist.
