11.040.10 - Anaesthetic, respiratory and reanimation equipment
ICS 11.040.10 Details
Anaesthetic, respiratory and reanimation equipment
Wiederbelebungs-, Anastesie- und Beatmungsgerate
Matériel d'anesthésie, de réanimation et respiratoire
Anestezijska, respiratorna in reanimacijska oprema
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This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to: a) a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016; b) the pressure outlet of a regulator conforming with ISO 10524-1:2018; or c) to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets). This document applies to the following types of flow control devices (FCDs): a) flowmeters; b) flowgauge FCDs; and c) fixed orifice FCDs. NOTE Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1. This document applies to flow control devices for the following gases: — oxygen; — oxygen 93 %; — nitrous oxide; — medical air; — carbon dioxide; — oxygen/nitrous oxide mixture 50/50 (% volume fraction); — oxygen-enriched air; — helium; — xenon; and — specified mixtures of the gases listed above. NOTE Flow control devices can be available for other gases. This document does not apply to flow control devices that are: a) for use with gases for driving surgical tools; b) an integral part of a regulator (see ISO 10524-1:2018); or c) an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).
- Standard22 pagesEnglish languagesale 15% off
- Standard23 pagesFrench languagesale 15% off
- Draft17 pagesEnglish languagesale 15% off
- Draft24 pagesFrench languagesale 15% off
This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both.
NOTE 1 This type of connection is primarily used for small cylinders (5 l or below).
NOTE 2 In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2).
This document specifies:
— basic dimensions;
— requirements for alternative designs of the yoke-type valve connections;
— dimensions and positions for the holes and pins for the outlet connections.
It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft23 pagesEnglish languagesale 10% offe-Library read for1 day
This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both.
NOTE 1 This type of connection is primarily used for small cylinders (5 l or below).
NOTE 2 In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2).
This document specifies:
— basic dimensions;
— requirements for alternative designs of the yoke-type valve connections;
— dimensions and positions for the holes and pins for the outlet connections.
It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.
- Standard26 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft23 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions.
This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end.
Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
- Draft33 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system.
This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers.
This document does not specify the minimum performance of nebulizing systems.
This document does not apply to:
a) devices intended for nasal deposition;
b) devices intended solely to provide humidification or hydration by providing water in aerosol form.
NOTE 1 ISO 80601-2-74 and ISO 20789 cover these devices.
c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers).
NOTE 2 ISO 20072 covers these devices.
NOTE 3 See Annex A for rationale.
- Draft46 pagesEnglish languagesale 10% offe-Library read for1 day
This document is applicable to pin-index yoke-type valve connections for medical gas cylinders, with a working pressure up to a maximum of 200 bar or test pressure up to a maximum of 300 bar, or both. NOTE 1 This type of connection is primarily used for small cylinders (5 l or below). NOTE 2 In this document the unit bar is used, due to its universal use in the field of technical gases. It should, however, be noted that bar is not an SI unit, and that the corresponding SI unit for pressure is Pa (1 bar = 105 Pa = 105 N/m2). This document specifies: — basic dimensions; — requirements for alternative designs of the yoke-type valve connections; — dimensions and positions for the holes and pins for the outlet connections. It also specifies the dimensions and positions for the holes and pins for the outlet connections for gases and gas mixtures.
- Standard19 pagesEnglish languagesale 15% off
- Standard20 pagesFrench languagesale 15% off
- Draft19 pagesEnglish languagesale 15% off
- Draft19 pagesEnglish languagesale 15% off
This document specifies requirements for the safety and performance testing of general-purpose nebulizing systems intended for continuous or breath-actuated delivery of liquids, in aerosol form, to humans through the respiratory system. This document includes gas-powered nebulizers (which can be powered by, e.g., compressors, pipeline systems, cylinders, etc.) and electrically powered nebulizers [e.g. spinning disc, ultrasonic, vibrating mesh (active and passive), and capillary devices] or manually powered nebulizers. This document does not specify the electrical requirements of electrically powered nebulizers. This document does not specify the minimum performance of nebulizing systems. This document does not apply to: a) devices intended for nasal deposition; b) devices intended solely to provide humidification or hydration by providing water in aerosol form. NOTE 1 ISO 80601-2-74 and ISO 20789 cover these devices. c) drug-specific nebulizers or their components (e.g. metered dose inhalers, metered liquid inhalers, dry powder inhalers). NOTE 2 ISO 20072 covers these devices. NOTE 3 See Annex A for rationale.
- Standard33 pagesEnglish languagesale 15% off
- Standard35 pagesFrench languagesale 15% off
- Draft33 pagesEnglish languagesale 15% off
- Draft33 pagesEnglish languagesale 15% off
- Draft36 pagesFrench languagesale 15% off
This document specifies minimum requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturer’s instructions. This document is applicable to breathing sets which include special components (e.g. water traps) between the patient end and machine end. Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing sets and breathing tubes suitable for use with patient end adaptors.
- Standard27 pagesEnglish languagesale 15% off
- Standard28 pagesFrench languagesale 15% off
- Draft27 pagesEnglish languagesale 15% off
- Draft27 pagesEnglish languagesale 15% off
- Draft28 pagesFrench languagesale 15% off
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
— intended for use in the home healthcare environment;
— intended for use by a lay operator; and
— intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
- Draft145 pagesEnglish languagesale 10% offe-Library read for1 day
ISO/IEC 80601-2-72:2023 This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:
- intended for use in the home healthcare environment;
- intended for use by a lay operator; and
- intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
- Standard142 pagesEnglish languagesale 15% off
- Standard153 pagesFrench languagesale 15% off
This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment: — intended for use in the home healthcare environment; — intended for use by a lay operator; and — intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients. This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.
- Standard142 pagesEnglish languagesale 15% off
- Standard153 pagesFrench languagesale 15% off
- Draft142 pagesEnglish languagesale 15% off
- Draft142 pagesEnglish languagesale 15% off
This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.
Example user-powered resuscitators include:
— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and
NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.
— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source.
This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.
Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
This document does not specify the requirements for:
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— electrically-powered resuscitators;
— gas powered resuscitators for professional healthcare facilities; and
— anaesthetic reservoir bags, which are given in ISO 5362.
NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E.
NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft79 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1 There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.
- Standard54 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft55 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range.
Example user-powered resuscitators include:
— self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and
NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations.
— flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source.
This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator.
Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment.
This document is also applicable to point-of-use packaging.
This document does not specify the requirements for:
— gas-powered emergency resuscitators, which are given in ISO 10651-5;
— electrically-powered resuscitators;
— gas powered resuscitators for professional healthcare facilities; and
— anaesthetic reservoir bags, which are given in ISO 5362.
NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E.
NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.
- Standard76 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft79 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.
NOTE There is guidance or rationale for this list item contained in A.2.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for user-powered resuscitators intended for use with all age groups and which are intended to provide lung ventilation to patients whose breathing is inadequate. User-powered resuscitators are designated according to ideal body mass range. Example user-powered resuscitators include: — self-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by elastic recoil; and NOTE 1 Self-inflating bag resuscitators are generally transit-operable and can be used in a wide range of environmental and emergency situations. — flow-inflating bag resuscitators intended to be squeezed by the user’s hand and refilled by a flow from a medical gas source. This document is also applicable to those accessories that are intended for use with resuscitators where the characteristics of those accessories can affect the safety of the user-powered resuscitator. Examples of such accessories include face masks, PEEP valves, capnometric indicators, manometers, metronomes, flow restrictors, filters, gas refill valves, oxygen gas mixers, connectors, electronic feedback devices, electronic sensors and transmission of data to other equipment. This document is also applicable to point-of-use packaging. This document does not specify the requirements for: — gas-powered emergency resuscitators, which are given in ISO 10651-5; — electrically-powered resuscitators; — gas powered resuscitators for professional healthcare facilities; and — anaesthetic reservoir bags, which are given in ISO 5362. NOTE 2 This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D. NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex E. NOTE 4 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[23] as indicated in Annex F.
- Standard66 pagesEnglish languagesale 15% off
- Standard80 pagesFrench languagesale 15% off
- Draft68 pagesEnglish languagesale 15% off
- Draft68 pagesEnglish languagesale 15% off
- Draft72 pagesFrench languagesale 15% off
This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1 There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.
- Standard54 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft55 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required.
Tracheal tubes that include bronchus blockers are excluded from the scope of this document
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft19 pagesEnglish languagesale 10% offe-Library read for1 day
This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications. Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document. Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document. NOTE 1 There is guidance or rationale for this clause contained in Annex A.2. NOTE 2 ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.
- Standard45 pagesEnglish languagesale 15% off
- Standard46 pagesFrench languagesale 15% off
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.
- Standard44 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft39 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes.
This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.
The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.
NOTE There is guidance or rationale for this list item contained in A.2.
- Standard20 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft17 pagesEnglish languagesale 10% offe-Library read for1 day
ISO 81060-3:2022 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.
- Standard36 pagesEnglish languagesale 15% off
- Standard36 pagesFrench languagesale 15% off
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.
- Standard36 pagesEnglish languagesale 15% off
- Standard40 pagesFrench languagesale 15% off
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and
— intended for transit-operable use.
NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.
EXAMPLE probes, cables distributed alarm system
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft63 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies safety and performance requirements for manually powered suction equipment intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both.
The commonest use of manually powered suction is in situations outside of healthcare settings often described as field use or transport use. Use in these situations may involve extreme conditions of weather or terrain. Additional/alternative requirements for manually powered suction equipment intended for field use or transport use are included in this document.
This document does not apply to mucus extractors.
- Standard9 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft7 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs.
This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration.
This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft13 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies basic safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be standalone or part of an integrated system.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft8 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.
This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation.
This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).
EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document.
This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document.
This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.
- Standard47 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft48 pagesEnglish languagesale 10% offe-Library read for1 day
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator;
— intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and
— intended for transit-operable use.
NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor.
EXAMPLE probes, cables distributed alarm system
- Standard68 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft63 pagesEnglish languagesale 10% offe-Library read for1 day
This device-specific standard specifies requirements for nasal cannulae used in both home-care and hospital environments for the administration of oxygen therapy.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft14 pagesEnglish languagesale 10% offe-Library read for1 day
NEXT ACTION: PUBLICATION EXPECTED BY 2019-10-31
2019-07-04 IP: BT decision D163/C033 - remove link to MDD
NEXT ACTION: TB Action by 21-22 May 2019 i.e. Next CLC TC 62 Plenary Meeting
2019-01-16 JO - In contact with CLC TC 62 to know if they will take a ballot to decouple this WI (upon BT approval) and proceed to PUB
- Amendment16 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft8 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy.
This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft14 pagesEnglish languagesale 10% offe-Library read for1 day
This document gives requirements for labels attached to syringes so that the contents can be identified just before use during anaesthesia. It covers the colour, size, design and general properties of the label and the typographical characteristics of the wording for the drug name.
NOTE National or regional regulations might require additional labelling, which can include bar coding. No requirements for this additional labelling are given.
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft13 pagesEnglish languagesale 10% offe-Library read for1 day
This document establishes a vocabulary of terms used for anaesthetic and respiratory equipment and supplies, related devices and supply systems.
NOTE 1 To avoid multiple definitions of the same term in different categories, this document attempts to ensure consistency by the inclusion of a ‘general’ category, and by use of domain specifiers and unique pre-coordinated domain-specific term names.
NOTE 2 In addition to terms and definitions used in two of the three official ISO languages (English and French), this document gives the equivalent terms in the German language; these are published under the responsibility of the member body for Germany. However, only the terms and definitions given in the official languages can be considered as ISO terms and definitions.
- Standard72 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft64 pagesEnglish languagesale 10% offe-Library read for1 day
EN-ISO 80601-2-13 is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: - anaesthetic gas delivery system; - anaesthetic breathing system; - anaesthetic gas scavenging system (AGSS); - anaesthetic vapour delivery system; - anaesthetic ventilator; monitoring equipment; - alarm system; - protection device.
- Standard114 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft131 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for safety, materials, design and information supplied with
tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is
required.
Tracheal tubes that include bronchus blockers are excluded from the scope of this document.
- Standard21 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft19 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies essential performance and safety requirements for cuff pressure indicators
used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes
or tracheostomy tubes.
This document is also applicable to devices that combine intracuff pressure indication with a method
of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically
maintaining cuff inflation at a specific pressure or within a pressure range.
The requirements specified in this document apply to stand-alone cuff pressure indicators and those
integrated into other medical devices (e.g. ventilators, anaesthesia workstations, etc.).
- Standard17 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for low-flow nasal cannulae, used in both home care and hospital environments for the administration of oxygen therapy. This document does not include requirements to prevent the proliferation of fire within the tubing but does specify a user-detachable connection that can be used to fit a fire-activated oxygen shut-off device.
- Standard9 pagesEnglish languagesale 15% off
- Standard9 pagesFrench languagesale 15% off
This document applies to the basic safety and essential performance of an infant cardiorespiratory monitor, as defined in 3.10, hereafter also referred to as ME equipment, in combination with its accessories: — intended for use in the home healthcare environment; — intended for use by a lay operator; — intended to monitor cardiorespiratory parameters in sleeping or resting children under three years of age; and — intended for transit-operable use. NOTE An infant cardiorespiratory monitor can also be used in professional health care facilities. This document is also applicable to those accessories intended by their manufacturer to be connected to the infant cardiorespiratory monitor, where the characteristics of those accessories can affect the basic safety or essential performance of the infant cardiorespiratory monitor. EXAMPLE probes, cables distributed alarm system
- Standard57 pagesEnglish languagesale 15% off
- Standard60 pagesFrench languagesale 15% off
This document specifies basic safety and performance requirements for medical suction equipment
powered from a vacuum or positive pressure gas source generating venturi suction. It applies to suction
equipment connected to medical gas pipeline systems or cylinders and venturi attachments and can be
standalone or part of an integrated system.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft8 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies requirements for safety, materials, design and information supplied with tracheobronchial tubes. These devices are used when isolation of the airways of one or both lungs is required. Tracheal tubes that include bronchus blockers are excluded from the scope of this document
- Standard13 pagesEnglish languagesale 15% off
- Standard13 pagesFrench languagesale 15% off
This document specifies minimum performance and safety requirements for air entrainment devices
used for delivery of designated oxygen concentrations to patients. It provides a test method to check
the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment
devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to
deliver a range of oxygen concentration outputs.
This document also specifies marking requirements and recommends an optional system of colour
coding to assist the user in identifying the designated oxygen concentration.
This document does not cover air entrainment devices which are integral with medical devices specified
in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).
- Standard16 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft13 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies safety and performance requirements for manually powered suction equipment
intended for oro-pharyngeal suction. It applies to equipment operated by foot or by hand or both.
The commonest use of manually powered suction is in situations outside of healthcare settings often
described as field use or transport use. Use in these situations may involve extreme conditions of weather
or terrain. Additional/alternative requirements for manually powered suction equipment intended for
field use or transport use are included in this document.
This document does not apply to mucus extractors.
- Standard9 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft7 pagesEnglish languagesale 10% offe-Library read for1 day
This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator.
This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification:
anaesthetic gas delivery system;
anaesthetic breathing system;
anaesthetic gas scavenging system (AGSS);
anaesthetic vapour delivery system;
anaesthetic ventilator;
monitoring equipment;
alarm system;
protection device.
NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.
An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.
NOTE 2 The applicability of this document is indicated in Table AA.2.
This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation.
If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories 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 an anaesthetic workstation and its individual components including accessories, as relevant.
Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories 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 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.
- Standard114 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft131 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies essential performance and safety requirements for cuff pressure indicators used to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This document is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device can also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range. The requirements specified in this document apply to stand-alone cuff pressure indicators and those integrated into other medical devices e.g. ventilators anaesthesia workstations etc.
- Standard9 pagesEnglish languagesale 15% off
- Standard10 pagesFrench languagesale 15% off
- Draft9 pagesEnglish languagesale 15% off
This document specifies safety and performance requirements for electrically powered medical and
surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for
domiciliary care of patients and for field use and transport use.
- Standard10 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft8 pagesEnglish languagesale 10% offe-Library read for1 day
This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients. It provides a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs. This document also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration. This document does not cover air entrainment devices which are integral with medical devices specified in other standards (e.g. emergency lung ventilators, humidifiers, nebulizers).
- Standard8 pagesEnglish languagesale 15% off
- Standard8 pagesFrench languagesale 15% off
This document specifies general requirements for medical suction equipment that are common to all parts of the ISO 10079 series.
This document is not applicable to the following:
a) end-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips;
b) syringes;
c) dental suction equipment;
d) anaesthetic gas scavenging systems;
e) laboratory suction;
f) autotransfusion systems;
g) mucus extractors including neonatal mucus extractors;
h) suction equipment where the collection container is downstream of the vacuum pump;
i) ventouse (obstetric) equipment;
j) suction equipment marked for endoscopic use only; and
k) plume evacuation systems.
- Standard43 pagesEnglish languagesale 10% offe-Library read for1 day
- Draft39 pagesEnglish languagesale 10% offe-Library read for1 day