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

IEC 60601-2-49:2011 applies to the basic safety and essential performance requirements of multifunction patient monitoring equipment. It applies to medical electrical equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. Medical electrical equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to me equipment for those environments of use. The scope of this standard is restricted to medical electrical equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part. This second edition cancels and replaces the first edition of IEC 60601-2-49, published in 2001. This edition constitutes a technical revision to the new structure of IEC 60601-1:2005 (third edition).

Appareils électromédicaux - Partie 2-49: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de surveillance multifonction des patients

La CEI 60601-2-49:2011 s'applique aux exigences pour la sécurité de base et les performances essentielles des appareils de surveillance multifonction des patients. Elle s'applique aux appareils électromédicaux utilisés dans un environnement hospitalier ainsi qu'à ceux utilisés hors de l'environnement hospitalier, par exemple dans les ambulances et dans le transport aérien. Les appareils électromédicaux destinés à être utilisés dans des conditions d'environnement extrêmes ou non contrôlées hors de l'environnement hospitalier, par exemple dans les ambulances et dans le transport aérien, doivent être conformes à la présente norme particulière. Des normes complémentaires peuvent s'appliquer aux appareils em utilisés dans ces environnements. Le domaine d'application de la présente norme est restreint aux appareils électromédicaux destinés à la connexion à un patient unique qui comportent soit deux ou plusieurs parties appliquées, soit des fonctions multiples sur une partie appliquée. Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-49 publiée en 2001. Cette édition constitue une révision technique par rapport à la nouvelle structure de la CEI 60601-1:2005 (troisième édition).

General Information

• Status: Replaced
• Publication Date: 24-Feb-2011
• ICS: 11.040.55 - Diagnostic equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 08-Mar-2018

Relations

• Replaced By: IEC 80601-2-49:2018 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-49:2001 - Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-49 ®
Edition 2.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitoring equipment

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance multifonction des patients

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IEC 60601-2-49 ®
Edition 2.0 2011-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-49: Particular requirements for the basic safety and essential performance
of multifunction patient monitoring equipment

Appareils électromédicaux –
Partie 2-49: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de surveillance multifonction des patients

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XA
ICS 11.040.55 ISBN 978-2-88912-369-8

– 2 – 60601-2-49  IEC:2011
CONTENTS
FOREWORD . 4

INTRODUCTION . 7

201.1 Scope, object and related standards . 8

201.2 Normative references . 10

201.3 Terms and definitions . 10

201.4 General requirements . 11

201.5 General requirements for testing of ME EQUIPMENT . 12

201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 12
201.7 ME EQUIPMENT identification, marking and documents. 12
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 14
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 16
201.10 Protection against unwanted and excessive radiation HAZARDS . 16
201.11 Protection against excessive temperatures and other HAZARDS . 16
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 18
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 18
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 18
202 Electromagnetic compatibility – Requirements and tests . 18
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 26
Annexes . 32
Annex AA (informative) General guidance and rationale . 33
Annex BB (informative) Alarm diagrams of Clause 208/IEC 60601-1-8:2006 . 43
ANNEX CC (informative) Examples of the connection of the measuring device (MD) for
measurement of the PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT . 46
Bibliography . 49
Index of defined terms used in this particular standard. 50

Figure 202.101 – Test layout for conducted and radiated emission and radiated
immunity test with non-conductive APPLIED PART . 20
Figure 202.102 – Test layout for radiated and conducted emission test and radiated
immunity test with a PATIENT CONNECTION . 21
Figure 202.103 –Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with PATIENT CONNECTIONS . 24
Figure 202.104 – Test setup for HF surgery protection measurement according to
subclause 202.6.2.1.101 . 25
Figure 202.105 – Test circuit for HF surgery protection measurement according to
subclause 202.6.2.1.101 with non-conductive APPLIED PART . 26
Figure AA.1 – Single APPLIED PART with MULTIPLE FUNCTIONS and PATIENT CONNECTIONS . 35

60601-2-49  IEC:2011 – 3 –
Figure AA.2 – Single APPLIED PART (6) with MULTIPLE FUNCTIONS and

PATIENT CONNECTIONS and multiple APPLIED PARTS (7) with SINGLE FUNCTIONS and

PATIENT CONNECTIONS . 36

Figure BB.1 – NON-LATCHING ALARM SIGNALS without ALARM RESET . 43

Figure BB.2 – NON-LATCHING ALARM SIGNALS with ALARM RESET . 44

Figure BB.3 – LATCHING ALARM SIGNALS with ALARM RESET . 44

Figure BB.4 – Two ALARM CONDITIONS with ALARM RESET . 45

Figure CC.1 – PART LEAKAGE CURRENT measurement of TYPE BF APPLIED PARTS with

MULTIPLE FUNCTIONS . 46

Figure CC.2 – PART LEAKAGE CURRENT measurement of TYPE CF APPLIED PARTS with
MULTIPLE FUNCTIONS . 47
Figure CC.3 – Total PATIENT LEAKAGE CURRENT of TYPE BF and CF APPLIED PARTS with
MULTIPLE FUNCTIONS caused by an external voltage on the PATIENT CONNECTIONS . 48

Table 201.101 – ESSENTIAL PERFORMANCE requirements . 11
Table 208.101 – ALARM CONDITION priorities . 27
Table 208.102 – Characteristics of the BURST of auditory ALARM SIGNALS . 28

– 4 – 60601-2-49  IEC:2011
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-49: Particular requirements for the basic

safety and essential performance of multifunction

patient monitoring equipment
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