CSA Z316.4 : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PERFORMANCE SPECIFICATIONS FOR PORTABLE WHOLE BLOOD GLUCOSE MONITOR SYSTEMS FOR USE IN DIABETES MANAGEMENT
Hardcopy , PDF
01-02-2005
English
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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Superseded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 |
| 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 |
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