iTeh StandardsiTeh Standards
EURUSD
Your shopping cart is empty.
CEN

EN 1820:2005+A1:2009

(Main)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

This European Standard 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.
This document 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 this document.

Anästhesie-Reservoirbeutel (ISO 5362:2000, modifiziert)

Diese Europäische Norm legt Anforderungen an antistatische und nicht antistatische Reservoirbeutel für den Gebrauch mit Anästhesie- oder Beatmungsgeräten fest. Es enthält Festlegungen zur Ausführung der Muffe, den Größen, der Dehnung und gegebenenfalls zum elektrischen Widerstand.
Beutel für besondere Zwecke, z. B. Bälge und selbstentfaltende Beutel, gehören nicht zum Anwendungs-bereich dieses Dokuments. Beutel für den Gebrauch mit Anästhesiegas-Fortleitungssystemen werden nicht als Anästhesie-Reservoirbeutel angesehen und gehören nicht zum Anwendungsbereich dieses Dokuments.

Ballons réservoirs d'anesthésie (ISO 5362:2000, modifiée)

La présente Norme européenne fixe les prescriptions relatives aux ballons réservoirs antiélectrostatiques et non
antiélectrostatiques destinés à être utilisés avec les appareils d'anesthésie ou les systèmes respiratoires
de ventilateurs pulmonaires. Elle fixe des prescriptions relatives à la conception du col, la désignation de la taille,
la distension et, le cas échéant, les prescriptions relatives à la résistance électrique.
Les ballons destinés à une utilisation spéciale, par exemple les soufflets ou les ballons à autodilatation, ne sont pas
traités dans le présent document. Les ballons destinés à être utilisés avec les systèmes d'évacuation de gaz
d'anesthésie en excès ne sont pas considérés comme des ballons réservoirs d'anesthésie, et ne relèvent donc pas
du domaine d'application du présent document.

Dihalni baloni (ISO 5362:2000, spremenjen)

General Information

Status
Withdrawn
Publication Date
11-Aug-2009
Withdrawal Date
17-Sep-2019
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
9960 - Withdrawal effective - Withdrawal
Completion Date
18-Sep-2019
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
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 1820:2005+A1:2009 - Anaesthetic reservoir bags (ISO 5362:2000, modified)

Relations

Merged From
EN 1820:2005/prA1 - Anaesthetic reservoir bags (ISO 5362:2000, modified)
Effective Date
19-Jan-2023
Merged From
EN 1820:2005 - Anaesthetic reservoir bags (ISO 5362:2000, modified)
Effective Date
20-Jun-2009
Replaced By
EN ISO 5362:2019 - Anaesthetic reservoir bags (ISO 5362:2006)
Effective Date
25-Sep-2019

Buy Standard

EN 1820:2005+A1:2009EN 1820:2005+A1:2009
PreviousNext
Standard
EN 1820:2005+A1:2009
English language
20 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dihalni baloni (ISO 5362:2000, spremenjen)Anästhesie-Reservoirbeutel (ISO 5362:2000, geändert)Ballons réservoirs d'anesthésie (ISO 5362:2000, modifiée)Anaesthetic reservoir bags (ISO 5362:2000, modified)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 1820:2005+A1:2009SIST EN 1820:2005+A1:2009en,fr,de01-oktober-2009SIST EN 1820:2005+A1:2009SLOVENSKI
STANDARD



SIST EN 1820:2005+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1820:2005+A1
August 2009 ICS 11.040.10 Supersedes EN 1820:2005English Version
Anaesthetic reservoir bags (ISO 5362:2000, modified)
Ballons réservoirs d'anesthésie (ISO 5362:2000, modifiée) Anästhesie-Reservoirbeutel (ISO 5362:2000, geändert) This European Standard was approved by CEN on 25 April 2005 and includes Amendment 1 approved by CEN on 16 July 2009.
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:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1820:2005+A1:2009: ESIST EN 1820:2005+A1:2009



EN 1820:2005+A1:2009 (E) 2 Contents Page Foreword .4 Introduction .5 1 Scope .6 2 Normative references .6 3 Terms and definitions .6 4 General requirements .7 5 Prevention of electrostatic charges .9 6 Requirements for bags supplied sterile .9 7 Marking .9 8 Information to be supplied by the manufacturer . 10 Annex A (informative)
Test for leakage . 11 A.1
Principle . 11 A.2
Apparatus . 11 A.3
Procedure . 11 A.4
Expression of results . 11 Annex B (normative)
Determination of capacity . 12 B.1
Principle . 12 B.2
Apparat
...

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 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).

  • 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 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
CEN
EN ISO 5361:2023(Main)
Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2023, Corrected version 2023-11)
SIST EN ISO 5361:2023

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.

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