TC 62 - Medical equipment, software, and systems

IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system.
This document applies to the communication of the radiotherapy treatment planning system with other devices
– used in medical practice,
– that imports data either through input by the operator or from other devices,
– that outputs data to other devices, and
– that is intended to be
- for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training,
- used and maintained in accordance with the recommendations given in the instructions for use, and
– used within the environmental conditions specified in the technical description.
This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system.
IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
– modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems;
– Adaptive radiotherapy is added with Clause 16;
– The title reflects different implementations of radiotherapy treatment planning systems.

IEC 61267:2025 applies to test procedures which, for the determination of characteristics of systems or components of medical diagnostic X-ray equipment, require well-defined X-ray radiation conditions. This document deals with methods for generating X-ray radiation conditions which can be used under test conditions typically found in test laboratories or in manufacturing facilities for the determination of characteristics of medical diagnostic X-ray equipment.
IEC 61267:2025 cancels and replaces the second edition published 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) removing former Annex C “Measurement of the practical peak voltage”;
b) inserting informative “Tabulated values for the squared signal-to-noise ratio per air kerma (SNR2in)” and normative “Additional X-ray radiation conditions as used in mammography and determination of the corresponding nominal aluminium half-value layers”;
c) revision of X-ray radiation conditions;
d) new method for verification of X-ray radiation conditions;
e) change of term definitions.

IEC 60601-2-64:2025 applies to the BASIC SAFETY and essential performance of LIGHT ION BEAM ME EQUIPMENT, hereafter referred to as ME EQUIPMENT, used for treatment of patients. 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 document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacturer and specified installation aspects of LIGHT ION BEAM ME EQUIPMENT
– intended for RADIOTHERAPY in human medical practice, including those in which the selection and DISPLAY of operating parameters can be controlled automatically by PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, in NORMAL USE, deliver a RADIATION BEAM of LIGHT IONS having ENERGY PER NUCLEON in the range 10 MeV/n to 500 MeV/n,
and
– intended to be
• for NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular SPECIFIED clinical purposes maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE,
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 60601-2-64:2025 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) harmonization with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2011 and IEC 60601-1:2005/AMD2:2020;
b) harmonization with IEC 62667:2017 for defined terms and definitions;
c) address revision to neutrons outside the field of irradiation.

IEC 80601-2-89:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL BEDS, hereafter referred to as MEDICAL BEDS as defined in 201.3.219, 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 document applies to both electrical and non-electrical(manual) MEDICAL BEDS with or without adjustable functions. This document applies to MEDICAL BEDS with an INTERNAL LENGTH of up to 180 cm suitable to a body length of 155 cm.
If a MANUFACTURER wishes to make a bed that can be used by both a CHILD and an ADULT, e.g. INTERNAL LENGTH of 180 cm or more, then IEC 80601-2-52 and this document apply.
This document does not apply to:
• ADULT only beds covered by IEC 80601-2-52;
• SPECIALITY MATTRESS covered by the ISO 20342 series;
• incubators covered by IEC 60601-2-19;
• devices for which the INTENDED USE is mainly for examination or transportation under medical supervision (e.g. stretcher, examination table).
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 BEDS or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.

This document specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).
This document applies to masks and their accessories used to connect sleep apnoea breathing therapy equipment to the patient.
The requirements in this document take priority over the requirements in ISO 18190.
This document does not cover oral appliances.
NOTE This document has been prepared to address the relevant essential principles [14] and labelling principles [15] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex I.

ISO 80601-2-70:2025 This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.
This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial ventilation such as patients with central sleep apnoea.
This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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 2 See also 4.2 of the general standard.
This document does not specify the requirements for:
– ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.

This document specifies general interface requirements for small-bore connectors that form part of a medical device or accessory that conveys liquids or gases to a patient. This document also identifies the applications for which these small-bore connectors are intended to be used, which include, but are not limited to:
- respiratory;
- enteral;
- limb cuff inflation;
- neural;
- intravascular or hypodermic;
- other use cases utilizing an ISO 80369-7 small-bore connector.
This document provides the methodology to assess non-interconnectable characteristics of small-bore connectors based on their inherent design in order to reduce the risk of misconnections between medical devices or between accessories for different applications as specified in this document as well as those that can be developed under future parts of the ISO and IEC 80369 series.
NOTE Clause A.2 contains guidance or rationale for this Clause.

IEC 62570:2025 applies to medical devices and other items that are anticipated to enter the magnetic resonance (MR) environment.
This document specifies the marking of items anticipated to enter the MR environment by means of terms and icons, and recommends information that should be included in the labeling.
MR image artifacts are not in the scope of the mandatory portions of this practice because they do not present a direct safety issue resulting from specific characteristics of the MR examination.

IEC 63322:2025 establishes security requirements of ME EQUIPMENT using high-activity SEALED RADIOACTIVE SOURCES, directly or indirectly, for medical treatment and other clinical procedures. ME EQUIPMENT containing SEALED RADIOACTIVE SOURCES that are defined as Category 1, 2 and 3 RADIOACTIVE SOURCES by IAEA are subject to this document. The object of this document is to specify requirements for the security of ME EQUIPMENT containing high-activity SEALED RADIOACTIVE SOURCES with the aim to minimize the risk of unauthorized access to the contained SEALED RADIOACTIVE SOURCES, and to serve as the basis for other standards. This document contains requirements for the MANUFACTURER of the ME EQUIPMENT and, separately, for the RESPONSIBLE ORGANIZATION regarding security at the location during use and storage. The requirements of this document apply when the SEALED RADIOACTIVE SOURCES are contained in the ME EQUIPMENT, i.e. from the time when the SEALED RADIOACTIVE SOURCES are inserted into the ME EQUIPMENT, during the INTENDED USE and when the ME EQUIPMENT is not being used for its INTENDED USE or taken out of regular use, until the equipment is being decommissioned, i.e. until all SEALED RADIOACTIVE SOURCES are permanently removed from the equipment.

NOTE Clause A.2 contains guidance or rationale for this clause.
This document specifies requirements for small-bore connectors intended to be used for connections in neural applications.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific medical devices or accessories.

IEC 60601-2-68:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-ray based IMAGE-GUIDED RADIOTHERAPY equipment for use with EXTERNAL BEAM EQUIPMENT (EBE). This document covers safety aspects of kilovoltage (kV) and megavoltage (MV) X-ray imaging devices integrated in a specified geometrical relationship with EBE for the purpose of IGRT. It covers aspects of communication and relationships between the EXTERNAL BEAM EQUIPMENT and X-ray imaging devices, attached or not directly attached to, but in the same RADIATION shielded area as, and dedicated for use only with, the EXTERNAL BEAM EQUIPMENT. This document deals with equipment for OFFLINE X-IGRT, ONLINE X-IGRT and REAL-TIME X-IGRT. It covers procedures to reduce the risk of over-reliance on the X-IGRT EBE SYSTEM. For example, in the case of ONLINE X-IGRT, the MANUFACTURER will provide an interactive interface for user interaction with the correction suggested by the system. This document does not apply to CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY, and X-RAY EQUIPMENT for RADIOSCOPY, which are not intended for use for IGRT. Requirements that are being tested according to another standard can be identified by the manufacturer and if equivalent do not require retesting, instead evidence can refer to the CT SCANNER, X-RAY EQUIPMENT for RADIOGRAPHY, or X-RAY EQUIPMENT for RADIOSCOPY EQUIPMENT manufacturer's providing compliance statements or test reports. If the X-IGRT EQUIPMENT is combined with an MEE, any requirement that is the same for the X-IGRT EQUIPMENT and the MEE, such as a PATIENT POSITIONER, is not required to be tested twice, but can be accepted as tested by the MEE. This document applies for X-ray equipment for radiography, radioscopy, and COMPUTER tomography used for IGRT. If a clause or subclause is specifically intended to be applicable to X-IGRT EBE SYSTEMS, the content of that clause or subclause will say so. Where that is not the case, the clause or subclause applies only to X-IGRT EQUIPMENT.
This document, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the MANUFACTURER and some installation aspects of X-IGRT EBE SYSTEMS intended to be:
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS having the required skills for a particular medical application, for particular specified clinical purposes, e.g., STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY,
• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and
• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON.
IEC 80601-2-68:2024 cancels and replaces the first edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alignment with the new editions of the relevant standards:
– IEC 60601-2-1:2020;
– IEC 60601-2-44:2009, IEC 60601-2-44:2009/AMD1:2012 and IEC 60601-2-44:2009/AMD2:2016;
– IEC 60601-2-64:2014;
b) clarification of the use of IEC 60601-2-68 for CT SCANNERS, X-RAY EQUIPMENT for RADIOGRAPHY and RADIOSCOPY used in the same room with an EXTERNAL BEAM EQUIPMENT (EBE);
c) introduction of updated requirements related to MECHANICAL HAZARDS, RADIATION HAZARDS, PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS), ACCOMPANYING DOCUMENTATION of an ME SYSTEM, and REMOTE OPERATION.

IEC 80601-2-71:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of FUNCTIONAL NIRS EQUIPMENT, as defined in 201.3.205, intended to be used by itself, or as a part of an ME SYSTEM hereinafter referred to as ME 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 IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, 7.2.13 and 8.4.1.
This document is not applicable to
– equipment for the measurement of oxygen saturation of the haemoglobin in the micro vessels (capillaries, arterioles and venules), i.e. tissue oximeters;
– frequency-domain and time-domain equipment for functional near-infrared spectroscopy;
– equipment for the measurement of changes in the concentration of chromophores other than oxy- and deoxy-haemoglobin;
– equipment for the measurement of changes in the concentration of oxy- and deoxy-haemoglobin in tissues other than the brain.
This document does not specify the requirements for:
– cerebral tissue oximeter equipment, which are given in ISO 80601-2-85; and
– pulse oximeter equipment, which are given in ISO 80601-2-61.
IEC 80601-2-71:2025 cancels and replaces the first edition published in 2015. 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, IEC 60601-1:2005/AMD1:2012, IEC 60601-1:2005/AMD2:2020, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-6:2010/AMD2:2020;
b) added requirements for ESSENTIAL PERFORMANCE;
c) added requirements for PRIMARY OPERATING FUNCTIONS;
d) added requirements for protection against excessive temperatures;
e) added requirements for the display legibility for OPERATORS wearing personal protective equipment;
f) harmonization with ISO 20417, where appropriate.

This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organizations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties. An assurance case can be used to communicate information and knowledge about different risks to other roles.
This document establishes:
- an assurance case framework for HDOs and health software and MDMs for identifying, developing, interpreting, updating and maintaining assurance cases.
- one of the possible means to bridge the gap between manufacturers and HDOs in providing adequate information to support the HDOs risk management of IT-networks;
- best practice by leveraging ISO/IEC/IEEE 15026-2 and other standards to identify key considerations and for the structure and contents of an assurance case, e.g. iterative and continuous approaches;
- example structure, method and format to improve the consistency and comparability of assurance cases.
This document is applicable to all parties involved in the health software and health IT systems life cycle, including:
a) organizations, health informatics professionals and clinical leaders specifying, acquiring, designing, developing, integrating, implementing and operating health software and health IT systems, for example health software developers and MDMs, system integrators, system administrators (including cloud and other IT service providers);
b) healthcare service delivery organizations, healthcare providers and others who use health software and health IT systems in providing health services;
c) governments, health system funders, monitoring agencies, professional organizations and customers seeking confidence in an organization’s ability to consistently provide safe, effective and secure health software, health IT systems and services;
d) organizations and interested parties seeking to improve communication in managing safety, effectiveness and security risks through a common understanding of the concepts and terminology used in safety, effectiveness and security management;
e) providers of training, assessment or advice in safety, effectiveness and security risk management for health software and health IT systems;
f) developers of related safety, effectiveness and security standards.
This document is for use by organizations and people who build, acquire, operate, maintain, use or decommission health software and health IT systems (including medical devices). It is applicable to all organizations involved, regardless of size, complexity or business model.

IEC 60601-2-16:2025 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT. It applies to HAEMODIALYSIS EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including HAEMODIALYSIS EQUIPMENT operated by the PATIENT, regardless of whether the HAEMODIALYSIS 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. This document does not take into consideration specific safety details of the DIALYSIS FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSIS FLUID or CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety. This document specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These HAEMODIALYSIS EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision. This document includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT, independent of the treatment duration and location. If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments.
The particular requirements in this document do not apply to:
– EXTRACORPOREAL CIRCUITS (see ISO 8637-2),
– DIALYSERS (see ISO 8637-1 [2]),
– DIALYSIS FLUID CONCENTRATES (see ISO 23500-4),
– pre-manufactured DIALYSIS FLUID bags,
– DIALYSIS WATER supply systems (see ISO 23500-2),
– CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4), described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
IEC 60601-2-16:2024 cancels and replaces the fifth edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601‑1:2005, IEC 60601‑1:2005/AMD1:2012 and IEC 60601‑1:2005/AMD2:2020, of references to IEC 60601‑1‑2:2014 and IEC 60601‑1‑2:2014/AMD1:2020, of references to IEC 60601‑1‑8:2006, IEC 60601‑1‑8:2006/AMD1:2012 and IEC 60601‑1‑8:2006/AMD2:2020, of references to IEC 60601‑1‑9:2007, IEC 60601‑1‑9:2007/AMD1:2013 and IEC 60601‑1‑9:2007/AMD2:2020, of references to IEC 60601‑1‑10:2007, IEC 60601‑1‑10:2007/AMD1:2013 and IEC 60601‑1‑10:2007/AMD2:2020 and of references to IEC 60601‑1‑11:2015 and IEC 60601‑1‑11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601‑1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including withdrawn IEC PAS 63023 as Annex CC;
e) including SECURITY (CYBERSECURITY) requirements;
f) consideration of HAEMODIALYSIS EQUIPMENT using pre-manufactured DIALYSIS FLUID bags;
g) improvements for labelling;
h) other minor technical improvements;
i) editorial improvements.

IEC 60601-2-40:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTROMYOGRAPHS and EVOKED RESPONSE EQUIPMENT, hereafter referred to as ME EQUIPMENT.
The following ME EQUIPMENT are excluded:
- ME EQUIPMENT intended for therapeutic application;
- ME EQUIPMENT intended for transcutaneous electrical nerve stimulators and electrical muscle stimulators (ME EQUIPMENT covered by IEC 60601-2-10).
IEC 60601-2-40:2024 cancels and replaces the second edition published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) added requirements for constant voltage stimulators;
b) clarified requirements for VISUAL STIMULATORS.

IEC 60601-2-39:2024 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PERITONEAL DIALYSIS ME EQUIPMENT, 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.
This document does not take into consideration specific safety details of the DIALYSING SOLUTION control system of PD EQUIPMENT using regeneration of DIALYSING SOLUTION or CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION. It does, however, take into consideration the specific safety requirements of such PD EQUIPMENT concerning electrical safety and PATIENT safety.
This document specifies the minimum safety requirements for PD EQUIPMENT. These PD EQUIPMENT are intended for use either by medical staff or for use by the PATIENT or other trained personnel under medical supervision.
This document includes all ME EQUIPMENT that is intended to deliver a PERITONEAL DIALYSIS treatment to a PATIENT, independent of the treatment duration and location.
These particular requirements do not apply to:
– PRE-MANUFACTURED DIALYSING SOLUTION bags,
– DIALYSING SOLUTION CIRCUITS,
– DIALYSING SOLUTION CONCENTRATE,
– DIALYSIS WATER supply systems (see ISO 23500-2) ,
– CENTRAL DELIVERY SYSTEMS for DIALYSING SOLUTION CONCENTRATES, described as systems for bulk mixing concentrate at a dialysis facility,
– equipment used to perform HAEMODIALYSIS (see IEC 60601-2-16).
IEC 60601-2-39:2024 cancels and replaces the third edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) update of references to IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601 1:2005/AMD2:2020, of references to IEC 60601 1 2:2014 and IEC 60601 1 2:2014/AMD1:2020, of references to IEC 60601-1-8:2006, IEC 60601 1 8:2006/AMD1:2012 and IEC 60601 1 8:2006/AMD2:2020, of references to IEC 60601 1 9:2007, IEC 60601 1 9:2007/AMD1:2013 and IEC 60601 1 9:2007/AMD2:2020, of references to IEC 60601 1 10:2007, IEC 60601 1 10:2007/AMD1:2013 and IEC 60601 1 10:2007/AMD2:2020 and of references to IEC 60601 1 11:2015 and IEC 60601 1 11:2015/AMD1:2020;
b) consideration of ESSENTIAL PERFORMANCE in SINGLE FAULT CONDITION regarding IEC 60601 1:2005/AMD1:2012/ISH1:2021;
c) including the information given in the document 62D/1771A/INF regarding 201.11.8;
d) including the information given in the document 62D/1734/INF regarding technical issues of the previous edition;
e) including SECURITY (CYBERSECURITY) requirements;
f) additions related to online PD SOLUTION generation (ONLINE PD);
g) improvements regarding the definition of the APPLIED PART;
h) improvement of the essential performance requirements clause/subclauses;
i) improvements for labelling;
j) other minor technical improvements;
k) editorial improvements.

NOTE Clause A.2 contains guidance or rationale for this clause.
This document specifies the common test methods to evaluate the performance requirements for small-bore connectors specified in the ISO and IEC 80369 series as well as the ISO 18250 series.

IEC 60601-2-34:2024 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT.
This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT.
This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME.
This document does not apply to non-invasive blood pressure monitoring 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 follows:
The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM.
IEC 60601-2-34:2024 cancels and replaces the third edition of IEC 60601-2-34 published in 2011 and constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) revision to align with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, as well as new versions of collateral standards and amendments thereto;
b) expansion of the scope to the emergency medical service environment;
c) changed essential performance in Table 201.101;
d) changed requirement for ingress protection;
e) added primary operating functions;
f) deleted Annex BB Alarm diagrams.

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.

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory insufficiency, as defined in 201.3.302, hereafter also referred to as ME equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
- intended for use by a lay operator;
- intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;
- intended for transit-operable use; and
- not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with moderate to severe chronic obstructive pulmonary disease (COPD), moderate amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dysplasia or muscular dystrophy.
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system of ventilatory support equipment for ventilatory insufficiency, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory insufficiency.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, 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 document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
- ventilatory support equipment or accessories intended for ventilatory impairment, which are given in ISO 80601‑2‑79;
- sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
- high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
- high-frequency oscillatory ventilators (HFOVs);
- respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
- user-powered resuscitators, which are given in ISO 10651-4;
- gas-powered emergency resuscitators, which are given in ISO 10651-5;
- oxygen therapy constant flow ME equipment; and
- cuirass or “iron-lung” ventilation equipment.

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.
This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.302, for ventilatory impairment, as defined in 201.3.300, hereafter also referred to as ME equipment, in combination with its accessories:
- intended for use in the home healthcare environment;
NOTE 2 In the home healthcare environment, the supply mains driving the ventilatory support equipment is often not reliable.
NOTE 3 Such ventilatory support equipment can also be used in professional health care facilities.
- intended for use by a lay operator;
- intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and
- not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
Ventilatory support equipment is not considered to use a physiologic closed-loop control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings.
This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, 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 document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
This document does not specify the requirements for:
- ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
- ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
- ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84;
- ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
- ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80;
- sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70;
- high-frequency jet ventilators (HFJVs), which are given in ISO 80601‑2‑87;
- high-frequency oscillatory ventilators (HFOVs);
- respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 6 Ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
- user-powered resuscitators, which are given in ISO 10651-4;
- gas-powered emergency resuscitators, which are given in ISO 10651-5;
- oxygen therapy constant flow ME equipment; and
- cuirass or “iron-lung” ventilation equipment.

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

This document specifies the design and dimensions for two small-bore connectors intended to be used for connections in respiratory applications of medical devices and accessories. One connector (R1) is intended for use on medical devices and accessories subjected to pressures up to 15 kPa (e.g. a breathing system). The other connector (R2) is intended for use on medical devices and accessories subjected to higher pressures between 15 kPa and 600 kPa (e.g. oxygen therapy tubing).
NOTE 1 The pressure is related to pressure available at the source to which the medical device is connected.
NOTE 2 The intended application does not preclude the use of other connectors on medical devices or accessories within this application.
NOTE 3 Requirements for alternative connectors for this intended application are specified in ISO 80369-1.
This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in device-specific standards.
NOTE 4 If a device-specific standard does not exist, the performance and material requirements specified in ISO 80369-1 can be used as guidance.

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 TS 60601-4-6:2024 provides practical methods to help achieve basic safety and essential performance with regard to the possible effects of em disturbances throughout the expected service life of me equipment or an me system.
These practical methods attempt to address all of the different types of errors, malfunctions or failures that can be caused by em disturbances in me equipment or me systems.
The purpose of this document is to provide recommendations for the techniques and measures used in the design, verification, and validation of systems, hardware, software, and firmware used in me equipment or me systems to help achieve basic safety and essential performance with regard to the em disturbances that could occur throughout the expected service life.

This document specifies test methods for the exoskeleton-type walking RACA robot used as medical electrical equipment which is intended to move from one location to another, by making reciprocating motion having intermittent contact with the travel surface.
This document does not apply to passive or non-powered exoskeletons.
NOTE These tests can be used to verify conformity with the requirements of IEC 80601-2-78.

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 TS 60601-4-2:2024 applies to the performance of MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM in the presence of EM DISTURBANCES. Hereafter, MEDICAL ELECTRICAL EQUIPMENT or a MEDICAL ELECTRICAL SYSTEM are referred to as ME EQUIPMENT or an ME SYSTEM, respectively.
The object of this document is to provide guidance on the assessment of the performance of ME EQUIPMENT or an ME SYSTEM in the presence of EM DISTURBANCES.
IEC TS 60601-4-2:2024 cancels and replaces the first edition of IEC TR 60601-4-2 published in 2016. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC TR 60601-4-2:2016:
a) aligned with IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020,
b) updated references,
c) changed conducted disturbance cable length exclusion (Table 6) from 3 m to 1 m and added a citation of IEC 61000-4-6:2013, Annex B.

IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
IEC 80601-2-78:2019 does not apply to
• external limb prosthetic devices (use ISO 22523),
• electric wheelchairs (use ISO 7176 (all parts)),
• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
• personal care ROBOTS (use ISO 13482).

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.

IEC 80601-2-26:2019 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 electro-convulsive 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.
IEC 80601-2-26:2019 cancels and replaces the third edition of IEC 60601-2-26 published in 2012. This edition constitutes a technical revision to align with Amendment 1:2012 of IEC 60601-1:2005, new versions of collateral standards and amendments thereto.
The contents of the corrigendum of October 2021 have been included in this copy.

IEC 60601-2-35:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.
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.
If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then 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 60601-2-35:2020 does not apply to:
- HEATING DEVICES intended for physiotherapy;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- cooling devices.
IEC 60601-2-35:2020 cancels and replaces IEC 80601-2-35 published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-35:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

IEC 80601-2-77:2019 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS (RASS), referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION CONDITIONS and INTERFACE CONDITIONS.

IEC 60601-2-20:2020 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. IEC 60601-2-20:2020 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;
- INFANT INCUBATORS which are not INFANT TRANSPORT INCUBATOR; for information see IEC 60601-2-19;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- INFANT PHOTOTHERAPY; for information, see IEC 60601-2-50.
IEC 60601-2-20:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision.
IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, 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. IEC 60601-2-19:2020 specifies safety requirements for INFANT 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.
IEC 60601-2-19:2020 does not apply to:
- INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
- INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
- devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
- INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

IEC 60601-2-21:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT RADIANT WARMERS as defined in 201.3.204, 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. IEC 60601-2-21:2020 specifies the safety requirements for INFANT RADIANT WARMERS, 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;
- INFANT INCUBATORS; for information, see IEC 60601-2-19;
- INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20;
- INFANT PHOTOTHERAPY EQUIPMENT, for information, see IEC 60601-2-50.
SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED RADIANT WARMER including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-21:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-21:2020 includes the following significant technical change with respect to the previous edition: alignment with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012.