SIST EN ISO 11197:2005
(Main)Medical supply units (ISO 11197:2004)
Medical supply units (ISO 11197:2004)
2004-07-29 (LUP): The draft is recorded for submission to FV on 2004-06-17. FV closes on 2048-08-17. Hence the corresponding WI number has to be removed from the list proposed for deletion under BT 32/2004. For details please contact responsible Programme Manager. Ludwig Paul: +3225500831 or email ludwig.paul@cenorm.be
TC215 sent the text on 9 May 2003 to CMC for parallel FV issue and it was approved by the CEN consultant on 13 June 2003. CMC who informed TC 215 that he the document had to be with ISO/CS and he would prompt ISO for action on 1 March 2004
The ISO SC has been contacte and is looking to the reason why no formal reply was given to the CMC production departement. By the mean time the CMC production confirm that they still have the draft and reinitiated the request to ISO for processing the vote (see list of questions given to STDDEV sector management for resolutions in coordination meeting with CMC production). (LP 2004-05-18)
Medizinische Versorgungseinheiten (ISO 11197:2004)
Abschnitt 1 der EN 60601-1:1990 gilt mit folgenden Abweichungen:
Diese Norm gilt für medizinische Versorgungseinheit nach 3.5.
Diese Besonderen Festlegungen gelten zusammen mit denen der EN 60601-1.
Die Anforderungen dieser Besonderen Norm haben Vorrang vor denen der EN 60601-1.
Gaines techniques a usage médical (ISO 11197:2004)
L'article 1 de l'EN 60601-1:1990 s'applique en ajoutant les éléments suivants :
Le présent document s'applique aux gaines techniques a usage médical définies au paragraphe 3.5.
Le présent document s'applique conjointement a la norme EN 60601-1.
Les exigences du présent document prévalent sur celles de la norme EN 60601-1.
Enote za oskrbo v medicini (ISO 11197:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11197:2005
01-marec-2005
Enote za oskrbo v medicini (ISO 11197:2004)
Medical supply units (ISO 11197:2004)
Medizinische Versorgungseinheiten (ISO 11197:2004)
Gaines techniques a usage médical (ISO 11197:2004)
Ta slovenski standard je istoveten z: EN ISO 11197:2004
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 11197:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11197:2005
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SIST EN ISO 11197:2005
EUROPEAN STANDARD
EN ISO 11197
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2004
ICS 11.040.01 Supersedes EN 793:1997
English version
Medical supply units (ISO 11197:2004)
Gaines techniques à usage médical (ISO 11197:2004) Medizinische Versorgungseinheiten (ISO 11197:2004)
This European Standard was approved by CEN on 23 September 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 Central Secretariat 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 Central Secretariat 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 11197:2004: E
worldwide for CEN national Members.
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SIST EN ISO 11197:2005
EN ISO 11197:2004 (E)
Contents
page
Foreword.5
Introduction .6
SECTION ONE - GENERAL .7
1 Scope .7
2 Normative references .7
3 Terms and definitions .8
4 General requirements and requirements for tests.8
5 Classification.9
6 Identification, marking and documents.9
7 Power input .13
SECTION TWO - ENVIRONMENTAL CONDITIONS .14
8 Basic safety categories.14
9 Removable protection means.14
10 Environmental conditions.14
11 Not Used .14
12 Not Used .14
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS.15
13 General.15
14 Requirements related to classification.15
15 Limitation of voltage and/or energy.15
16 Enclosures and protective covers .15
17 Separation .15
18 Protective earthing, functional earthing and potential equalization .15
19 Continuous leakage current and patient auxiliary currents.15
20 Dielectric strength .16
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS .17
21 Mechanical strength .17
22 Moving parts.17
23 Surfaces, corners and edges.17
24 Stability in normal use .17
25 Expelled parts .18
26 Vibration and noise.18
27 Pneumatic and hydraulic power.18
28 Suspended masses .18
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EN ISO 11197:2004 (E)
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION.19
29 X-Radiation.19
30 Alpha, beta, gamma, neutron radiation and other particle radiation .19
31 Microwave radiation .19
32 Light radiation (including lasers).19
33 Infra-red radiation .19
34 Ultraviolet radiation.19
35 Acoustical energy (including ultrasonics).19
36 Electromagnetic compatibility .19
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC
MIXTURES .21
37 Locations and basic requirements .21
38 Marking and accompanying documents.21
39 Common requirements for Category AP and Category APG Equipment.21
40 Requirements and tests for Category AP Equipment, parts and components thereof .21
41 Requirements and tests for Category APG Equipment, parts and components thereof.21
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY
HAZARDS .22
42 Excessive temperatures.22
43 R Fire prevention .22
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection.22
45 Pressure vessels and parts subject to pressure.22
46 Human errors .23
47 Electrostatic charges .23
48 Material in applied parts in contact with the body of the patient .23
49 Interruption of the power supply .23
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS
OUTPUT .24
50 Accuracy of operating data .24
51 Protection against hazardous output.24
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS.25
52 Abnormal operation and fault conditions .25
53 Environmental tests .25
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS .25
54 General.25
55 Enclosures and covers .25
56 Components and general assembly.25
57 Mains parts, components and layout .25
58 Protective earthing - terminals and connections .26
59 Construction and layout .27
Annexes.39
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EN ISO 11197:2004 (E)
Annex A A (normative) Special National Conditions .40
Annex B B (informative) Rationale.41
Annex ZA (Informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives.43
Annex ZB (Informative) Normative references to international publications with their relevant
European publications .45
Bibliography .46
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SIST EN ISO 11197:2005
EN ISO 11197:2004 (E)
Foreword
This document (EN ISO 11197:2004) has been prepared by CEN /TC 215, "Respiratory and anaesthetic
equipment", the secretariat of which is held by BSI, in collaboration with ISO/TC121/SC6 "Medical gas
systems".
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 June 2005, and conflicting national standards shall be withdrawn at
the latest by June 2005.
This document supersedes EN 793: 1997.
This European Standard 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 special national conditions for Clauses 6.1 k), 6.1 bb), 6.2 aa) and 57.1, see Annex AA.
For relationship with EU Directives, see informative Annex ZA, which is an integral part of this standard.
For a list of International Standards identical to the European Standards referred to in this European Standard,
see informative Annex ZB.
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.
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SIST EN ISO 11197:2005
EN ISO 11197:2004 (E)
Introduction
This particular standard applies in conjunction with EN 60601-1 "Medical electrical equipment — Part 1:
General requirements for safety".
As stated in EN 60601-1 the requirements of this Particular Standard take priority over those of EN 60601-1.
As in EN 60601-1 the requirements are followed by the relevant tests. The structure of this particular standard
corresponds to that of EN 60601-1 and the sections, clauses and sub-clauses refer to those of EN 60601-1.
Clauses, subclauses, Tables and Figures additional to those in EN 60601-1 are numbered beginning at "101".
Additional annexes are lettered beginning at "AA" except for annexes "ZA" and "ZB".
Additional items in lettered lists are lettered beginning "aa)".
Annex BB contains rationale statements for some of the requirements of EN ISO 11197. It is included to
provide additional insight into the reasoning that led to the requirements and recommendations that have been
incorporated into EN ISO 11197. The clauses and subclauses marked with R after their number have
corresponding rationale contained in Annex BB. It is considered that knowledge of the reasons for the
requirements will not only facilitate the proper application of this standard, but will expedite any subsequent
revision.
In any health care facility it is strongly recommended that terminal units of only one type (i.e. with the same set
of specific dimensions) are used for each medical gas system, anaesthetic gas scavenging system and liquid
system.
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SIST EN ISO 11197:2005
EN ISO 11197:2004 (E)
SECTION ONE - GENERAL
1 Scope
Clause 1 of EN 60601-1:1990 applies with the following addition:
This document applies to medical supply units as defined in 3.5.
This particular document applies in conjunction with EN 60601-1.
The requirements of this particular document take priority over those of EN 60601-1.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
EN 737-1, Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum.
EN 737-2, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems – Basic
requirements.
EN 737-3, Medical gas pipeline systems — Part 3: Pipelines for compressed medical gases and vacuum.
EN 737-4, Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems.
EN 739:1998, Low-pressure hose assemblies for use with medical gases.
EN ISO 3744, Acoustics — Determination of sound power levels of noise sources using sound pressure -
Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994).
EN ISO 14971, Medical devices - Application of risk management to medical devices (ISO 14971:2000).
IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature.
EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989).
EN 60598-1, Luminaires — Part 1: General requirements and tests (IEC 60598-1:1999, modified).
EN 60601-1:1990, Medical electrical equipment — Part 1: General requirements for safety (IEC 60601-
1:1988).
EN 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard:
Electromagnetic compatibility; Requirements and tests (IEC 60601-1-2:2001).
EN 60669-1, Switches for household and similar fixed electrical installations — Part 1: General requirements
(IEC 60669-1:1998, modified).
EN 61386-1, Conduit systems for electrical installations – Part 1: General requirements (IEC 61386-
1:1996+A1:2000).
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 60601-1:1990 and the following
apply.
3.1
compartment
part of an enclosure with openings necessary for interconnection, control or ventilation
3.2
enclosure
surrounding case constructed to provide a degree of protection to personnel against accidental contact with
live parts and also the equipment enclosed against specified environmental conditions (IEC 61950:1997)
NOTE An enclosure can be subdivided into compartments.
3.3
junction point
connection point(s) between the medical supply unit and the system(s) already installed
3.4
medical gas
any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic
purposes, or for driving surgical tools
NOTE In some applications this term includes medical vacuum.
3.5
medical supply unit
fixed equipment intended to supply electric power and/or medical gases and/or liquids and anaesthetic gas
scavenging systems to medical areas of a health-care facility
NOTE Medical supply units can include medical electrical equipment or medical electrical systems or parts thereof.
Medical supply units can also consist of modular sections for electrical supply, lighting for therapy or illumination,
communication, supply of medical gases and liquids, anaesthetic gas scavenging systems. Some typical
examples of medical supply units are bed head services modules, ceiling pendants, beams, booms, columns
and pillars. Examples of configurations are given in Figures 101, 102 and 103.
4 General requirements and requirements for tests
4.1 Modifications to clause 3 of EN 60601-1:1990
Clause 3 of EN 60601-1:1990 applies with the following addition:
3.6 Add the following items:
3.6 aa) R An oxidant leak which is not detected by e.g. an alarm or periodic inspection shall be considered a
normal condition and not a single fault condition.
3.6 bb) Medical supply units shall, when transported, stored, installed, operated in normal use and maintained
according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk
analysis procedures in accordance with EN ISO 14971 and which is connected with its intended application, in
normal condition and in single fault condition.
3.101 Equipment and components incorporated into the medical supply unit shall comply with the relevant
standard(s) for such equipment or components.
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EN ISO 11197:2004 (E)
4.2 Clause 4 of EN 60601-1:1990
Clause 4 of EN 60601-1:1990 applies.
5 Classification
Clause 5 of EN 60601-1:1990 applies.
6 Identification, marking and documents
Clause 6 of EN 60601-1:1990 applies with the following amendments:
6.1 Marking on the outside of equipment or equipment parts
a) Mains-operated equipment
Replace with the following:
Mains-operated equipment, including separable components thereof which have a mains part, shall be
provided with permanent and legible marking on the outside of the major part of the equipment indicating the
origin and model or type reference.
g) Connection to the supply
Replace with the following:
Due to the possible complexity of external marking, diagrams indicating all electrical and electronic
connections to the medical supply unit shall be located at the junction point inside the equipment.
For electrical connections the diagram shall indicate voltages, number of phases and number of circuits. For
electronic connections, the diagram shall indicate connector numbers and wire identification.
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EN ISO 11197:2004 (E)
k) Mains power output
Replace with the following:
Mains socket-outlets for special purposes (e.g. for x-ray equipment) shall be marked with: type of mains, rated
voltage, rated current and with a label (e.g."x-ray").
See Annex AA for Special National Conditions
NOTE 1 Mains socket-outlets for special purpose areas which are fused in a single circuit can be marked with identical
numbers.
Add the following:
When a medical supply unit is provided with socket-outlets for connection to an essential electrical supply
circuit [e.g. uninterruptable power supply (UPS)], these socket-outlets shall comply with the national
installation rules or be individually identified if not covered by those rules.
See Annex AA for Special National Conditions.
NOTE 2 If socket-outlets in the same location are supplied from different power sources, each source should be readily
identifiable.
l) Classification
Replace dash three with the following:
Medical supply units shall be designed and constructed as CLASS I, Type B equipment according to degree
of protection against electric shock. Built-in units of Type BF or CF and outlets forming part of them, contained
in medical supply units, shall be clearly marked with the relevant symbols according to appendix D, Table D II
of EN 60601-1:1990.
NOTE The term “Type B (BF, CF) equipment (unit)” used in this standard is equivalent to the term “Type B (BF, CF)
applied part” used in EN 60601-1.
y) Earth terminals
Add the following:
Facilities for the connection of supplementary equipotential earth bonding (if provided) shall be marked with
symbol 9 of appendix D, Table D I of EN 60601-1:1990.
NOTE The term "equipotential earth bonding" used in this standard is equivalent to the term "potential equalisation
conductor" used in EN 60601-1.
Add the following:
aa) Particular applications
If the medical supply unit is intended to be used in conjunction with patient monitors for electromyograph
and/or electroencephalograph and/or electrocardiograph, the medical supply unit shall be marked with the
particular application as follows:
for electromyograph EMG
for electroencephalograph EEG
for electrocardiograph ECG or EKG
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bb) Terminal units
Terminal units for medical gases and vacuum shall be marked in accordance with EN 737-1 or national
regulations. Colour coding, if used, shall be in accordance with EN 737-1 or national regulations.
See Annex AA for Special National Conditions.
Terminal units for anaesthetic gas scavenging systems shall be marked in accordance with EN 737-4 or
national regulations. Colour coding, if used, shall be in accordance with EN 737-4 or national regulations.
Terminal units for liquids shall be marked with the name of the liquid in accordance with Table 101 or the
equivalent national language.
Table 101 — Marking for liquids
Name of liquid
Potable water, cold
Potable water, warm
Cooling water
Cooling water, feed-back
De-mineralized water
Distilled water
Dialysing concentrate
Dialysing permeate
6.2 Marking on the inside of equipment and equipment parts
Add the following:
aa) Junction points and pipelines for medical gases shall be marked in accordance with EN 737-3 or national
regulations. Colour coding, if used, shall be in accordance with EN 737-3 or national regulations.
See Annex AA for Special National Conditions.
bb) Junction points and pipelines for anaesthetic gas scavenging systems shall be marked in accordance with
EN 737-2 or national regulations. Colour coding, if used, shall be in accordance with EN 737-2 or national
regulations.
cc) Junction points and pipelines for liquids shall be marked with the name of the liquid in accordance with
Table 101 or the equivalent in national language.
dd) The neutral connection point within the medical supply unit shall be clearly identified using the letter N
and/or colour coded blue (See appendix D, Table D I, symbol 8 of EN 60601-1:1990, IEC 60364-5-51 and IEC
60446).
6.8 Accompanying documents
Clause 6.8 of EN 60601-1:1990 applies with the following amendments:
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EN ISO 11197:2004 (E)
6.8.2 Instructions for use
a) General information
Add the following:
Instructions for use shall state which parts of the equipment are capable of bearing additional loads. The
maximum safe working load shall be stated.
If flexible hoses and hose assemblies are used for supplying medical gases, anaesthetic gas scavenging
or liquids in an operator-adjustable system (e.g. a ceiling pendant), the instructions for use shall include a
procedure for, and the recommended frequency of, inspection and replacement.
If flexible hoses are used for supplying medical gases in an operator-adjustable system (e.g. a ceiling
pendant), the instructions for use shall state that the following tests given in EN 737-3 shall be carried out
following modification or replacement of the flexible hose:
• test for leakage;
• test for obstruction;
• test for particulate contamination;
• test of gas identity.
If flexible hoses are used for supplying anaesthetic gas scavenging in an operator-adjustable system (e.g.
a ceiling pendant), the instructions for use shall state that the following tests given in EN 737-2 shall be
carried out following modification or replacement of the flexible hose:
• test for leakage;
• test of flow and pressure drop.
If flexible hoses are used for supplying liquids in an operator-adjustable system (e.g. a ceiling pendant),
the instructions for use shall state that the following test, given in clause 59.103.2 b), shall be carried out
following modification or replacement of the flexible hose:
• test for leakage
b) Responsibility of the manufacturer
Replace with the following:
The manufacturer shall provide evidence that the following production tests have been performed for each
medical supply unit and that the specified requirements are met:
i) Impedance of protective earthing in accordance with 18 f) of EN 60601-1:1990;
ii) Earth leakage current in accordance with 19.3 and 19.4 of EN 60601-1:1990;
iii) Dielectric strength in accordance with 20.3 and 20.4 of EN 60601-1:1990;
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