• EN ISO 10993-1:2020

    Current The latest, up-to-date edition.

    Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

    Available format(s): 


    Published date:  16-12-2020

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

    Abstract - (Show below) - (Hide below)

    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.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.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. 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 hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 206
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current
    • Access your standards online with a subscription


      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective