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

D139/C149: BT approved the modified Annex ZZ for EN 60601-2-2:2009

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• Status: Withdrawn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: 13-Oct-2011
• Withdrawal Date: 30-Sep-2014
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 18-May-2021
• Completion Date: 18-May-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 60601-2-2:2009/A11:2012 - 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: 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
• Effective Date: 23-Jan-2023
• Amends: EN 60601-2-2:2009 - 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
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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
...