EN 60601-2-34:2014
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
27-06-2014
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
Annex ZA (normative) - Normative references to international
Publications with their corresponding
European publications
Annex ZZ (informative) - Coverage of Essential Requirements
of EC Directives
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 |
CLC/TC 62
|
| DocumentType |
Standard
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Standards | Relationship |
| IEC 60601-2-34:2011 | Identical |
| NBN EN 60601 2-34 : 2014 | Identical |
| NEN EN IEC 60601-2-34 : 2014 | Identical |
| NEN 10601-2-34 : 1995 | Identical |
| I.S. EN 60601-2-34:2014 | Identical |
| PN EN 60601-2-34 : 2014 | Identical |
| SN EN 60601-2-34 : 2014 | Identical |
| DIN EN 60601-2-34 : 2015 | Identical |
| VDE 0750-2-34 : 2015 | Identical |
| BS EN 60601-2-34:2014 | Identical |
| CEI EN 60601-2-34 : 2015 | Identical |
| NF EN 60601-2-34 : 2014 | Identical |
| UNE-EN 60601-2-34:2001 | Identical |
| UNE-EN 60601-2-34:2014 | Identical |
| PNE-FprEN 60601-2-34 | Identical |
| I.S. EN 740:1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| CEI EN 60601-2-49 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| I.S. EN 16372:2014 | AESTHETIC SURGERY SERVICES |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| 17/30357644 DC : 0 | BS EN ISO 81060-2 - NON-INVASIVE SPHYGMOMANOMETERS - PART 2: CLINICAL INVESTIGATION OF INTERMITTENT AUTOMATED MEASUREMENT TYPE |
| 13/30278952 DC : 0 | BS EN 16372 - AESTHETIC SURGERY AND AESTHETIC NON-SURGICAL MEDICAL SERVICES |
| 12/30266576 DC : 0 | BS EN 13718-2 - MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS OF AIR AMBULANCES |
| BS 5724-2.204(1999) : 1999 | ANAESTHETIC WORKSTATIONS AND THEIR MODULES - PARTICULAR REQUIREMENTS |
| 15/30317874 DC : 0 | BS EN 16844 - AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| UNE-EN 16372:2015 | Aesthetic surgery services |
| BS EN 60601-2-49:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| DIN EN 13718-2:2015-05 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| I.S. EN 60601-2-49:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-49: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MULTIFUNCTION PATIENT MONITORING EQUIPMENT |
| UNE-EN 13718-2:2015 | Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
| UNE-EN 60601-2-49:2016 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| BS EN 13718-2:2015 | Medical vehicles and their equipment. Air ambulances Operational and technical requirements for air ambulances |
| BS EN 740:1999 | Anaesthetic workstations and their modules. Particular requirements |
| I.S. EN 13718-2:2015 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| I.S. EN 13718-2:2015+A1:2020 | MEDICAL VEHICLES AND THEIR EQUIPMENT - AIR AMBULANCES - PART 2: OPERATIONAL AND TECHNICAL REQUIREMENTS FOR AIR AMBULANCES |
| EN 16372:2014 | Aesthetic surgery services |
| BS EN 16372:2014 | Aesthetic surgery services |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| EN 60601-2-49:2015 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| EN 60601-2-49:2015 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| EN 60601-2-27:2014 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| IEC 80601-2-30:2009+AMD1:2013 CSV | Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
| IEC 60601-2-27:2011 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
| EN 60601-1-8:2007/A11:2017 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |
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