UNE-EN 60601-2-49:2016

INTRODUCTION
SECTION ONE - GENERAL
1 Scope and object
2 Terminology and definitions
5 Classification
6 Identification, marking and documents
SECTION TWO - ENVIRONMENTAL CONDITIONS
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK
                HAZARDS
14 Requirements related to classification
17 Separation
19 Continuous leakage currents and patient auxiliary
   currents
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM
               UNWANTED OR EXCESSIVE RADIATION
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION
              OF FLAMMABLE ANAESTHETIC MIXTURES
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE
                TEMPERATURES AND OTHER SAFETY HAZARDS
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
                AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS,
               ENVIRONMENTAL TESTS
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
56 Components and general assembly
Appendix L - References - Publications mentioned in this
             standard
Annex AA (informative) - Guidance and rationale
Annex BB (informative) - Alarm diagrams of clause 51
Annex EE (informative) - Survey of insulation paths and
         test circuit
Annex KK (informative) - Examples of patient leakage
         current measurements
Annex ZA (normative) - Normative references to
         international publications with their
         corresponding European publications
Annex ZB (informative) - International publications
         mentioned in this standard with the references
         of the relevant European publications
Index of defined terms

Clause 1 of the general standard1 applies, except as follows:201.1.1 * ScopeReplacement:This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements ofMULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to asME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies toMULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as wellas in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT.The scope of this standard is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMSintended for connection to a single PATIENT that has either two or morePHYSIOLOGICAL MONITORING UNITS.Note 1: For purposes of this standard, a pregnant mother and her fetus(es) are considered a single PATIENT.This standard does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITSsuch as ECG, invasive pressure and pulse oximetry. The particular standards related to thesePHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-aloneME EQUIPMENT. This particular standard addresses the additional requirements related toMULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated intoother ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEM. When this is the case, other relevantstandards also apply.EXAMPLE 1 MULTIFUNCTION PATIENT MONITOR incorporated into a critical care ventilator where ISO 80601-2-12 also applies.EXAMPLE 2 MULTIFUNCTION PATIENT MONITOR incorporated into a homecare ventilator for dependentPATIENTS where ISO 80601-2-72 also applies.EXAMPLE 3 MULTIFUNCTION PATIENT MONITOR incorporated into anesthetic workstation where ISO 80601-2-13 also applies.EXAMPLE 4 MULTIFUNCTION PATIENT MONITOR incorporated into haemodialysis equipment IEC 60601-2-16also applies.This standard does not apply to MULTIFUNCTION PATIENT MONITORS implanted in a PATIENT.