Codes & Standards - Purchase

CAN/CSA-ISO 17664:18

Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices (Adopted ISO 17664:2017, second edition, 2017-10)

SKU: 2426425 Published by CSA Group Publication Year 2018 44 pages

Product Details

Preface/Scope

CSA Preface

This is the second edition of CAN/CSA-ISO 17664, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 17664 (second edition, 2017-10). It supersedes the previous edition published in 2006 as CAN/CSA-Z17664, Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices (adopted ISO 17664:2004).

Scope

This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.

This includes information for processing prior to use or reuse of the medical device. The provisions of this document are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:

a) initial treatment at the point of use;

b) preparation before cleaning;

c) cleaning;

d) disinfection;

e) drying;

f) inspection and maintenance;

g) packaging;

h) sterilization;

i) storage;

j) transportation.

This document excludes processing of the following:

— non-critical medical devices not intended for direct patient contact;

— textile devices used in patient draping systems or surgical clothing;

— medical devices specified by the manufacturer for single-use only and supplied ready for use.

Request Copyright Permissions

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

CAN/CSA-ISO 17664:18

Product Details

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

CAN/CSA-ISO 17664:18

Product Details