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SIST

SIST EN 60601-2-2:2009/A11:2012

(Amendment)

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT as defined in 201.3.222. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-COAGULATION, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.

Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten und HF-chirurgischem Zubehör

Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence

Medicinska električna oprema - 2-2. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega kirurškega pribora

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI HF KIRURŠKE OPREME, kot je določeno v 201.3.222. HF KIRURŠKA OPREMA, ki ima OCENJENO IZHODNO MOČ manjšo od 50 W (na primer za mikroKOAGULACIJO ali za uporabo v zobozdravstvu ali oftamologiji), je izvzeta iz določenih zahtev tega konkretnega standarda. Te izjeme so navedene v ustreznih zahtevah.

General Information

Status
Withdrawn
Publication Date
14-Nov-2011
Withdrawal Date
15-Aug-2021
ICS
11.040.30 - Surgical instruments and materials
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
30-Jul-2021
Due Date
22-Aug-2021
Completion Date
16-Aug-2021
Directive
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Ref Project
EN 60601-2-2:2009/A11:2011 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Relations

Replaced By
SIST EN IEC 60601-2-2:2018 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2017)
Effective Date
22-May-2018
Amends
SIST EN 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)
Effective Date
28-Jan-2023
Revised
SIST EN IEC 60601-2-2:2018 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2017)
Effective Date
03-Nov-2015
Amends
SIST EN 60601-2-2:2009 - Medical electrical equipment - Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2009)
Effective Date
07-Jun-2022

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EN 60601-2-2:2009/A11:2012EN 60601-2-2:2009/A11:2012
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EN 60601-2-2:2009/A11:2012
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-2-2:2009/A11:2012
01-januar-2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLYLVRNRIUHNYHQþQHNLUXUãNHRSUHPHLQYLVRNRIUHNYHQþQHJD
NLUXUãNHJDSULERUD
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and
essential performance of high frequency surgical equipment and high frequency surgical
accessories
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
und HF-chirurgischem Zubehör
Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base
et les performances essentielles des appareils d'électrochirurgie à courant haute
fréquence et des accessoires d'électrochirurgie à courant haute fréquence
Ta slovenski standard je istoveten z: EN 60601-2-2:2009/A11:2011
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN 60601-2-2:2009/A11:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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

SIST EN 60601-2-2:2009/A11:2012

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

SIST EN 60601-2-2:2009/A11:2012

EUROPEAN STANDARD
EN 60601-2-2/A11

NORME EUROPÉENNE
October 2011
EUROPÄISCHE NORM

ICS 11.040.30


English version


Medical electrical equipment -
Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and high frequency
surgical accessories



Appareils électromédicaux -  Medizinische elektrische Geräte -
Partie 2-2: Exigences particulières pour la Teil 2-2: Besondere Festlegungen für die
sécurité de base et les performances Sicherheit einschließlich der wesentlichen
essentielles des appareils Leistungsmerkmale von Hochfrequenz-
d'électrochirurgie à courant haute Chirurgiegeräten und HF-chirurgischem
fréquence et des accessoires Zubehör
d'électrochirurgie à courant haute
fréquence




This amendment A11 modifies the European Standard EN 60601-2-2:2009; it was approved by CENELEC on
2011-10-01. 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
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

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