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11.040.55 - Diagnostic equipment

ICS 11.040.55 Details

Diagnostic equipment

Diagnosegerate

Matériel de diagnostic

Diagnostična oprema

General Information

Parent
11.040 - Medical equipment

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Standardization Organization
Technical Committee
Directive
Mandate
50
SIST
SIST EN IEC 62570:2026(Main)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (IEC 62570:2025)
EN IEC 62570:2025

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.

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EN IEC 62570:2025(Main)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment
SIST EN IEC 62570:2026

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.

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SIST
SIST EN ISO/IEEE 11073-10425:2025(Main)
Health informatics - Device interoperability - Part 10425: Personal Health Device Communication - Device Specialization- Continuous Glucose Monitor (CGM) (ISO/IEEE 11073-10425:2024)
EN ISO/IEEE 11073-10425:2025

This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

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IEC
IEC 60601-2-33:2022/ISH2:2025(Main)
Interpretation Sheet 2 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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IEC 62570:2025(Main)
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

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.

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    English and French language
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ISO
IEC 80601-2-71:2025(Main)
Medical electrical equipment — Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (functional NIRS) equipment

This document 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.

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SIST
SIST EN IEC 80601-2-71:2025(Main)
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment (IEC 80601-2-71:2025)
EN IEC 80601-2-71:2025

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.

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ISO
ISO 8600-1:2025(Main)
Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements

This document gives definitions of terms and requirements for endoscopes and endotherapy devices used in the practice of medicine.

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EN IEC 80601-2-71:2025(Main)
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
SIST EN IEC 80601-2-71:2025

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.

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SIST EN IEC 60601-2-40:2025(Main)
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment (IEC 60601-2-40:2024)
EN IEC 60601-2-40:2025

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.

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EN IEC 60601-2-40:2025(Main)
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
SIST EN IEC 60601-2-40:2025

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.

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IEC
IEC 80601-2-71:2025(Main)
Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment

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.

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SIST EN IEC 60601-2-34:2025(Main)
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment (IEC 60601-2-34:2024)
EN IEC 60601-2-34:2024

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.

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EN IEC 60601-2-34:2024(Main)
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
SIST EN IEC 60601-2-34:2025

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.

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IEC
IEC 60601-2-40:2024(Main)
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment

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.

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SIST
SIST EN IEC 60601-2-37:2025(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2024)
EN IEC 60601-2-37:2024

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.

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EN IEC 60601-2-37:2024(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
SIST EN IEC 60601-2-37:2025

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.

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SIST EN IEC 80601-2-49:2019/A1:2024(Amendment)
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors (IEC 80601-2-49:2018/AMD1:2024)
EN IEC 80601-2-49:2019/A1:2024
  • Amendment
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IEC
IEC 60601-2-34:2024(Main)
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

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.

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EN IEC 80601-2-49:2019/A1:2024(Amendment)
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
SIST EN IEC 80601-2-49:2019/A1:2024
  • Amendment
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SIST EN IEC 60601-2-75:2019/A1:2024(Amendment)
Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (IEC 60601-2-75:2017/AMD1:2023)
EN IEC 60601-2-75:2019/A1:2024
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SIST
SIST EN IEC 60601-2-33:2024(Main)
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2022)
EN IEC 60601-2-33:2024

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.

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EN IEC 60601-2-33:2024(Main)
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
SIST EN IEC 60601-2-33:2024

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.

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ISO
IEC 80601-2-49:2018/Amd 1:2024(Amendment)
Medical electrical equipment — Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment — Amendment 1
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IEC
IEC 80601-2-49:2018/AMD1:2024(Amendment)
Amendment 1 - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
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IEC
IEC 80601-2-49:2018(Main)
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors

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.

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IEC
IEC 60601-2-37:2024(Main)
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

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.

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ISO
ISO/TS 23961-3:2024(Main)
Traditional Chinese medicine — Vocabulary for diagnostics — Part 3: Abdomen

This document defines terms for abdominal diagnosis. The equivalent terms in Chinese characters (Pinyin), Japanese characters and Korean characters are given in Annex A.

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SIST
SIST EN IEC 80601-2-26:2020/A1:2024(Amendment)
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph (IEC 80601-2-26:2019/AMD1:2024)
EN IEC 80601-2-26:2020/A1:2024
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SIST
SIST EN ISO 81060-2:2020/A2:2024(Amendment)
Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type - Amendment 2 (ISO 81060-2:2018/Amd 2:2024)
EN ISO 81060-2:2019/A2:2024
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EN IEC 80601-2-26:2020/A1:2024(Amendment)
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
SIST EN IEC 80601-2-26:2020/A1:2024
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SIST
SIST EN IEC 61676:2023/AC:2024(Corrigendum)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of x-ray tube voltage in diagnostic radiology (IEC 61676:2023/COR1:2024)
EN IEC 61676:2023/AC:2024-02
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IEC 80601-2-26:2019/Amd 1:2024(Amendment)
Medical electrical equipment — Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs — Amendment 1
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EN IEC 61676:2023/AC:2024-02(Corrigendum)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of x-ray tube voltage in diagnostic radiology
SIST EN IEC 61676:2023/AC:2024
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IEC 61676:2023/COR1:2024(Corrigendum)
Corrigendum 1 - Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
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SIST
SIST EN ISO/IEEE 11073-10419:2023(Main)
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
EN ISO/IEEE 11073-10419:2023

This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

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ISO
ISO 6028:2023(Main)
Healthcare organization management — Pandemic response — Functional requirements for self-symptom checker app

This document specifies functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19. There are four functional components specified in this document: a) self-registration (see 7.2); b) symptom checking (see 7.3); c) guidance on screening stations (see 7.4); d) health consultation (see 7.5).

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SIST EN IEC 61676:2023(Main)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2023)
EN IEC 61676:2023

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".

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IEC
IEC 60601-2-33:2022/ISH1:2023(Main)
Interpretation Sheet 1 - Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
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EN IEC 61676:2023(Main)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology
SIST EN IEC 61676:2023

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".

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SIST EN ISO/IEEE 11073-10404:2023(Main)
Health informatics - Device interoperability - Part 10404: Personal health device communication - Device specialization - Pulse oximeter (ISO/IEEE 11073-10404:2022)
EN ISO/IEEE 11073-10404:2022

Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth pulse oximeters.

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SIST EN ISO/IEEE 11073-10415:2023(Main)
Health informatics - Device interoperability - Part 10415: Personal health device communication - Device specialization - Weighing scale (ISO/IEEE 11073-10415:2022)
EN ISO/IEEE 11073-10415:2022

Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth weighing scale devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth weighing scales.

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SIST EN ISO/IEEE 11073-10408:2023(Main)
Health informatics - Device interoperability - Part 10408: Personal health device communication - Device specialization - Thermometer (ISO/IEEE 11073-10408:2022)
EN ISO/IEEE 11073-10408:2022

Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth thermometer devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth thermometer devices.

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SIST EN ISO/IEEE 11073-10420:2023(Main)
Health informatics - Device interoperability - Part 10420: Personal health device communication - Device specialization - Body composition analyzer (ISO/IEEE 11073-10420:2022)
EN ISO/IEEE 11073-10420:2022

Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between personal body composition analyzer agents and managers (e.g., cell phones, personal computers, personal health appliances, set-top boxes) is established by this document in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments to restrict optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth body composition analyzers. In this context, the phrase “body composition analyzer” is used broadly to cover analyzing devices that measure body impedances and compute the various body components including body fat from the impedance.

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SIST EN ISO/IEEE 11073-10407:2023(Main)
Health informatics - Device interoperability - Part 10407: Personal health device communication - Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2022)
EN ISO/IEEE 11073-10407:2022

Within the context of the ISO/IEEE 11073 family of standards for device communication, this document establishes a normative definition of communication between personal telehealth blood pressure monitor devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This document defines a common core of communication functionality for personal telehealth blood pressure monitors.

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IEC
IEC 61676:2023(Main)
Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology

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".
The contents of the corrigendum of January 2024 have been included in this copy.

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SIST EN ISO 81060-3:2023(Main)
Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type (ISO 81060-3:2022)
EN ISO 81060-3:2023

This document specifies the requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers used for the measurement of the blood pressure of a patient.
This document does not cover usability aspects such as the form and manner of the data display or output. This document does not specify a numerical threshold on the minimum output period. A continuous automated non-invasive sphygmomanometer providing blood pressure parameters (e.g., systolic blood pressure, diastolic blood pressure or mean arterial pressure) with an output period considerably larger than 30 s is not typically considered a continuous automated non-invasive sphygmomanometer.
This document covers both trending continuous automated non-invasive sphygmomanometers and absolute accuracy continuous automated non-invasive sphygmomanometers and focuses solely on requirements for the clinical investigation. Representation of output is not covered by this document.
NOTE 1    IEC 62366-1 provides requirements on the application of usability engineering to medical devices. The usability engineering process can be used to clarify for the intended user whether the displayed data concerns absolute accurate values or trending values.
The requirements and methods for the clinical investigation of continuous automated non-invasive sphygmomanometers provided in this document are applicable to any subject population, and any condition of use of the continuous automated non-invasive sphygmomanometers.
NOTE 2    Subject populations can, for example, be represented by age or weight ranges.
NOTE 3    This document does not provide a method to assess the effect of artefacts during the clinical investigation (e.g. motion artefacts induced by the movement of the subject or the movement of the platform supporting the subject).
This document specifies additional disclosure requirements for the accompanying documents of continuous automated non-invasive sphygmomanometers that have undergone clinical investigation according to this document.
This document is not applicable to:
—    the clinical investigation of a non-automated sphygmomanometer as given in ISO 81060-1,
—    the clinical investigation of an intermittent automated non-invasive sphygmomanometer as given in ISO 81060-2,
—    an automated non-invasive sphygmomanometer as given in IEC 80601-2-30, or
—    invasive blood pressure monitoring equipment as given in IEC 60601‑2‑34.

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SIST EN IEC 80601-2-59:2019/A1:2023(Amendment)
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 80601-2-59:2017/AMD1:2023)
EN IEC 80601-2-59:2019/A1:2023

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

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EN IEC 80601-2-59:2019/A1:2023(Amendment)
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
SIST EN IEC 80601-2-59:2019/A1:2023

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

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IEC 80601-2-59:2017/Amd 1:2023(Amendment)
Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening — Amendment 1
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