SIST EN 60601-1-9:2008/A1:2014

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

This International Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard.

Medizinische elektrische Geräte - Teil 1-9: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen zur Reduzierung von Umweltauswirkungen

Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour une conception éco-responsable

Medicinska električna oprema - 1-9. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za okoljsko osveščeno snovanje

Ta mednarodni standard se uporablja za omejevanje negativnih OKOLJSKIH VPLIVOV MEDICINSKE ELEKTRIČNE OPREME, v nadaljnjem besedilu: ME OPREMA. MEDICINSKI ELEKTRIČNI SISTEMI so izključeni s področja uporabe tega spremljevalnega standarda.

General Information

• Status: Published
• Publication Date: 05-Dec-2013
• ICS: 11.040.01 - Medical equipment in general
• ICS: 13.020.01 - Environment and environmental protection in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 03-Dec-2013
• Due Date: 07-Feb-2014
• Completion Date: 06-Dec-2013
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: EN 60601-1-9:2008/A1:2013 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

Relations

• Amends: SIST EN 60601-1-9:2008 - Medical electrical equipment -- Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• Effective Date: 08-Oct-2012
• Amends: SIST EN 60601-1-9:2008 - Medical electrical equipment -- Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-9:2008/A1:2014
01-januar-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG=DKWHYH]DRNROMVNRRVYHãþHQR
VQRYDQMH
Medical electrical equipment - Part 1-9: General requirements for basic safety and
essential performance - Collateral Standard: Requirements for environmentally
conscious design
Medizinische elektrische Geräte - Teil 1-9: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
zur Reduzierung von Umweltauswirkungen
Appareils électromédicaux - Partie 1-9: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Exigences pour une conception éco-
responsable
Ta slovenski standard je istoveten z: EN 60601-1-9:2008/A1:2013
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
13.020.01 Okolje in varstvo okolja na Environment and
splošno environmental protection in
general
SIST EN 60601-1-9:2008/A1:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-1-9:2008/A1:2014

---------------------- Page: 2 ----------------------

SIST EN 60601-1-9:2008/A1:2014

EUROPEAN STANDARD
EN 60601-1-9/A1

NORME EUROPÉENNE
November 2013
EUROPÄISCHE NORM

ICS 11.040; 13.020


English version


Medical electrical equipment -
Part 1-9: General requirements for basic safety and essential performance -
Collateral Standard: Requirements for environmentally conscious design
(IEC 60601-1-9:2007/A1:2013)


Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 1-9: Exigences générales pour la Teil 1-9: Allgemeine Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles - Leistungsmerkmale -
Norme collatérale: Exigences pour une Ergänzungsnorm: Anforderungen zur
conception éco-responsable Reduzierung von Umweltauswirkungen
(CEI 60601-1-9:2007/A1:2013) (IEC 60601-1-9:2007/A1:2013)





This amendment A1 modifies the European Standard EN 60601-1-9:2008; it was approved by CENELEC on 2013-
07-23. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
conditions for giving this amendment 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 amendment 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.

CENELEC
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


© 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-1-9:2008/A1:2013 E

---------------------- Page: 3 ----------------------

SIST EN 60601-1-9:2008/A1:2014
EN 60601-1-9:2008/A1:2013 - 2 -
Foreword
The text of document 62A/874/FDIS, future IEC 60601-1-9:2007/A1, 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-
9:2008/A1:2013.
The following dates are fixed:
• latest date by which the document has
(dop) 2014-04-23
to be implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national
(dow) 2018-12-31
standards conflicting with the

document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent
rights.

Endorsement notice
The text of the International Standard IEC 60601-1-9:2007/A1:2013 was approved by CENELEC as a
European Standard without any modification.

---------------------- Page: 4 ----------------------

SIST EN 60601-1-9:2008/A1:2014
- 3 - EN 60601-1-9:2008/A1:2013
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications


The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.

Replacement in Annex ZA of EN 60601-1-9:2008:
Publication Year Title EN/HD Year
In the existing introductory paragraph, replace the first sentence with:
The following documents, in whole or part, are normatively referenced in this document and are
indispensable for its application.
Replace the reference to IEC 60601-1:2005 with the following new reference:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
+ A1 2012 Part 1: General requirements for basic + A1 2013
safety and essential
...