Codes & Standards - Purchase

ISO 14160:2020

Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices

SKU: iso_073159_167402 Published by ISO Publication Year 2020 3 Edition 37 pages

Product Details

Overview

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).
This document is not applicable to material of human origin.
This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).
This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.
The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).
This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).
This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).
Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.
NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.
NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.
NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.
NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process.
NOTE 5 Such testing is a crucial part of the design and development of a medical device.
NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.
NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

Language

English

French

Format

PDF

GST REG No R119441681
QST REG No R1006017360

Features	CSA Advantage^TM	CSA OnDemand^TM
Offline access	CSA Advantage^TM. feature available. Offline access	CSA OnDemand^TM. feature available. Offline access
Full-text search	CSA Advantage^TM. feature available. Full-text search	CSA OnDemand^TM. feature available. Full-text search
Create highlights and personal notes	CSA Advantage^TM. feature available. Create highlights and personal notes	CSA OnDemand^TM. feature available. Create highlights and personal notes
Newest editions added automatically	CSA Advantage^TM. feature available. Newest editions added automatically	CSA OnDemand^TM. feature available. Newest editions added automatically
Includes all supported languages and archive versions	CSA Advantage^TM. feature not available. Includes all supported languages and archive versions	CSA OnDemand^TM. feature available. 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	CSA Advantage^TM. feature available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference	CSA OnDemand^TM. feature not available. 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	CSA Advantage^TM. feature available. Toggle between your files and the full standard to maintain context	CSA OnDemand^TM. feature not available. Toggle between your files and the full standard to maintain context
Instantly preview cross referenced material within the book	CSA Advantage^TM. feature available. Instantly preview cross referenced material within the book	CSA OnDemand^TM. feature not available. Instantly preview cross referenced material within the book
Export personal notes to Excel	CSA Advantage^TM. feature available. Export personal notes to Excel	CSA OnDemand^TM. feature not available. Export personal notes to Excel
Transfer notes and highlights when updates are available	CSA Advantage^TM. feature available. Transfer notes and highlights when updates are available	CSA OnDemand^TM. feature not available. Transfer notes and highlights when updates are available
Adobe Reader PDF and browser compatible for iOS and Android	CSA Advantage^TM. feature not available. Adobe Reader PDF and browser compatible for iOS and Android	CSA OnDemand^TM. feature available. Adobe Reader PDF and browser compatible for iOS and Android
Web, Android, iOS Compatible	CSA Advantage^TM. feature available. Web, Android, iOS Compatible	CSA OnDemand^TM. feature not available. 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 14160:2020

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 14160:2020

Product Details

Language

Format