NEN EN ISO 10993-11 : 2009

Committees responsible
National foreword
Foreword
Introduction
Method
1 Scope
2 Normative references
3 Definitions
4 Test sample requirements and recommendations
5 Method for extraction from medical devices
6 Selection of test procedures for systemic toxicity
7 Selection of test procedures for pyrogenicity
8 Assessment of results
9 Test report
Annex
A (informative) Addresses
ZA (normative) Normative references to international
    publications with their relevant European
    publications

Defines requirements and provides guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.