The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite …

Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes …

2025年2月20日 · Reviewing a Tech Talk from MD&M West 2025: Key Updates to the New Revision of ISO 10993-1. February 20, 2025 | By: Kate Corr. At this year’s MD&M West trade …

ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process, is the most widely used standard for assessing the …

ISO 10993 series is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcome of the evaluation …

2024年4月2日 · ISO 10993-3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity: (latest 2014) Addressing potential long-term risks, this standard outlines testing methods to …

The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact). This document is …

2025年1月16日 · The ISO 10993 standard, acknowledged globally, outlines the biological evaluation of medical instruments, providing a comprehensive framework for assessing …

ISO/TS 10993-20: NBRISO7405 - Odontologia - Avaliação da biocompatibilidade de produtos para a saúde utilizados em odontologia: NBRISO11135-1 - Esterilização de produtos de …

Norma ISO 10993 - NormasISO.org