oxygen concentrators for medical use — safety requirements...

BS EN ISO 8359:2009

ICS 11.040.10

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

BRITISH STANDARD

Oxygen concentrators for medical use — Safety requirements (ISO 8359:1996)

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July2009.

© BSI 2009

ISBN 978 0 580 65020 8

Amendments/corrigenda issued since publication

Date Comments

BS EN ISO 8359:2009

National foreword

This British Standard is the UK implementation of EN ISO 8359:2009. It is identical to ISO 8359:1996. It supersedes BS EN ISO 8359:1997 which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Lung ventilators, tracheal tubes and related equipment.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

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EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN ISO 8359

April 2009

ICS 11.040.10 Supersedes EN ISO 8359:1996

English Version

Oxygen concentrators for medical use - Safety requirements(ISO 8359:1996)

Concentrateurs d'oxygène à usage médical - Prescriptionsde sécurité (ISO 8359:1996)

Sauerstoff-Konzentratoren für medizinische Zwecke -Sicherheitsanforderungen (ISO 8359:1996)

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 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 8359:2009: E

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BS EN ISO 8359:2009EN ISO 8359:2009 (E)

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Foreword

The text of ISO 8359:1996 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 8359:2009 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 8359:1996.

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 8359:1996 has been approved by CEN as a EN ISO 8359:2009 without any modification.

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BS EN ISO 8359:2009EN ISO 8359:2009 (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

All 1 (1st paragraph), 2, 3

1.7 13.3 (a): This relevant Essential Requirement is not fully addressed in this European Standard

1.7 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard

1.7 1st dash to 4th dash 13.3

1.7 1st dash to 6th dash 13.4

1.7 6th dash to 5.8 dash 9.2

3.1 to 3.8 12.6

4.1 to 4.8 4, 12.7.1, 12.7.2, 12.7.3, 12.7.4

4.1 to 7.8 4

10.1 to 10.6 12.6

1.6 12.6

1.7 12.6, 13.1

1.7 4th dash 7.2

1.7 5th dash 13.2

1.7 6th dash 7.2, 8.1, 9.1, 13.6, (except e) and j))

1.7 7th dash 9.1, 13.6, (except e) and j))

1.7 8th dash 13.6 (except e and j)

1.8 12.6

2.3 4, 5

5.8 12.5

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BS EN ISO 8359:2009EN ISO 8359:2009 (E)

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Clause(s)/sub-clause(s) of this EN

Essential Requirements (ERs) of Directive 93/42/EEC

Qualifying remarks/Notes

6.1 to 6.5 9.3

7.1 7.1, 7.2, 12.7.5

7.2 7.1, 7.3, 9.3

7.2 a) 2) 7.5

- 1 (2nd paragraph, 1st dash) This relevant Essential Requirement is not specifically addressed in this European Standard

- 1 (2nd paragraph, 2nd dash) This relevant Essential Requirement is not specifically addressed in this European Standard

- 6a This relevant Essential Requirement is not addressed in this European Standard

7.3 7.6, 8.1

7.3 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

- 12.1a) This relevant Essential Requirement is not addressed in this European Standard.

8.1 9.2, 12.8.1, 12.8.2

8.2 9.2, 12.8.1, 12.8.2

8.2 2nd dash 7.1, 7.2, 8.1

8.2 3rd dash 12.4

9.1 4, 7.5, 9.3, 12.6

9.2 12.6

10.3 12.7.4

10.3 1st dash 12.9

10.3 2nd dash 12.9

10.4 12.7.4

11.2 12.3

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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BS EN ISO 8359:2009EN ISO 8359:2009 (E)

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For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity for the machinery directive.

Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard

(according to article 3 of amended Directive 93/42/EEC) Clause(s)/sub-clause(s) of this EN

EHSR of 2006/42/EC Qualifying remarks/Notes

- 1.1.4 This relevant EHSR is not addressed in this European Standard

8

1.2.2

This relevant EHSR is not fully addressed in this European Standard

-

1.5.4

This relevant EHSR is not addressed in this European Standard

- 1.6.1


-

1.6.2


-

1.6.3


- 3.6.2

This relevant EHSR is not fully addressed in this European Standard

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BS EN ISO 8359:2009

INTERNATIONAL STANDARD

ISO 8359

Second edition 1996-12-15

Oxygen concentrators for medical use Safety requirements

Concentrateurs d'oxygene a usage medical - Prescriptions de securite

-~-- -- -

~ISOJ =~= =- -== Reference number

ISO 8359: 1996(E)

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BS EN ISO 8359:2009ISO 8359:1996(E)

Contents Page

Section 1 General...................... ...... .... ... ...... ................... ........... ..... 1

1.1 Scope 1

1.2 Normative references 1

1.3 Definitions 2

1.4 General requirements 2

1.5 Genera l requirements for tests 2

1.6 Classification 2

1.7 Identification, marking and documents 2

1.8 Power input 5

Section 2 Safety requirements ........... ............ ............... .............. 6

2.1 Basic safety categories .........•...•.• ... ..... .. " 6

2.2 Removable protective means .............. . 6

2.3 Environmental conditions ............. ...... .... .. 6

Section 3 Protection against electric shock hazards ........ ... ..... 7

3.1 General 7

3.2 Requirements related to classif ication 7

3.3 Limitation of voltage and/or energy 7

3.4 Enclosures and protective covers ..... ... 7

3.5 Separation 7

3.6 Protective earthing, functional earthing and potential equalization ... .... ...... ................... .......... ............. .. ........ .... .. ... 7

3.7 Continuous leakage currents and patient auxiliary currents 7

3.8 Dielectric strength ..... ... .... ...................... ......... ... 7

Section 4 Protection against mechanical hazards ....... ........ ..... 8

4.1 Mechanical strength 8

elsa 1996 All rights reserved. Unless otherwise specified, no part of th is publica tion may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher.

International Organization for Standardization Case Postale 56 · CH· 121 1 Geneve 20 . Switz.erland

Printed in Switzerland

"

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BS EN ISO 8359:2009© ISO ISO 8359:1996(E)

4.2 Moving parts 8

4.3 Surfaces. corners and edges 8

4.4 Stability in normal use 8

4.5 Expelled parts 8

4.6 Vibration and noise 8

4.7 Pneumatic and hydraulic power 8

4.8 Suspended masses 8

Section 5 Protection against hazards from unwanted or excessive radiation .... .......................................... ...... ............ ........ 9

5.1 X-Radiation 9

5.2 Alpha. beta. gamma. neutron radiation and other particle radiation .. .... ....... .......... ......... 9

5.3 Microwave radiation ........................ 9

5.4 Light radiation (including visual radiation and lasers) ............. 9

5.5 Infrared radiation 9

5.6 Ultraviolet radiation 9

5.7 Acoustical energy (including ultrasonics) 9

5.8 Electromagnetic compatibility 9

Section 6 Protection against hazards of explosions in medically used rooms ................................................................. 10

6.1 Locations and basic requirements 10

6.2 Marking. accompanying documents 10

6.3 Common requirements for category AP and category APG equipment ...................................... ............... 10

6.4 Requirements and tests for category AP equipment. parts and components thereof .................. 10

6.5 Requirements and tests for category APG equipment. parts and components thereof ........................ 10

Section 7 Protection against excessive temperatures and other safety hazards ............................................................ 11

7.1 Excessive temperatures 11

7.2 Fire prevention 11

7.3 Overflow. spillage. leakage. humidity. ingress of liquids. cleaning, sterilization and disinfection ................... ....... .... ........... . 12

7.4 Pressure vessels and parts subject to pressure 12

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BS EN ISO 8359:2009ISO 8359:1996(E) © ISO

7.5 Human errors 12

7.6 Electrostatic charges 12

7.7 Materia ls in applied parts in contact with the body of the patient .. ... .. .... ..... .. ... ... .... ... ... ..... ... 12

7.8 Interruption of the power supply ..... ........ 12

Section 8 Accuracy of operating data and protection against hazardous output ... ... ... .. ............ ...... .. .. .... ......... ......... 13

8.1 Accuracy of operating data 13

8.2 Protection against hazardous output 14

Section 9 Abnormal operation and fault conditions; environmental tests .......... ............. .... ...... .... ...... .. .... .. .... ....... ... .... ........ 16

9.1 Abnormal operation and faul t conditions 16

9.2 Environmental tests 16

Section 10 Constructional requirements ........ ...... ..... ........ .. .... . 17

10.1 Genera l 17

10.2 Enclosures and covers 17

10.3 Components and general assembly 17

10.4 Mains parts, components and layout 17

10.5 Protect ive earth ing - Terminals and connections 17

10.6 Const ru ction and layout 17

Section 11 Additional clauses ... .......... ... ......... ..... .... ...... .... .. ..... . 18

11.1 Auditory indicators

11.2 Indication of loss of mains power

Annexes

N Test apparatus ..... .

p

o

IV

Rationale statement.. .....

Bibliography.

18

18

20

21

24

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BS EN ISO 8359:2009o ISO ISO 8359:1996(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing In te rnational 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-governmen ta l, in liaison wi th ISO, also take part in the work. ISO collaborates closely w ith the Intern ational Electrotechnical Commission (lEC) on all matters of electrotechnical standardization.

Draft International Standards adopted by the technica l committees are circulated to the member bodies for voting. Publication as an International Standard requires approva l by at least 75 % of the member bodies casting a vote.

Internationa l Standard ISO 8359 was prepared by Technical Committee ISOITC 121, Anaesthetic and respiratory equipment. Subcommittee SC 3, Lung ventila tors and related equipment.

This second edit ion cance ls and rep laces the first edition (ISO 8359: 1988), which has been technically revised.

Annexes A to N form an integral pa rt of this International Standard. Annexes P and Q are for informati on only.

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BS EN ISO 8359:2009ISO 8359:1996(E) o ISO

Introduction

Oxygen concentrators provide a safe sou rce of oxygen-enriched air for patients in need. These devices raise the level of inspired oxygen by separating nitrogen or oxygen from ambient air.

Oxygen concentrators fa ll into two main classes according to the means whereby gas separation is effected, namely:

a) oxygen concentrators in which oxygen selectively permeates or transports through a membrane or lattice,

b) pressure sw ing absorbers (PSA) in w hich air is exposed at a certain pressure to molecular sieve material which selectively re ta ins nitrogen and other components until they are subsequently released when the pressure is reduced.

Details of the arrangement of test apparatus for carrying out a number of the tests to check compliance with certain requirements are given in annex N.

A ra tiona le for the most important requirements is given in annex P. It IS

considered that a knowledge of the reasons for the requirements w ill not only facilitate the proper application of this International Standard, but Will expedite any subsequent revision.

Test methods other than those specified in this International Standard, but of equal or greater accuracy, may be used to ve rify comp liance with the given requirements. However, in the event of a dispute, the methods specified in this International Standard are to be used as the reference methods.

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BS EN ISO 8359:2009INTERNATIONAL STANDARD © ISO ISO 8359:1996(E)

Oxygen concentrators for medical use - Safety requirements

Section 1: General

1.1 Scope

NOTE 1 See the rationale in annex P

ISO 8359 is one of a series of International Standards based on IEC 601-1. In IEC 601-1 (the "General Standard"), this type of International Standard is referred to as a "Particular Standard". As stated in 1.3 of IEC 601-1 :1988, the requirernents of this International Standard take precedence over those of IEC 601-1.

The scope and object given in clause 1 of I EC 601-1 :1988 apply, except that 1.1 shall be replaced by the following:

This International Standard specifies safety requirernents for continuous-flow oxygen concentrators, as defined In 1.3.8 (in this International Standard). This International Standard does not apply to oxygen concentrators intended to supply gas to several patients via a piped rnedical gas installation or to those intended for use in the presence of flarnrnable anaesthetic and/or cleaning agents.

The scope of this International Standard is not restricted to rnernbrane oxygen concentrators and pressure swing absorbers (see Introduction!, as alternative rnethods of concentrating oxygen rnay becorne available and it is not intended that this International Standard should restrict future developrnents.

1.2 Normative references

The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the tirne of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreernents based on this International Standard are encouraged to investigate the POSSI

bility of applying the rnost recent editions of the standards indicated below. Mernbers of IEC and ISO rnaintain registers of currently valid I nternational Standards.

ISO 3744:1994, Acoustics - Determination of sound power levels of noise sources using sound pressure - Engineering method in an essentially free field over a reflecting plane.

ISO 9703-1: 1992, Anaesthesia and respiratory care alarm signals - Part 1: Visual alarm signals.

ISO 9703-2:1994, Anaesthesia and respiratory care alarm signals - Part 2: Auditory alarm signals.

IEC 601-1 :1988, Medical electrical equipment - Part 1: General requirements for safety.

I EC 601-1-2: 1993, Medical electrical equipment - Part 1: General requirements for safety. 2. Collateral standard: Electromagnetic compatibility requirements and tests.

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BS EN ISO 8359:2009ISO 8359:1996(E) Q ISO

IEC 65 1 :1979, Sound level meters.

1.3 Definitions

For the purposes of this International Standard, the definitions given in clause 2 of I EC 601-1: 1988 apply, except that the definition given in 2. 1.5 shall be replaced by the following:

2.1.5 applied part: Oxygen concentrator outlet.

For the purposes of this International Standard, the following definitions also apply:

1.3.1 administration accessories: All accessories for conducting the product gas from the oxygen concentrator outlet to the patient, but excluding any fixed tubing extensions.

1.3.2 oxygen concentrator outlet: Port of the oxygen concentrator from which the product gas flows.

1.3.3 flow control device: Device which controls the flow of the product gas.

1.3.4 flow indicator: Device which shows the vo lume of product gas passing through the oxygen concentrator in a specified unit of t ime.

1.3.5 operator control: Control to enable the user, w ithout the need for tools, to cause the oxygen concentrator to perform its intended function.

1.3.6 outlet pressure: Gauge pressure at the oxygen concentrator outlet under the test f low conditions.

1.3.7 oxygen analyzer: Device which measures and quantitatively indicates the concentration of oxygen present in a gaseous mixture.

1.3.8 oxygen concentrator: Device which, by selective removal of constituents of ambient ai r, increases the concentration of oxygen in the product gas.

1.3.9 product gas: Output f rom the oxygen concent ra tor consisting of respirable oxygen-enriched air.

1.3.10 oxygen concentration status indicator (OCSI): Device w hich indicates w hen the proportion of oxygen in the product gas is at an abnormal level.

1.4 General requirements

The requirements given in clause 3 of I EC 601-1 1988 app ly.

1.5 General requirements for tests

The requirements given in clause 4 of IEC 601-1 :1 988 apply.

1.6 Classification

The classi ficat ion given in clause 5 of IEC 601 -1: 1988 applies, except for the following deletions.

- Delete 5.5.

- In 5.6 delete all except for " continuous operation" and " intermittent operation"

1,7 Identification. marking and documents

The requirements given in clause 6 of IEC 601-1:1 988 apply. except for the following additions and modifications.

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- The foilowing additional general requirement also applies.

All markings pertaining to the operation of the oxygen concentrator shall be legib le to an opera tor having visual acu ity, corrected if necessary, of at least 1,0 and seated or standing 1 m from the oxygen concentrator flooded with illuminance of 215 lux.

NOTE 2 All markings should have a luminance contrast of at least 50 % when compared with the surrounding background material.

In 6.1 e) add the following.

The oxygen concentrator shall be marked with its country of origin plus the address of the manufacturer.

Delete 6.1 r)

- To 6.1 add the following additional items.

aa) The marking on the outside shall addit iona lly include the following:

1) a warning against removal of the cover by unauthorized persons;

2) a warning "NO SMOKING OR NAKED FLAMES" ;

3) the nominal concentration of oxygen in the product gas, expressed as a percent volume fraction, at a flowrate of 2 Ilmin or at the recom mended maximum flowrate;

4) the statement "USE NO OIL OR GREASE" ;

5) on the flow indicato r, the output (e .g. output. gas flow, etc.) .

Replace 6.7 a) by the following.

If visua l indicators are used on the oxygen concentrator, w ith the exception of alphanumeric displays, their colouring sha ll conform to ISO 9703-1 and the following additional requirements:

1) continuous red shall be used to indicate to the operator that the oxygen concentrator, or a portion of it, has failed;

2) the function of all lights and displays shall be marked.

Compliance shall be checked by functional test and inspection.

In 6.8.2 a), add the fo llowing.

Instructions for use shall also inc lude the following information:

1) intended use of the oxygen concentrator;

2) at least one type of humidifier which is suitable for use w ith the oxygen concentrator when needed;

3) statement that use of certain humidifiers and administration accessories not specified for use with this oxygen concentrator may impair the performance;

4) preferred location of any humidifier in the administration accessories;

5) statement that in certain circumstances oxygen therapy can be hazardous and that seeking medical advice before using the machine is advisable;

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BS EN ISO 8359:2009ISO 8359:1996(E) I:> ISO

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6) statement of the time required from switching on the oxygen concentrator to reach a stated performance;

7) statement that the air intake of the oxygen concentrator should be located in a well-venti lated space;

8) intervals at which cleaning procedu res need to be performed and the items required for such cleaning;

9) statement that no lubricants are to be used other than those recommended by the manufacturer;

10) statement that advises the operator of actions to take when the oxygen concentration status indicator indicates an abnormal oxygen concentration level;

11) statement that the oxygen concentrator shou ld be located so as to avoid pollutants or fumes.

In 6.8.2 d) , add the following.

Instructions for use shall also include the following information:

A specification for at least one complete set of administ rat ion accessories w hich is suitable for use w ith the oxygen concentrator and, except for administration accessories, intended for single use, recommendations fo r thei r cleaning, sterilization and disinfection.

In 6.8.3 a) , add the following.

The technica l description shall also include the following information:

1) table or graph showing values of oxygen concentration as a function of flowrate at specified operator settings at a nominal outlet pressure of zero;

2) maximum recommended flow, expressed in litres per minute;

3) flowrate, expressed in litres per minute, at a specified control setting at nomina l outlet pressures of zero and 7 kPa;

4) maximum outlet pressure when the oxygen concentrator is operated in accordance w ith the method given in new clause 50.8 presented in this International Standard;

5) maximum A-weighted sound pressure leve l, expressed in decibels, when the oxygen concentrator is operated under the test conditions specified in new clause 26.2 presented in this International Standard;

6) if a pressure relief rnechanism is provided, the range of pressures, expressed in ki lopascals, at which the mechanism operates;

7) nominal concentration of oxygen in the product gas, expressed as a percent volume fraction, at a flow rate of 2 Ilmin or at the recommended maximum flowrate;

8) statement of the concentration of oxygen in the product gas, expressed as a percent volume fraction, at the maximum recommended flowrate;

9) statement of the oxygen concentration (with tolerances) at which the OCSI gives an indication of abnormal oxygen concentration in the product gas;

10) statement of the ranges of temperature and atmospheric pressure at which the OCSI is intended for use;

11) temperature range within which the oxygen concentrator is intended to be operated;

12) va riation of oxygen concentration w ith flowrate over a barometric pressure corresponding to the altitude range 0 to 4000 m above sea level.

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BS EN ISO 8359:2009

o ISO ISO 8359:1996(E)

1.8 Power input

The requirements given in clause 7 of lEe 601 -1 : 1 9BB apply.

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BS EN ISO 8359:2009ISO 8359:1996(E) 0 ISO

Section 2: Safety requirements

2.1 Basic safety categories

The requirements given in Appendix A 1.2 of IEC 601-1: 1988 do not apply, as they are not relevant to oxygen concentrators.

2.2 Removable protective means

The requ irements given in clause 6.1 z} of IEC 601-1: 1988 apply.

2.3 Environmental conditions

The requirements given in clause 10 of lEe 601 -1:1 988 apply.

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Section 3: Protection against electric shock hazards

3.1 General

The requirements given in clause 13 of lEe 601-1:1988 apply.

3.2 Requirements related to classification

The requirements given in clause 14 of lEe 601-1:1988 apply .

3.3 Limitation of voltage and/or energy


3.4 Enclosures and protective covers

The requirements given in clause 16 of lEe 601·1:1988 apply .

3.5 Separation

The requirements given In clause 17 of lEe 601-1:1988 apply.

3.6 Protective earthing, functional earthing and potential equalization

The requirements given in clause 18 of lEe 601·1: 1988 apply.

3.7 Continuous leakage currents and patient auxiliary currents

The requirements given in clause 19 of lEe 601-1 :1988 apply.

3.8 Dielectric strength

The requirements given in clause 20 of lEe 601-1: 1988 apply.

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BS EN ISO 8359:2009ISO 8359:1996(E) CJ ISO

Section 4: Protection against mechanical hazards

4.1 Mechanical strength

The requirements given in clause 21 of IEC 601-1: 1988 apply, except that 21.3 shall be deleted.

4.2 Moving parts

The requirements given in clause 22 of IEC 601 -1 :1988 apply.

4.3 Surfaces, corners and edges

The requirements given in clause 23 of IEC 601 -1 :1988 apply.

4.4 Stability in normal use

The requirements given in clause 24 of IEC 60H :1 988 apply.

4.5 Expelled parts

The requirements given in cla use 25 of IEC 601-1:1988 apply.

4.6 Vibration and noise

Clause 26 of IEC 601 -1 :1 988 shall be replaced by the following requirements.

26.1 In normal use the maximum A-weighted sound pressure level (steady or peak value) of the oxygen concentrator shall not exceed 60 dB.

Compliance shall be checked by the test specified in 26.2.

26.2 Place the microphone of a sound level meter complying with the requirements for a type 1 instrument specified in IEC 651 at the position of maximum sound pressure level in the horizontal plane passing through the geometric centre of the oxygen concentrator at a radius of 1 m. The measured sound pressure level shall not exceed the specified va lue.

For this test, the oxygen concentrator sha ll be operated over its normal working range of flow, including the maximum flowrate recommended by the manufacturer. Measurements shall be taken using the frequencyweighting characteristic A and the time-weighting characteristic F on the sound level meter. The measurements shall be taken in a free field over a reflecting plane as speci fied in ISO 3744.

The A-weighted background level of extraneous noise shall be at least 10 dB below tha t measured during the test.

4.7 Pneumatic and hydraulic power

The requirements given in clause 27 of IEC 601-1.1 988 apply.

4.8 Suspended masses

The requ irements given in clause 28 of IEC 601-1:1988 apply.

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Section 5: Protection against hazards from unwanted or excessive radiation

5.1 X-Radiation

The requirements given in clause 29 of lEe 60H:1988 apply.

5.2 Alpha, beta, gamma, neutron radiation and other particle radiation

The requirements given in clause 30 of lEe 601-1 :1988 apply

5.3 Microwave radiation

The requirements given in clause 31 of lEe 60H:1988 apply.

5.4 Light radiation (including visual radiation and lasers)

The requirements given in clause 32 of lEe 60H :1988 apply.

5.5 Infrared radiation

The requ irements given in clause 33 of lEe 601-1:1988 apply.

5.6 Ultraviolet radiation


5.7 Acoustical energy (including ultrasonics)

The requirements given in clause 35 of lEe 601-1: 1988 apply.

5.8 Electromagnetic compatibility

The requirements given in clause 36 of lEe 601 -1 :1988 apply. In addition the requirements given in lEe 60H-2:1992 apply.

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BS EN ISO 8359:2009ISO 8359:1996(E) c:> ISO

Section 6: Protection against hazards of explosions in medically used rooms

6.1 Locations and basic requirements

The requirements given in clause 37 of IEC 60 1-1:1988 do not apply, as oxygen concentrators intended for use in the presence of flammable anaesthetic and/or cleaning agents are outside the scope of this International Standard.

6.2 Marking, accompanying documents

The requirements given in clause 38 of I EC 60 1-1: 1988 do not apply, as oxygen concentrato rs intended for use in the presence of flammable anaesthetic and/or cleaning agents are outside the scope of this International Standard.

6.3 Common requirements for category AP and category APG equipment

The requirements given in clause 39 of IEC 60 1-1 :1988 do not apply, as oxygen concent rato rs intended for use in the presence of f lammable anaesthetic and/or cleaning agents are outs ide the scope of this International Sta ndard.

6.4 Requirements and tests for category AP equipment, parts and components thereof

The requirements given in clause 40 of I EC 601-1: 1988 do not apply, as oxygen concentrators intended for use In

the presence of flammable anaesthetic and/or cleaning agents are outside the scope of this International Standard.

6.5 Requirements and tests for category APG equipment, parts and components thereof

The requirements given in clause 41 of IEC 601-1 : 1988 do not app ly, as oxygen concentrators intended for use in the presence of flammable anaesthetic and/or cleaning agents are outside the scope of this International Standard.

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BS EN ISO 8359:2009c> ISO ISO 8359:1996(E)

Section 7: Protection against excessive temperatures and other safety hazards

7.1 Excessive temperatures

The requirements given in clause 42 of IEC 601-1 :1988 app ly, w ith the following modifications.

42.1 Amend the last entry in table Xa as fo llows.

Equipment parts which may in normal use have unintentional contact with a patient shall not attain tempera· tures exceeding 50 °C if made from metal or 60 °C if made from nonmetal.

42.3 Replace the existing text by the following.

The gas temperature at the oxygen concen trator outlet sha ll not exceed 6 °C above ambient temperature w hen the oxygen concentrator is operated in accordance w ith the manufacturer's instructions.

Compliance shall be checked by the test given in a) and b).

a) Use the test apparatus described in annex N (in thi s International Standardl . With the variable restrictor fu lly open, set the flowrate adjuster to give approximately the maximum fl owrate recommended by the manufacturer in the technica l description. Operate the oxygen concentrator for 0,5 h and readjust the flow so that exactly the maximum flowrate recommended by the manufacturer is indicated on the flowmeter of the test apparatus. Operate the oxygen concentrator for a further 9 h and take readings of the product gas temperature at intervals not exceeding 0,5 h, the first reading being taken 1 h from the onset of operation.

The temperature of the product gas sha ll not exceed the specif ied value.

b) The gas temperature at the oxygen concentrator outlet shall not exceed 46 °C when opera ted in accordance with the manufactu re r's instructions over the ra nge of ambient temperatu re recommended by the manufacturer.

Compliance shall be checked by repeating the test given in a) above with the oxygen concentra tor in an atmosphere maintained at the maximum operating temperature recommended by the manufacturer.

7.2 Fire prevention

The requirements given in clause 43 of IEC 60 1-1 :1988 apply, together w ith the fo llowing additional requirements.

a) In order to reduce the risk to patients, other persons or the surroundings due to fire, ignitable materia l, under normal and single-fault conditions, shall not simultaneously be subjected to conditions in which:

11 the temperature of the material is raised to its minim um ignition temperature, and

2) an oxidant is present.

b) The minimum ignition temperature is determined in accordance w ith IEC 79-4: 1975 using the oxidizing conditions present under normal and single-fault conditions .

cl Compliance is checked by determining the temperature to w hich the material is rai sed under normal and single-fa ult condit ions.

d) If sparking can occur under normal or single-fault conditions, the material subjected to the energy dissipation of the spark shall not ignite under the oxidizing conditions present.

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BS EN ISO 8359:2009ISO 8359:1996(E) " ISO

Compliance is checked by observing if ignition occurs under the most unfavourable combination of normal conditions with a single fault

7.3 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection

The requirements given in clause 44 of I EC 601·1: 1988 apply_

7.4 Pressure vessels and parts subject to pressure

The requirements given in clause 45 of I EC 601-1: 1988 apply_

7.5 Human errors

The requirements given in clause 46 of IEC 601-1 :1988 apply_

7.6 Electrostatic charges

The requirements given in clause 47 of IEC 601-1:1988 apply_

7.7 Materials in applied parts in contact with the body of the patient

The requirements given in clause 48 of I EC 601-1: 1988 apply_

7.8 Interruption of the power supply

The requirements given in clause 49 of IEC 601-1:1988 apply_

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BS EN ISO 8359:2009" ISO ISO 8359:1996(E)

Section 8: Accuracy of operating data and protection against hazardous output

8.1 Accuracy of operating data

The requirements given in clause 50 of IEC 601 -1: 1988, together with the following additional subc lauses, apply.

50.3 Flow indicator

A flow indicator, which indicates total product gas flowrate, shall be provided on the oxygen concentrator. It shall be graduated in lit res per minute and be accurate to ± 10 % of the indicated flow rate or ± 200 ml jmin, whichever is greater.

Compliance shall be checked by the following test:

Use the test apparatus described in annex N (in this International Standardl . W ith the variable restrictor completely open, set the flow ad juster on the oxygen concentrator so that the flow indicator shows 20 % of the maximum f lowrate stated by the manufacturer. Operate the oxygen concentrator for 15 min and measure the flowrate of the product gas using the flowmeter of the test apparatus. Repeat the procedure at the indicated 100 % fl ow and at the indicated 50 % flow. If a fi xed orifice device is used to regu late flow, each orifice shall be tested.

The flowrate shown on the flow indicator shall be within the tolerance specified.

50.4 Oxygen concentration

The concentrat ion of oxygen in the product gas, at a flowrate of 2 Ijmin, shall not be more than 3 % volume fraction below the value stated by the manufacturer in the accompanying documents.

Compliance shall be checked by the following test

Use the test apparatus described in annex N in this International Standard and set the mains voltage 10 % above the rated supply vol tage. With the variable restrictor completely open, set the flow adjuster to give an output of approximately 2 I{min, or at the recommended maximum flowrate. Operate the oxygen concentrator for 0,5 h and then adjust the f lowrate to exactly 2 Ijmin, or at the recommended maximum flowrate, as indicated on the flowmeter of the apparatus. Operate the oxygen concentrator for a further 1 h and take five consecutive readings of the concentration of oxygen in the product gas, as displayed on the oxygen analyser at intervals of 1 min. Repeat the test w ith the mains voltage set 15 % below the rated supply voltage.

The concentration of oxygen in the product gas shall be w ithin the tolerance specified.

50.5 Mean oxygen concentration

When the oxygen concentrator is operated at the maximum flow rate recommended by the manufacturer in the technical description, the mean concentration of oxygen in the product gas over an 8-h period shall be not more than 3 % volume fraction below the value stated by the manufacturer in the accompanying documents and no individual reading of oxygen content shall vary by more than ± 3 % volume fraction from the mean .

Compliance shall be checked by the foll owing test

Use the apparatus described in annex N (in this International Standardl and set the ma ',ns voltage 10 % above the rated supply voltage. With the variable restrictor completely open, set the flow adjuster to give approximately the maximum flowrate recommended by the manufacturer in the technica l description. Operate the oxygen concentrator for 0,5 h and readjust the flowrate so that exactly the maximum fl owrate recommended by the manufacturer is indicated on the flowmeter of the test apparatus. Operate the oxygen concen trator for

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BS EN ISO 8359:2009ISO 8359:1996(E) o ISO

a further 9 h and take readings of the concentration of oxygen in the product gas, as indicated on the oxygen analyser, averaged over 1 min at intervals of 0,5 h, the first reading being taken after 1 h. Calculate the arithmetic mean of the readings obtained. Repeat the test with the mains voltage set 15 % below the rated supply voltage.

The mean concentration of oxygen in the product gas and the individual readings shall be w ithin the tolerances specified.

50,6 Tolerance on flowrate

When the oxygen concentrator is set to the maximum flowrate recommended by the manufacturer in the technical description and operated for 8 h, the mean of the flowrates recorded at interva ls of 0,5 h over that period shall be w ithin ± 10 % of the stated va lue or ± 0,5 Ilmin, w hichever is greater, and no individual reading shall vary by more than ± 10 % of the mean va lue.

Compliance shall be checked by the following test:

During the test given in 50.5, note the flowrate from the oxygen concentrator, as indicated on the flowmeter of the test apparatus, at the same time as taking readings of the concentration of oxygen in the product gas. Calculate the arithmetic mean of the flow rate readings obtained.

The mean of the flowrates recorded and the individual flowrates shall be w ithin the tolerances specified.

50.7 Backpressure effect

The change in the maximum recommen ded flowrate when a backpressure of 7 kPa is applied shall be with in ± 10% of the figure stated by the manufactu rer in the technical description.

Compliance sha ll be checked by the follow ing test:

Use the test apparatus described in annex N (in this International Standard). Set the flowrate from the oxygen concentrator so that its flow indicator shows the maximurn flowrate recommended by the manufacturer in the tech nical description . Adjust the variable restrictor in the test apparatus to give a backpressure of 7 kPa. Opera te the oxygen concentrator for 15 min and record the flowrate indicated on the flowmeter of the test apparatus. Subtract this figure from the manufacturer 's recommended f lowra te to give the change in flowrate when a backpressure of 7 kPa is applied.

The change in flowrate sha ll be w ithin the tolerance specified.

50.8 Outlet pressure

The maximum outlet pressu re shal l be within ± 10% of the value stated by the manufacturer in the technical description.

Compliance sha ll be checked by the following test:

Use the test apparatus described in annex N (in this International Standard ). Operate the oxygen concentrator at the maximum flowrate recommended by the manufacturer in the technical description and adjust the variab le restrictor to stop the f low. Record the pressure indicated . The pressure indicated shall be within the tolera nce specified.

8.2 Protection against hazardous output

The requirements given in clause 51 of IEC 60H :1988 apply, except for the following modifica tions.

51 .1 Replace the existing text by the following :

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51.1 Flow control device

The oxygen concentrator shall be fitted with a flow control device.

Compliance shall be checked by inspection.

NOTE 3 The flow control device should be provided with a means to prevent adjustments by the patient.


51.2 Filter

A filter capable of retaining particles of 1 0 ~m diameter or greater shall be provided between the oxygenconcentrating elements and the oxygen concentrator outlet.


Add the following subclause.

51.5 Oxygen concentration status indicator

An oxygen concentration status indicator shall be provided to warn the operator when the oxygen concentration in the product gas is below 82 % volume fraction.

Compliance shall be checked by verifying that an oxygen concentration status indicator indicates when the oxygen concentration in the product gas is below 82 % volume fraction at temperatures between 10 °C and 40 °C. Compliance shall also be checked by simulating conditions which cause lower oxygen concentrations in the product gas than the stated value.

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BS EN ISO 8359:2009ISO 8359:1996(E) © ISO

Section 9: Abnormal operation and fault conditions; environmental tests

9.1 Abnormal operation and fault conditions

The requirements given in clause 52 of IEC 601-1 :1988 apply.

9.2 Environmental tests

See subclause 4.10 and clause 10 of IEC 601-1:1988.

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Section 10: Constructional requirements

10.1 General

The requirements given in clause 54 of IEC 601-1:1988 apply .

10.2 Enclosures and covers

The requirements given in clauses 16, 21 and 24 of IEC 601-1 :1 988 apply .

10.3 Components and general assembly

The requirements given in clause 56 of IEC 601-1 1988 apply, with the following additions and modifications.

56.8 Add the following requirements .

1) Indication of continued mechanical and electrical function or of malfunction shall be provided on the oxygen concentrator.

Compliance shall be checked by operating the oxygen concentrator and, inducing the following faults individually, where appr,cable:

al compressor failure;

b) pump fai lure;

c) cycle fa ilure;

d) pressure failure;

e) vacuum failure.

2) A nonresettable elapsed-t ime indicator show ing the total operating time, in hours, shall be provided on the oxygen concentrator.



Preset controls shall either be inside the casing or shall require the use of a tool for adjustment.


10.4 Mains parts, components and layout

The requirements given in clause 57 of IEC 601-1:1988 apply .

10.5 Protective earthing - Terminals and connections

The requirements given in clause 58 of I EC 601-1: 1988 apply.

10.6 Construction and layout

The requirements given in clause 59 of I EC 601 -1: 1988 apply.

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BS EN ISO 8359:2009ISO 8359:1996(E) 0 ISO

Section 11: Additional clauses

11 .1 Auditory indicators

Any aud itory indicator provided with the oxygen concentrator shall announce in a tone distinctly diffe rent from the sounds generated by the oxygen concentrator during normal opera tion. in order to avoid masking.

If an oxygen concentrator of the domici liary type is intended to be used in a health ca re facility. the auditory indicators shall comply with the requirements of ISO 9703-2.

11.2 Indication of loss of mains power

An audito ry alarm shall be provided to indicate when mains power has been interrupted.

Compliance shall be checked by inspection .

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Annexes

Annexes A to M given in lEe 601 -1: 1988, together w ith annexes N, P and Q in th is International Standard apply.

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BS EN ISO 8359:2009ISO 8359:1996(E) © ISO

Annex N

(normative)

Test apparatus

N.1 Apparatus

N.1.1 Flowmeter, accurate to within ± 2 % of the flow to be measured.

N.1.2 Oxygen analyser, accurate to within ± 1 % of the oxygen concentration to be measured and which gives a reading equal to at least 90 % of the actual oxygen concentration within lOs of exposure of the sensing element to the gas flow. If a pump is required to aspirate the gas sample, it shall neither reduce the pressure at the outlet of the flowmeter to below atmospheric nor draw air back through the open end of the tube.

N.1.3 Pressure indicator, accurate to within ± 2 % of the pressure to be measured.

N.1.4 Thermometer, accurate to within ± 0,5'C of the temperature to be measured.

N.2 Test assembly

Assemble the apparatus as shown in figure N.l using tubing with an internal diameter of 6 mrn ± 1 mm.

Dimensions in millimetres

Oxygen concentrator

Tubing i.d. 6 mm ±1 mm

Thermometer Pressure indicator (N.1.3) (N.1.4) (measuring outlet pressure)

250 i ---- -- 500

Oxygen concentrator outLet

VariabLe outlet flow restrictor

~ 1 m

NOTE - Ambient temperature shall be measured simultaneously_

Figure N.1 - Test apparatus

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FLowmeter IN.1.11

Oxygen product Line \

500

250 ----!

Oxygen analyser (N.l2) (aspirating or total flow)

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BS EN ISO 8359:2009© ISO

Annex P

(informative)

Rationale statement

ISO 8359:1996{E)

This annex provides a concise rationale for the important requirements of this International Standard and is intended for those who are familiar with the subject of this International Standard but who have not participated in its development. An understanding of the reasons for the main requirements is considered to be essential for the proper application of this International Standard. Furthermore, as clinical practice and technology change, it is believed that a rationale for the present requirements will facilitate any revision of this International Standard necessitated by those developments.

Remarks made in this annex apply to the relevant clause or subclause in this International Standard; the numbers, therefore, are not consecutive.

1.1 Scope

This International Standard does not apply to institutional pressure swing absorber devices (molecular sieve devices) which use the separation principle to deliver oxygen of a specified minimum concentration to a hospital or similar distribution system at a minimum pressure of 400 kPa. The performance and safety requirements for such devices vary considerably from those for the portable oxygen concentrators covered in this International Standard.

1,7 Identification. marking and documents

6,7 a) The use of the existing standardized colour system for visible indicators decreases the likelihood of patient and operator error.

- 6.8.2 a) It was recognized that the supplier cannot be required to test or approve all types of humidifiers which might be used with the oxygen concentrator. Such equipment. which requires a high pressure, might seriously degrade the performance of the oxygen concentrator.

- 6.8.2 d) The supplier is required to recommend oxygen administration accessories which are suitable for use with the oxygen concentrator because administration accessories suitable for use with medical gas pipeline or cylinder regulators may not be satisfactory.

- 6.8,3 a) These performance data provide important information concerning the functioning of oxygen concentrators. It is necessary that the user understand these data for safe and effective prescription.

4,6 Vibration and noise

It is essential that the noise level be related to patient acceptability and comfort. It is desirable to reduce the noise level as far as possible for devices which interfere with sleeping. It is recognized that oxygen concentrators (pressure swing absorbers) may have both a steady sound level and a peak sound level. The peak sound pressure level was considered to be the more likely to be obtrusive to the patient during continuous machine performance.

7.1 Temperatures outside the specified range may constitute a thermal hazard.

7.2 Fire prevention

It is important that particular care be taken to reduce the fire hazard of oxygen concentrators because they may contain gas of high oxygen concentration.

7.2.1 Reports of fire caused by medical devices are unusual. However, when such fires occur in the hospital or home environment they can have tragic consequences.

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BS EN ISO 8359:2009ISO 8359:1996(E) (> ISO

The risk of fire is fundamentally determined by the three elements w hich are necessary in order to start a fire:

- ignitable material (fuel);

- temperature equal to or above the minimum ignition temperature of the material or sparks with energy dissipation equal to or above the minimum ignition energy of the material;

an oxidant.

Therefore, following the basic safety concepts of IEC 601 -1, the objective in the design of the equipment must be to ensure that under both normal and single-fault conditions and under the oxidizing conditions to which the materia l may be exposed, the temperature of any material is not raised to its minimum ignition temperature or the spark energy does not exceed the material ignition energy level. Alternatively, contained ignition may occur provided it is self-limiting so that no hazard is created, e.g. a fuse or a resistor w ithin a sealed compartment.

Minimum ignition temperatures for a large number of specif ic materials are well established in published literatu re, although normally only for ambient air and pure oxygen environments. The minimum ignition temperature may be critica lly dependent upon the concentration of oxidant present. If ignition temperatures for other materials or oxygen concentrations are required, these may be determined using the methods and appara tus described In IEC 79-4.

In considering the ignitable materials, particular attention should be paid to materials which may accumulate during prolonged use, e.g. airborne particles of paper or cotton.

The ri sk of fire directly caused by sparking of electrical circu its is generally considered insignificant in medical equipment, as temperature rise resulting from the power dissipation caused by a spark wil l not normally reach the ignition temperature of the solid materials generally used when following good design practice.

However, if materials with a low ignition temperature and a very low thermal capacity, e.g. cotton, wool, paper or organic fibre accumulations, are present then it may not be possible to determine the surface temperatu res attained during exposure to spark energy, and specific tests, e.g. ignition tests, may be necessary to assure safety under these conditions .

In certain standards currently in use, the requirements to minimize fi re risk are based on limitation of temperature, electrical energy and oxidant concentration to absolute va lues.

The temperature value is based on the minimum hotplate ignition temperature for fire-retardant cotton in 100 % oxygen, which is given in the American NFPA publication 53M as 310 ' C. The assumption was therefore made that 300 'C was an acceptable temperature limit in medical equipment with oxygen-enriched atmospheres.

The origin of the electrical energy values which have been used is less clear and it would Seem that. in the absence of specific controlled tests, figures have been adopted from other published standards. However, simple tests and detailed analysis of the known factors involved in causing an oxygen f ire show that these figures can be either overrestrictive or potentially hazardous depending, in particular, on the manner in which the power may be dissipated and the proximity and type of any " fuel " present.

It is now generally accepted that there are no single or universally applicable ranges of temperature, energy and concentration of oxidant w hich can ensure safety under all circumstances. Ult imately, electrical energy is only significant in respect of its ability to ra ise the temperature of ignitable materials, and this in turn depends upon the particular configuration and the proximity of any ignitable materia ls.

Under single-fault conditions in a typica l electrica l circuit, the possible number of fa ilure modes is very high. In this case, full assurance of safety may only be possible by the use of appropriate hazard and safety analysis procedures, taking into consideration the three basic elements, i.e. material, temperature and oxidant.

An appropriate design might limit the electrical energy in the circuit to ensure that temperatures remain below the minimum air ignition temperature under normal conditions, and seal compartments or add forced venti lation to ensure that the oxygen content does not exceed that of ambient air under a single-fault condition.

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Alternatively, it may be appropriate to limit the electrical energy to ensure temperatures below the minimum ignition temperature for a pure oxygen environment, even under single-fault conditions.

The particular combination of material, oxidant and temperature determines whether a fire will occur, not a Single value of anyone these variables.

8.1 Accuracy of operating data

8.1.1 A medical need was expressed for these accuracies. The design of a molecular sieve oxygen concentrator is such that oxygen concentration decreases with increasing flowrate, whilst the total volume of oxygen delivered generally increases with flowrate . Oxygen administration by flowrate adjustment should be accurate and related to the device used for administration, the patient minute ventilation and the desired arterial blood oxygen concentration.

8.1.2 There is a medical need for accurate oxygen concentrations. Deviations within ± 3 % oxygen concentration were considered to be achievable by the manufacturer and were acceptable medically.

Measurement of stability of oxygen concentra tion over a long period is necessary to give a meaningful result.

8.1.3 A medical need was expressed for flowrate stability without attention on the part of the patient for this period of time. The maintenance of a stable flowrate with its resu ltant oxygen concentrator is, therefore, important to the patient.

8.2.1 Flow control device

A flow control device was considered necessary to match the output of the oxygen concentrator to variations in the needs of the patient.

It was considered that in some clinical circumstances a deterrent to operator adjustment of flowrate was important. The presence of this deterrent might remind the patient to consult the physician before making any f lowrate change.

8.2.3 Oxygen concentration status indicator (OCSI)

An OC51 was considered necessary to indicate to the operator w hen the concentra tor is delivering product gas with an oxygen concentration below 82 % volume fraction.

10.3.1.1 Function indicator

It was considered advisable that some mechanism be available to inform the operator whether or not the oxygen concentrator is performing adequately during continued operation.

10.3.1.2 Elapsed-time indicator

An elapsed-time indicator is essential for maintenance procedures.

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BS EN ISO 8359:2009ISO 8359:1996(E)

Annex Q

(informative)

Bibliography

o ISO

[1] lEe 79-4:1975, Electrical apparatus for explosive gas atmospheres - Part 4: Method of test for ignition temperature.

[2] ASTM F 1464-93, Standard specifica tion for oxygen concentrators for domiciliary use.

[3] NFPA 53:1 994, Fire hazards in oxygen-enriched atmospheres.

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BS EN ISO8359:2009

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