Biological evaluation of medical devices. Part 55, Interlaboratory study on cytotoxicity = Évaluation biologique des dispositifs médicaux. Partie 55, Étude interlaboratoire sur la cytotoxicité / prepared by Technical Committee ISO/TC 194.

Format:

Book

Contributor:

International Organization for Standardization, issuing body.

Danish Standards Association

Series:

International standard ; ISO 10993-55:2023.

Technical report ; ISO/TR 10993-55:2023

Language:

English

Subjects (All):

Medical instruments and apparatus--Testing--Standards.

Medical instruments and apparatus.

Toxicity testing--Standards.

Toxicity testing.

Biomedical engineering--Standards.

Biomedical engineering.

Physical Description:

v, 23 pages : color illustrations ; 28 cm.

Edition:

First edition 2023-02.

Other Title:

Interlaboratory study on cytotoxicity

Évaluation biologique des dispositifs médicaux. Partie 55, Étude interlaboratoire sur la cytotoxicité

Étude interlaboratoire sur la cytotoxicité

Title in Danish on cover: Biologisk vurdering af medicinsk udstyr. Del 55: Sammenlignende laboratorieundersøgelser af cytotoksicitet

Place of Publication:

Geneva, Switzerland : ISO, 2023.

Contents:

Foreword

Introduction

Scope

Normative references

Terms and definitions

Participants

Materials and sample preparation

Test procedures

Results

Assessment of results

Annex A (informative). Interlaboratory study protocol for the neutral red uptake cytotoxicity test

Annex B. (informative). Interlaboratory study protocol for the colony formation cytotoxicity test

Bibliography.

Notes:

"Reference number ISO/TR 10993-55:2023(E)."

"DS-information DS/ISO/TR 10993-55:2023, 2023-02-09, Danish Standards Association"--Cover.

"ICS 11.100.20"--Page 4 of cover.

Includes bibliographical references.

OCLC:

1594930996