iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

FprEN ISO 5362

(Main)

Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO/FDIS 5362:2024)

Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO/FDIS 5362:2024)

ISO 5362:2006 specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.
ISO 5362:2006 includes requirements for both single-use and reusable bags. Reusable bags are intended to comply with the requirements of ISO 5362:2006 for the recommended product life.
ISO 5362:2006 is not applicable to special-purpose bags, for example bellows and self-expanding bags.
Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of ISO 5362:2006.

Anästhesie- und Beatmungsgeräte - Anästhesie-Reservoirbeutel (ISO/FDIS 5362:2024)

Dieses Dokument legt Anforderungen an Anästhesie-Reservoirbeutel für die Verwendung mit Anästhesie- und Beatmungsgeräten fest. Es enthält Anforderungen zur Ausführung der Muffe, zu den Größen und zur Elastizität.
Beutel für besondere Zwecke, z. B. Bälge und selbstaufblasende Beutel und Beutel für den Gebrauch mit Anästhesiegas-Fortleitungssystemen, gehören nicht zum Anwendungsbereich dieses Dokuments.
Die Anforderungen in dieser gerätespezifischen Norm haben Vorrang vor jedweden gegenteiligen Anforderungen in der allgemeinen Norm für Atemwegsvorrichtungen (ISO 18190:2016). Alle gemeinsamen Anforderungen, die in der allgemeinen Norm für Atemwegsvorrichtungen erscheinen, wurden aus diesem Dokument entfernt.

Matériel d’anesthésie et de réanimation respiratoire - Ballons réservoirs d’anesthésie (ISO/FDIS-5362:2024)

L'ISO 5362:2006 spécifie les exigences relatives aux ballons réservoirs antistatiques et non antistatiques destinés à être utilisés avec les appareils d'anesthésie ou les systèmes respiratoires de ventilateurs pulmonaires. Elle inclut également les exigences relatives à la conception du col, à la désignation de la taille, à la distension et, le cas échéant, les exigences relatives à la résistance électrique.
L'ISO 5362:2006 inclut des exigences relatives aux ballons réutilisables ou non réutilisables. Les ballons réutilisables doivent satisfaire aux exigences de l'ISO 5362:2006 pendant toute la durée de vie recommandée du produit.

Anestezijska in dihalna oprema - Dihalni baloni (ISO/FDIS 5362:2024)

General Information

Status
Not Published
Publication Date
11-Jul-2024
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
5060 - Closure of Vote - Formal Approval
Start Date
11-Apr-2024
Completion Date
11-Apr-2024
Ref Project
kSIST FprEN ISO 5362:2024 - Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO/FDIS 5362:2024)

Relations

Revises
EN ISO 5362:2019 - Anaesthetic reservoir bags (ISO 5362:2006)
Effective Date
19-Jan-2023

Buy Standard

prEN ISO 5362:2023prEN ISO 5362:2023
PreviousNext
Draft
prEN ISO 5362:2023
English language
18 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 5362:2023
01-marec-2023
Anestezijska in dihalna oprema - Dihalni baloni (ISO/DIS 5362:2023)
Anaesthetic and respiratory equipment - Anaesthetic reservoir bags (ISO/DIS
5362:2023)
Anästhesie- und Beatmungsgeräte - Anästhesie-Reservoirbeutel (ISO/DIS 5362:2023)
Matériel d’anesthésie et de réanimation respiratoire - Ballons réservoirs d’anesthésie
(ISO/DIS-5362:2023)
Ta slovenski standard je istoveten z: prEN ISO 5362
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
oSIST prEN ISO 5362:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 5362:2023

---------------------- Page: 2 ----------------------
oSIST prEN ISO 5362:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5362
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-01-13 2023-04-07
Anaesthetic and respiratory equipment – Anaesthetic
reservoir bags
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 5362:2023(E)
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. © ISO 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 5362:2023
ISO/DIS 5362:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 5362
ISO/TC 121/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
Anaesthetic and respiratory equipment – Anaesthetic
reservoir bags
ICS: 11.040.10
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 5362:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 4 ----------------------
oSIST prEN ISO 5362:2023
ISO/DIS 5362:2022(E)
20 Contents
21 Foreword . 4
22 Introduction. 4
23 Scope . 6
1
24 2 Normative references . 6
25 3 Terms and definitions . 6
26 4 General requirements . 7
27 5 Materials .
...

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)
kSIST FprEN 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.

  • 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 80601-2-84:2023(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 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 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 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 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 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