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CEI EN IEC 60601-2-43

CEI Classification: 62-123

Apparecchi elettromedicali
Parte 2: Prescrizioni particolari per la sicurezza fondamentale e le prestazioni essenziali degli apparecchi radiologici per procedure interventistiche
standard
CEI
CEI
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Publication Date: 2023-04
ValidFrom: 2023-05
Language: EN
Pages: 70
Issue Num.:  19353 E
Commitee: CEI-CT62, CEI-SC62B
shopping_cart Starting from € 46.00
The publication contains images and text that need color printing for a better reading.
La presente Norma si applica alla SICUREZZA DI BASE e alle PRESTAZIONI ESSENZIALI di APPARECCHI A RAGGI X fissi e mobili, dichiarati dal FABBRICANTE idonei per PROCEDURE INTERVENTISTICHE A GUIDA RADIOSCOPICA. Sono escluse dal suo campo di applicazione, in particolare:
- apparecchiature per RADIOTERAPIA;
- apparecchiature per TOMOGRAFIA COMPUTERIZZATA;
- ACCESSORI destinati ad essere introdotti nel PAZIENTE;
- APPARECCHI A RAGGI X mammografici;
- APPARECCHI A RAGGI X odontoiatrici.
Esempi di PROCEDURE INTERVENTISTICHE A GUIDA RADIOSCOPICA, per le quali si raccomanda l'utilizzo di APPARECCHI A RAGGI X per PROCEDURE INTERVENTISTICHE conformi alla presente Norma, sono riportati nell'Allegato AA. I requisiti specifici per i dispositivi di navigazione magnetici e per l'uso di APPARECCHI A RAGGI X per PROCEDURE INTERVENTISTICHE in un ambiente di sala operatoria non sono stati considerati in questa Norma particolare. L'APPARECCHIO per PROCEDURE INTERVENTISTICHE A RAGGI X, quando utilizzato per la modalità CT cone-beam, è coperto dalla presente Norma e non dalla CEI EN IEC 60601-2-44.
La Norma in oggetto sostituisce completamente la Norma CEI EN 60601-2-43:2011-08, che rimane applicabile fino al 09-01-2026.
Questa Norma viene pubblicata dal CEI nella sola lingua inglese, in quanto particolarmente mirata a settori specialistici.
La presente Norma recepisce il testo originale inglese della Pubblicazione IEC.

Relations

Replaces: CEI EN 60601-2-43/EC
Replaces: CEI EN 60601-2-43/A2
Replaces: CEI EN 60601-2-43/A1
Replaces: CEI EN 60601-2-43

See also

EN IEC 60601-2-43:2023
IEC 60601-2-43:2022

International Coding Standard (ICS)

37.040.25
Radiographic films
* Including dental, medical and industrial radiographic films
11.040.50
Radiographic equipment
* Including radiographic diagnostic and therapy equipment
* Dental, medical and industrial radiographic films, see 37.040.25

Annotation

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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

You can identify the ICS code of your interest by typing the code or a keywordword in the dropdown ICS field, and by selecting one of the filtered results.

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By flagging this control, the search for keywords will not be limited to the Standard Number and Title fields, but will also be performed in the Abstract of the standard.

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You should use this option when you can not find the desired result with the standard approach and it is necessary to extend the scope of the search: by increasing the number of results, you will increase the number of non-relevant elements, as well.