I.S. EN 60601-3-1:1998
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - PART 3-1: ESSENTIAL PERFORMANCE REQUIREMENTS FOR TRANSCUTANEOUS OXYGEN AND CARBON DIOXIDE PARTIAL PRESSURE MONITORING EQUIPMENT
Hardcopy , PDF
English
01-01-1998
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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INTRODUCTION
1 Scope and object
2 Normative references
3 Definitions
4 Test conditions
5 Accompanying documents
6 Accuracy
7 Response time
8 Recorder
9 Warning signals
10 Internal electrical power source
11 Transducers and cables
Figures
1 Suggested test fixture for transducer test, if the
manufacturer does not recommend another test
chamber
2 Test cycle for linearity test - Example of typical
results
Annex A (informative) Guidance and rationale
Annex ZA (normative) Normative references to international
publications with their corresponding European
publications
Specifies essential requirements for the performance of transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment. Applies to transcutaneous monitors intended for use with adults, children and neonates, and includes the use of these devices in foetal monitoring during birth.
| DevelopmentNote |
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
|
| DocumentType |
Standard
|
| Pages |
42
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Standards | Relationship |
| IEC 60601-3-1:1996 | Identical |
| BS EN 60601-3-1:1997 | Identical |
| NF EN 60601-3-1 : 2002 | Identical |
| SN EN 60601-3-1 : 1996 | Identical |
| EN 60601-3-1:1996 | Identical |
| UNE-EN 60601-3-1:1997 | Identical |
| DIN EN 60601-3-1:1998-11 | Identical |
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