NF EN ISO 10993-4

NF EN ISO 10993-4

June 2017
Standard Cancelled

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

June 2017

Number of pages

81 p.

Reference

NF EN ISO 10993-4

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

Classification index

S99-501-4

Print number

1

International kinship

ISO 10993-4:2017

European kinship

EN ISO 10993-4:2017
Sumary
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood.

It describes

a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1,

b) the fundamental principles governing the evaluation of the interaction of devices with blood,

c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.

Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.

Standard replaced by (1)
NF EN ISO 10993-4
July 2018
Standard Current
Biological evaluation of medical devices - Part 4 : selection of tests for interactions with blood

<p>ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood.</p> <p>It describes</p> <p>a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1,</p> <p>b) the fundamental principles governing the evaluation of the interaction of devices with blood,</p> <p>c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests.</p> <p>Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.</p> <p>The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.</p>

Table of contents
View the extract
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et definitions
  • 4 Abréviations
  • 5 Types de dispositifs en contact avec le sang (selon la classification de l' ISO 10993-1)
  • 6 Caractérisation des interactions avec le sang
  • Annexe A Évaluation préclinique des dispositifs et prothèses cardio-vasculaires
  • Annexe B Essais de laboratoire recommandés - Principes, base scientifique et interprétation
  • Annexe C Thrombose - Méthodes d'essai in vivo
  • Annexe D Hématologie/hémolyse - Méthodes d'essai - Évaluation des propriétés hémolytiques de dispositifs médicaux et de matériaux de dispositifs médicaux
  • Annexe E Complément - Méthodes d'essai
  • Annexe F Essais de laboratoire peu courants
  • Annexe G Essais non recommandés
  • Bibliographie
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ