NF EN ISO 10993-1
NF EN ISO 10993-1

NF EN ISO 10993-1

July 2010
Standard Cancelled
  • Free consultation authorized exceptionally by ISO and IEC in the context of the Covid-19 crisis

Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process

ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of 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.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2010

Number of pages

35 p.

Reference

NF EN ISO 10993-1

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501-1

Print number

2 - 01/08/2010

International kinship

ISO 10993-1:2009

European kinship

EN ISO 10993-1:2009
Sumary
Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management system process

ISO 10993-1:2009 describes:

  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of 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.
Standard replaced by (1)
NF EN ISO 10993-1
NF EN ISO 10993-1
December 2020
Standard Current
Biological evaluation of medical devices - Part 1 : evaluation and testing within a risk management process

Le présent document spécifie : les principes généraux sur lesquels repose l'évaluation biologique des dispositifs médicaux dans un processus de gestion du risque ; la classification générale des dispositifs médicaux, fondée sur la nature et la durée de leur contact avec le corps humain ; l'évaluation de toutes les données pertinentes existantes ; l'identification de lacunes dans les ensembles de données disponibles sur la base d'une analyse de risque ; l'identification d'ensembles de données supplémentaires nécessaires à l'analyse de la sécurité biologique du dispositif médical ; l'évaluation de la sécurité biologique du dispositif médical.

Table of contents
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  • Avant-propos
    iv
  • Introduction
    VI
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Principes généraux applicables à l'évaluation biologique des dispositifs médicaux
    4
  • 5 Classification des dispositifs médicaux
    7
  • 5.1 Généralités
    7
  • 5.2 Classification suivant la nature du contact avec le corps du patient
    7
  • 5.3 Classification suivant la durée du contact
    9
  • 6 Processus d'évaluation biologique
    9
  • 6.1 Caractérisation de matériau
    9
  • 6.2 Essais d'évaluation biologique
    10
  • 7 Interprétation des données d'évaluation biologique et estimation biologique globale de sécurité
    15
  • Annexe A (informative) Essais d'évaluation biologique
    16
  • Annexe B (informative) Directives concernant le processus de gestion du risque
    17
  • Annexe C (informative) Processus suggéré de revue de littérature scientifique
    20
  • Bibliographie
    22
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