IEMO - Electrical equipment in medical practice

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/295

2021-02.09 -JO - positive assessment for MDD (EN IEC 60601-2-83:2020 - PR= 64477) and the comments of the HAS consultant for MDR was resolved by the TC for EN IEC 60601-2-83:2020/prA11 - PR= 72969
This A11 introduces a revised Annex ZA & Annex ZZ  to EN IEC 60601-2-83:2020 in view of offering it for citation in OJEU under MDD (93/42/EEC) and MDR (2017/745)

IEC 60336:2020 applies to FOCAL SPOTS in medical diagnostic X-RAY TUBE ASSEMBLIES for medical use, operating at X-RAY TUBE VOLTAGES up to and including 150 kV.
This document describes the test methods employing digital detectors for determining:
a) FOCAL SPOT dimensions in terms of NOMINAL FOCAL SPOT VALUES, ranging from 0,1 to 3,0;
b) LINE SPREAD FUNCTIONS;
c) one-dimensional MODULATION TRANSFER FUNCTIONS;
d) FOCAL SPOT PINHOLE RADIOGRAMS,
and the means for indicating compliance.
In informative annexes, STAR PATTERN imaging and BLOOMING VALUE are described.
IEC 60336:2020 cancels and replaces the fourth edition published in 2005. This edition constitutes a technical revision.
The significant changes of this fifth edition with respect to the previous edition are detailed in Clause E.6. These changes are:
a) introduction of digital detectors and discretization errors;
b) fewer normative requirements;
c) support for both SLIT CAMERA and PINHOLE CAMERA;
d) reintroduction of distorted (skewed) FOCAL SPOT;
e) keeping of STAR PATTERNS and BLOOMING VALUE as informative.

This document applies to X-RAY TUBE ASSEMBLIES and to FILTERING MATERIAL, in medical
diagnostic applications up to a HIGH VOLTAGE of 150 kV. For HIGH VOLTAGES greater than 50 kV,
this document applies to X-RAY TUBE ASSEMBLIES with tungsten or tungsten-alloy TARGETS only.
NOTE 1 The FILTERING MATERIAL in the X-RAY BEAM can be removable or irremovable; it can be positioned in any
orientation or can have any shape (e.g. tapering thickness) – although usually plane-parallel material, perpendicular
to the REFERENCE AXIS is applied. Examples of FILTERING MATERIALS are ADDED FILTERS, a PATIENT table (in case of
an under-table X-RAY TUBE ASSEMBLY), materials in the BEAM LIMITING DEVICE, or a breast COMPRESSION DEVICE.
NOTE 2 The methodology and statement of compliance given in this document is for flat FILTERS only, but the
methodology can be used for any kind of non-flat FILTER. In that case further data are included in order to produce
useful results, e.g. field size, geometry/position of FILTER, etc.
This document defines the concept of PERMANENT FILTRATION of X-RAY TUBE ASSEMBLIES, and it
defines the term FILTERING MATERIAL.
Methods are given to determine the PERMANENT FILTRATION of an X-RAY TUBE ASSEMBLY and for
determining the QUALITY EQUIVALENT FILTRATION of FILTERING MATERIALS.
It contains requirements for statements of compliance of X-RAY TUBE ASSEMBLIES in
ACCOMPANYING DOCUMENTS and for markings on X-RAY TUBE ASSEMBLIES, and for indications and
statements of compliance of FILTERING MATERIAL.
NOTE 3 This document does not contain requirements for any specific values of PERMANENT FILTRATION. For X-RAY
EQUIPMENT used for diagnostic purposes, FILTRATION requirements are given in e.g. IEC 60601-1-3:2008 and
IEC 60601-1-3:2008/AMD1:2013 or in the applicable particular standard.
NOTE 4 The method of determination described in this document is suitable as a type test. It is not intended as a
test to be applied by the USER.

This document specifies terminology and test methods for describing the characteristics of
SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT) systems designed specifically for
tomographic cardiac imaging. This includes dedicated systems or general purpose systems with
dedicated sub-systems which are not included in the scope of IEC 61675-2.

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT
TRANSPORT INCUBATOR equipment, as defined in 201.3.208, 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.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS
within the scope of this document are not covered by specific requirements in this document,
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 safety requirements for INFANT TRANSPORT INCUBATORS, but
alternate methods of compliance with a specific clause, by demonstrating equivalent safety,
will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK
MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an
acceptable level when weighed against the benefit of treatment from the device.
This particular standard does not apply to:
– devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information,
see IEC 60601-2-35 [1]2;
– INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see
IEC 60601-2-19 [2];
– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [3];
– INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50 [4].

2020-10-13_JO_CLC/TC 62 Decision  2019-05-21/22 in Oslo to remove the link to the published standard

2020-10-13:JO-CLC/TC 62 Decision  2019-05-21/22 in Oslo to remove the link to the published standard

2019-04-04-JO-: link to legislation to the MDD 93/42/EEC and mandate M/432 removed following CLC/BT decision D162/C076

EN-IEC 62386-105 applies to control gear and control devices.Typically, a bus unit according to IEC 62386 (all parts) contains firmware. There arecircumstances where it might be necessary to change the firmware after production orshipping of the product. For example if the bus unit does not operate as intended. In such acase, a firmware update of a bus unit via the interface is beneficial.This firmware update process is primarily designed to be a bug fix process, not a featureextension process. Nevertheless the firmware update process can be used for featureextensions. But it is important that the risk of negative effects to the complete system isconsidered in detail.

This part of IEC 61223 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when
used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and
dose.
Excluded from the scope of this document are:
– MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC
TOMOSYNTHESIS;
– 2D images synthesised from the tomosynthesis images;
– reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS;
– CT SCANNERS covered by IEC 61223-3-5.
This document defines:
a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC
TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to
image quality and dose,
b) the methods of testing whether measured quantities related to those parameters comply
with specified tolerances, and
c) CONSTANCY TEST frequency when required.
This document is intended to be applied along with the acceptability criteria included in
IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for
MAMMOGRAPHIC TOMOSYNTHESIS modes of operation.
These methods mainly rely on non-invasive measurements that use appropriate test equipment
and are performed during or after the installation. Signed statements covering steps in the
installation procedure can be used as part of the ACCEPTANCE TEST. Tests required by a higher
level of compliance take precedence over similar tests with a lower level of compliance.
When the results of the ACCEPTANCE TEST are in compliance with the expected values, the
BASELINE VALUES for the subsequent CONSTANCY TESTS are established.

2020-01-08 CV: BT decision (D164/C119) to proceed to publication without link to legislation
2019-11-07 mah: consultant assessment missing: blocked.
2019-11-12 - JO: BT document to remove link to the MDD under review

EN-IEC 60601-2-31 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206. HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This document does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered by ISO 14708-1. This document does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS. This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and antitachycardia ME EQUIPMENT.

2020-03-17-JO- BT decision BT164/DG11529/DV to remove the link to the MDD (93/42/EEC)
Publication on hold due to negative assessment

EN-IEC 60601-2-83 is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HOME LIGHT THERAPY EQUIPMENT, intended for use in the HOME HEALTHCARE ENVIRONMENT. HOME LIGHT THERAPY EQUIPMENT is typically used by a LAY OPERATOR. The scope of this document includes all light sources except laser. 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.

EN-IEC 60580 specifies the performance and testing of DOSE AREA PRODUCT METERS intended to measure DOSE AREA PRODUCT and/or DOSE AREA PRODUCT RATE to which the PATIENT is exposed during MEDICAL RADIOLOGICAL EXAMINATIONS. This document is applicable to the following types of DOSE AREA PRODUCT METERS: a) FIELD-CLASS DOSE AREA PRODUCT METERS normally used for the measurement of DOSE AREA PRODUCTS during MEDICAL RADIOLOGICAL EXAMINATIONS; b) REFERENCE-CLASS DOSE AREA PRODUCT METERS normally used for the CALIBRATION of FIELDCLASS DOSIMETERS. The object of this document is 1) to establish requirements for a satisfactory level of performance for DOSE AREA PRODUCT METERS, and 2) to standardize the methods for the determination of compliance with this level of performance. Two levels of performance are specified: - a lower level of performance applying to FIELD-CLASS DOSE AREA PRODUCT METERS; - a higher level of performance applying to REFERENCE-CLASS DOSE AREA PRODUCT METERS.

EN-IEC 80601-2-60 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. 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 document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

IEC 80601-2-26 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROENCEPHALOGRAPHS as defined in 201.3.204, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. This document is applicable to ELECTROENCEPHALOGRAPHS intended for use in professional healthcare facilities, the EMERGENCY MEDICAL SERVICES ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. This document does not cover requirements for other equipment used in electroencephalography such as: - phono-photic stimulators; - EEG data storage and retrieval; - ME EQUIPMENT particularly intended for monitoring during electroconvulsive therapy. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title or 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 follows. The clause or subclause applies to ME EQUIPMENT, as default. For ME EQUIPMENT with the corresponding safety measure or function not completely integrated into the ME EQUIPMENT but instead implemented in an ME SYSTEM, the ME EQUIPMENT MANUFACTURER specifies in the ACCOMPANYING DOCUMENTS which functionality and safety requirements are provided by the ME SYSTEM to comply with this document. The ME SYSTEM is verified accordingly. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document.

This document describes and defines the PROCESS of REFURBISHMENT of USED MEDICAL IMAGING EQUIPMENT and applies to the restoring of USED MEDICAL IMAGING EQUIPMENT to a condition of safety and performance comparable to that of new MEDICAL IMAGING EQUIPMENT i.e. MEDICAL IMAGING EQUIPMENT that was not in use. This restoration includes actions such as REPAIR, REWORK, software/hardware updates, and the replacement of worn parts with original parts. This document enumerates the actions, that are performed, and the manner consistent, with relevant specifications and service procedures required to ensure that the REFURBISHMENT of MEDICAL IMAGING EQUIPMENT is done without changing the finished MEDICAL IMAGING EQUIPMENT’s performance, safety specifications, or INTENDED USE according to its original or applicable valid registration. The MEDICAL IMAGING EQUIPMENT and systems covered by this document include: - X-RAY EQUIPMENT; - X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES; - X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY; - MAGNETIC RESONANCE EQUIPMENT; - ULTRASONIC DIAGNOSTIC EQUIPMENT; - GAMMA CAMERAS; - PLANAR WHOLEBODY IMAGING EQUIPMENT; - equipment for SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY (SPECT); - SPECT/CT hybrid systems, combining a GAMMA CAMERA with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); - POSITRON EMISSION TOMOGRAPHS (PET); - PET/CT hybrid systems combining a POSITRON EMISSION TOMOGRAPH with X-RAY EQUIPMENT FOR COMPUTED TOMOGRAPHY (CT); - PET/MRI hybrid systems combining a POSITRON EMISSION TOMOGRAPH with MAGNETIC RESONANCE EQUIPMENT; and - other combinations of the MEDICAL IMAGING EQUIPMENT or systems listed above. This document does not apply to endoscopic equipment, funduscopic equipment, radiation therapy equipment, nor associated systems.

This document applies to CT SCANNERS that conform to IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016. IEC 60601-2-44 and this document - defines the essential parameters which describe the performance of CT SCANNERS wih regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in 4.3, - defines the methods of testing the essential parameters, and - evaluates compliance with the tolerances of the parameters SPECIFIED by the ACCOMPANYING DOCUMENTS. The methods defined in IEC 60601-2-44 and this document rely on non-invasive measurements, using appropriate test equipment, performed during or after installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST report. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on a CT SCANNER. The aim of the ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The CONSTANCY TESTS are performed to ensure that the functional performance of EQUIPMENT meets ESTABLISHED CRITERIA and to enable the early recognition of changes in the properties of components of the EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements associated with ACCEPTANCE TEST and CONSTANCY TEST for the ACCOMPANYING DOCUMENTS of the CT SCANNER. This document does not apply to - aspects of mechanical and electrical safety, and - aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and are directly affecting image quality, RADIATION OUTPUT and PATIENT positioning.

IEC 60601-2-28:2010 establishes particular basic safety and essential performance requirements for X-ray tube assemblies for medical diagnosis. This second edition cancels and replaces the first edition published in 1993. This edition constitutes a technical revision. The second edition of this particular standard has been prepared to fit IEC 60601-1:2005 (the third edition of IEC 60601-1), which is referred to as the general standard.

IEC 60601-2-46:2010 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. This second edition cancels and replaces the first edition published in 1998 and constitutes a technical revision. This edition of IEC 60601-2-46 was revised to align structurally with the 2005 edition of IEC 60601-1.

This document applies to - CT SCANNERS that are able to display and report CTDIVOL in accordance with IEC 60601-2-44, and - RADIATION dose index monitoring software (RDIMS) for the purpose of calculating, displaying and recording the SIZE SPECIFIC DOSE ESTIMATE (SSDE) and its associated components. Specifically, this document provides standardized methods and requirements for calculating, displaying, or recording of SSDE, SSDE(z), WATER EQUIVALENT DIAMETER (DW), and DW(z), where z represents a specific longitudinal position of the scanned object. This document provides a method of determining a reference WATER EQUIVALENT DIAMETER, DW,REF(z), using CT scans of two cylindrical water PHANTOMS and one or more anthropomorphic PHANTOM(S), which conform to the specifications defined in this document. The method of calculating the WATER EQUIVALENT DIAMETER that is implemented by the MANUFACTURER, DW,IMP(z), is tested and validated against DW,REF(z) using the TEST OBJECTS and methods defined within this document. This document also describes the methods for calculating SSDE and DW, which represent the average values of SSDE(z) and DW(z) over the RECONSTRUCTION LENGTH.

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. 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.

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of SCREENING THERMOGRAPHS intended to be used for the individual non-invasive febrile temperature screening of a human under controlled environmental conditions, hereafter referred to as ME EQUIPMENT. This document sets laboratory characterization test limits for the SCREENING THERMOGRAPH. NOTE 101 A SCREENING THERMOGRAPH is intended for screening of a human subject and detection of SKIN TEMPERATURE elevated above normal. An elevated SKIN TEMPERATURE needs to be followed up by a subsequent temperature measurement using a clinical thermometer (see ISO 80601-2-56 [30]). NOTE 102 The main part of such equipment is commonly referred to as an infrared camera. 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.

This part of the 80601 International Standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORS as defined in 201.3.201, hereafter referred to as ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. This particular standard applies to MULTIFUNCTION PATIENT MONITORS intended for use in professional healthcare facilities as well as in the EMERGENCY MEDICAL SERVICE ENVIRONMENT or the HOME HEALTHCARE ENVIRONMENT. The scope of this document is restricted to ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS intended for connection to a single PATIENT that has two or more PHYSIOLOGICAL MONITORING UNITS. NOTE For purposes of this document, a pregnant mother and her fetus(es) are considered a single PATIENT. This document does not specify requirements for individual PHYSIOLOGICAL MONITORING UNITS such as ECG, invasive pressure and pulse oximetry. The particular standards related to these PHYSIOLOGICAL MONITORING UNITS specify requirements from the perspective of stand-alone ME EQUIPMENT. This particular standard addresses the additional requirements related to MULTIFUNCTION PATIENT MONITORS.MULTIFUNCTION PATIENT MONITORS can be integrated into other ME EQUIPMENT or MEDICAL ELECTRICAL SYSTEMS. When this is the case, other relevant standards 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 dependent PATIENT 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 60601-2-16 also applies. This document does not apply to implantable parts of MULTIFUNCTION PATIENT MONITORS.

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. This particular standard does not apply to implantable defibrillators, remote control DEFIBRILLATORS, external transcutaneous pacemakers, or separate stand-alone cardiac monitors (which are standardized by IEC 60601-2-27). Cardiac monitors which use separate ECG monitoring electrodes are not within the scope of this standard unless they are used as the sole basis for AED rhythm recognition detection or beat detection for synchronized cardioversion. Defibrillation waveform technology is evolving rapidly. Published studies indicate that the effectiveness of waveforms varies. The choice of a particular waveform including waveshape, delivered energy, efficacy, and safety has been specifically excluded from the scope of this standard. However, due to the critical importance of the therapeutic waveform, comments have been added to the rationale which addresses considerations in waveform selection.

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS 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 document are not covered by specific requirements in this document
except in 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document applies to PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT
used for compensation or alleviation of disease, injury or disability.
In the case of combined equipment (e.g. equipment additionally provided with a function or an
APPLIED PART for the target area) such equipment shall also comply with any particular
standard specifying safety requirements for the additional function.
This particular standard does not apply to:
• light therapy equipment intended for use in photothermal ablation, coagulation, and
hyperthermia;
• low-level laser therapy equipment not intended for use with a PHOTOSENSITIZER;
• illumination equipment intended for use in observation, monitoring, and diagnosis, not
intended for use with a PHOTOSENSITIZER.

IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. 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. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.

IEC 60601-2-76:2018 applies to the basic safety and essential performance of low energy ionized gas haemostasis equipment. Hazards inherent in the intended physiological function of ME Equipment or ME Systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. This particular standard amends and supplements IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.

IEC 60601-2-16:2018 applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16:2018 does not take into consideration the dialysis fluid control system of Haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety. IEC 60601-2-16:2018 specifies the minimum safety requirements for haemodialysis equipment. These devices are intended for use either by medical staff or for use by the patient or other trained personnel under the supervision of medical expertise. IEC 60601-2-16:2018 includes all electromedical equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient suffering from kidney failure. This fifth edition cancels and replaces the fourth edition of IEC 60601-2-16, published in 2012. This edition includes the following significant technical changes with respect to the previous edition: a) update of references to IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, of references and requirements to IEC 60601-1-2:2014, of references to IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013, of references and requirements to IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, of references to IEC 60601-1-9:2007 and IEC 60601-1-9:2007/AMD1:2013, of references to IEC 60601-1-10:2007 and IEC 60601-1-10:2007/AMD1:2013 and of references to IEC 60601-1-11:2015; b) widening of the scope; c) editorial improvements; d) addition of requirements for anticoagulant delivery means; e) other few small technical changes.

2019-04-04-JO-: link to legislation and mandate M/295 removed following CLC/BT decision D162/C076
2018-10-31: Lack of compliance from the HAS consultant
2018-08-23 : Consultant's assessment is missing.
in-check - 2018-07-12 - Consultant's assessment is rejected at CDV stage.

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as
PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the
supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of
whether the PD EQUIPMENT is used in a hospital or domestic environment.
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 document are not covered by specific requirements in this document except
in 7.2.13 and 8.4.1 of the general standard.
This document can also be applied to PD EQUIPMENT used for compensation or alleviation of
disease, injury or disability.
These particular requirements do not apply to the DIALYSING SOLUTION, or the DIALYSING
SOLUTION CIRCUIT.

This part of the 80601 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 non-continuous indirect estimation of the
BLOOD PRESSURE without arterial puncture.
NOTE 1 Equipment that performs indirect DETERMINATION of the BLOOD PRESSURE without arterial puncture does
not directly measure the BLOOD PRESSURE. It only estimates the BLOOD PRESSURE.
This document 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 document covers automatic electrically-powered ME EQUIPMENT used for the intermittent,
indirect estimation of the BLOOD PRESSURE without arterial puncture, including BLOOD
PRESSURE monitors for the HOME HEALTHCARE ENVIRONMENT.
Requirements for indirect estimation 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 [2].
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 document are not covered by specific requirements in this document
except in 201.11 and 201.105.3.3, as well as 7.2.13 and 8.4.1 of IEC 60601-1:2005.

This part of IEC 62464 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for
– quality assessment in the ACCEPTANCE TEST, and
– quality assurance in the CONSTANCY TEST.
Required levels of performance for ACCEPTANCE TESTS are not provided for all tests.
This document does not address
– image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated,
– image quality affected by MR-compatibility issues,
– special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications, and
– TYPE TESTS.
The scope of this document is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images.
The measurement procedures specified in this document are directed to
– MANUFACTURERS, who can demonstrate compliance by performing ACCEPTANCE and
CONSTANCY TESTS as described by this document,
– test houses, who can confirm performance of MR EQUIPMENT using methods described in this document,
– regulatory authorities, who can reference this document, and
– RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this document.
The essential image quality parameters and measurement methodologies defined in this document are
– SIGNAL TO NOISE RATIO,
– UNIFORMITY,
– SLICE THICKNESS in 2-D scanning,
– 2-D GEOMETRIC DISTORTION,
– SPATIAL RESOLUTION, and
– GHOSTING ARTEFACTS.
Each of these procedures can be performed standalone or in combination with any of the other procedures.
This document describes the preferred measurement procedures. It also describes alternative normative methods in Annex A. The preferred test methods may be substituted with these alternative normative methods. If necessary, other methods not described in this document can be used, provided those other test methods are documented and validated against the methods described in the document: it means an analysis is done by comparison to the original method that demonstrates a similar, or better, level of sensitivity to the same parameter of interest and a similar, or better, level of robustness against unrelated parameters. All methods will produce quantitative results. The rationale to the preferred and alternate methods, and their pitfalls, are described in Annex B.
This document also presents requirements for CONSTANCY TESTS suitable for MR EQUIPMENT quality assurance programs concerning essential image quality parameters. There are no preferred CONSTANCY TEST methods, to provide flexibility in using existing automated procedures where available, but suggested examples of test methods can be found in Annex A. This document places an emphasis on consistently repeatable, automated measuring tools that facilitate trend analysis and the frequent quick testing of a small set of important parameters that are sensitive to the overall operating characteristics of the MR EQUIPMENT.
NOTE None of the methods found in this document have been extensively tested at a static magnetic field intensity above 3 T. Initial tests indicate the methods function correctly when appropriate TEST DEVICE fillers are used.

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.

EN-IEC 80601-2-71 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT intended to be used by themselves, or as a part of an ME SYSTEM, for the production of FUNCTIONAL NIRS EQUIPMENT output for adjunctive diagnostic purposes, hereinafter referred to as ME EQUIPMENT. Not included within the scope of this particular standard are: a) the part of ME EQUIPMENT, if provided, that measures oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules); b) near-infrared spectroscopy (NIRS) tissue oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output; c) pulse oximeter equipment, which is not intended for obtaining FUNCTIONAL NIRS EQUIPMENT output. The requirements for pulse oximeter equipment are found in ISO 80601-2-61. d) frequency-domain and time-domain equipment for functional near-infrared spectroscopy, which may require different test procedures than defined herein. e) FUNCTIONAL NEAR-INFRARED SPECTROSCOPY EQUIPMENT which measure changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin, which may require different test procedures than defined herein.

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF
SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.
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.

2018-03-06: Link to MDD removed.

This document applies to LIGHT ION BEAM ME EQUIPMENT when used, for therapy purposes, in
human medical practice.
This document applies to LIGHT ION BEAM ME EQUIPMENT which delivers LIGHT ION BEAMS with an
ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n.
This document describes measurements and test procedures to be performed by the
MANUFACTURER of LIGHT ION BEAM ME EQUIPMENT but does not specify ACCEPTANCE TESTS.
This document specifies test procedures for the determination and disclosure of performance
characteristics, knowledge of which is necessary for proper selection, application, and use of
LIGHT ION BEAM ME EQUIPMENT and which are to be declared in the ACCOMPANYING
DOCUMENTATION together with the greatest deviation or variation to be expected under specific
conditions in NORMAL USE. A format for presentation of performance values is given in
Annex A.
It is recognized that inaccuracies in the test methods can occur when assessing performance.
However, it was felt preferable not to combine the errors into an overall performance
tolerance but rather to keep them separate in the expectation that more accurate test methods
will evolve.
It is not intended that this document in any way inhibit the future development of new designs
of equipment which may have operating modes and parameters different from those described
herein, provided that such equipment achieves equivalent or better levels of performance for
the TREATMENT of PATIENTS.
This document applies to both ISOCENTRIC and non-ISOCENTRIC GANTRIES but many of the tests
assume that the LIGHT ION BEAM ME EQUIPMENT has an ISOCENTRIC GANTRY. Where the
equipment is non-ISOCENTRIC, the description of performance and test methods may be
suitably adapted.

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.218, intended for CHILDREN as defined in 201.3.207, and ADULTS with atypical anatomy (ADULTS ranging outside the definition for ADULTS in 201.3.201).
This standard applies to medical beds with nonadjustable and electrical / mechanical adjustable functions.
This Standard applies to MEDICAL BEDS with an internal length of up to 180 cm suitable to a body length of 155 cm.
NOTE 1   The limitation of 180 cm is in order to minimize the foreseeable misuse, of a parent sharing the bed with the child or that the bed will be used by an ADULT.
If a manufacturer wishes to make a bed that can be used by both a child and an ADULT, e.g. length of 180 cm or more, then it will fulfil both EN 60601-2-52 and this particular standard.
This Standard does not apply to MEDICAL BEDS intended for ADULTS as defined in 201.3.201 (covered by EN 60601-2-52).
This Standard does not apply to :
-   incubators covered by EN 60601-2-19 ;
-   beds for children, covered by EN 716-1 and EN 716-2 ;
-   cribs and cradles covered by EN 1130 (all parts) ;
-   bunk beds and high beds, covered by EN 747-1 and 747-2.
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 BEDS 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 EN 60601-1:2006.
NOTE 2   See also 4.2 of EN 60601-1:2006.
NOTE 3   Body length is measured from crown to sole.
1.2 Object
The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements and test methods for MEDICAL BEDS as defined in 201.3.218 intended for CHILDREN as defined in 201.3.207.
(...)

This Part of 82304 applies to the SAFETY and SECURITY of HEALTH SOFTWARE PRODUCTS
designed to operate on general computing platforms and intended to be placed on the market
without dedicated hardware, and its primary focus is on the requirements for MANUFACTURERS.

D155/C077: BT adopted the revised Annexes ZA and ZZ to EN 60601-1-8:2007 --> publication without TC proofing