IEC 60601-2-23:2011
Current
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
Hardcopy , PDF
English, English - French
02-25-2011
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME
EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and
documents
201.8 Protection against electrical HAZARDS from ME
EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS of ME
EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
radiation HAZARDS
201.11 Protection against excessive temperatures and
other HAZARDS
201.12 Accuracy of controls and instruments and
protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS
(PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
202 Electromagnetic compatibility - Requirements
and tests
208 General requirements, tests and guidance for
alarm systems in medical electrical equipment
and medical electrical systems
Annexes
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Alarm diagrams of Clause
208/IEC 60601-1-8:2006
Index of defined terms used in this particular standard
IEC 60601-2-23:2011 applies to the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. It applies to transcutaneous monitors used with adults, children and neonates, and it includes the use of these devices in foetal monitoring during birth. IEC 60601-2-23:2011 does not apply to haemoglobin saturation oximeters or to devices applied to surfaces of the body other than the skin (for example conjunctiva, mucosa). This third edition cancels and replaces the second edition published in 1999 and constitutes a technical revision. This edition of IEC 60601-2-23 was revised to align structurally with the 2005 edition of IEC 60601-1.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Stability Date: 2018. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
100
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN EN IEC 60601-2-23 : 2015 | Identical |
| DIN EN 60601-2-23:2016-08 | Identical |
| EN 60601-2-23:2015 | Identical |
| I.S. EN 60601-2-23:2015 | Identical |
| IS 13450 : Part 2 : Sec 23 : 2018 | Identical |
| CEI EN 60601-2-23 : 2016 | Identical |
| VDE 0750-2-23:2016-08 | Identical |
| CSA C22.2 NO. 60601-2-23:12 (R2026) | Identical |
| PN EN 60601-2-23 : 2016 | Identical |
| BS EN 60601-2-23:2015 | Identical |
| UNE-EN 60601-2-23:2001 | Identical |
| UNE-EN 60601-2-23:2015 | Identical |
| BS 5724-2.123(1996) : AMD 10042 | Identical |
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