IEC 60601-2-34:2011
Superseded
View Superseded by
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
Hardcopy , PDF
English, English - French
05-19-2011
10-25-2024
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 208/IEC 60601-1-8:2006
Bibliography
Index of defined terms used in this particular standard
IEC 60601-2-34:2011 concerns the basic safety and essential performance of invasive blood pressure monitoring equipment. It amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The third edition of IEC 60601-2-34 cancels and replaces the second edition published in 2001 and constitutes a technical revision in order to align structurally with the 2005 edition of IEC 60601-1. IEC 60601-2-34 applies to basic safety and essential performance of invasive blood pressure monitoring equipment. It does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables connected. It does not apply to non-invasive blood pressure monitoring equipment.
| Committee |
TC 62/SC 62D
|
| DevelopmentNote |
Stability Date: 2018. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
138
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| AS/NZS IEC 60601.2.34:2022 | Identical |
| BS 5724-2.34(1995) : 1995 | Identical |
| NF EN 60601-2-34 : 2014 | Identical |
| CEI EN 60601-2-34 : 2015 | Identical |
| VDE 0750-2-34 : 2015 | Identical |
| BS EN 60601-2-34:2014 | Identical |
| EN 60601-2-34:2014 | Identical |
| NBN EN 60601 2-34 : 2014 | Identical |
| PN EN 60601-2-34 : 2014 | Identical |
| NEN EN IEC 60601-2-34 : 2014 | Identical |
| BIS IS 13450 : Part 2 : Sec 34 : 2019 | Identical |
| DIN EN 60601-2-34 : 2015 | Identical |
| CEI EN 60601-2-34 : 2001 | Identical |
| I.S. EN 60601-2-34:2014 | Identical |
| DS EN 60601-2-34 : 2014 | Identical |
| NEN 10601-2-34 : 1995 | Identical |
| UNE-EN 60601-2-34:2014 | Identical |
| AAMI SP9 : 2ED 94 | Corresponds |
| UNE-EN 60601-2-34:2001 | Identical |
A newer version of this standard is available.
View Current Edition
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.