IEC 61010-2-040:2015
(Main)Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
IEC 61010-2-040:2015 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. It has the status of a group safety publication, as specified in IEC Guide 104. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) A new clause (4.3.2.101) has been added for non-electrical supplies and services.
b) Additional requirements for marking and documentation (Clause 5) have been added.
c) Additional requirements for protection against mechanical hazards (Clause 7) have been included.
d) Additional requirements for protection against radiation, including laser sources, and against sonic and ultrasonic pressure (Clause 12) have been included.
Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs utilisés pour traiter le matériel médical
L'IEC 61010-2-040:2015 définit les règles de sécurité pour les appareils électriques destinés à la stérilisation, au lavage et à la désinfection des matériaux médicaux dans les domaines médicaux, vétérinaires, pharmaceutiques et de laboratoire, lorsqu'ils sont utilisés dans les conditions d'environnement de 1.4. Elle a le statut d'une publication groupée de sécurité, conformément au Guide 104 de l'IEC. Cette deuxième édition annule et remplace la première édition parue en 2005. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
a) un nouvel article (4.3.2.101) a été ajouté pour les services et alimentations non électriques;
b) des exigences supplémentaires ont été ajoutées pour le marquage et la documentation (Article 5);
c) des exigences supplémentaires ont été incluses pour la protection contre les DANGERS mécaniques (Article 7);
d) des exigences supplémentaires ont été incluses pour la protection contre les radiations, y compris les sources laser, et contre la pression acoustique et ultra-sonique (Article 12).
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IEC 61010-2-040 ®
Edition 2.0 2015-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-040: Particular requirements for sterilizers and washer-disinfectors used
to treat medical materials
Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire –
Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs
utilisés pour traiter le matériel médical
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IEC 61010-2-040 ®
Edition 2.0 2015-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control, and
laboratory use –
Part 2-040: Particular requirements for sterilizers and washer-disinfectors used
to treat medical materials
Règles de sécurité pour appareils électriques de mesurage, de régulation et de
laboratoire –
Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs
utilisés pour traiter le matériel médical
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 19.080; 71.040.10 ISBN 978-2-8322-2776-3
– 2 – IEC 61010-2-040:2015 © IEC 2015
CONTENTS
FOREWORD . 3
1 Scope and object . 5
2 Normative references . 6
3 Terms and definitions . 6
4 Tests . 7
5 Marking and documentation . 9
6 Protection against electric shock . 14
7 Protection against mechanical HAZARDS and against HAZARDS related to
mechanical functions . 14
8 Mechanical resistance to shock and impact . 19
9 Protection against the spread of fire . 19
10 Equipment temperature limits and resistance to heat . 19
11 Protection against HAZARDS from fluids . 20
12 Protection against radiation, including laser sources, and against sonic and
ultrasonic pressure . 23
13 Protection against liberated gases, substances, explosion and implosion . 25
14 Components . 31
15 Protection by interlocks . 32
16 HAZARDS resulting from application . 32
17 RISK assessment . 32
Annexes . 33
Annex G (informative) Leakage and rupture from fluids under pressure . 33
Annex L (informative) Index of defined terms . 34
Bibliography . 35
Table 101 – Lamp or lamp systems considered photobiologically safe . 24
Table 102 – Lamp or lamp systems considered photobiologically safe under certain
conditions . 24
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL, AND LABORATORY USE –
Part 2-040: Particular requirements for sterilizers and
washer-disinfectors used to treat medical materials
FOREWORD
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International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66:
Safety of measuring, control and laboratory equipment.
It has the status of a group safety publication, as specified in IEC Guide 104.
This second edition cancels and replaces the first edition published in 2005. This edition
constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous
edition:
a) A new clause (4.3.2.101) has been added for non-electrical supplies and services.
b) Additional requirements for marking and documentation (Clause 5) have been added.
– 4 – IEC 61010-2-040:2015 © IEC 2015
c) Additional req
...
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