Codes & Standards - Purchase

ISO/TR 22442-4:2010

Medical devices utilizing animal tissues and their derivatives -- Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes

SKU: iso_051985_149550 Published by ISO Publication Year 2010 1 Edition 14 pages

Product Details

Overview

ISO/TR 22442-4:2010 offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal tissues might serve to reduce the risk of iatrogenic transmission of transmissible spongiform encephalopathies (TSEs).

The TSE-removal methods used to process animal tissues should also reduce the risk of transmitting TSE infections via non-viable tissues of human origin; this Technical Report does not address this issue. Some current information on human tissues and TSEs is presented which may be applied by analogy to other animal tissues.

ISO/TR 22442-4:2010 does not intend to imply a need for validation of methods involving specific materials identified as having a negligible risk of contamination with TSE agents as listed in Annex C of ISO 22442-1:2007.

It is intended to clarify final draft international standards included in the ISO 22442 series, as well as in ISO 14160.

ISO/TR 22442-4:2010 builds upon the specific discussion in ISO 22442-3 relative to TSE agents and attempts to summarize the current state of the art in the arena of TSE agent elimination. As the understanding of inactivation and elimination of TSE agents evolves, this document will be revised when possible.

Language

English

Format

PDF

GST REG No R119441681
QST REG No R1006017360

Features	CSA Advantage^TM	CSA OnDemand^TM
Offline access
Full-text search
Create highlights and personal notes
Newest editions added automatically
Includes all supported languages and archive versions
My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference
Toggle between your files and the full standard to maintain context
Instantly preview cross referenced material within the book
Export personal notes to Excel
Transfer notes and highlights when updates are available
Adobe Reader PDF and browser compatible for iOS and Android
Web, Android, iOS Compatible

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

en

fr

Catalogue

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Subscription

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

Services

en

fr

Codes & Standards - Purchase

ISO/TR 22442-4:2010

Product Details

Language

Format

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

Language

en

fr

Currency

CAD

USD

Catalogue

Browse By Subject Area

Browse By Publisher

ICS Catalogue

Subscription

Browse By Subject Area

CSA Subscriptions

ICS Catalogue

Services

Language

en

fr

Currency

CAD

USD

Search Section

Codes & Standards - Purchase

ISO/TR 22442-4:2010

Product Details

Language

Format