EN ISO 15001:2004
(Main)Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)
This European Standard specifies minimum requirements for the oxygen compatibility of materials which can come in contact with oxygen at pressures greater than 50 kPa in medical devices. Aspects of compatibility that are addressed include: cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition. NOTE: It is expected that particular device standards will make reference to this horizontal standard but may, if appropriate, strengthen these minimum requirements.
Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2003)
Diese Internationale Norm legt Mindestanforderungen an die Sauerstoffverträglichkeit von Werkstoffen, Bauteilen und Geräten für Anwendungen bei der Anästhesie und Beatmung fest, die im Normalzustand oder beim Ersten Fehler mit Sauerstoff bei Drücken über 50 kPa in Berührung kommen können.
Diese Internationale Norm gilt für Anästhesie- und Beatmungsgeräte, die innerhalb des Aufgabenbereichs des ISO/TC 121 liegen, z. B. Rohrleitungssysteme für medizinische Gase, Druckregler, Entnahmestellen, medizinische Versorgungseinheiten, flexible Verbindungsstücke, Durchflussmessgeräte, Anästhesie-Arbeitsplätze und Lungenbeatmungsgeräte.
Zu den in dieser Internationalen Norm behandelten Gesichtspunkten der Sauerstoffverträglichkeit gehören die Sauberkeit, die Widerstandsfähigkeit gegen Zündung und die Toxizität von Verbrennungs- und/oder Zerfallsprodukten.
Matériel d'anesthésie et respiratoire - Compatibilité avec l'oxygène (ISO 15001:2003)
Anestezijska in respiratorna oprema – Združljivost s kisikom (ISO 15001:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2004
Anestezijska in respiratorna oprema – Združljivost s kisikom (ISO 15001:2003)
Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2003)
Anästhesie- und Beatmungsgeräte - Verträglichkeit mit Sauerstoff (ISO 15001:2003)
Matériel d'anesthésie et respiratoire - Compatibilité avec l'oxygene (ISO 15001:2003)
Ta slovenski standard je istoveten z: EN ISO 15001:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15001
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2004
ICS 11.040.10
English version
Anaesthetic and respiratory equipment - Compatibility with
oxygen (ISO 15001:2003)
Matériel d'anesthésie et respiratoire - Compatibilité avec Anästhesie- und Beatmungsgeräte - Verträglichkeit mit
l'oxygène (ISO 15001:2003) Sauerstoff (ISO 15001:2003-
This European Standard was approved by CEN on 23 April 2004.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15001:2004 E
worldwide for CEN national Members.
Contents Page
FOREWORD. 3
ANNEX ZA (NORMATIVE) NORMATIVE REFERENCES TO INTERNATIONAL PUBLICATIONS WITH
THEIR RELEVANT EUROPEAN PUBLICATIONS .4
ANNEX ZB (INFORMATIVE) CLAUSES OF THIS EUROPEAN STANDARD ADDRESSING ESSENTIAL
REQUIREMENTS OR OTHER PROVISIONS OF EU DIRECTIVES. 5
Foreword
The text of ISO 15001:2003 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
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 November 2004, and conflicting national standards shall be withdrawn
at the latest by November 2004.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this document.
Details of corresponding International and European standards are given in Annex ZA, which is normative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
and United Kingdom.
Endorsement notice
The text of ISO 15001:2003 has been approved by CEN as EN ISO 15001:2004 without any modifications.
Annex ZA
(normative)
Normative references to international publications with their relevant
European publications
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.),
the relevant EN/HD applies.
Publication Year Title EN Year
ISO 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices
Annex ZB
(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.
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 normative
clauses of this standard given in Table ZB.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.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
TABLE ZB.1 - Correspondence between this European Standard and EU Directives
Clause/subclause of this Corresponding Essential Comments
European Standard Requirement of Directive
93/42/EEC
All 7.2, 7.3, 9.2, 9.3, 12.7.4 This standard specifies minimum
requirements for the oxygen
compatibility of materials,
components and devices that
can come into contect with
oxygen in normal or single fault
condition.
INTERNATIONAL ISO
STANDARD 15001
First edition
2003-05-15
Anaesthetic and respiratory equipment —
Compatibility with oxygen
Matériel d'anesthésie et respiratoire — Compatibilité avec l'oxygène
Reference number
ISO 15001:2003(E)
©
ISO 2003
ISO 15001:2003(E)
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ii © ISO 2003 — All rights reserved
ISO 15001:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 R Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Cleanliness . 2
5 R Resistance to ignition . 3
6 Risk analysis . 3
Annex A (informative) Examples of cleaning procedures. 4
Annex B (informative) Typical methods for validation of cleaning procedures . 11
Annex C (informative) Design considerations. 14
Annex D (informative) Selection of materials . 19
Annex E (informative) Recommended method for combustion and quantitative analysis of
combustion products of non-metallic materials. 31
Annex F (informative) Rationale. 36
Bibliography . 37
ISO 15001:2003(E)
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 2.
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 document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15001 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 6, Medical gas systems.
iv © ISO 2003 — All rights reserved
ISO 15001:2003(E)
Introduction
Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and
clinical personnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a
fire occurs in an oxygen-enriched atmosphere. A common cause of fire is the heat produced by adiabatic
compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some
combustion products, especially of some non-metals (e.g. plastics, elastomers and lubricants) are toxic and
thus patients remote from that equipment who are receiving oxygen from a medical gas pipeline system might
be injured when a problem occurs.
Other equipment which is in close proximity to the equipment using oxygen, or that utilizes oxygen as its
source of power can be damaged or fail to function properly if there is a problem with the oxygen equipment.
Reduction or avoidance of these risks depends on the choice of appropriate materials and cleaning
procedures and correct design and construction of equipment so that it is compatible with oxygen under the
conditions of use.
This document establishes recommended minimum criteria for the safe use of oxygen and the design of
systems for use in oxygen and oxygen-enriched atmospheres.
Annex F contains rationale statements for some of the requirements of this International Standard. It is
included to provide additional insight into the reasoning that led to the requirements and recommendations
that have been
...
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