anæstesi- og respirationsudstyr – fugt- og varmevekslere ...en iso 9360-1:2009 (e) 3 foreword the...
TRANSCRIPT
Dansk standard
DS/EN ISO 9360-1
2. udgave
2009-06-10
Anæstesi- og respirationsudstyr –
Fugt- og varmevekslere til fugtning af respirationsgasser i mennesker – Del 1: Fugt- og varmevekslere til brug med et tidalvolumen på minimum 250 ml
Anaesthetic and respiratory equipment – Heat and moisture exchangers (HMEs) for humidifying respired gases in humans – Part 1: HMEs for use with minimum tidal volumes of 250 ml
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DS-publikationstyper Dansk Standard udgiver forskellige publikationstyper. Typen på denne publikation fremgår af forsiden. Der kan være tale om: Dansk standard
• standard, der er udarbejdet på nationalt niveau, eller som er baseret på et andet lands nationale standard, eller • standard, der er udarbejdet på internationalt og/eller europæisk niveau, og som har fået status som dansk standard
DS-information • publikation, der er udarbejdet på nationalt niveau, og som ikke har opnået status som standard, eller • publikation, der er udarbejdet på internationalt og/eller europæisk niveau, og som ikke har fået status som standard, fx en
teknisk rapport, eller • europæisk præstandard DS-håndbog • samling af standarder, eventuelt suppleret med informativt materiale
DS-hæfte • publikation med informativt materiale
Til disse publikationstyper kan endvidere udgives
• tillæg og rettelsesblade DS-publikationsform Publikationstyperne udgives i forskellig form som henholdsvis
• fuldtekstpublikation (publikationen er trykt i sin helhed) • godkendelsesblad (publikationen leveres i kopi med et trykt DS-omslag) • elektronisk (publikationen leveres på et elektronisk medie)
DS-betegnelse Alle DS-publikationers betegnelse begynder med DS efterfulgt af et eller flere præfikser og et nr., fx DS 383, DS/EN 5414 osv. Hvis der efter nr. er angivet et A eller Cor, betyder det, enten at det er et tillæg eller et rettelsesblad til hovedstandarden, eller at det er indført i hovedstandarden. DS-betegnelse angives på forsiden. Overensstemmelse med anden publikation: Overensstemmelse kan enten være IDT, EQV, NEQ eller MOD
• IDT: Når publikationen er identisk med en given publikation. • EQV: Når publikationen teknisk er i overensstemmelse med en given publikation, men
præsentationen er ændret. • NEQ: Når publikationen teknisk eller præsentationsmæssigt ikke er i overensstemmelse med en
given standard, men udarbejdet på baggrund af denne. • MOD: Når publikationen er modificeret i forhold til en given publikation.
DS/EN ISO 9360-1 København DS projekt: M235091 ICS: 11.040.10 Første del af denne publikations betegnelse er: DS/EN ISO, hvilket betyder, at det er en international standard, der har status både som europæisk og dansk standard. Denne publikations overensstemmelse er: IDT med: ISO 9360-1:2000. IDT med: EN ISO 9360-1:2009. DS-publikationen er på engelsk. Denne publikation erstatter: DS/EN ISO 9360-1:2000.
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EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
EN ISO 9360-1
April 2009
ICS 11.040.10 Supersedes EN ISO 9360-1:2000
English Version
Anaesthetic and respiratory equipment - Heat and moistureexchangers (HMEs) for humidifying respired gases in humans -
Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO9360-1:2000)
Matériel d'anesthésie et de réanimation respiratoire -Échangeurs de chaleur et d'humidité (ECH) utilisés pour
humidifier les gaz respirés par les êtres humains - Partie 1:ECH pour utilisation avec des volumes courants d'au moins
250 ml (ISO 9360-1:2000)
Anästhesie- und Beatmungsgeräte - Wärme- undFeuchtigkeitsaustauscher zur Anfeuchtung von Atemgasen
beim Menschen - Teil 1: Wärme- undFeuchtigkeitsaustauscher zur Verwendung bei
Mindesthubvolumina von 250 ml (ISO 9360-1:2000)
This European Standard was approved by CEN on 28 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 STANDARDIZATIONC O M I T É E U R O P É E N D E N O R M A LI S A T I O NEUR OP ÄIS C HES KOM ITEE FÜR NOR M UNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.
Ref. No. EN ISO 9360-1:2009: E
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EN ISO 9360-1:2009 (E)
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Contents Page
Foreword ..............................................................................................................................................................3
Annex ZA (Informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC ............................................................................................4
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EN ISO 9360-1:2009 (E)
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Foreword
The text of ISO 9360-1:2000 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 9360-1:2009 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 9360-1:2000.
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 9360-1:2000 has been approved by CEN as a EN ISO 9360-1:2009 without any modification.
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EN ISO 9360-1:2009 (E)
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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
4 13.2
5 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard
- 7.5 (2nd paragraph) This relevant Essential Requirement is not addressed in this European Standard
- 7.5 (3rd paragraph) This relevant Essential Requirement is not addressed in this European Standard
5.1 9.1, 13.6 c)
5.2 9.1, 13.6 c)
5.3 8.3
5, 6, 7 1 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard
5, 6, 7 1 (2nd paragraph, 1st dash) This relevant Essential Requirement is not fully addressed in this European Standard
5, 6, 7 1 (2nd paragraph, 2nd
dash)
This relevant Essential Requirement is not fully addressed in this European Standard
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Clause(s)/sub-clause(s) of this EN
Essential Requirements (ERs) of Directive 93/42/EEC
Qualifying remarks/Notes
- 6a)
This relevant Essential Requirement is not addressed in this European Standard
7.1 a) 9.1, 13.2, 13.3 k), 13.6 c)
7.1 b) 9.1, 13.2, 13.3 j)
7.2 13.1
7.2 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard
- 13.3 (f) This relevant Essential Requirement is not addressed in this European Standard
- 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not addressed in this European Standard
7.2 a) 13.3 a)
7.2 b) 13.3 b)
7.2 c) 8.7, 13.3 c)
7.2 d) 13.3 i)
7.2 e) 13.3 l)
7.2 f) 13.3 e)
7.3 13.3 f)
7.4 13.1
7.4 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard
7.4 a) 13.1, 13.6 a), 13.6 b)
7.4 b) 9.1, 13.3 j)
7.4 d) 13.6 b)
7.4 f) 13.6 b)
7.4 g) 13.6 b)
7.4 h) 13.3 j), 13.3 k)
7.4 i) 13.3 m), 13.6 h)
7.4 j) 13.3 j), 13.3 k)
7.4 k) 13.6 n)
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
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Reference numberISO 9360-1:2000(E)
© ISO 2000
INTERNATIONALSTANDARD
ISO9360-1
First edition2000-03-15
Anaesthetic and respiratory equipment —Heat and moisture exchangers (HMEs) forhumidifying respired gases in humans —
Part 1:HMEs for use with minimum tidal volumesof 250 ml
Matériel d'anesthésie et de réanimation respiratoire — Échangeurs dechaleur et d'humidité (ECH) utilisés pour humidifier les gaz respirés parles êtres humains —
Partie 1: ECH pour utilisation avec des volumes courants d'au moins250 ml
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ISO 9360-1:2000(E)
© ISO 2000 – All rights reserved iii
Contents Page
Foreword....................................................................................................................... ..............................................iv
Introduction ................................................................................................................... ..............................................v
1 Scope ......................................................................................................................... .....................................1
2 Normative references ........................................................................................................... .........................1
3 Terms and definitions ........................................................................................................... ........................1
4 Symbols and abbreviated terms .................................................................................................... ..............2
5 General requirements and recommendations ......................................................................................... ...25.1 HME patient port connector..................................................................................................... .....................25.2 Additional ports ............................................................................................................. ................................25.3 Packaging of sterile HME....................................................................................................... .......................3
6 Test methods................................................................................................................... ...............................36.1 General..................................................................................................................... .......................................36.2 Measurement of moisture loss................................................................................................... ..................36.3 Measurement of pressure drop ................................................................................................... ...............136.4 Test for gas leakage ........................................................................................................... .........................136.5 Test for compliance........................................................................................................... ..........................13
7 Marking ....................................................................................................................... ..................................15
Annex A (informative) Lists of parts and specifications in Figures 1 and 2 .......................................................17
Annex B (informative) Rationale ...................................................................................................................... ........18
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ISO 9360-1:2000(E)
iv © ISO 2000 – All rights reserved
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
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 9360 may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 9360-1 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratoryequipment, Subcommittee SC 3, Lung ventilators and related equipment.
This first edition of ISO 9360-1 cancels and replaces, in part, the first edition of ISO 9360 (ISO 9360:1992), whichhas been technically revised.
ISO 9360 consists of the following parts, under the general title Anaesthetic and respiratory equipment — Heat andmoisture exchangers (HMEs) for humidifying respired gases in humans:
— Part 1: HMEs for use with minimum tidal volumes of 250 ml
— Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
Annexes A and B of this part of ISO 9360 are for information only.
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© ISO 2000 – All rights reserved v
Introduction
The gases generally available for medical use lack sufficient moisture to be physiologically acceptable to therespiratory tract of patients. Heat and moisture exchangers are used to raise the water content and the temperatureof the gas delivered to the respiratory tract. They are primarily intended for use independently or as part of abreathing system.
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INTERNATIONAL STANDARD ISO 9360-1:2000(E)
© ISO 2000 – All rights reserved 1
Anaesthetic and respiratory equipment — Heat and moistureexchangers (HMEs) for humidifying respired gases in humans —
Part 1:HMEs for use with minimum tidal volumes of 250 ml
1 Scope
This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including thoseincorporating breathing system filters, intended for the humidification of respired gases for use primarily withpatients with a tidal volume equal to or greater than 250 ml, and incorporating at least one machine port, anddescribes test methods for their evaluation.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions ofthis part of ISO 9360. For dated references, subsequent amendments to, or revisions of, any of these publicationsdo not apply. However, parties to agreements based on this part of ISO 9360 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undatedreferences, the latest edition of the normative document referred to applies. Members of ISO and IEC maintainregisters of currently valid International Standards.
ISO 4135: 1995, Anaesthesiology — Vocabulary.
ISO 5356-1:1996, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.
ISO 5356-2:1987, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors.
ISO 7000:1989, Graphical symbols for use on equipment — Index and synopsis.
ISO 11607, Packaging for terminally sterilized medical devices.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
3 Terms and definitions
For the purposes of this part of ISO 9360, the terms and definitions given in ISO 4135 and the following apply.
3.1heat and moisture exchangerHMEdevice intended to retain a portion of the patient's expired moisture and heat, and return it to the respiratory tractduring inspiration
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