PERFORMANCE EVALUATION OF IN-VITRO DIAGNOSTIC MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Language(s)

German

Published date

01-01-2002

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

Foreword
Introduction
1 Scope
2 Terms and definitions
3 General requirements for the performance evaluation
  3.1 Responsibilities and resources
  3.2 Documentation
  3.3 Final assessment and review
4 Organisation of a performance evaluation study
  4.1 Preconditions
  4.2 Evaluation plan
  4.3 Sites and resources
  4.4 Basic design information
  4.5 Experimental design
  4.6 Performance study records
  4.7 Observations and unexpected outcomes
  4.8 Evaluation report
5 Modifications during the performance evaluation study
6 Re-evaluation
7 Protection and safety of probands
Annex ZA (informative) Clauses of this European Standard
         addressing essential requirements or other
         provisions of EU Directives
Bibliography

This standard is included in DIN Handbook 378. Specifies performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. Also defines the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer.

DocumentType	Standard
Pages	20
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
NF EN 13612 : 2002	Identical
NBN EN 13612 : 2002 COR 2002	Identical
NEN EN 13612 : 2003	Identical
NS EN 13612 : 1ED 2002	Identical
I.S. EN 13612:2002	Identical
SN EN 13612 : 2002 CORR 2003	Identical
UNI EN 13612 : 2002	Identical
BS EN 13612:2002	Identical
EN 13612:2002/AC:2002	Identical
UNE-EN 13612:2002	Identical

DIN HDBK 378 : 3ED 2014

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DIN EN 13612:2002-08

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Category

Subcategory

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