EN ISO 11197:2004
(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 à 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 à usage médical définies au paragraphe 3.5.
Le présent document s'applique conjointement à 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)
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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
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
...
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