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DIN German institute for standardization
EN European Standard
IEC International Electrical Committee
ISO International Organization for Standardization
Medical devices, active Medical electrical equipment, medical and electrical systems and components
VDE Rules and regulations of the VDE (Verband der Elektrotechnik Elektronik Informationstechnik e.V.). The VDE is one of Europe’s largest technical-scientific associations.
Regulations in the field of active medical devices retracted from the standardization that are still in use due to existing non-European regulatory requirements and are part of the accreditation. This also applies to valid regulations (for instance DIN EN 60601-1-1) which relate to retired regulations (DIN EN 60601-1 Ed. 2).

 

Number Title Scope
DIN EN 60601-1: 2007-07 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.
NOTE See also 4.2.
This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.
In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1 3).
DIN EN 60601-1-1: 2002-08images/asterisk.gif Medical electrical equipment –
Part 1-1:
General requirements for safety –
Collateral standard: Safety requirements
for medical electrical systems
This standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.201. It
describes the safety requirements necessary to provide protection for the PATIENT, the
OPERATOR and surroundings.
DIN EN 60601-1-2: 2007-12 Medical electrical equipment –
Part 1-2:
General requirements for basic
safety and essential performance –
Collateral standard:
Electromagnetic compatibility –
Requirements and tests
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.
This collateral standard applies to ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and
ME SYSTEMS.
IEC 60601-1-2: 2014-02
Edition 4.0
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS in the presence of ELECTROMAGNETIC DISTURBANCES and to ELECTROMAGNETIC DISTURBANCES emitted by ME EQUIPMENT and ME SYSTEMS. BASIC SAFETY with regard to ELECTROMAGNETIC DISTURBANCES is applicable to all ME EQUIPMENT and ME SYSTEMS.
DIN EN 60601-1-3: 2014-06 Medical electrical equipment –
Part 1-3: General requirements for basic safety and essential performance –
Collateral Standard: Radiation protection in diagnostic X-ray equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.
This collateral standard applies to X-RAY EQUIPMENT and to subassemblies of such equipment,
where RADIOLOGICAL IMAGES of a human PATIENT are used for diagnosis, planning or guidance
of medical procedures.
DIN EN 60601-1-4: 2001-04images/asterisk.gif Medical electrical equipment –
Part 1-4:
General requirements for safety –
Collateral Standard:
Programmable electrical medical systems
This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter
referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS).
NOTE Some systems which incorporate software and are used for medical purposes fall outside the scope of this
Collateral Standard, e.g. many medical informatics systems. The distinguishing factor/criterion is whether or not
the system satisfies the definition of MEDICAL ELECTRICAL EQUIPMENT in 2.2.15 of IEC 60601-1 or the definition of
MEDICAL ELECTRICAL SYSTEM in 2.203 of IEC 60601-1-1.
DIN EN 60601-1-6:2016-02 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met (see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).
DIN EN 60601-1-8: 2014-04 Medical electrical equipment –
Part 1-8: General requirements for safety – Collateral standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical electrical systems
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in
ME EQUIPMENT and ME SYSTEMS.
It also provides guidance for the application of ALARM SYSTEMS.
DIN EN 60601-1-9: 2008-09images/asterisk.gif Medical electrical equipment –
Part 1-9:
General requirements for basic
safety and essential performance –
Collateral Standard: Requirements for environmentally conscious design
This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of
MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT.
MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard.
DIN EN 60601-1-10: 2008-11 Medical electrical equipment –
Part 1-10: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for the development of physiologic closed-loop controllers
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as
ME EQUIPMENT and ME SYSTEMS.
This collateral standard specifies requirements for the development (analysis, design,
VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a
PHYSIOLOGIC CLOSED-LOOP CONTROL SYSTEM (PCLCS) in ME EQUIPMENT and ME SYSTEMS to
control a PHYSIOLOGIC VARIABLE.
NOTE A PHYSIOLOGIC VARIABLE can be a body chemistry (e.g. electrolytes, blood glucose), a physical property
(e.g. PATIENT temperature, electrophysiologic, hemodynamic), or a pharmaceutical concentration.
This collateral standard applies to various types of PCLC, e.g. linear and non-linear, adaptive,
fuzzy, neural networks.
This collateral standard does not specify:
− additional mechanical requirements; or
− additional electrical requirements.
This collateral standard applies to a closed-loop controller (see Figure 1) that sets the
CONTROLLER OUTPUT VARIABLE in order to adjust (i.e., change or maintain) the measured
PHYSIOLOGIC VARIABLE by relating it to the REFERENCE VARIABLE.
A closed-loop controller that maintains a physical or chemical VARIABLE, using feedback that is
not measured from a PATIENT, is outside the scope of this standard.
DIN EN 60601-1-11: 2016-04 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel. The HOME HEALTHCARE ENVIRONMENT includes: – the dwelling place in which a PATIENT lives; – other places where PATIENTS are present both indoors and outdoors, excluding professional healthcare facility environments where OPERATORS with medical training are continually available when PATIENTS are present. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the EMERGENCY MEDICAL SERVICES ENVIRONMENT, covered by IEC 60601-1-12 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-12 or this collateral standard. Nonetheless, ME EQUIPMENT or ME SYSTEMS can be intended for multiple use environments, and as such, if also intended for use in the HOME HEALTHCARE ENVIRONMENT, are within the scope of this standard. EXAMPLE ME EQUIPMENT or ME SYSTEMS intended for both the HOME HEALTHCARE ENVIRONMENT and the professional healthcare facility environment. NOTE HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations with unreliable electrical sources and poor electrical grounding.
DIN EN 60601-1-12: 2016-01 Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES ENVIRONMENT), as defined in 3.1. NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use. The RESPONSIBLE ORGANIZATION and the OPERATOR need to be aware that any other use outside the MANUFACTURER’S INTENDED USE can result in a HAZARDOUS SITUATION for the PATIENT. The EMS ENVIRONMENT includes – responding to and providing life support at the scene of an emergency to a PATIENT reported as experiencing injury or illness in a pre-hospital setting, and transporting the PATIENT, while continuing such life support care, to an appropriate professional healthcare facility for further care. – providing monitoring, treatment or diagnosis during transport between professional healthcare facilities. This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within the scope of this standard. EXAMPLE ME EQUIPMENT or ME SYSTEM intended for both the EMS ENVIRONMENT and the professional healthcare facility environment. NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical sources and outdoor environmental conditions.
DIN EN 60601-2-2: 2010-01 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
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
SURGICAL EQUIPMENT as defined in 201.3.222.
HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for
micro-COAGULATION, or for use in dentistry or ophthalmology) is exempt from certain of the
requirements of this particular standard. These exemptions are indicated in the relevant
requirements.
DIN EN 60601-2-4: 2012-05 Medical electrical equipment –
Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
CARDIAC DEFIBRILLATORS, hereafter referred to as ME EQUIPMENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this standard are not covered by specific requirements in this standard
except in 7.2.13 and 8.4.1 of the general standard.
DIN EN 60601-2-7: 2000-03images/asterisk.gif Medical electrical equipment –
Part 2-7:
Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
This Particular Standard applies to HIGH-VOLTAGE GENERATORS of medical diagnostic X-RAY
GENERATORS and to their subassemblies including the following:
– HIGH-VOLTAGE GENERATORS that are integrated with an X-RAY TUBE ASSEMBLY;
– HIGH-VOLTAGE GENERATORS of radiotherapy treatment simulators.
Where appropriate, requirements for X-RAY GENERATORS are given
DIN EN 60601-2-10: 2017-09 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators This International Standard specifies the requirements for the safety of nerve and muscle STIMULATORS, defined in subclause 201.3.204, for use in the practice of physical medicine, hereinafter referred to as ME EQUIPMENT. This includes transcutaneous electrical nerve STIMULATORS (TENS) and electrical muscle STIMULATORS (EMS). NOTE A muscle STIMULATOR may also be known as a neuromuscular STIMULATOR. The following ME EQUIPMENT is excluded: – ME EQUIPMENT intended to be implanted or to be connected to implanted electrodes; – ME EQUIPMENT intended for the stimulation of the brain (e.g. electroconvulsive therapy ME EQUIPMENT); – ME EQUIPMENT intended for neurological research; – external cardiac pacemakers (see IEC 60601-2-31); – ME EQUIPMENT intended for averaged evoked potential diagnosis (see IEC 60601-2-40); – ME EQUIPMENT intended for electromyography (see IEC 60601-2-40); – ME EQUIPMENT intended for cardiac defibrillation (see IEC 60601-2-4).
DIN EN 60601-2-12: 2007-03images/asterisk.gif Medical electrical equipment –Part 2-12:
Particular requirements for the safety of lung ventilators – Critical care ventilators
This Particular Standard specifies the safety requirements for VENTILATORS, as defined in
2.1.125, intended for use in critical care settings.
Continuous positive airway pressure (CPAP) devices, sleep apnea therapy devices, supportcare
VENTILATORs, emergency and transport VENTILATORs, jet and high frequency VENTILATORs
and oscillators are outside the scope of this Particular Standard, nor are devices that may be
used within hospitals, intended solely to augment the ventilation of spontaneously breathing
PATIENTS. Standards for other types of VENTILATORs, e.g. high frequency jet and oscillation
ventilators, are under consideration.
Requirements for VENTILATORs intended for anaesthetic applications are given in IEC 60601-2-13.
DIN EN 60601-2-18: 2016-10 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for ENDOSCOPIC EQUIPMENT [as defined in 201.3.204]. NOTE This object includes endoscopic intense light source equipment which is part of the ENDOSCOPIC EQUIPMENT including its supply unit, therefore IEC 60601-2-57 does not apply.
DIN EN 60601-2-22: 2015-08 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment  This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a CLASS 3B or CLASS 4 LASER PRODUCT as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as LASER EQUIPMENT. Throughout this International Standard, light emitting diodes (LED) are included whenever the word “laser” is used. NOTE 1 Refer to Definition 3.49 in IEC 60825-1. NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1 and IEC 60601-1. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the General Standard. NOTE See also 4.2 of the General Standard. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability.
DIN EN 60601-2-24: 2016-04 Medical electrical equipment - Part 2-24: Particular requirements for basic safety and essential performance of infusion pumps and controllers This Particular Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS, hereafter referred to as ME EQUIPMENT. This standard applies to ADMINISTRATION SETS insofar as their characteristics influence the BASIC SAFETY or ESSENTIAL PERFORMANCE of INFUSION PUMPS and VOLUMETRIC INFUSION CONTROLLERS. However, this standard does not specify requirements or tests for other aspects of ADMINISTRATION SETS If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This particular standard specifies the requirements for ENTERAL NUTRITION PUMPS, INFUSION PUMPS, INFUSION PUMPS FOR AMBULATORY USE, SYRINGE OR CONTAINER PUMPS, VOLUMETRIC INFUSION CONTROLLERS and VOLUMETRIC INFUSION PUMPS, as defined in 201.3.204, 201.3.206, 201.3.207, 201.3.220, 201.3.222 and 201.3.223. These particular standard does not apply to the following: a) devices specifically intended for diagnostic or similar use (e.g. angiography or other pumps permanently controlled or supervised by the OPERATOR); b) devices for extracorporeal circulation of blood; c) implantable devices; d) ME EQUIPMENT specifically intended for diagnostic use within urodynamics (measurement of pressure-volume relationship of the urinary bladder when filled through a catheter with water); e) ME EQUIPMENT specifically intended for diagnostic use within male impotence testing (measurement of amount of liquid infused, necessary to maintain a preset pressure level for maintaining penile erection: cavernosometry, cavernosography); f) devices covered by ISO 28620.
DIN EN 60601-2-25: 2016-08 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHS as defined in 201.3.63 intended by themselves or as a part of an ME SYSTEM, for the production of ECG REPORTS for diagnostic purposes, hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT that provides vectorcardiographic loops; b) ambulatory electrocardiographic ME EQUIPMENT covered by IEC 60601-2-47 where not intended for obtaining ECG REPORTS for diagnostic purposes; c) cardiac monitors covered by IEC 60601-2-27 where not intended for obtaining ECG REPORTS for diagnostic purposes. NOTE 1 For example. ME EQUIPMENT includes: a) direct-writing ELECTROCARDIOGRAPHS; b) other ME EQUIPMENT that produce ECG REPORTS for diagnostic purposes, e.g. patient monitors, defibrillators, exercise testing devices; c) ELECTROCARDIOGRAPHS having a display that is remote from the PATIENT (e.g. via phone lines, networks or storage media). These ME EQUIPMENT or ME SYSTEMS are within the scope of this particular standard excluding transmission media. NOTE 2 ME EQUIPMENT that provide selection between diagnostic and monitoring functions shall meet the requirements of the appropriate standard when configured for that function. ME EQUIPMENT intended for use under extreme or uncontrolled environmental conditions outside the hospital environment or physician’s office, 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.
DIN EN 60601-2-26: 2016-02 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS (EEG) as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This standard is applicable to ME EQUIPMENT used in a clinical environment (e.g., hospital, physician’s office, etc.). This standard does not cover requirements for other equipment used in electroencephalography such as: – phono-photic stimulators; – electroencephalographic telemetry; – EEG data storage and retrieval; – ME EQUIPMENT particularly intended for monitoring during electro-convulsive therapy; – ambulatory electroencephalographic recorders. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard.
DIN EN 60601-2-27: 2015-04 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROCARDIOGRAPHIC (ECG) MONITORING EQUIPMENT as defined in 201.3.63 and hereinafter also referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. This particular standard also applies to ECG telemetry systems used in a hospital environment. ME 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. This standard is not applicable to electrocardiographic monitors for home use. However, MANUFACTURERS should consider using relevant clauses of this standard as appropriate for their INTENDED USE. Ambulatory ("Holter") monitors, fetal heart rate monitoring, pulse plethysmographic devices, and other ECG recording equipment are outside the scope of this particular standard.
DIN EN 60601-2-28: 2010-11 Medical electrical equipment –
Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY
TUBE ASSEMBLIES and to components thereof:
– hereafter referred to as ME EQUIPMENT;
– intended for medical diagnosis and imaging.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE This International Standard is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE
ASSEMBLIES and X-RAY TUBE HEADS.
DIN EN 60601-2-32: 1995-11images/asterisk.gif Medical electrical equipment
Part 2-32:
Particular requirements for the safety of associated equipment of X-ray equipment
This Particular Standard applies to equipment and devices associated with X-RAY
EQUIPMENT as used for supporting and relatively positioning the functional components
including the PATIENT SUPPORT used for the application of the X-RADIATION.
This Particular Standard applies to all ASSOCIATED EQUIPMENT not covered by other
Particular Standards.
DIN EN 60601-2-33: 2011-07 Medical electrical equipment –
Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
MR EQUIPMENT and MR SYSTEMS, hereafter referred to also as ME EQUIPMENT.
This standard does not cover the application of MR EQUIPMENT beyond the INTENDED USE.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
The standard does not formulate ESSENTIAL PERFORMANCE requirements related to
INTERVENTIONAL MR EXAMINATIONS.
DIN EN 60601-2-34: 2015-01 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter referred to as ME EQUIPMENT. This particular standard does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME. This particular standard does not apply to NON-INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT.
DIN EN 60601-2-36: 2015-11 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES, hereafter referred to as ME EQUIPMENT. The applicability of this particular standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to: – ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy; – ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND (HITU) and other therapy equipment as described in Annex AA;
DIN EN 60601-2-37: 2016-11 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of this standard. NOTE See also subclause 4.2 of this standard. This particular standard does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered.
DIN EN 60601-2-40: 1998-12   IEC 60601-2-40:2016 Medical electrical equipment – Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment  This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT. NOTE Myofeedback equipment, where the capturing of muscle contraction is based on electromyography, is within the scope of this particular standard. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. The following ME EQUIPMENT is excluded: ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10.)
DIN EN 60601-2-41: 2016-02 Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis This particular standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SURGICAL LUMINAIRES AND LUMINAIRES FOR DIAGNOSIS, hereafter referred to as ME EQUIPMENT. This particular standard does not apply to – headlights; – endoscopes, laparoscopes and their light sources, which are covered by IEC 60601-2-18; – luminaires used in dentistry, which are covered by ISO 9680; – luminaires for general purposes, which are covered by IEC 60598-2-1 and IEC 60598-2-4; – luminaires dedicated to therapeutic purposes; – special purpose lights with different conditions of use such as UV lights for dermatological diagnosis, slit lamps for ophthalmology, lights for surgical microscopes and lights for surgical navigation systems; – lights connected to surgical instruments; – luminaires of an emergency lighting, which are covered by IEC 60598-2-22. NOTE See also 4.2 of the general standard.
DIN EN 60601-2-43: 2011-03 Medical electrical equipment –
Part 2-43: Particular requirements for the basic safety and essential performance
of X-ray equipment for interventional procedures
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY
EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED
INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its
scope excludes, in particular:
– equipment for RADIOTHERAPY;
– equipment for COMPUTED TOMOGRAPHY;
– ACCESSORIES intended to be introduced into the PATIENT;
– mammographic X-RAY EQUIPMENT;
– dental X-RAY EQUIPMENT.
NOTE 1 Examples of RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, for which the use of INTERVENTIONAL
X-RAY EQUIPMENT complying with this standard is recommended, are given in Annex AA.
NOTE 2 Specific requirements for magnetic navigation devices, and for the use of INTERVENTIONAL X-RAY
EQUIPMENT in an operating room environment were not considered in this particular standard; therefore no specific
requirements have been developed for these devices or uses. In any case, such devices or uses remain under the
general clause requirements.
NOTE 3 INTERVENTIONAL X-RAY EQUIPMENT when used in cross-sectional imaging mode (sometimes described as
CT-like mode or cone-beam CT) is covered by this particular standard and not by IEC 60601-2-44 [2]2. Additional
requirements for operation in CT-like mode or cone-beam CT were not considered in the present standard.
INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT
SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this
standard.
If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY
EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will
say so. If that is not the case, the clause or subclause applies both to INTERVENTIONAL X-RAY
EQUIPMENT and to ME SYSTEMS, as relevant.
NOTE 4 See also 4.2 of the general standard.
DIN EN 60601-2-44: 2017-03 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 1 See also 4.2 of the general standard. The scope of this document is limited to CT SCANNERS intended to be used for both head and body characterised by an ENCLOSURE of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the XRAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY. NOTE 2 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of IEC 60601-2-44. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the 3rd edition scheme for COMPUTED TOMOGRAPHY.
DIN EN 60601-2-45: 2017-01 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT. NOTE 1 This includes MAMMOGRAPHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or integrated storage phosphor subsystems. Excluded from the scope of this document are: – reconstructive tomography modes of operation; – diagnostic consoles; – picture archiving and communication systems (PACS); – non-integrated storage phosphor readers; – hard copy cameras; – films, screens and cassettes; – computer aided detection (CAD); – devices for performing core biopsy and other biopsy instruments; – modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography); If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3rd edition scheme for MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES.
DIN EN 60601-2-46: 2011-12 Medical electrical equipment –
Part 2-46: Particular requirements for the basic safety and essential performance
of operating tables
This particular standard specifies safety requirements for OPERATING TABLES, whether or not
having electrical parts, including TRANSPORTERS, used for the transportation of the table top to
or from the base or pedestal of an OPERATING TABLE with detachable table top.
NOTE See also 4.2 of the General Standard.
This particular standard does not apply to
– dental patient chairs;
– examination chairs and couches;
– patient-supporting systems of diagnostic and therapeutic devices;
– OPERATING TABLE heating blankets;
– patient transfer equipment;
– delivery tables and beds;
– medical beds;
– field tables.
NOTE If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the relevant
requirements of each particular standard have to be considered.
DIN EN 60601-2-47: 2016-02 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AMBULATORY ELECTROCARDIOGRAPHIC SYSTEMS, hereafter referred to as ME SYSTEMS If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. Within the scope of this standard are systems of the following types: a) systems that provide continuous recording and continuous analysis of the ECG allowing full re-analysis giving essentially similar results. The systems may first record and store the ECG and analyse it later on a separate unit, or record and analyse the ECG simultaneously. The type of storage media used is irrelevant with regard to this standard; b) systems that provide continuous analysis and only partial or limited recording not allowing a full re-analysis of the ECG. The safety aspects of this standard apply to all types of systems falling in one of the abovementioned categories. If the AMBULATORY ELECTROCARDIOGRAPHIC SYSTEM offers automatic ECG analysis, minimal performance requirements for measurement and analysis functions apply. MEDICAL ELECTRICAL EQUIPMENT covered by IEC 60601-2-25 and IEC 60601-2-27 are excluded from the scope of this standard. This standard does not apply to systems that do not continuously record and analyse the ECG (for example, ‘intermittent event recorders’).
DIN EN 60601-2-49: 2016-10 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport. ME 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 ME EQUIPMENT intended for connection to a single PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART. This standard does not specify requirements for individual monitoring functions such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological parameters specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING EQUIPMENT, since such equipment has a broader INTENDED USE than this stand-alone ME EQUIPMENT.
DIN EN 60601-2-51: 2004-02 Medical electrical equipment –
Part 2-51:
Particular requirements for safety,
including essential performance,
of recording and analysing single channel and multichannel electrocardiographs
This Particular Standard specifies requirements for the safety, including essential performance,
of RECORDING AND ANALYSING SINGLE CHANNEL AND MULTICHANNEL ELECTROCARDIOGRAPHS as
defined in 2.101, 2.111, 2.117, 2.123, 2.126, hereinafter referred to as EQUIPMENT. The
EQUIPMENT may be attended or unattended.
This Particular Standard complements IEC 60601-2-25 and its Amendment 1 (1999).
DIN EN 60601-2-52: 2016-04 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS intended for adults, hereafter referred to as MEDICAL BED as defined in 201.3.212. If a clause or subclause is specifically intended to be applicable to a MEDICAL BED only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEDICAL BED and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of MEDICAL BED or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the General Standard
DIN EN 60601-2-54: 2016-07 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and RADIOSCOPY. IEC 60601-2-43 applies to ME EQUIPMENT and ME SYSTEMS intended to be used for interventional applications and refers to applicable requirements in this particular standard. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental applications are excluded from the scope of this International Standard. The scope of this International Standard also excludes radiotherapy simulators. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. NOTE Taking into account economic and social factors, the scope of this particular standard includes ME EQUIPMENT intended to be used for DIRECT RADIOSCOPY. In some countries examinations performed with DIRECT RADIOSCOPY are prohibited
DIN EN 60601-2-57: 2011-11 Medical electrical equipment –
Part 2-57: Particular requirements for the basic safety and essential performance
of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
This International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment
incorporating one or more sources of OPTICAL RADIATION in the wavelength range 200 nm to
3 000 nm, with the exception of laser radiation, and intended to create non-visual photobiological
effects in humans or animals for therapeutic, diagnostic, monitoring,
cosmetic/aesthetic or veterinary applications; hereafter referred to as light source equipment
(LS EQUIPMENT).
This particular standard does not apply to equipment for sun tanning, for ophthalmic
instruments or for infant phototherapy.
NOTE Safety requirements in this particular standard are intended to address only HAZARDS to the eye and skin;
hazards to internal tissues are not included in its scope.
LS EQUIPMENT may consist of a single or multiple sources of OPTICAL RADIATION, with or without
power supply, or may be incorporated into a complex system that includes optical, electrical
or mechanical systems or sources of other radiation.
NOTE Annexes AA to EE have been included for purposes of general guidance and to illustrate many typical
cases. However, the annexes should not be regarded as definitive or exhaustive.
DIN EN 60601-2-63: 2016-11 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes ME SYSTEMS containing such ME EQUIPMENT. NOTE 1 This includes PANORAMIC equipment, CEPHALOMETRIC equipment, and equipment for dental volumetric reconstruction (hereafter DVR) as defined in 201.3.203 below. NOTE 2 DVR includes dental CBCT (cone beam computed tomography), which is also known with other names in certain parts of the world, e.g. DVT (digital volumetric tomography); DVR also includes tomosynthesis. NOTE 3 This may include the imaging of other anatomical parts (e.g. the hand) as long as required for dental treatment (e.g. orthodontic treatment). NOTE 4 This may include anatomical objects of interest to the ENT (ear, nose, and throat) specialist. The scope of this standard is restricted to X-RAY EQUIPMENT where: ? the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and ? the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be arbitrarily altered by the OPERATOR during INTENDED USE. NOTE 5 DENTAL INTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard. NOTE 6 FOCAL SPOT TO IMAGE RECEPTOR DISTANCE and FOCAL SPOT to object distance are preset in the design of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 7 For DENTAL X-RAY EQUIPMENT not in the scope of this document because of the restriction above, applicable clauses of IEC 60601-2-54 may be used with this document. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. NOTE 8 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL EXTRA-ORAL X-RAY EQUIPMENT. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in the field. NOTE 9 Requirements particular to DENTAL X-RAY-EQUIPMENT which were included in previous editions of the collateral standard IEC 60601-1-3 or the particular standard IEC 60601-2-28 have been extracted and moved into this particular standard. NOTE 10 For X-RAY EQUIPMENT in the scope of this particular standard X-RAY TUBE ASSEMBLIES are X-RAY MONOBLOCK ASSEMBLIES.
DIN EN 60601-2-65: 2016-11 Medical electrical equipment - Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT. The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY. DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard NOTE 1 The X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT always comprises an X-RAY MONOBLOCK ASSEMBLY. Therefore, in this particular standard the concept of X-RAY TUBE ASSEMBLY is replaced by that of X-RAY MONOBLOCK ASSEMBLY. NOTE 2 Main components may be for instance the X-RAY MONOBLOCK ASSEMBLY and an ELECTRONIC X-RAY IMAGE RECEPTOR. NOTE 3 Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope of this particular standard, since they have no electrical APPLIED PARTS in the PATIENT ENVIRONMENT, and are not ME EQUIPMENT. ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-2-45 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY. Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment. NOTE 4 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or in this particular standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3rd edition scheme for DENTAL INTRA-ORAL X-RAY EQUIPMENT. All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard.
DIN EN 61010-2-040: 2016-06 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. Examples of such equipment include the following: a) sterilizers and disinfectors using steam, and/or hot water as the sterilant; b) sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant; c) sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and d) washer disinfectors.
DIN EN 61010-2-101: 2003-09 Safety requirements for electrical equipment for measurement, control, and
laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD)
medical equipment
 
DIN EN 61326-2-6: 2013-09 Electrical equipment for measurement, control and laboratory use – EMC
requirements –
Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical equipment
In addition to the scope of IEC 61326-1, this part of IEC 61326 series specifies minimum
requirements for immunity and emissions regarding electromagnetic compatibility for in vitro
diagnostic medical equipment, taking into account the particularities and specific aspects of
this electrical equipment and their electromagnetic environment.
DIN EN ISO 80601-2-12: 2012-02 Medical electrical equipment —
Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:
intended to be attended by a professional OPERATOR for those PATIENTS who are dependent on mechanical ventilation; and
NOTE 1 Such VENTILATORS are considered a LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.
intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. NOTE 2 A critical care VENTILATOR intended for use in transport within a professional healthcare facility is not considered an emergency and transport ventilator.
This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM, or to a VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR.
This International Standard is not applicable to ME EQUIPMENT or an ME SYSTEM operating in ventilation modes intended for patients who are not dependent on mechanical ventilation.
NOTE 3 A critical care VENTILATOR, when operating in such a mode, is not considered LIFE-SUPPORTING ME EQUIPMENT OR ME SYSTEM.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601-1:2005, 4.2.
This International Standard is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, sleep apnoea therapy ME EQUIPMENT, HOME HEALTHCARE ENVIRONMENT VENTILATORS, ventilatory support ME EQUIPMENT, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs).[26] This International Standard does not specify the requirements for ME EQUIPMENT that is intended solely to augment the ventilation of spontaneously breathing PATIENTS within a professional healthcare facility.
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for anaesthetic applications which are given in ISO 80601-2-13.
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home care ventilators for ventilator-dependent PATIENTS which are given in ISO 10651-21).
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651-32).
This International Standard does not specify the requirements for VENTILATORS or ACCESSORIES intended for home-care ventilatory support devices which are given in ISO 10651-63).
DIN EN 80601-2-30: 2016-02 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of AUTOMATED SPHYGMOMANOMETERS, hereafter referred to as ME EQUIPMENT, which by means of an inflatable CUFF, are used for intermittent indirect measurement of the BLOOD PRESSURE without arterial puncture. NOTE 1 Equipment that performs indirect measurement of the BLOOD PRESSURE without arterial puncture does not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE. This standard specifies requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE for this ME EQUIPMENT and its ACCESSORIES, including the requirements for the accuracy of a DETERMINATION. This standard covers electrically-powered intermittent, indirect measurement of the BLOOD PRESSURE without arterial puncture, ME EQUIPMENT with automatic methods for estimating BLOOD PRESSURE, including BLOOD PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT. Requirements for indirect measurement of the BLOOD PRESSURE without arterial puncture ME EQUIPMENT with an electrically-powered PRESSURE TRANSDUCER and/or displays used in conjunction with a stethoscope or other manual methods for determining BLOOD PRESSURE (NON-AUTOMATED SPHYGMOMANOMETERS) are specified in document ISO 81060-1. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1. NOTE 2 See also 4.2 of the general standard
DIN EN 80601-2-35: 2010-08 Medical electrical equipment –
Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
 
DIN EN ISO 80601-2-55: 2012-03 Medical electrical equipment —
Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
This International Standard specifies particular requirements for the BASIC SAFETY and ESSENTIAL PERFORMANCE of a RESPIRATORY GAS MONITOR (RGM), hereafter referred to as ME EQUIPMENT, intended for CONTINUOUS OPERATION for use with a PATIENT.
This International Standard specifies requirements for
anaesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring. NOTE 1 An RGM can be either standalone ME EQUIPMENT or integrated into other equipment, e.g. an anaesthetic workstation or a ventilator.
This International Standard is not applicable to an RGM intended for use with flammable anaesthetic agents.
Environmental aspects are addressed in Annex BB.
NOTE 2 Additional aspects of environmental impact are addressed in ISO 14971 and IEC 60601-1-9.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this particular standard, except in 7.2.13 and 8.4.1 of the general standard (IEC 60601-1).
NOTE 3 See also 4.2 of the general standard.
DIN EN ISO 80601-2-56: 2013-02 Medical electrical equipment —
Part 2-56:
Particular requirements for basic safety
and essential performance of clinical thermometers for body temperature measurement
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL
THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard
specifies the general and technical requirements for electrical CLINICAL THERMOMETERS. This standard applies
to all electrical CLINICAL THERMOMETERS that are used for measuring the body temperature of PATIENTS.
CLINICAL THERMOMETERS can be equipped with interfaces to accommodate secondary indicators, printing
equipment, and other auxiliary equipment to create ME SYSTEMS. This standard does not apply to auxiliary
equipment.
ME EQUIPMENT that measures a temperature not as a primary purpose, but as a secondary function, is outside
the scope of this standard.
EXAMPLE 1 Swan-Ganz thermodilution determination of cardiac output is not in the scope of this standard.
EXAMPLE 2 A Foley catheter that includes a temperature PROBE is in the scope of this standard.
EXAMPLE 3 PATIENT heating ME EQUIPMENT that includes a skin temperature measurement such as infant incubators,
heating blankets, heating pads and heating mattresses are not in the scope of this standard, unless they indicate a
temperature of a REFERENCE BODY SITE in which they are in the scope of this standard.
Requirements for ME EQUIPMENT intended to be used for non-invasive human febrile temperature screening of
groups of individuals under indoor environmental conditions are given in IEC 80601-2-59:2008 and such
ME EQUIPMENT is not covered by this standard.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only,
the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of
this standard are not covered by specific requirements in this standard except in IEC 60601-1:2005, 7.2.13
and 8.4.1.
NOTE Additional information can be found in IEC 60601-1:2005, 4.2.
DIN EN ISO 80601-2-61: 2012-01 Medical electrical equipment —
Part 2-61:
Particular requirements for basic safety
and essential performance of puls oximeter equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PULSE OXIMETER
EQUIPMENT intended for use on humans, hereafter referred to as ME EQUIPMENT. This includes any part necessary
for NORMAL USE, including the PULSE OXIMETER MONITOR, PULSE OXIMETER PROBE, and PROBE CABLE EXTENDER.
These requirements also apply to PULSE OXIMETER EQUIPMENT, including PULSE OXIMETER MONITORS, PULSE
OXIMETER PROBES and PROBE CABLE EXTENDERS, which have been REPROCESSED.
The intended use of PULSE OXIMETER EQUIPMENT includes, but is not limited to, the estimation of arterial oxygen
haemoglobin saturation and pulse rate of PATIENTS in professional healthcare institutions as well as PATIENTS
in the HOME HEALTHCARE ENVIRONMENT.
This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended for use in laboratory
research applications nor to oximeters that require a blood sample from the PATIENT.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only,
the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause
applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of
this standard are not covered by specific requirements in this standard except in 201.11 and in 7.2.13 and
8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This standard can also be applied to PULSE OXIMETER EQUIPMENT and their ACCESSORIES used for
compensation or alleviation of disease, injury or disability.
This International Standard is not applicable to PULSE OXIMETER EQUIPMENT intended solely for foetal use.
This International Standard is not applicable to remote or slave (secondary) devices that display SpO2 values
that are located outside of the PATIENT ENVIRONMENT.
DIN EN 80601-2-60: 2016-03  Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment  This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL UNITS, DENTAL PATIENT CHAIRS, DENTAL HANDPIECES and DENTAL OPERATING LIGHTS, hereafter referred to as DENTAL EQUIPMENT. Excluded are amalgamators, sterilizers and dental X-ray equipment. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard
DIN EN ISO 80601-2-72: 2016-04 Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients IEC 60601‐1:2005+AMD1:2012, 1.1 is replaced by: This part of ISO 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in EQUIPMENT: combination with its ACCESSORIES, hereafter referred to as MECARE ENVIRONMENT; — intended for use in the HOME HEALTH — intended for use by a LAY OPERATOR; — intended for use with PATIENTS who are dependent on mechanical ventilation for their life support. NOTE 1 Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support. NOTE 2 In the HOME HEALTHCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable. NOTE 3 Such VENTILATORS can also be used in non‐critical care applications of professional health care facilities. This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those S ca ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR. EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER, external electrical power source, and DISTRIBUTED ALARM SYSTEM. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in 01 IEC 606‐1:2005+AMD1:2012, 7.2.13 and 8.4.1. NOTE 4 Additional information can be found in IEC 60601–1:2005+AMD1:2012, 4.2. This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT, high‐frequency jet ventilators (HFJVs), and high‐frequency oscillatory ventilators (HFOVs)[35]. This part of ISO 80601 does not specify the requirements for cuirass and “iron‐lung” VENTILATORS. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for critical care applications, which are given in ISO 80601‐2‐12. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for anaesthetic applications, which are given in ISO 80601‐2‐13. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for emergency and transport which are given in ISO 10651‐3. NOTE 5 In the future, ISO 10651‐3 is expected to be harmonized with IEC 60601‐1:2005, at which time it will be replaced by ISO 80601‐2‐xx. This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for home‐care ventilatory support equipment (intended only to augment the ventilation of spontaneously g breathing PATIENTS), which are given in ISO 10651‐6. NOTE 6 In the future, ISO 10651‐6 is expected to be harmonized with IEC 60601‐1:2005 and IEC 60601‐1‐ 11:2015, at which time it will be replaced by ISO 80601‐2‐xx. This part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601‐2‐70.[16] This part of ISO 80601 is a particular International Standard in the IEC 60601‐1 and ISO/IEC 80601 series of standards.

 



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