Standards for evaluating biocompatibility of medical devices
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]
For the purpose of the ISO 10993 family of standards, biocompatibility is defined as the "ability of a medical device or material to perform with an appropriate host response in a specific application".
^"Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)" (PDF). fda.gov. FDA. Retrieved 23 January 2017.
The ISO10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were...
testing within a risk management process (ISO10993-1:2009). International Organization for Standardization (ISO). 2009. OCLC 839985896. "Selective Laser...
that is a large battery of in vitro test that is used in accordance with ISO10993 (or other similar standards) to determine if a certain material (or rather...
medical applications and comply with both ISO10993-1 and USP Class VI standards (occasionally referred to as PC-ISO). Class VI is the most stringent of the...
Tygon Medical/Surgical Tubing S-50-HL — Characterized to the latest ISO10993 standards and U.S. Food and Drug Administration (FDA) guidelines for biocompatibility...
or ISO 5832-1 compliant Steel that is ISO10993-6, 10993-10, and/or 10993-11 compliant Titanium (Ti6Al4V ELI) that is ASTM F136 compliant or ISO 5832-3...
Biological Reactivity Test and the International Standards Organization 10993 (ISO10993) Biological Evaluation of Medical Devices. The main objective of biocompatibility...
consistent performance. EN ISO 15223-1 defines symbols that can be used to convey important information on packaging and labeling. ISO10993 - Biological Evaluation...
and advertise ISO 13485 certification. ISO 13485 (quality management for the design and manufacturing of medical devices) and ISO10993 (biocompatibility...
applications: Orthopaedic Dental ISO and FDA set standards for evaluating and determining biocompatibility. ISO10993 Standards-"Biological Evaluation...
219–239, ed. by S. Kurfürst and S. Wehner. Transcript (Bielefeld). hdl:10993/43963. Wikimedia Commons has media related to: ក្រុងភ្នំពេញ (category) Official...
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