Biological evaluation of medical devices Principles and methods for immunotoxicology testing of medical devices

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

29-09-2006

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Risk assessment and risk management
5 Identification of hazards
6 Methods of assessment of immunotoxicity
  6.1 General
  6.2 Inflammation
  6.3 Immunosuppression
  6.4 Immunostimulation
  6.5 Hypersensitivity
  6.6 Auto-immunity
7 Extrapolation of data provided by pre-clinical assays
Annex A (informative) Current state of knowledge
Annex B (informative) Clinical experience with medical devices
Annex C (informative) Flow chart for immunotoxicity testing
Bibliography

Provides an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices.

This part of ISO10993 presents an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. It gives guidance on methods for testing for immunotoxicity of various types of medical devices.

This part of ISO10993 is based on several publications written by various groups of immunotoxicologists over the last few decades in which the development of immunotoxicology as a separate entity within toxicology took place.

The current state of knowledge with regard to immunotoxicity is described in AnnexA. A summary of clinical experience to date with immunotoxicology associated with medical devices is given in AnnexB.

NOTE See also Bibliographic Reference [11].

Committee	CH/194
DocumentType	Standard
Pages	26
PublisherName	British Standards Institution
Status	Current

Standards	Relationship
ISO/TS 10993-20:2006	Identical

ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017	Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO 10993-6:2016	Biological evaluation of medical devices Part 6: Tests for local effects after implantation

View more information

$407.85

Including GST where applicable

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

Get in touch with us

Log into your Account

DD ISO/TS 10993-20:2006

Current

Table of Contents

Abstract

Scope

General Product Information

International Equivalents

Standards Referencing This Book

Category

Subcategory

Access your standards online with a subscription