Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Essential requirements
5 Labels and marking
6 Elements of the instructions for use
7 Content of the instructions for use
Bibliography

Abstract

Describes requirements for information supplied by the manufacturer of IVD instruments for self-testing.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 212