iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN ISO 23747:2007

(Main)

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

This International Standard specifies requirements for peak expiratory flow meters (PEFMs) intended for the assessment of pulmonary function in spontaneously breathing humans. This International Standard covers all devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function device or as a stand-alone device. Planning and design of products applying to this International Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E.

Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratorischen Spitzenfluss zur Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007)

Diese Internationale Norm legt Anforderungen für Spirometer für den exspiratorischen Spitzenfluss (PEFM) fest, die zur Beurteilung der Lungenfunktion bei spontan atmenden Menschen bestimmt sind.
Diese Internationale Norm gilt für alle Geräte, die den exspiratorischen Spitzenfluss bei spontan atmenden Menschen als Teil eines kombinierten Geräts zur Messung der Lungenfunktion oder als Einzelgerät messen.
Bei der Planung und Auslegung von Produkten, für die diese Internationale Norm gilt, sollten die Umweltauswirkungen des Produkts während seines Lebenszyklus berücksichtigt werden. Umweltgesichts¬punkte werden in Anhang E behandelt.
ANMERKUNG   Zusätzliche Gesichtspunkte der Umweltauswirkungen werden in ISO 14971 behandelt.

Matériel d'anesthésie et de réanimation respiratoire - Débitmètres à débit de pointe expiratoire pour l'évaluation de la fonction pulmonaire chez les êtres humains respirant spontanément (ISO 23747:2007)

Anestezijska in dihalna oprema - Merilniki največjega pretoka zraka med izdihom za oceno funkcije pljuč pri spontano dihajočih ljudeh (ISO 23747:2007)

General Information

Status
Withdrawn
Publication Date
14-Jul-2007
Withdrawal Date
03-Mar-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 2 - Lung ventilators
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
04-Mar-2009
Completion Date
04-Mar-2009
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 23747:2008 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)

Relations

Replaces
EN 13826:2003 - Peak expiratory flow meters
Effective Date
22-Dec-2008
Replaced By
EN ISO 23747:2009 - Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
Effective Date
08-Jun-2022

Buy Standard

EN ISO 23747:2008EN ISO 23747:2008
PreviousNext
Standard
EN ISO 23747:2008
English language
33 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 23747:2008
01-april-2008
1DGRPHãþD
SIST EN 13826:2003
$QHVWH]LMVNDLQGLKDOQDRSUHPD0HULOQLNLQDMYHþMHJDSUHWRND]UDNDPHGL]GLKRP
]DRFHQRIXQNFLMHSOMXþSULVSRQWDQRGLKDMRþLKOMXGHK ,62
Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment
of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
Anästhesie- und Beatmungsgeräte - Spirometer für den exspiratoischen Spitzenfluss zur
Bewertung der Lungenfunktion bei spontan atmenden Menschen (ISO 23747:2007)
Matériel d'anesthésie et de réanimation respiratoire - Débitmetres de débit expiratoire de
pointe pour l'évaluation de la fonction pulmonaire chez les etres humains respirant
spontanément (ISO 23747:2007)
Ta slovenski standard je istoveten z: EN ISO 23747:2007
ICS:
11.040.10
SIST EN ISO 23747:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN ISO 23747
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.040.10 Supersedes EN 13826:2003
English Version
Anaesthetic and respiratory equipment - Peak expiratory flow
meters for the assessment of pulmonary function in
spontaneously breathing humans (ISO 23747:2007)
Matériel d'anesthésie et de réanimation respiratoire - Anästhesie- und Beatmungsgeräte - Spirometer für den
Débitmètres à débit de pointe expiratoire pour l'évaluation exspiratorischen Spitzenfluss zur Bewertung der
de la fonction pulmonaire chez les êtres humains respirant Lungenfunktion bei spontan atmenden Menschen (ISO
spontanément (ISO 23747:2007) 23747:2007)
This European Standard was approved by CEN on 28 June 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23747:2007: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN ISO 23747:2007 (E)






Foreword


This document (EN ISO 23747:2007) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and
respiratory equipment" in collaboration with Technical Committee CEN/TC 215 "Respiratory and anaesthetic
equipment", the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an identical text
or by endorsement, at the latest by January 2008, and conflicting national standards shall be withdrawn at the
latest by January 2008.

This document supersedes EN 13826:2003.

This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.


Endorsement notice

The text of ISO 23747:2007 has been approved by CEN as EN ISO 23747:2007 without any modifications.


2

---------------------- Page: 3 ----------------------

EN ISO 23747:2007 (E)
Annex ZA
(informative)

Relationship between this International Standard and the Essential Requirements
of EU Directive 93/42/EEC


This International Standard has been prepared under a mandate given to CEN by the European Commission and
the European Free Trade Association to provide one me
...

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

CEN
EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

  • Standard
    45 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    48 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

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).

  • Standard
    31 pages
    English language
    sale 10% off
    e-Library read for
    1 day
  • Draft
    28 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
  • Amendment
    14 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 80601-2-12:2023(Main)
Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (ISO 80601-2-12:2023)
SIST EN ISO 80601-2-12:2024

This document applies to the basic safety and essential performance of a critical care ventilator in combination with its accessories, hereafter referred to as ME equipment:
¾     intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 2      For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.
NOTE 3      For the purposes of this document, such a critical care ventilator can provide ventilation during transport within a professional healthcare facility (i.e. be a transit-operable ventilator).
NOTE 4      A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.
¾     intended to be operated by a healthcare professional operator; and
¾     intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.
A critical care ventilator 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 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.
NOTE 5     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 6     Additional information can be found in IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.
This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.
NOTE 7     A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.
This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.
This document does not specify the requirements for:
NOTE 8     See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient.
¾     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13;
¾     ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84;
¾     ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72;
¾     ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79 and ISO 80601-2-80;
¾     obstructive sleep a

  • Standard
    168 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 80601-2-84:2023(Main)
Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (ISO 80601-2-84:2023)
SIST EN ISO 80601-2-84:2024

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment:
¾     intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients;
¾     intended to be operated by a healthcare professional operator;
¾     intended for use in the EMS environment; and
¾     intended for invasive or non-invasive ventilation.
NOTE 2     An EMS ventilator can also be used for transport within a professional healthcare facility.
An EMS ventilator 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, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.
NOTE 3     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.
This document does not specify the requirements for the following:
NOTE 5     See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. 
¾     ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12.
¾     ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72.
¾     ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13.
¾     ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601‑2-79 and ISO 80601-2-80.
¾     obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‐2‐70.
¾     user-powered resuscitators, which are given in ISO 10651‐4.
¾     gas-powered emergency resuscitators, which are given in ISO 10651‐5.
¾     continuous positive airway pressure (CPAP) ME equipment.
¾     high‐frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87.
¾     high‐frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.
NOTE 6      An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes.
¾     respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.
NOTE 7      An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
¾     oxygen therapy constant flow ME equipment.
¾     cuirass or “iron‐lung” ventilators.

  • Standard
    149 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10524-1:2019/A1:2023(Amendment)
Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices - Amendment 1 (ISO 10524-1:2018/Amd 1:2023)
SIST EN ISO 10524-1:2019/A1:2024
  • Amendment
    7 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 5367:2023(Main)
Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)
SIST EN ISO 5367:2023

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.

  • Standard
    35 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 27427:2023(Main)
Anaesthetic and respiratory equipment - Nebulizing systems and components (ISO 27427:2023)
SIST EN ISO 27427:2023

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.

  • Standard
    41 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 80601-2-72:2023(Main)
Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2023)
SIST EN ISO 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.

  • Standard
    152 pages
    English language
    sale 10% off
    e-Library read for
    1 day
CEN
EN ISO 10651-4:2023(Main)
Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
SIST EN ISO 10651-4:2023

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.

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