AS/NZS IEC 60601.2.34:2022
Medical electrical equipment, Part 2.34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring
Standard identically adopts IEC 60601 2 34:2011, which specifies requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (ME equipment).
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AS/NZS IEC 60601.2.34:2022 Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
English
CONTENTS
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
Figures
Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery test
Figure 201.102 – Diaphragm leak test
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)
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.
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
Figure 201.106– Clarification of leakage current tests
Figure 201.107 – Over-pressure test
Figure 201.108 – Test for accuracy of pressure measurements
Figure 201.109 – Test sequence for sensitivity, repeatability,non-linearity, drift and hysteresis
Figure 201.110 – Pressure measurement system for accuracy ofsystolic and diastolic pressure
Figure 201.111 – Frequency response of me€equipment and transducer
Figure 202.101 – Test layout for conducted and radiated emissionand radiated immunity test
Figure 202.102 – Test circuit for high-frequency surgery interference measurement,when the isolation of the applied part is in the monitor
Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation of the applied part is in the transducer
Figure 202.104 – Test set-up for high-frequency surgery protection
Figure 208.101 – Test for delay times of alarm signals indicating physiological alarm conditions
Figure 208.102 – Test for delay times of alarm signals indicating physiological alarm conditions
Figure AA.1 – Pressure transducer error band
Figure BB.101 – Non-latching alarm signals without alarm reset
Figure BB.102 – Non-latching alarm signals with alarm reset
Figure BB.103 – Latching alarm signals with alarm reset
Figure BB.104 – Two alarm conditions with alarm reset
Tables
Table 201.101 – Essential performance requirements
Table€208.101 – Alarm condition priorities for me equipment intended to monitor patients who are not continuously attended by a clinical operator
Table 208.102 – Characteristics of the burst of auditory alarm signals for me equipment intended to monitor patients who are not continuously attended by a clinical operator
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AS/NZS IEC 60601.2.34:2022 Medical electrical equipment Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
English
CONTENTS
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
Figures
Figure 201.101 – Dynamic test for limitation of energy from different parts – Recovery test
Figure 201.102 – Diaphragm leak test
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)
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.
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
Figure 201.106– Clarification of leakage current tests
Figure 201.107 – Over-pressure test
Figure 201.108 – Test for accuracy of pressure measurements
Figure 201.109 – Test sequence for sensitivity, repeatability,non-linearity, drift and hysteresis
Figure 201.110 – Pressure measurement system for accuracy ofsystolic and diastolic pressure
Figure 201.111 – Frequency response of me€equipment and transducer
Figure 202.101 – Test layout for conducted and radiated emissionand radiated immunity test
Figure 202.102 – Test circuit for high-frequency surgery interference measurement,when the isolation of the applied part is in the monitor
Figure 202.103 – Test circuit for high-frequency surgery protection, when the isolation of the applied part is in the transducer
Figure 202.104 – Test set-up for high-frequency surgery protection
Figure 208.101 – Test for delay times of alarm signals indicating physiological alarm conditions
Figure 208.102 – Test for delay times of alarm signals indicating physiological alarm conditions
Figure AA.1 – Pressure transducer error band
Figure BB.101 – Non-latching alarm signals without alarm reset
Figure BB.102 – Non-latching alarm signals with alarm reset
Figure BB.103 – Latching alarm signals with alarm reset
Figure BB.104 – Two alarm conditions with alarm reset
Tables
Table 201.101 – Essential performance requirements
Table€208.101 – Alarm condition priorities for me equipment intended to monitor patients who are not continuously attended by a clinical operator
Table 208.102 – Characteristics of the burst of auditory alarm signals for me equipment intended to monitor patients who are not continuously attended by a clinical operator
Previous versions
AS/NZS IEC 60601.2.34:2022
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.