• There are no items in your cart

CSA Z316.4 : 0

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

PERFORMANCE SPECIFICATIONS FOR PORTABLE WHOLE BLOOD GLUCOSE MONITOR SYSTEMS FOR USE IN DIABETES MANAGEMENT

Available format(s)

Hardcopy , PDF

Superseded date

02-01-2005

Language(s)

English

TECHNICAL COMMITTEE ON LABORATORY MEDICINE
SUBCOMMITTEE ON BLOOD GLUCOSE MONITORS
PREFACE
FOREWORD
INTRODUCTION
Clause
1 Scope and object
2 Normative references
3 Definitions
4 Tests
5 Marking and documentation
6 Protection against electric shock
7 Protection against mechanical hazards
8 Mechanical resistance to shock, vibration and impact
9 Equipment temperature limits and protection against
   the spread office
10 Resistance to heat
11 Resistance to moisture and liquids
12 Protection against radiation, including laser sources,
   and against sonic and ultrasonic pressure
13 Protection against liberated gases, explosion
   and implosion
14 Components
15 Humidity test
16 Precision and accuracy test
17 Accuracy test using fresh capillary specimens
Annex A - Recommendations for the safe use of skin
          puncture devices

Covers requirements for portable whole blood glucose monitor systems, used to help determine an individual's blood glucose concentration for the purpose of diabetes management. The aim is to assure the performance of the blood glucose monitor system, and to specify tests that can be used to verify compliance with the requirements.

DocumentType
Standard
Pages
33
PublisherName
Canadian Standards Association
Status
Superseded
SupersededBy

PLUS 317 (1st ed. pub. 2000) Guidelines for Elementary Assessments of Building Systems in Health Care Projects
00/560160 DC : DRAFT JAN 2000 BS ISO 15197 DETERMINATION OF PERFORMANCE CRITERIA FOR IN VITRO BLOOD GLUCOSE MONITORING SYSTEMS FOR MANAGEMENT OF HUMAN DIABETES MELLITUS
11/30208525 DC : 0 BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
PREN ISO 15197 : DRAFT 2011 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS

CSA C22.2 No. 1010.1 : 0 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL, AND LABORATORY USE - GENERAL REQUIREMENTS

View more information
US$50.00
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.