IEC 60601-2-12:2001

INTERNATIONAL IEC
STANDARD
60601-2-12
[ISO 10651-1]
Second edition
2001-10
Medical electrical equipment –
Part 2-12:
Particular requirements for the safety of lung
ventilators – Critical care ventilators
Appareils électromédicaux –
Partie 2-12:
Règles particulières de sécurité pour ventilateurs
pulmonaires – Ventilateurs pour utilisation en soins intensifs
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INTERNATIONAL IEC
STANDARD
60601-2-12
[ISO 10651-1]
Second edition
2001-10
Medical electrical equipment –
Part 2-12:
Particular requirements for the safety of lung
ventilators – Critical care ventilators
Appareils électromédicaux –
Partie 2-12:
Règles particulières de sécurité pour ventilateurs
pulmonaires – Ventilateurs pour utilisation en soins intensifs
 IEC 2001  Copyright - all rights reserved
No part of this publication 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 Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http://www.iec.ch
PRICE CODE
X
For price, see current catalogue

– 2 – 60601-2-12 © IEC:2001(E)
CONTENTS
FOREWORD.4
INTRODUCTION.6
SECTION ONE – GENERAL
1 Scope and object .7
2 Terminology and definitions .8
3 General requirements .12
4 General requirements for tests.12
5 Classification .12
6 Identification, marking and documents .12
7 Power input .16
SECTION TWO – ENVIRONMENTAL CONDITIONS
8 Basic safety categories .16
9 Removable protective means .16
10 Environmental conditions .16
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General .17
14 Requirements related to classification .17
15 Limitation of voltage and/or energy.17
16 ENCLOSURES and PROTECTIVE COVERS.17
17 Separation.18
18 Protective earthing, functional earthing and potential equalization.18
19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS.18
20 Dielectric strength.18
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength.18
22 Moving parts.18
23 Surfaces, corners and edges .18
24 Stability in NORMAL USE.18
25 Expelled parts.18
26 Vibration and noise .18
27 Pneumatic and hydraulic power.19
28 Suspended masses .19
SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
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 Ultra-violet radiation.19

60601-2-12 © IEC:2001(E) – 3 –
35 Acoustical energy (including ultrasonics) .19
36 Electromagnetic compatibility.19
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and basic requirements .20
38 Marking, ACCOMPANYING DOCUMENTS .20
39 Common requirements for CATEGORY AP and CATEGORY APG EQUIPMENT .20
40 Requirements and tests for CATEGORY AP EQUIPMENT, parts and components thereof.20
41 Requirements and tests for CATEGORY APG EQUIPMENT, parts and components thereof .20
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures.20
43 * Fire prevention .20
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility .21
45 Pressure vessels and parts subject to pressure.21
46 Human errors .22
47 Electrostatic charges .22
48 Biocompatibility.22
49 Interruption of the power supply .22
SECTION EIGHT – ACCURACY OF OPERATING DATA
AND PROTECTION AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.23
51 Protection against hazardous output .24
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions.26
53 Environmental tests .26
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General .27
55 ENCLOSURES and covers .27
56 Components and general assembly.27
57 MAINS PARTS, components and layout.29
58 Protective earthing – Terminals and connections.30
59 Construction and layout .30
Appendix L References – Publications mentioned in this standard .31
Annex AA (informative) Rationale .34
Annex BB (normative) Legibility and visibility of visual indications .39
Annex CC (informative) Intelligent alarm systems .40
Bibliography .41
Terminology – Index of defined terms.42

– 4 – 60601-2-12 © IEC:2001(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-12: Particular requirements for the safety of lung ventilators –
Critical care ventilators
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization, comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international cooperation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization
for Standardization (ISO) in accordance with conditions determined by agreement between the two
organizations.
2) The formal decisions or agreements of the IEC on technical matters, express as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides, and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national standard shall be clearly indicated in the
latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. IEC shall not be held responsible for identifying any such patent rights.
International Standard IEC 60601-2-12 has been prepared by subcommittee 62D: Electro-
medical equipment, of IEC technical committee 62: Electrical equipment in medical practice.
ISO TC 121/SC 3, Lung ventilators and related equipment, also participated in the preparation
of this standard.
This second edition replaces the first edition of IEC 60601-2-12:1988, Medical electrical
equipment – Part 2: Particular requirements for the safety of lung ventilators for medical use,
and ISO 10651-1:1993, Lung ventilators for
...