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CEI EN IEC 60601-2-2

CEI Classification: 62-11

Apparecchi elettromedicali
Parte 2: Prescrizioni particolari relative alla sicurezza fondamentale e alle prestazioni essenziali degli apparecchi ed accessori per elettrochirurgia ad alta frequenza
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Publication Date: 2019-04
ValidFrom: 2018-10
Language: IT
Pages: 92
Issue Num.:  16818
Commitee: CEI-CT62, CEI-SC62D
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La presente Norma si applica alla sicurezza di base e alle prestazioni essenziali delle apparecchiature e degli accessori chirurgici per la elettrochirurgia ad alta frequenza (HF). Le apparecchiature chirurgiche aventi potenza di uscita nominale non superiore a 50 W (ad esempio per micro-coagulazione o per uso in odontoiatria o oftalmologia) sono esenti da alcuni dei requisiti di questa particolare Norma. Queste esenzioni sono indicate nei relativi requisiti. L'obiettivo di questa Norma è stabilire particolari requisiti di sicurezza di base e prestazioni essenziali per le apparecchiature e gli accessori per l’elettrochirurgia HF.
La Norma in oggetto sostituisce completamente la Norma CEI EN 60601-2-2:2011-03, che rimane applicabile fino al 18-05-2021. Questa edizione costituisce una revisione tecnica ed include le seguenti significative modifiche tecniche rispetto alla precedente edizione:
- perfezionamento e aggiunte alle definizioni;
- ulteriore separazione dei requisiti per le apparecchiature chirurgiche HF e gli accessori chirurgici HF;
- un nuovo requisito per gli elettrodi neutri per adulti utilizzati come elettrodi neutri per il controllo della qualità del contatto;
- nuovi requisiti per gli apparecchi che hanno o utilizzano una modalità a corrente elevata.

La presente Norma riporta la traduzione completa della EN IEC 60601-2-2; la versione inglese è riportata nel fascicolo 16386E di settembre 2018.

Relations

Replaces: CEI EN 60601-2-2

See also

EN IEC 60601-2-2:2018
IEC 60601-2-2:2017

International Coding Standard (ICS)

11.040.30
Surgical instruments and materials
* Including surgical dressings, sutures, etc.
11.040.60
Therapy equipment

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ICS

International Classification for Standards (ICS) is an international classification system for technical standards.

The ICS is a hierarchical classification organized on three levels.

Level 1 covers the main fields of activity in standardization, e.g. road vehicle engineering, agriculture, metallurgy.

Each field has a two-digit notation, e.g.

  43    Road Vehicle Engineering

The main fields are subdivided into groups (level 2). The notation of a group consists of the field notation and a three-digit group number, separated by a point, e.g.

  43.040    Road vehicle systems

Some groups are further divided into sub-groups (level 3). The notation of a sub-group consists of the group notation and a two-digit number, separated by a point, e.g.

  43.040.20 Lighting, signaling and warning devices

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