SIST EN ISO 10651-4:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Lungenbeatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2002)Ventilateurs pulmonaires - Partie 4: Exigences relatives aux ressuscitateurs à puissance motrice manuelle (ISO 10651-4:2002)Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 10651-4:2009SIST EN ISO 10651-4:2009en01-julij-2009SIST EN ISO 10651-4:2009SLOVENSKI
STANDARDSIST EN ISO 10651-4:2002/AC:2006SIST EN ISO 10651-4:20021DGRPHãþD



SIST EN ISO 10651-4:2009



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10651-4April 2009ICS 11.040.10Supersedes EN ISO 10651-4:2002
English VersionLung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)Ventilateurs pulmonaires - Partie 4: Exigences relatives auxressuscitateurs à puissance motrice manuelle (ISO 10651-4:2002)Lungenbeatmungsgeräte - Teil 4: Anforderungen ananwenderbetriebene Wiederbelebungsgeräte(Handbeatmungsgeräte) (ISO 10651-4:2002)This European Standard was approved by CEN on 21 March 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards 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 translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10651-4:2009: ESIST EN ISO 10651-4:2009



EN ISO 10651-4:2009 (E) 2 Contents Page Foreword .3Annex ZA (Informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 10651-4:2009



EN ISO 10651-4:2009 (E) 3 Foreword The text of ISO 10651-4:2002 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10651-4:2009 by 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 October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10651-4:2002. 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 EC Directive. For relationship with EC Directive, 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 the United Kingdom. Endorsement notice The text of ISO 10651-4:2002 has been approved by CEN as a EN ISO 10651-4:2009 without any modification. SIST EN ISO 10651-4:2009



EN ISO 10651-4:2009 (E) 4 Annex ZA (Informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 – Correspondence between this European Standard and EU Directives
Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes All 1 (1st paragraph), 2
4.1 3, 9.1
4.2 3, 9.1
4.3 3, 9.1
4.4 9.1
4.5 3, 9.1
4.6 3, 7.1, 7.6, 9.1
4.7 3, 7.3, 9.1
4, 5, 9, 10 1 (2nd
paragraph, 1st dash) This relevant Essential Requirement is not fully addressed in this European Standard 4, 5, 9, 10 1 (2nd
paragraph, 2nd
dash) This relevant Essential Requirement is not fully addressed in this European Standard - 6a)
This relevant Essential Requirement is not addressed in this European Standard 5.1 4, 9.2
5.2 3, 4, 9.2
5.3 3, 4, 7.6
5.4 3, 4, 5
5.5 4, 5
5.7 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard SIST EN ISO 10651-4:2009



EN ISO 10651-4:2009 (E) 5
Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes5.7 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 7.5 (3rd paragraph) This relevant Essential Requirement is not addressed in this European Standard 6.1 3, 9.1
6.2 3, 9.2
6.3 3, 9.2
6.4 3, 9.1,
6.5 3, 7.5, 9.2
6.6 3, 9.2
6.7.1 3
6.7.2 3, 9.2, 12.8.2
7.1 3, 5, 9.2
7.2 3, 9.2
8.1 8.1, 8.3, 8.4, 8.5
8.2 8.1, 8.3, 8.4, 8.5
9 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard 9.1 2, 6, 13.1, 13.2
9.2 5, 9.2, 13.1, 13.2
9.3 13.3, 13.4
9, 10 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 9, 10 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard 10 9.3, 13.1, 13.2, 13.3, 13.4, 13.6
10 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard
All other requirements are not applicable to this standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. SIST EN ISO 10651-4:2009



SIST EN ISO 10651-4:2009



Reference numberISO 10651-4:2002(E)© ISO 2002
INTERNATIONAL STANDARD ISO10651-4First edition2002-03-01Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators Ventilateurs pulmonaires — Partie 4 : Exigences relatives aux ressuscitateurs à puissance motrice manuelle
SIST EN ISO 10651-4:2009



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ii © ISO 2002 – All rights reserved
SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) © ISO 2002 – All rights reserved iii 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 established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 10651 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10651-4 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read ".this European Standard." to mean ".this International Standard.". ISO 10651 consists of the following parts, under the general title Lung ventilators: — Part 1: Requirements — Part 2: Particular requirements for home care ventilators — Part 3: Particular requirements for emergency and transport ventilators — Part 4: Particular requirements for operator-powered resuscitators Annex A forms a normative part of this part of ISO 10651. Annex B is for information only. For the purposes of this part of ISO 10651, the CEN annex regarding fulfilment of European Council Directives has been removed. SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) iv © ISO 2002 – All rights reserved
ContentsPageForeword.v1Scope.12Normative references.13Terms and definitions.14Connectors.35Operational requirements.36Ventilatory requirements.47Storage and operating conditions.68Requirements for resuscitator, or parts, supplied sterile.69Marking.610Information to be provided by the manufacturer in operating and maintenance instructions.7Annex A (normative)
Test methods.9Annex B (informative)
Rationale.19Bibliography.22SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) © ISO 2002 – All rights reserved v
ForewordThis document (EN ISO 10651-4:2002) has been prepared by Technical Committee CEN/TC 215 "Respiratory andanaesthetic equipment", the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC121 "Anaesthetic and respiratory equipment".This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by September 2002, and conflicting national standards shall be withdrawn at thelatest by September 2002.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).Annex A is normative and form part of this European Standard.Annex B is for information only.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.SIST EN ISO 10651-4:2009



SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) © ISO 2002 – All rights reserved 1 1 ScopeThis European Standard specifies requirements for operator-powered resuscitators intended for use with all agegroups and which are portable and intended to provide lung ventilation to individuals whose breathing isinadequate. Operator-powered resuscitators for infants and children are designated according to body mass rangeand approximate age equivalent.Electrically- and gas-powered resuscitators are not covered by this European Standard.NOTEAnnex B contains rationale statements for this Part of this European Standard. The clauses and subclauses whichhave corresponding rationale statements are marked with R) after their number.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in text and the publications are listed hereafter. For datedreferences, subsequent amendments to or revisions of any of these publications apply to this European Standardonly when incorporated in it by amendment or revision. For undated references the latest edition of the publicationreferred to applies (including amendments).EN 148-1, Respiratory protective devices - Threads for facepieces –Part 1: Standard thread connection.EN 556: 1994+A1:1998, Sterilization of medical devices - Requirements for terminally-sterilized medical devices tobe labelled “STERILE”.EN 737-1, Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum.EN 868-1, Packaging materials and systems for medical devices which are to be sterilized - Part 1: Generalrequirements and test methods .EN 1041, Information supplied by the manufacturer with medical devices.EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.prEN 13544-2:2000, Respiratory therapy equipment – Part 2 : Specifications for tubing and connectors.EN ISO 4135:1996, Anaesthesiology – Vocabulary (ISO 4135 :1995).3 Terms and definitionsFor the purposes of this part of EN ISO 10651, the terms and definitions given in EN ISO 4135:1996 and thefollowing terms and definitions apply.NOTESome of the definitions have been taken from EN ISO 4135, but they are included in this European Standard forconvenience; other definitions, which are given in EN ISO 4135, for apparatus in general, have been modified slightly for thepurposes of this European Standard as they apply specifically to resuscitators.3.1reverse leakagevolume of expired gas which does not pass through the expiratory port but returns to the resuscitator3.2bag inlet valvevalve activated by the subatmospheric pressure in the compressible unit of the resuscitator to refill thecompressible unit with gas at ambient pressure3.3bag refill valvevalve, with no manual trigger, activated by the sub-atmospheric pressure in the compressible unit of theresuscitator to refill the compressible unit from a pressurized gas sourceSIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) 2 © ISO 2002 – All rights reserved 3.4compressible unitthat part of an operator-powered resuscitator e.g. a bag or bellows that, when compressed by the operator, deliversa volume of gas3.5delivered oxygen concentrationaverage concentration of oxygen in the gas delivered from the resuscitator3.6delivered volume, Vdelvolume of gas, expressed in millilitres, leaving the resuscitator through the patient connection port during theinspiratory phase3.7forward leakagevolume of gas produced by the resuscitator during the inspiratory phase which does not pass through the patientport to the patient but passes to the atmosphere3.8minute volume, Vvolume of gas per minute entering or leaving the patient’s lungs3.9operator-powered resuscitatorresuscitation device in which ventilation of the lungs is produced by the operator compressing the compressibleunit of the deviceNOTEHereinafter called "resuscitator".3.10patient connection portthat opening through which gas flows to and from the patient3.11patient connection port connectorconnector at the patient connection port which connects directly to a face mask or an appropriate mating airwaydevice3.12patient valvevalve in the breathing system that directs gas into the lungs for the inspiratory phase and into the atmosphereduring the expiratory phase3.13pressure limiting systemmeans for limiting the maximum delivery pressure3.14resuscitator deadspace, VD,appthat volume of previously exhaled gas which is delivered from the resuscitator in the succeeding inspiratory phase3.15tidal volume, VTvolume of gas, expressed in millilitres, entering or leaving the patient or the lung model during the inspiratory orexpiratory phase3.16ventilatory cycleventilation cycle comprising the inspiratory phase plus the expiratory phase of breathingSIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) © ISO 2002 – All rights reserved 3 4 Connectors4.1 Patient connection port connectorThe patient connection port connector of the resuscitator shall be a 15 mm female and 22 mm male coaxialconnector complying with EN 1281-1.4.2 R) Expiratory port connector for breathing gasesIf an expiratory port connector is provided, it shall be one of the following :a) a 30 mm male conical connector complying with EN 1281-1 or ;b) a permanent connection or propriatory connector incompatible with EN 1281-1 and EN 737-1 ;and with a means to prevent connection with internal lumen to any breathing attachment.4.3 Face mask connectorsIf provided with the resuscitator, face masks shall have either a 22 mm female connector or a 15 mm maleconnector which shall mate with the corresponding connectors specified in EN 1281-1.4.4 R) Bag refill valve connectorsIf a conical connector is provided for attachment of a bag refill valve, it shall be a unique 32 mm female design. Thedimensions of this connector, when submitted to the test gauge given in Figure A.1, shall fit within the tolerancesteps.4.5 Bag inlet valve connectorsBag inlet valve connectors shall not be compatible with connectors dimensioned in accordance with EN 1281-1.The bag inlet valve should be designed to minimize the risk of unintentional connection of breathing attachmentswhich might block the valve4.6 Threaded gas filter connectorsIf the resuscitator is fitted with a threaded gas filter connection, it shall comply with EN 148-1.4.7 Oxygen tube connector and pressure gauge connectorThe oxygen tube connector, if provided, shall comply with prEN 13544-2:2000. The pressure gauge connector (ifprovided) shall not be compatible with tubing fitting the oxygen tube connector.5 Operational requirements5.1 GeneralAll test performance requirements in this European Standard shall be satisfied when the resuscitator is operated byone person.5.2 R) Dismantling and reassemblyA resuscitator intended to be dismantled by the user, e.g. for cleaning, etc. should be designed so as to minimizethe risk of incorrect reassembly when all parts are mated.The manufacturer shall recommend a functional test of operation to be carried out after reassembly (see 10.2d)).SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) 4 © ISO 2002 – All rights reserved 5.3 R) Patient valve function after contamination with vomitusAfter the resuscitator has been tested in accordance with the test described in A.4.3, it shall meet the requirementsspecified in 6.2, 6.4, 6.7.1 and 6.7.2.NOTEIt is preferable that the valve housing be constructed so that operation of the mechanism can be observed by theoperator, e.g. through a transparent housing. Observation of the functioning mechanism of the patient valve can assist theoperator in detecting abnormal operation.5.4 Mechanical shock5.4.1 R) Drop testThe resuscitator shall meet, at room temperature, the requirements specified in 6.2, 6.4 and 6.7.1, following thedrop test described in A.4.4.5.5 Immersion in waterAfter immersion in water by the method described in A.4.5, the resuscitator shall comply with the requirementsspecified in 6.2, 6.4, 6.7.1 and 6.7.2.5.6 R) Bag refill valvesBag refill valves for use with resuscitators shall not have provision for manual operation.5.7 Materials of constructionAll gas conducting parts shall be from materials selected to take into account the chemical and physical propertiesof any substances that the manufacturer declares can be administered by the resuscitator6 Ventilatory requirements6.1 R) Supplementary oxygen and delivered oxygen concentrationWhen tested by the method described in A.4.6 in accordance with the requirements of its classification (see 6.7.1)a resuscitator shall provide a minimum delivered oxygen concentration of at least 35 % (V/V) when connected to anoxygen source supplying not more than 15 l/min and, in addition, shall be capable of providing an oxygenconcentration of at least 85 % (V/V) (see note). The manufacturer shall state the range of delivered oxygenconcentrations at representative flows, i.e. 2 l/min, 4 l/min, 6 l/min, 8 l/min, etc.NOTEThe 85 % (V/V) requirement can be accomplished with the use of an attachment.6.2 R) Expiratory resistanceIn the absence of positive end-expiratory pressure devices, and when tested by the method described in A.4.7, thepressure generated at the patient connection port shall not exceed 0,5 kPa ( 5 cmH20). (See also 10.2 c) 8)).6.3 R) Inspiratory resistanceWhen tested by the method described in A.4.8, the pressure at the patient connection port shall not exceed 0,5 kPa( 5 cmH20) below atmospheric pressure. (See also 10.2 c) 8)).6.4 R) Patient valve malfunctionWhen tested by the method described in A.4.9, an inadvertent positive expiratory pressure greater than 0,6 kPa( 6 cmH2O) shall not be created at an added input flow of up to 30 l/min when this flow is added in accordancewith the manufacturer’s instructions.SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) © ISO 2002 – All rights reserved 5 6.5 R) Patient valve leakage - Forward leakageIf forward leakage is a design feature, it shall be so stated in the instruction manual.6.6 R) Resuscitator deadspace and rebreathingWhen tested by the method described in A.4.10, the resuscitator deadspace shall not exceed 5 ml + 10 % of theminimal delivered volume specified for the classification of the resuscitator (see 6.7.1).Excessive rebreathing should not occur during spontaneous breathing.6.7 R) Ventilation performance6.7.1 R) Minimum delivered volume (Vdel)When tested as described in A.4.11 using the compliance, resistance, frequency and I:E ratio given in Table 1, theminimum delivered volume shall be as given in Table 1.6.7.2 R) Pressure limitation6.7.2.1For resuscitators designated for use with a body mass less than 10 kg, a pressure-limiting system shallbe provided so that the airway pressure does not exceed 4,5 kPa ( 45 cmH20) under the test conditions describedin A.4.12. However, it shall be possible to generate an airway pressure of at least 3 kPa ( 30 cm H2O).NOTEAn override mechanism can be provided.6.7.2.2If a pressure-limiting system is provided for a resuscitator designated for use with patients of over10 kg body mass, the pressure at which it operates shall be stated in the instruction manual [see 10.2 c)9)]. Anypressure-limiting device provided that limits pressure to below 6 kPa ( 60 cmH20) shall be equipped with anoverride mechanism. If provided with a locking mechanism, pressure override mechanisms shall be so designedthat the operating mode, i.e. on or off, is readily apparent to the user by obvious control position, flag, etc.Compliance is tested by visual inspection.SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) 6 © ISO 2002 – All rights reserved Table 1 — Test conditions for ventilatory performancePatient Bodymass BaComplianceResistanceInspiration:ExpirationratioFrequency fBreaths/minMinimumdeliveredvolume VDelKgl/kPakPa/(l/s)± 20 %± 10 %mlB
50,01401:160205 < B
100,121:22515010 < B
400,221:22015
B1)B > 400,221:220600aB = Body mass, in kilograms, designated by the manufacturer in the manual.7 Storage and operating conditions7.1 StorageThe resuscitator and the resuscitator kit (if provided) shall, after storage at temperatures of - 40 °C and + 60 °C andat any relative humidity between 40 % r.h. and 95 % r.h., comply with clause 6 except 6.6 (deadspace).7.2 R) Operating conditionsWhen tested by the method described in A.4.13, the resuscitator shall comply with clause 6 throughout the range ofrelative humidity from 15 % r.h. to 95 % r.h either : throughout the temperature range from - 18 °C to + 50 °C ; or if a specific operating range is given (see 9.2 and 10) throughout the temperature range declared by themanufacturer.8 Requirements for resuscitator, or parts, supplied sterile8.1 Sterility assuranceResuscitators or parts supplied and marked as “STERILE” shall satisfy requirement 4.1 of EN 556:1994+A1:1998for the assurance of sterility needed to make the claim of being sterile.8.2 Packaging for resuscitators or parts supplied sterileThe packaging shall serve as an effective barrier to the penetration of micro-organisms and particulate material inaccordance with EN 868-1.The packaging shall not be capable of reclosure without clearly revealing that it has been opened.9 Marking9.1 GeneralMarking of resuscitators, or parts if applicable, packages, inserts and information to be supplied by themanufacturer shall comply with EN 1041.NOTESome requirements of 9 can be met by the use of appropriate symbols as given in EN 980.SIST EN ISO 10651-4:2009



ISO 10651-4:2002(E) © ISO 2002 – All rights reserved 7 9.2 Indication of operating conditionsIf the resuscitator cannot function as specified in 7.2 between - 18 °C and + 50 °C, a warning shall be marked onthe device.NOTEExamples of warnings are : “only for use between . °C and . °C ; or a symbol as shown in Figure 1.Figure 1 — Example of symbol for showing operation condition between - 10 °C and + 50 °C9.3 Indication of pressure-limiting system settingIf the resuscitator is supplied with a pressure-limiting system set at one fixed pressure, the nominal pressure settingat which the system is activated shall be marked on the resuscitator.10 Information to be provided by the manufacturer in operating and maintenanceinstructions10.1 GeneralThe manufacturer shall provide instructions for use and maintenance. The size and shape of these instructions foruse should be such that they can be enclosed with or attached to the resuscitator container.10.2 ContentsIn addition of EN 1041 the instructions for use and maintenance shall include the following inform
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