ISO 10993

Area	Medical technology, testing laboratories
title	Biological assessment of medical devices
Latest edition	2006-2010
ISO	10993

The standard ISO 10993 is an ISO standard set for the biological evaluation of medical devices . The standard is particularly relevant for manufacturers of medical devices and testing laboratories. The aim of the standard is to evaluate the biological assessment of the compatibility of the materials used with the body. It not only examines products, but also raw materials for the manufacture of medical products. The series of standards is not limited to implantable medical devices, but affects a large number of medical devices. In addition to biological testing, the standard also includes physical-chemical tests and analyzes of dissolved substances and substances and stipulates that limit values for leachable substances must be adhered to.

ISO 10993 is published in Germany as the DIN standard DIN EN ISO 10993.

ISO 10993 consists of several parts:

ISO 10993-1 Assessment and testing as part of a risk management process
ISO 10993-2 animal welfare regulations
ISO 10993-3 tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-4 Selection of tests for interaction with blood
ISO 10993-5 tests for in vitro cytotoxicity
ISO 10993-6 tests for local effects after implantations
ISO 10993-7 ethylene oxide sterilization residues
ISO 10993-8 Selection and suitability of reference materials for biological testing
ISO 10993-9 framework for the identification and quantification of possible degradation products
ISO 10993-10 tests for irritation and skin sensitization
ISO 10993-11 Systemic Toxicity Tests
ISO 10993-12 sample preparation and reference materials
ISO 10993-13 Qualitative and quantitative detection of degradation products in medical devices made from polymers
ISO 10993-14 Qualitative and quantitative evidence of ceramic degradation products
ISO 10993-15 Qualitative and quantitative evidence of decomposition products from metals and alloys
ISO 10993-16 Design and interpretation of toxicokinetic studies with regard to breakdown products and leachable components
ISO 10993-17 Proof of permissible limit values for detachable components
ISO 10993-18 Chemical characterization of materials
ISO 10993-19 Physical / chemical, mechanical and morphological characterization
ISO 10993-20 Principles and procedures for the immunotoxicological testing of medical devices