IEC 60601-2-34:2011

Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

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.

Appareils électromédicaux - Partie 2-34: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance de la pression sanguine prélevée directement

La CEI 60601-2-34:2011 concerne la sécurité de base et les performances essentielles pour les appareils de surveillance de la pression sanguine prélevée directement. Elle modifie et complète la CEI 60601-1 (troisième édition, 2005): Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. La troisième édition de CEI 60601-2-34 annule et remplace la deuxième édition publiée en 2001et constitue une révision technique pour l'alignement structurel à l'édition 2005 de la CEI 60601-1. La CEI 60601-2-34 s'applique à la sécurité de base et aux performances essentielles des appareils de surveillance de la pression sanguine prélevée directement. Cette norme particulière ne s'applique pas aux tubes et aiguilles de cathéter, aux connecteurs Luer, et aux prises et panneaux de prises connectés. Cette norme ne s'applique pas non plus aux appareils de surveillance de la pression sanguine prélevée indirectement.

General Information

• Status: Published
• Publication Date: 18-May-2011
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 31-May-2011
• Completion Date: 19-May-2011

Relations

• Revises: IEC 60601-2-34:2000 - Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-34 ®
Edition 3.0 2011-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-34: Particular requirements for the basic safety and essential performance
of invasive blood pressure monitoring equipment

Appareils électromédicaux –
Partie 2-34: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression sanguine prélevée
directement
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IEC 60601-2-34 ®
Edition 3.0 2011-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-34: Particular requirements for the basic safety and essential performance
of invasive blood pressure monitoring equipment

Appareils électromédicaux –
Partie 2-34: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance de la pression sanguine prélevée
directement
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XB
ICS 11.040.55 ISBN 978-2-88912-495-4

– 2 – 60601-2-34  IEC:2011
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents. 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 13
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 20
201.10 Protection against unwanted and excessive radiation HAZARDS . 21
201.11 Protection against excessive temperatures and other HAZARDS . 21
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 23
201.13 HAZARDOUS SITUATIONS and fault conditions . 29
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 29
201.15 Construction of ME EQUIPMENT . 29
201.16 ME SYSTEMS . 30
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 30
202 Electromagnetic compatibility – Requirements and tests . 30
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 36
Annexes . 45
Annex AA (informative) Particular guidance and rationale . 46
Annex BB (informative) Alarm diagrams 208/IEC 60601-1-8:2006 . 59
Bibliography . 61
Index of defined terms used in this particular standard. 62

Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery
test . 15
Figure 201.102 – Diaphragm leak test . 16
Figure 201.103 – Measuring circuit for PATIENT LEAKAGE CURRENT via the PATIENT
CONNECTION(S) of an F-TYPE APPLIED PART to earth caused by an external voltage on the
PATIENT CONNECTION(S) . 17
Figure 201.104 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of CLASS I ME EQUIPMENT caused by an external voltage on a metal
ACCESSIBLE PART that is not PROTECTIVELY EARTHED. . 18
Figure 201.105 – Measuring circuit for the PATIENT LEAKAGE CURRENT from the APPLIED
PART to earth of INTERNALLY POWERED ME EQUIPMENT caused by an external voltage on
a metal ACCESSIBLE PART that is not PROTECTIVELY EARTHED . 19
Figure 201.106– Clarification of leakage current tests . 20
Figure 201.107 – Over-pressure test . 21
Figure 201.108 – Test for accuracy of pressure measurements . 25

60601-2-34  IEC:2011 – 3 –
Figure 201.109 – Test sequence for sensitivity, repeatability, non-linearity, drift and
hysteresis . 26
Figure 201.110 – Pressure measurement system for accuracy of systolic and diastolic
pressure . 27
Figure 201.111 – Frequency response of ME EQUIPMENT and TRANSDUCER . 28
Figure 202.101 – Test layout for conducted and radiated emission and radiated
immunity test . 31
Figure 202.102 – Test circuit for high-frequency surgery interference measurement,
when the isolation of the APPLIED PART is in the monitor . 34
Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation
of the APPLIED PART is in the TRANSDUCER . 35
Figure 202.104 – Test set-up for high-frequency surgery protection . 36
Figure 208.101 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 41
Figure 208.102 – Test for delay times of ALARM SIGNALS indicating PHYSIOLOGICAL
ALARM CONDITIONS . 42
Figure AA.1 – Pressure TRANSDUCER error band . 53
Figure BB.101 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 59
Figure BB.102 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 59
Figure BB.103 – LATCHING ALARM SIGNALS with ALARM RESET . 60
Figure BB.104 – Two ALARM CONDITIONS with ALARM RESET . 60

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 10
Table 208.101 – ALARM CONDITION priorities . 37
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS . 38

– 4 – 60601-2-34  IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-34: Particular requirements for the basic safety and essential
performance of invasive blood pressure monitoring equipment

FOREWORD
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