Convert Swiss francs (CHF) to your currency. This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the …

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 agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1]

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications,...

It is intended to describe the biological evaluation of medical devices within a risk management process, as part of the overall evaluation and development of each medical device.

Feb 20, 2025 · At this year’s MD&M West trade show, Nicholas Christiano, Global Segment Leader for Biological Safety at Nelson Laboratories, presented on updates to the new revision of ISO 10993-1, the cornerstone standard guiding biocompatibility assessments for medical devices.

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 for each medical

ISO 10993-1 requires an actual identification of device constituents and manufacturing materials. If a material characterization is performed, it is to be performed in accordance with ISO 10993-18 (ISO/TR 10993-2 applies if nanomaterials are involved). The tested medical device should have completed all steps of its manufacturing

This fourth edition of ISO 10993-3 cancels and replaces the third edition (ISO 10993-3:2014), which has been technically revised. The main changes compared to the previous edition are as follows: Deletion of the Annex on Cellular Transformation;

ISO 10993, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing with a Risk Management System, provides a framework for determining the appropriate biocompatibility tests for a given medical device.