SIST EN ISO 8185:2009

SLOVENSKI STANDARD
SIST EN ISO 8185:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 8185:2008
Vlažilniki dihalnega trakta za uporabo v medicini - Posebne zahteve za dihalne
vlažilne sisteme (ISO 8185:2007)
Respiratory tract humidifiers for medical use - Particular requirements for respiratory
humidification systems (ISO 8185:2007)
Anfeuchter für Respirationsluft für medizinische Zwecke - Besondere Anforderungen an
Anfeuchtersysteme für Respirationsluft (ISO 8185:2007)
Humidificateurs respiratoires médicaux - Exigences spécifiques des systèmes
d'humidification respiratoires (ISO 8185:2007)
Ta slovenski standard je istoveten z: EN ISO 8185:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8185:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8185:2009

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SIST EN ISO 8185:2009
EUROPEAN STANDARD
EN ISO 8185
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 8185:2007
English Version
Respiratory tract humidifiers for medical use - Particular
requirements for respiratory humidification systems (ISO
8185:2007)
Humidificateurs respiratoires médicaux - Exigences Anfeuchter für Respirationsluft für medizinische Zwecke -
spécifiques des systèmes d'humidification respiratoires Besondere Anforderungen an Anfeuchtersysteme für
(ISO 8185:2007) Respirationsluft (ISO 8185:2007)
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 European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8185:2009: E
worldwide for CEN national Members.

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SIST EN ISO 8185:2009
EN ISO 8185:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 8185:2009
EN ISO 8185:2009 (E)
Foreword
The text of ISO 8185:2007 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 8185:2009 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 8185:2007.
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 8185:2007 has been approved by CEN as a EN ISO 8185:2009 without any modification.
3

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SIST EN ISO 8185:2009
EN ISO 8185:2009 (E)
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) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
All 1 (first paragraph), 2, 3
4 [3.6 cc)] 12.1
6 13.1, 13.2, 13.3 And via IEC 60601-1, Clause 6
6.1 aa) 13.1
6.1 d) 13.1, 13.2, 13.3 b)
6.1 e) 13.1, 13.3 a)
6.1 f) 13.1, 13.3 b)
6.3 10.1, 10.3, 12.9 And via IEC 60601-1, Subclause 6.3
6.4, 6.5 13.2
6.6 9.1 And via IEC 60601-1, Subclause 6.6
6.7 12.9 And via IEC 60601-1, Subclause 6.7
6.8.2 13.1
6.8.2 a)
2, 13.3 k), 13.3 m), 13.4, 13.5, 13.6
a),13.6 b), 13.6 c), 13.6 d), 13.6 i),
13.6 j),13.6 o)
6.8.2 d) 13.6 h)
10.1 5 And via IEC 60601-1, Subclause
10.1
4

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SIST EN ISO 8185:2009
EN ISO 8185:2009 (E)

Clause(s)/sub-clause(s) of Essential requirements (ERs) of Qualifying remarks/Notes
this International Standard EU Directive 93/42/EEC
10.2 4
10.2.101 12.7.4
15 12.6 Via IEC 60601-1, Clause 15
16 12.6 Via IEC 60601-1, Clause 16
17 12.6 Via IEC 60601-1, Clause 17
18 12.6 Via IEC 60601-1, Clause 18
19 12.6 Via IEC 60601-1, Clause 19
20 12.6 Via IEC 60601-1, Clause 20
21 4, 5, 9.2, 12.7.1 And via IEC 60601-1, Clause 21
22 12.7.1 Via 60601-1, Clause 22
23 4, 9.2, 12.7.1 Via IEC 60601-1, Clause 23
24 4, 12.7.1 And via IEC 60601-1, Clause 24
25 12.7.1 Via IEC 60601-1, Clause 25
26 12.7.2 Via IEC 60601-1, Clause 26
28 12.7.1 Via IEC 60601-1, Clause 28
29 11.3.1 Via IEC 60601-1, Clause 29
35 12.7.3 And via IEC 60601-1, Clause 35
35.101 4, 12.7.3
36 4, 9.2, 12.5 And via IEC 60601-1, Clause 36
36.202.1 9.2
37, 38, 39, 40, 41 9.3
42 12.7.5
42.101 4, 12.7.5, 12.8.1
43 7.1, 9.3 And via IEC 60601-1, Clause 43
43.101 7.1, 7.3
44 7.2, 7.5, 7.6
44.2 7.2, 7.5
44.3 7.6
44.4 7.5
44.6 7.6
44.7 8.1, 8.4, 8.5 Via IEC 60601-1, Subclause 44.7
5

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SIST EN ISO 8185:2009
EN ISO 8185:2009 (E)

Clause(s)/sub-clause(s) of Essential requirements (ERs) of Qualifying remarks/Notes
this International Standard EU Directive 93/42/EEC
44.8 7.1, 7.2, 7.3
45 9.2 Via IEC 60601-1, Clause 45
46 10.2 Via IEC 60601-1, Clause 46
48 7.1 Via IEC 60601-1, Clause 48
49 4, 9.2 And via IEC 60601-1, Clause 49
50 10.1, 12.8.1
50.1 12.9
50.2 10.1, 10.2
50.2 aa) 2, 12.8.1
50.2 bb) 2, 12.8.1
50.2 cc) 2, 12.8.2
51 12.8.1 Via IEC 60601-1, Clause 51
51 4
51.101, 51.102, 51.103 2, 12.8.1
52 7.2, 7.6, 9.2, 9.3, 12.7.1 Via IEC 60601-1, Clause 52
56 9.1, 12.6, 12.7.5 And via IEC 60601-1, Clause 56
56.3 9.1, 12.7.5
56.7 9.3 Via IEC 60601-1, Subclause 56.7
56.101 7.2, 7.3, 9.1, 12.8.1, 12.8.2, 13.5
56.102 7.5, 9.1, 13.5
57 12.6, 12.7.4 Via IEC 60601-1, Clause 57
58 12.6 Via IEC 60601-1, Clause 58
59 9.3, 12.6 Via IEC 60601-1, Clause 59
101 3, 4
102 3, 10.2
103 2, 9.1, 12.7.3, 12.9, 13.1, 13.2, Via IEC 60601-1, Clause 6 and via
13.6 d) IEC60601-8
201 2 Via IEC 60601-8
nd
- 1 (first paragraph and 2 This relevant Essential Requirement is
st
paragraph, 1 dash) not addressed in this European
Standard
nd
- 1 (first paragraph and 2 This relevant Essential Requirement is
nd
paragraph, 2 dash) not addressed in this European
Standard
- 6a This relevant Essential Requirement is
not addressed in this European
Standard
6

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SIST EN ISO 8185:2009
EN ISO 8185:2009 (E)
st
48 7.5 (1 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
nd
6.1 7.5 (2 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
rd
6.8.2 7.5 (3 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
- 12.1a) This relevant Essential Requirement is
not addressed in this European
Standard.
6.1 13.3 (a): This relevant Essential Requirement is
not fully addressed in this European
Standard
6.1 13.3 (f) This relevant Essential Requirement is
not fully addressed in this European
Standard
nd
6.8.2 13.6 (h)(2 paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
6.8.2 13.6 (h)(3rd paragraph) This relevant Essential Requirement is
not fully addressed in this European
Standard
6.8.2 13.6 (q) This relevant Essential Requirement is
not addressed in this European
Standard

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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SIST EN ISO 8185:2009
EN ISO 8185:2009 (E)
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 Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
2006/42/EC
- 1.1.4 Lighting This relevant EHSR is not
addressed in this European
Standard
50, 51 1.2.2 Control devices This relevant EHSR is not fully
addressed in this European
Standard

6, 56 1.5.4 Errors of fitting This relevant EHSR is not fully
addressed in this European
Standard

- 1.6.1 Machinery maintenance This relevant EHSR is not
addressed in this European
Standard
- 1.6.2 Access to operating positions This relevant EHSR is not
and servicing points addressed in this European
Standard

- 1.6.3 Isolation of energy sources This relevant EHSR is not
addressed in this European
Standard


- 3.6.2 Marking This relevant EHSR is not
addressed in this European
Standard



8

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SIST EN ISO 8185:2009

INTERNATIONAL ISO
STANDARD 8185
Third edition
2007-07-01


Respiratory tract humidifiers for medical
use — Particular requirements for
respiratory humidification systems
Humidificateurs respiratoires médicaux — Exigences spécifiques des
systèmes d'humidification respiratoires




Reference number
ISO 8185:2007(E)
©
ISO 2007

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SIST EN ISO 8185:2009
ISO 8185:2007(E)
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ii © ISO 2007 – All rights reserved

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SIST EN ISO 8185:2009
ISO 8185:2007(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references. 2
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 4
5 Classification. 4
6 Identification, marking and documents. 5
7 Power input. 7
8 Basic safety categories. 7
9 Removable protective means . 7
10 Environmental conditions. 7
11 Not used. 8
12 Not used. 8
13 General. 8
14 Requirements related to classification. 8
15 Limitation of voltage and/or energy. 8
16 Enclosures and protective covers . 8
17 Separation. 8
18 Protective earthing, functional earthing and potential equalization . 8
19 Continuous leakage currents and patient auxiliary currents. 8
20 Dielectric strength. 9
21 Mechanical strength. 9
22 Moving parts. 9
23 Surface, corners and edges. 9
24 Stability in normal use. 9
25 Expelled parts. 9
26 Vibration and noise. 9
27 Pneumatic and hydraulic power. 9
28 Suspended masses. 9
29 X-Radiation. 10
30 Alpha, beta, gamma, neutron radiation and other particle radiation . 10
31 Microwave radiation. 10
32 Light radiation (including lasers) . 10
33 Infra-red radiation . 10
34 Ultraviolet energy. 10
35 Acoustical energy (including ultrasonics) . 10
© ISO 2007 – All rights reserved iii

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SIST EN ISO 8185:2009
ISO 8185:2007(E)
36 Electromagnetic compatibility. 11
37 Locations and basic requirements. 11
38 Marking, accompanying documents. 11
39 Common requirements for category AP and category APG equipment . 11
40 Requirements and tests for category AP equipment, parts and components thereof. 11
41 Requirements and tests for category APG equipment, parts and components thereof . 11
42 Excessive temperatures. 11
43 * Fire prevention. 12
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection . 12
45 Pressure vessels and parts subject to pressure . 13
46 Human error. 13
47 Electrostatic charges. 13
48 Biocompatibility . 13
49 Interruption of power supply . 13
50 Accuracy of operating data. 14
51 * Protection against hazardous output . 14
52 Abnormal operation and fault conditions. 15
53 Environmental tests. 16
54 General. 16
55 Enclosure and covers. 16
56 Components and general assembly . 16
57 Mains parts, components and layout. 17
58 Protective earthing — Terminals and connections . 17
59 Construction and layout. 18
101 * Humidification system output . 18
102 Liquid container . 18
103 Alarm systems. 18
Annex AA (informative) Rationale. 20
Annex BB (normative) * Determination of the accuracy of the displayed temperature. 27
Annex CC (informative) Specific enthalpy calculations . 29
Annex DD (normative) Temperature sensors and mating ports. 35
Annex EE (normative) * Determination of humidification system output . 36
Annex FF (normative) * Standard temperature sensor. 39
Annex GG (informative) Environmental aspects. 41
Annex HH (informative) Reference to the essential principals of safety and performance. 44
Annex II (informative) Terminology — Index of defined terms . 46
Bibliography . 48

iv © ISO 2007 – All rights reserved

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SIST EN ISO 8185:2009
ISO 8185:2007(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 8185 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment.
This third edition cancels and replaces the second edition (ISO 8185:1997), which has been technically
revised. It also incorporates the Technical Corrigendum, ISO 8185:1997/Cor. 1:2001.

© ISO 2007 – All rights reserved v

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SIST EN ISO 8185:2009
ISO 8185:2007(E)
Introduction
This International Standard is a Particular Standard based on IEC 60601-1:1988, including Amendments 1
(1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic
standard for the safety of all medical electrical equipment used by, or under the supervision of, qualified
personnel in the general medical and patient environment; it also contains certain requirements for reliable
operation to ensure safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable
equipment, such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc.
The Particular Standards apply to specific equipment types, such as medical electron accelerators, high
frequency surgical equipment, hospital beds, etc.
NOTE Definitions of Collateral Standard and Particular Standard are found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this International Standard, the following drafting conventions have been applied.
This International Standard uses the same main Clause titles and numbering as the General Standard, to
facilitate cross-referencing of the requirements. The changes to the text of the General Standard are specified
by the use of the following words.
⎯ “Replacement” means that the indicated Clause or Subclause of the General Standard is replaced
completely by the text of this International Standard.
⎯ “Addition” means that the relevant text of this International Standard is supplementary to the requirements
of the General Standard.
⎯ “Amendment” means that existing text of the General Standard is modified as indicated by the text of this
International Standard.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this International Standard: subclauses, tables and figures are numbered
starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered AA, BB,
etc.
In this International Standard, the following print types are used:
⎯ requirements, compliance with which can be verified, and definitions: roman type;
⎯ notes and examples: smaller roman type;
⎯ description of type of document change and test methods: italic type;
⎯ terms defined in the General Standard IEC 60601-1:1988, Clause 2 or in this I
...