Iso 10993 wikipedia

Retrieved 23 January Categories : Regulation of medical devices Testing standards. Hidden category: Articles transcluded from other wikis. Personal tools Log in Request account. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy TSE agents and other pathogens.

Proof returned by secretariat 60 Publication Check out our FAQs. Buy this standard. This standard is available for free in read-only format. 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 nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device.

This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection e.

This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials.

Medical devices that come into contact with the human body are required by the regulatory authorities to be tested on possible interactions and potential unwanted side effects.

Therefore, medical devices are assigned to different categories dependent on the kind of contact and the contact time to the human body. The fundamental principles of toxicity evaluation expressed in ISO and in the Tripartite Guidance provide excellent guidelines for considering the safety of medical devices. These seven principles can be summarized as follows:. Materials should be characterized to provide an understanding of formulation, potential impurities, and extractables, and to provide the basis for specifications.

Leachable chemicals and degradation products should be considered in evaluating the toxicology of a device.

The availability of chemical extractables and degradation products to the patient when exposed to the device should be considered in designing testing programs.