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- Withdrawn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
- 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
Relations
- Effective Date
- 22-May-2018
- Effective Date
- 07-Jun-2022
- Effective Date
- 03-Nov-2015
Frequently Asked Questions
SIST EN 60601-2-2:2009/A11:2012 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "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 standard covers: 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.
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.
SIST EN 60601-2-2:2009/A11:2012 is classified under the following ICS (International Classification for Standards) categories: 11.040.30 - Surgical instruments and materials. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 60601-2-2:2009/A11:2012 has the following relationships with other standards: It is inter standard links to SIST EN IEC 60601-2-2:2018, SIST EN 60601-2-2:2009, SIST EN IEC 60601-2-2:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 60601-2-2:2009/A11:2012 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 60601-2-2:2009/A11:2012 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2012
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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
...
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