EN 60601-1-12:2015

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.

Medizinische elektrische Geräte - Teil 1-12: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme in der Umgebung für den Notfalleinsatz

Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

L'IEC 60601-1-12:2014 constitue une norme collatérale de l'IEC 60601-1: Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles désignée ci-après par norme générale. La pratique médicale utilise de plus en plus des appareils électromédicaux et des systèmes électromédicaux pour la surveillance, le traitement ou le diagnostic des patients dans l'environnement des services médicaux d'urgence. La sécurité des appareils électromédicaux dans cet environnement particulièrement difficile et non contrôlé, est source de préoccupation. La présente norme collatérale a été élaborée grâce aux contributions de médecins cliniciens, d'ingénieurs et d'autorités de tutelle. La terminologie, les exigences, les recommandations générales et les lignes directrices contenues dans la présente norme collatérale ont pour objectif d'être utiles aux fabricants d'appareils électromédicaux et de systèmes électromédicaux et aux comités techniques responsables de l'élaboration des normes particulières. La présente Norme internationale s'applique à la sécurité de base et aux performances essentielles des appareils électromédicaux et des systèmes électromédicaux, désignés ci-après par appareils EM et systèmes EM, destinés, comme indiqué dans les instructions d'utilisation, par leur fabricant à être utilisés dans l'environnement SMU (environnement des Services Médicaux d'Urgence). L'objet de la présente norme collatérale est de fournir des exigences générales pour les appareils EM et les systèmes EM acheminés et utilisés sur les lieux d'une intervention en urgence, ainsi que pour leur transport, dans des situations où les conditions ambiantes sont différentes des conditions intérieures. La présente norme collatérale est destinée à spécifier des exigences générales qui viennent s'ajouter à celles de la norme générale et à servir de base pour les normes particulières.

Medicinska električna oprema - 1-12. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za elektromedicinsko opremo in elektromedicinske sisteme, namenjene za uporabo v okolju nujne medicinske pomoči

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI MEDICINSKE ELEKTRIČNE OPREME in MEDICINSKIH ELEKTRIČNIH SISTEMOV (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEM), ki so namenjeni za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI (OKOLJE EMS), kot je PROIZVAJALEC navedel v navodilih za uporabo in
kot je določeno v poglavju 3.1. OPOMBA 1 Za namene tega standarda je namen PROIZVAJALCA naveden v navodilih za uporabo. ODGOVORNA ORGANIZACIJA in IZVAJALEC morata upoštevati, da se lahko zaradi uporabe, ki ni skladna z NAMERAVANO UPORABO PROIZVAJALCA, PACIENT znajde v NEVARNEM STANJU. OKOLJE NUJNE MEDICINSKE POMOČI vključuje:
– odzivanje na in oživljanje PACIENTA na mestu intervencije, ki je poškodovan ali pod vplivom bolezni v predbolnišničnem okolju, ter prevoz PACIENTA do primerne strokovne zdravstvene ustanove za nadaljnje zdravljenje, med katerim se nadaljuje z oživljanjem.
– nadzorovanje, zdravljenje ali diagnosticiranje med prevozom med strokovnimi zdravstvenimi ustanovami.
Ta mednarodni standard se ne uporablja za ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME, namenjene izključno za uporabo v OKOLJU DOMAČE ZDRAVSTVENE OSKRBE ki so zajeti v standardu IEC 60601-1-11, ali namenjene izključno za uporabo v strokovnih zdravstvenih ustanovah, ki so zajeti v standardu IEC 60601-1 brez dodatkov standarda IEC 60601-1-11 ali tega spremljevalnega standarda. ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI so pogosto namenjeni uporabi v različnih okoljih. Taka ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICISNKI SISTEMI so lahko namenjeni uporabi v različnih okoljih in so tako v področju uporabe tega standarda tudi, če so med drugim namenjeni za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI.
PRIMER: ELEKTROMEDICINSKA OPREMA ali ELEKTROMEDICINSKI SISTEMI namenjeni tako za uporabo v OKOLJU NUJNE MEDICINSKE POMOČI in okolju strokovnih zdravstvenih ustanov.
OPOMBA 2: ELEKTROMEDICINSKA OPREMA in ELEKTROMEDICINSKI SISTEMI, namenjeni uporabi v OKOLJU NUJNE MEDICINSKE POMOČI, se lahko uporabljajo na mestih z nezanesljivimi električnimi viri in v zunanjih okoljskih pogojih.

General Information

• Status: Published
• Publication Date: 21-May-2015
• Withdrawal Date: 30-Dec-2018
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 22-May-2015
• Completion Date: 22-May-2015
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-1-12:2015 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Relations

• Amended By: EN 60601-1-12:2015/A1:2020 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-12:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DHOHNWURPHGLFLQVNRRSUHPR
LQHOHNWURPHGLFLQVNHVLVWHPHQDPHQMHQH]DXSRUDERYRNROMXQXMQHPHGLFLQVNH
SRPRþL
Medical electrical equipment - Part 1-12: General requirements for basic safety and
essential performance - Collateral standard: Requirements for medical electrical
equipment and medical electrical systems intended for use in the emergency medical
services environment
Medizinische elektrische Geräte - Teil 1-12: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an medizinische elektrische Geräte und medizinische elektrische Systeme in der
Umgebung für den Notfalleinsatz
Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Exigences pour les appareils
électromédicaux et les systèmes électromédicaux destinés à être utilisés dans
l'environnement des services médicaux d'urgence
Ta slovenski standard je istoveten z: EN 60601-1-12:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-12:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-12:2015

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SIST EN 60601-1-12:2015


EUROPEAN STANDARD EN 60601-1-12

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040

English Version
Medical electrical equipment - Part 1-12: General requirements
for basic safety and essential performance - Collateral Standard:
Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical
services environment
(IEC 60601-1-12:2014)
Appareils électromédicaux - Partie 1-12: Exigences Medizinische elektrische Geräte - Teil 1-12: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: Exigences pour les wesentlichen Leistungsmerkmale - Ergänzungsnorm:
appareils électromédicaux et les systèmes électromédicaux Anforderungen an medizinische elektrische Geräte und
destinés à être utilisés dans l'environnement des services medizinische elektrische Systeme in der Umgebung für den
médicaux d'urgence Notfalleinsatz
(IEC 60601-1-12:2014) (IEC 60601-1-12:2014)
This European Standard was approved by CENELEC on 2014-07-24. CENELEC 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-CENELEC
Management Centre or to any CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.


European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1-12:2015 E

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SIST EN 60601-1-12:2015
EN 60601-1-12:2015
Foreword
The text of document 62A/932/FDIS, future edition 1 of IEC 60601-1-12, prepared by SC 62A
"Common aspects of electrical equipment used in medical practice", of IEC/TC 62 "Electrical
equipment in medical practice", was submitted to the IEC-CENELEC parallel vote and approved by
CENELEC as EN 60601-1-12:2015.
The following dates are fixed:
– latest date by which the document has to be implemented at (dop) 2015-11-22
national level by publication of an identical national
standard or by endorsement
– latest date by which the national standards conflicting with (dow) 2018-12-31
the document have to be withdrawn

Attention is drawn to the possibility that some of the elements of
...