Codes & Standards - Purchase

CAN/CSA-ISO 14971-07 (R2017)

Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)

SKU: 2418541 Published by CSA Group Publication Year 2007 Reaffirmed in 2017 100 pages Withdrawn

View Access for this document is only available for viewers in Canada

Product Details

Preface/Scope

CSA Preface

This is the second edition of CAN/CSA-ISO 14971, Medical devices - Application of risk management to medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 14971 (second edition, 2007-03-01). This Standard supersedes the previous edition published in 2001 as CAN/CSA-ISO 14971 (adopted ISO 14971:2000) and CSA Amendment 1:2003 to CAN/CSA-ISO 14971:01 (adopted ISO Amendment 1:2003).

Scope

This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.

This International Standard does not apply to clinical decision making.

This International Standard does not specify acceptable risk levels.

This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

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 14971-07 (R2017)

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 14971-07 (R2017)

Product Details