IEC/TC 62 - IEC_TC_62

IEC 60601-2-37:2024 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 document are not covered by specific requirements in this document except in 201.7.2.13. This document 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. IEC 60601-2-37:2024 cancels and replaces the second edition published in 2007 and Amendment 1:2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) technical and editorial changes resulting from the amended general standard IEC 60601 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and its collateral standards IEC 60601-1-xx, b) technical and editorial changes as a result of maintenance to normative references; c) technical and editorial changes resulting from relevant developments in TC 87 Ultrasonics standards. In particular, Clause 201.11 about protection against excessive temperatures and other hazards has been fully revised.

IEC 60601-2-54:2022 is available as IEC 60601-2-54:2022 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-54:2022 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME SYSTEMS intended to be used for projection RADIOGRAPHY and INDIRECT 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 document. ME EQUIPMENT and ME SYSTEMS intended to be used for bone or tissue absorption densitometry, computed tomography, mammography or dental or radiotherapy applications are excluded from the scope of this document. The scope of this document 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. IEC 60601-2-54:2022 edition cancels and replaces the first edition published in 2009, Amendment 1:2015 and Amendment 2:2018. This edition constitutes a technical revision. This edition includes editorial and technical changes to reflect the IEC 60601 1:2005/AMD2:2020. It also contains corrections and technical improvements. Significant technical changes with respect to the previous edition are as follows: a) a new specific term DOSIMETER is introduced to replace the general term DOSEMETER; b) terms and definitions taken exclusively from IEC TR 60788:2004 and which are specifically applicable in this document have been moved to 201.3; c) the collateral standards IEC 60601-1-11:2015, IEC 60601-1-11:2015/AMD1:2020, IEC 60601-1-12:2014 and IEC 60601-1-12:2014/AMD1:2020 are applicable if MANUFACTURER so declares; d) the subclause 201.11.101 “Protection against excessive temperatures of X-ray tube assemblies” has been removed from this document as its requirements are sufficiently and clearly covered by IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020 and IEC 60601-2-28:2017; e) to adopt changes which are introduced with respect to indicator lights in 7.8.1 of the IEC 60601-1:2005/AMD2:2020 clarification of requirements is provided to avoid conflicts with requirements of indicator lights stipulated for X-RAY EQUIPMENT; f) explanation of the term ESSENTIAL PERFORMANCE is provided in Annex AA to emphasize the performance of the clinical function under NORMAL and SINGLE FAULT CONDITIONS. CONDITIONS.

No scope available

IEC 80601-2-58:2024 is available as IEC 80601-2-58:2024 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-58:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, 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 document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601 1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. IEC 80601-2-58:2024 cancels and replaces the second edition published in 2014 and its Amendment 1:2016. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) the alignment of this particular standard based on the amendment of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020; b) updating collateral, particular and IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 references to align with amendments to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020 and other collateral standards; c) updated normative references; d) added new requirement for particulate matter from APPLIED PARTS in 201.9.5.101; e) adding the shadow light method in 201.12.1.101.7; f) clarify test conditions for EMC requirements in 202.7.1.2; g) updated Table D.4 references to include specific IEC references to the symbols and delete “Annex AA, 201.7.6.101”; h) include a new annex to address the relevant general safety and performance requirements of European regulation (EU) 2017/745 (Annex BB); i) remove all references of the LIQUEFACTION FRAGMENTATION LENS REMOVAL method.

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAGNETIC RESONANCE (MR) EQUIPMENT and MAGNETIC RESONANCE (MR) SYSTEMS. NOTE Where ME EQUIPMENT and ME SYSTEMS are used in the clause headings, this is to be understood to indicate MR EQUIPMENT and MR SYSTEMS. This document does not cover the application of MR EQUIPMENT beyond the INTENDED USE. If a clause or subclause is specifically intended to be applicable to MR EQUIPMENT only, or to MR 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 MR EQUIPMENT and to MR SYSTEMS, as relevant. This document does not formulate additional specific requirements for MR EQUIPMENT or MR SYSTEMS used in INTERVENTIONAL MR EXAMINATIONS.

IEC 60601-2-46:2023 specifies safety requirements for operating tables, whether or not having electrical parts, including transporters, used for the transportation of the operating table top to or from the base or pedestal of an operating table with detachable operating table top. This particular standard does not apply to - dental patient chairs (see ISO 7494-1), - examination chairs and couches, - patient-supporting systems of diagnostic, interventional and therapeutic equipment (see IEC 60601-2-54 or IEC 60601-2-43), - operating table heating blankets (see IEC 60601-2-35), - patient transfer equipment, - delivery tables and delivery beds, - medical beds (see IEC 60601-2-52 and EN 50637), and - field tables. IEC 60601-2-46:2023 cancels and replaces the third edition published in 2016. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition: structural alignment with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.

IEC 61674:2024 specifies the performance and some related constructional requirements of DIAGNOSTIC DOSIMETERS intended for the measurement of AIR KERMA, AIR KERMA LENGTH PRODUCT or AIR KERMA RATE, in photon radiation fields used in medical X-ray imaging, such as RADIOGRAPHY, RADIOSCOPY and COMPUTED TOMOGRAPHY (CT), for X-RADIATION with generating potentials in the range of 20 kV to 150 kV. This document is applicable to the performance of DOSIMETERS with VENTED IONIZATION CHAMBERS and/or SEMICONDUCTOR DETECTORS as used in X-ray diagnostic imaging. IEC 61674:2024 cancels and replaces the second edition published in 2012. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) for mammography, the manufacturer specifies the REFERENCE VALUE for the RADIATION QUALITY; b) for mammography, the manufacturer provides the MINIMUM RATED RANGE of RADIATION QUALITIES for the compliance test on energy dependence of response; c) the compliance test for analogue displays was removed; d) the compliance tests for range reset, the effect of leakage and recombination losses were removed. These tests are already covered by the test on linearity and cannot be conducted for modern devices. The estimation of COMBINED STANDARD UNCERTAINTY was changed accordingly; e) the compliance test for mains rechargeable and battery-operated dosimeters were updated for modern devices

IEC 61223-3-8:2024 applies to evaluation of the imaging performance and related quality control parameters of X‑ray equipment for radiography and radioscopy that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022. This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display. This document applies to acceptance tests and constancy tests, which are part of the quality assurance program in medical imaging departments and are intended to be performed by or under the responsibility of the responsible organization. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the manufacturer’s installation instructions. IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the responsible organization with respect to quality control. This document provides guidance to manufacturers regarding the acceptance and constancy tests for the X‑ray equipment in a manufacturer supplied quality control manual. Annex G provides guidance for such a manual.

IEC 62220-2-1:2023 describes the performance metrics associated with DUAL-ENERGY IMAGING capable DIGITAL X-RAY IMAGING DEVICES meant for medical applications and specifies the methods for their determination. These metrics can be used to analyse TISSUE-SUBTRACTED IMAGES and to evaluate dose performance, noise characteristics, and tissue-subtraction efficacy of DIGITAL X-RAY IMAGING DEVICES. The described methods indicate the procedures to obtain MULTI-SPECTRAL PRIMARY DATA and to compute their derived TISSUE-SUBTRACTED IMAGES. The intended users of this document are MANUFACTURERS and well-equipped test laboratories. This document is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for single or multiple exposure dual-energy radiographic imaging based on, for example, CR systems, direct and indirect flat panel-detector based systems. This document excludes and is not applicable to: – DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dental RADIOGRAPHY; – slot scanning DIGITAL X-RAY IMAGING DEVICES; – COMPUTED TOMOGRAPHY or CONE-BEAM COMPUTED TOMOGRAPHY; – photon-energy discriminating devices such as photon counting X-RAY IMAGING DEVICES; – devices for dynamic imaging (where series of images are acquired, as in fluoroscopy or cardiac imaging). – DIGITAL X-RAY IMAGING DEVICES intended to be used with RADIOTHERAPY beams.

IEC 61676:2023 is available as IEC 61676:2023 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61676:2023 specifies the performance requirements of instruments as used in the non-invasive measurement of X-RAY tube voltage up to 150 kV and the relevant compliance tests. This document also describes the method for calibration and gives guidance for estimating the uncertainty in measurements performed under conditions different from those during calibration. Applications for such measurement are found in diagnostic radiology including mammography, computed tomography (CT), dental radiology and radioscopy. This document is not concerned with the safety aspect of such instruments. The requirements for electrical safety applying to them are contained in IEC 61010-1. IEC 61676:2023 cancels and replaces first edition published in 2002, Amendment 1:2008. This edition constitutes a technical revision. It includes an assessment of the combined standard uncertainty for the performance of a hypothetical instrument for the non-invasive measurement of the tube high voltage (in Annex A) which replaces Annex A of the edition 1.1 titled "Recommended performance criteria for the invasive divider".

20211012-JO-Link to 93/42/EEC and M/295 removed

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of both FIXED and MOBILE 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 for cone-beam CT mode, is covered by this standard and not by IEC 60601-2-44 [2]2. No additional requirements for operation in cone-beam CT mode were identified for this standard (see also Note 4 in 203.6.4.5). 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. The subclauses of this standard supersede IEC 60601-2-54 subclauses. IEC 60601-2-54 applies only with regards to the cited subclauses; non-cited subclauses of IEC 60601-2-54 do not apply.

This International Standard is applicable to X-RAY SOURCE ASSEMBLIES and X-RAY TUBE ASSEMBLIES, for use in MEDICAL DIAGNOSTIC RADIOLOGY for techniques in which the X-RAY PATTERN will be received simultaneously in all points of the IMAGE RECEPTION AREA. This standard specifies a method for the determination of the greatest geometrically symmetrical RADIATION FIELD at a specified distance from the FOCAL SPOT for which the percentage AIR KERMA RATE along the major axes of the RADIATION FIELD does not fall below a permitted value. NOTE 1 AIR KERMA or AIR KERMA RATE are the only practical verifiable physical quantities for X-RAY SOURCES. X-RAY SOURCES must be tested independently from MEDICAL ELECTRICAL SYSTEMS. Conversion to the characteristics of the X-RAY IMAGE RECEPTOR used in a MEDICAL ELECTRICAL SYSTEM may be done in addition. In case multiple FOCAL SPOTS are not super-imposed, each focal spot has its own REFERENCE AXIS. Then the maximum RADIATION FIELD may be given for each FOCAL SPOT separately NOTE 2 The maximum symmetrical RADIATION FIELD may change from its initial value as the X-RAY TUBE ages through use. NOTE 3 If, for certain MEDICAL ELECTRICAL SYSTEMs the scope of IEC 60806 does not fit, then the special RADIATION FIELD requirements could be incorporated in the MEDICAL ELECTRICAL SYSTEM particular standard. However, a statement on the RADIATION FIELD while referring IEC 60806 is then no longer possible.

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.

IEC 61223-3-5:2019 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/AMD1:2012AMD2:2016. IEC 60601-2-44 and this document • defines the essential parameters which describe the performance of CT SCANNERS with regard to image quality, RADIATION OUTPUT and PATIENT positioning; the list of parameters to be tested can be found in section 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 and CONSTANCY TESTING 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 61223-3-5:2019 cancels and replaces the first edition published in 2004, and the second edition of IEC 61223-2-6 published in 2006. This edition constitutes a technical revision. This edition includes the following significant technical change with respect to the previous edition and to IEC 61223-2-6: 1) modification of the RADIATION protection and control; 2) modification of the acceptance testing; 3) introduction of constancy testing.

IEC 62985:2019 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.

IEC 80601-2-59:2017 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. This edition includes the following significant technical changes with respect to the previous edition: a) updates of the normative references and the bibliography; b) expansion of the applicability to pandemic infectious diseases in general.

NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31
2019-07-04 IP: BT decision D163/C033 - remove link to MDD  
NEXT ACTION: TB Action by 21-22 May 2019 i.e. Next CLC TC 62 Plenary Meeting
2019-01-16 JO - In contact with CLC TC 62 to know if they will take a ballot to decouple this WI (upon  BT approval)  and proceed to PUB

NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31
2019-07-04 IP: BT decision D163/C033 - remove link to MDD  
2017-10-09: Publication on hold due to negative assessment

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.

NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31
2019-07-04 IP: BT decision D163/C033 - remove link to MDD  
NEXT ACTION: TB Action by 21-22 May 2019 i.e. Next CLC TC 62 Plenary Meeting
2019-01-24: JO - In contact with CLC TC 62 secretary to know if an annex ZZ is expected or if a CIB will be launched to decouple this standard from the harmonization process.

IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, 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. 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. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.

IEC 60601-2-75:2017 applies to the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis 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 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 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. This document is to be used with IEC 60601-1:2005 and its amendment 1.

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.

NEW!IEC 80601-2-30:2018 is available as IEC 80601-2-30:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 80601-2-30:2018 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. 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. 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 second edition cancels and replaces the first edition published in 2009 and Amendment 1:2013. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with IEC 60601-1:2005/AMD1:2012 and IEC 60601-1-8:2006/AMD1:2012 , and with IEC 60601-1-2:2014 and IEC 60601-1-11:2015; b) referencing IEC 60601-1-10:2007 and IEC 60601-1-12; c) changing an operator-accessible cuff-sphygmomanometer connector from not compatible with the ISO 594 series to compatible with the ISO 80369 series; d) added additional requirements for public self-use sphygmomanometers; e) added a list of primary operating functions.

NEW!IEC 60601-2-16:2018 is available as IEC 60601-2-16:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.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.

NEW!IEC 60601-2-39:2018 is available as IEC 60601-2-39:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-39:2018 applies to the basic safety and essential performance of peritoneal dialysis medical electrical equipment. It applies to peritoneal dialysis equipment intended for use either by medical staff or under the supervision of medical experts, including peritoneal dialysis equipment operated by the patient, regardless of whether the peritoneal dialysis equipment is used in a hospital or domestic environment. This third edition cancels and replaces the second edition of IEC 60601-2-39. It constitutes a technical revision.This edition includes the following significant technical changes with respect to the previous edition: - update of the 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 and of references and requirements to IEC 60601-1-11:2015; - editorial improvements; - improvement of the essential performance requirements clause/subclauses; - new requirements for the interruption of the power supply.

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 61675-1:2022 specifies terminology and test methods for declaring the characteristics of POSITRON EMISSION TOMOGRAPHS. POSITRON EMISSION TOMOGRAPHS detect the ANNIHILATION RADIATION of positron emitting RADIONUCLIDES by COINCIDENCE DETECTION.

This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES. An informal overview of activities for HEALTH SOFTWARE is shown in Figure 2. [Figure 2] [derived from IEC 62304:2006[8], Figure 2] Figure 2 - HEALTH SOFTWARE LIFE CYCLE PROCESSES The purpose is to increase the CYBERSECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves. It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in ISO 81001-1[17]. This document excludes specification of ACCOMPANYING DOCUMENTATION contents.

This part of IEC 61223 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012 and IEC 60601-2-63:2012/AMD1:2017. NOTE 1 DENTAL CBCT EQUIPMENT is a subset of DENTAL EXTRA-ORAL X-RAY EQUIPMENT. NOTE 2 DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide one or more of PANORAMIC, CEPHALOMETRIC, tomosynthesis and DENTAL CBCT imaging modalities, all of which are in the scope of the IEC 60601-2-63 basic safety and performance standard. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT. The aim of 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 requirements specified in this document are minimal requirements. The MANUFACTURER can establish criteria for the tests described here that exceed the levels contained in this document. CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENT meets established criteria and to enable the early recognition of changes in the properties of components of the ME EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT. This document does not apply to: - aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety; - aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality, RADIATION OUTPUT and PATIENT positioning. NOTE 3 Such aspects are generally addressed by IEC 60601-1 (all parts). Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document. DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply. The object of this document is to establish: - the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning; - methods of testing and whether measured quantities related to those parameters comply with the specified requirements. These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed.

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 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.

Establishes particular requirements for the safety of electromyographs and evoked response equipment as defined in clause 2 of this standard.

This part of IEC 62563 establishes the performance CRITERIA and test frequencies for the ACCEPTANCE TESTS and CONSTANCY TESTS. The evaluation methods are defined in IEC 62563-1. The scope of this document is directed to practical tests that can be visually evaluated or measured using basic test equipment. This document applies to medical IMAGE DISPLAY SYSTEMS, which can display monochrome image information in the form of greyscale values on colour and greyscale IMAGE DISPLAY SYSTEMS. This document does not apply to information displays and to displays used solely for control of technical settings of all medical information.