Codes & Standards - Purchase

CAN/CSA-ISO 15197-05 (R2010)

In Vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus (Adopted ISO 15197:2003, first edition, 2003-05-01)

SKU: 2417203 Published by CSA Group Publication Year 2005 Reaffirmed in 2010 43 pages Withdrawn

Product Details

Preface/Scope

Preface

This is the first edition of CAN/CSA-ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15197 (first edition, 2003-05-01). This Standard replaces CSA Z316.4-94, Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management.

Scope

This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus.

This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.

This International Standard does not
- provide a comprehensive evaluation of all possible factors that could affect the performance of these systems,
- pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
- address the medical aspects of diabetes mellitus management, or
- apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).

Request Copyright Permissions

Language

English

French

Format

PDF

$158.00 CAD

Free updates to the latest version
Access historical versions
Access all supported languages

Learn More

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 15197-05 (R2010)

Product Details

Scope

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

CAN/CSA-ISO 15197-05 (R2010)

Product Details

Scope

Language

Format