DIN EN ISO 10993-1:2010 PDF

Standard No.: DIN EN ISO 10993-1:2010
Release Date: 2010
Published By: German Institute for Standardization
Status: Be replaced 2017-04
Replace By: DIN EN ISO 10993-1:2017
Latest: DIN EN ISO 10993-1:2010; DIN EN ISO 10993-1:2017; DIN EN ISO 10993-1:2021-05
Replace: DIN EN ISO 10993-1:2009 DIN EN ISO 10993-1:2007

Scope: The role of this part of ISO 10993 is to serve as a framework in which to plan a biological evaluation which, as scientific knowledge advances our understanding of the basic mechanisms of tissue responses, minimizes the number and exposure of test animals by giving preference to chemical constituent testing and in vitro models, in situations where these methods yield equally relevant information to that obtained from in vivo models. It is not intended that this international standard will provide a rigid set of test methods, including pass/fail criteria, as this might result in either an unnecessary constraint on the development and use of novel medical devices, or a false sense of security in the general use of medical devices. Where a particular application warrants it, experts in the product or in the area of application concerned can choose to establish specific tests and criteria, described in a product-specific vertical standard. This part of ISO 10993 is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcomes of the evaluation for each medical device, taking into consideration all the factors relevant to the device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.

DIN EN ISO 10993-1:2010 Referenced Document

ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements*， 2022-11-03 Update
ISO 10993-3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2014-10-01 Update
ISO 10993-4 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 cytotoxicity: in vitro methods
ISO 10993-6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation*， 2016-12-01 Update
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 10993-9 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update

2021 DIN EN ISO 10993-1:2021 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020
2017 DIN EN ISO 10993-1:2017 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
2010 DIN EN ISO 10993-1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009); German version EN ISO 10993-1:2009
2009 DIN EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003); German version EN ISO 10993-1:2009
0000 DIN EN ISO 10993-1:2007
2003 DIN EN ISO 10993-1:2003 Biological assessment of medical devices Part 1: Assessment and testing
1997 DIN EN ISO 10993-1 Berichtigung 1:1999 Biological assessment of medical devices – Part 1: Assessment and testing (ISO 10993-1: 1997)
1997 DIN EN ISO 10993-1:1998 Biological evaluation of medical devices – Part 1: Evaluation and testing