iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
SIST

SIST EN ISO 7376:2020/A1:2025

(Amendment)

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)

Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation - Änderung 1 (ISO 7376:2020/Amd 1:2025)

Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation trachéale - Amendement 1: Clarification concernant la puissance optique et les exigences relatives à l’éclairage (ISO 7376:2020/Amd 1:2025)

Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo - Dopolnilo A1: Pojasnilo zahtev optičnih izhodov in osvetlitev (ISO 7376:2020/Amd 1:2025)

General Information

Status
Not Published
Public Enquiry End Date
30-Oct-2024
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
VAZ - Healthcare
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
30-Jun-2025
Due Date
04-Sep-2025
Ref Project
EN ISO 7376:2020/A1:2025 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation - Amendment 1: Clarification of optical output and illumination requirements (ISO 7376:2020/Amd 1:2025)

Relations

Amends
SIST EN ISO 7376:2020 - Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2020)
Effective Date
01-Sep-2025

Buy Standard

EN ISO 7376:2020/oprA1:2024EN ISO 7376:2020/oprA1:2024
PreviousNext
Draft
EN ISO 7376:2020/oprA1:2024
English language
5 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)


SLOVENSKI STANDARD
SIST EN ISO 7376:2020/oprA1:2024
01-oktober-2024
Anestezijska in dihalna oprema - Laringoskopi za trahealno intubacijo - Dopolnilo
A1: Pojasnilo zahtev za optični izhod in osvetlitev (ISO 7376:2020/DAmd1:2024)
Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation -
Amendment 1: Clarification about optical output and illumination requirements (ISO
7376:2020/DAmd1:2024)
Anästhesie- und Beatmungsgeräte - Laryngoskope für Trachealintubation - Änderung 1
(ISO 7376:2020/DAmd1:2024)
Matériel d'anesthésie et de réanimation respiratoire - Laryngoscopes pour intubation
trachéale - Amendement 1: Clarification concernant la puissance optique et les
exigences relatives à l’éclairage (ISO 7376:2020/DAmd1:2024)
Ta slovenski standard je istoveten z: EN ISO 7376:2020/prA1
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 7376:2020/oprA1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 7376:2020/oprA1:2024

SIST EN ISO 7376:2020/oprA1:2024
DRAFT
Amendment
ISO 7376:2020/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Laryngoscopes for
tracheal intubation
Voting begins on:
2024-08-22
AMENDMENT 1: Clarification about
Voting terminates on:
optical output and illumination  2024-11-14
requirements
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 7376:2020/DAM 1:2024(en)
SIST EN ISO 7376:2020/oprA1:2024
DRAFT
ISO 7376:2020/DAM 1:2024(en)
Amendment
ISO 7376:2020/
DAM 1
ISO/TC 121/SC 2
Anaesthetic and respiratory
Secretariat: ANSI
equipment — Laryngoscopes for
tracheal intubation
Voting begins on:
AMENDMENT 1: Clarification about
Voting terminates on:
optical output and illumination
requirements
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO 7376:2020/DAM 1:2024(en)
ii
SIST EN ISO 7376:2020/oprA1:2024
ISO 7376:2020/DAM 1:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
establish
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

This May Also Interest You

SIST
SIST EN ISO 19211:2025(Main)
Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024)
EN ISO 19211:2025

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire.
NOTE 1        Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C.
NOTE 2        Respiratory therapy tubing is covered by ISO 17256.
NOTE 3        Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document.
The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min).
NOTE 4        There is rationale for this clause in A.2.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

  • Standard
    22 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 7396-3:2025(Main)
Medical gas pipeline systems - Part 3:Proportioning units for the production of synthetic medical air (ISO 7396-3:2025)
EN ISO 7396-3:2025

1.1        This document specifies requirements relating to the construction and operation of devices producing air through the blending of oxygen and nitrogen for use as sources of supply in supply systems for medical gases.
1.2        This document is applicable to proportioning units intended to produce synthetic medical air and air for driving surgical tools by mixing in defined proportions oxygen and nitrogen.
1.3        This document is applicable to proportioning units intended to be components of a medical gas supply system for medical air which supplies a medical gas pipeline distribution system complying with ISO 7396-1.
1.4        The number of proportioning units within the medical air supply system and their combination with other sources of supply (e.g. cylinder manifolds) to ensure that the supply system consists of at least three sources of supply is outside the scope of this document.
Requirements for the supply systems for medical air are given in ISO 7396-1.

  • Standard
    36 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 80369-20:2025(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods (ISO 80369-20:2024)
EN ISO 80369-20:2024

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

  • Standard
    41 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 18562-1:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
EN ISO 18562-1:2024

This document specifies:
—     the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;
—     the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;
—     the evaluation of existing relevant data from all sources;
—     the identification of gaps in the available data set on the basis of a risk analysis;
—     the identification of additional data sets necessary to analyse the biological safety of the gas pathway;
—     the assessment of the biological safety of the gas pathway.
This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, in normal use and normal condition. This document does not cover biological hazards arising from mechanical damage.
The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.
This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.
This document applies over the expected lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use).
This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE            Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).

  • Standard
    49 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 18562-4:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
EN ISO 18562-4:2024

This document specifies tests for substances leached by liquid water condensing in gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024.
This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE            Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device.
This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.

  • Standard
    29 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 18562-3:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
EN ISO 18562-3:2024

This document specifies tests for the emissions of volatile organic substances from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of volatile organic substances that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.
NOTE            Gaseous emission of volatile organic substances includes emissions of volatile organic compounds, semi-volatile organic compounds and very volatile organic compounds.
This document addresses potential contamination of the gas stream arising from the gas pathways of medical devices or accessories, which is then conducted to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE            Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series.
This document is intended to be read in conjunction with ISO 18562-1.

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 18562-2:2024(Main)
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
EN ISO 18562-2:2024

This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests.
This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter.
This document does not address particles larger than 10 µm diameter. These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction.
This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.
This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.
This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing.
This document does not address biological evaluation of the particles that are deliberately released by a nebulizer (i.e. the therapeutic agent).
This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.
Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.
This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.
EXAMPLE            Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 (all parts).

  • Standard
    27 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 80601-2-79:2024(Main)
Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2024)
EN ISO 80601-2-79:2024

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

  • Standard
    117 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 80601-2-80:2024(Main)
Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2024)
EN ISO 80601-2-80:2024

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

  • Standard
    131 pages
    English language
    sale 10% off
    e-Library read for
    1 day
SIST
SIST EN ISO 80369-2:2024(Main)
Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024)
EN ISO 80369-2:2024

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

  • Standard
    63 pages
    English language
    sale 10% off
    e-Library read for
    1 day