• 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

    Available format(s): 

    Language(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.

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

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

      Features

      • 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