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CEI EN IEC 60601-2-35

CEI Classification: 62-271

Apparecchi elettromedicali
Parte 2-35: Prescrizioni particolari per la sicurezza fondamentale e le prestazioni essenziali di dispositivi di riscaldamento che utilizzano coperte, cuscini e materassi destinati al riscaldamento per uso medico
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Publication Date: 2022-04
ValidFrom: 2022-05
Language: EN
Pages: 80
Issue Num.:  18542 E
Commitee: CEI-CT62, CEI-SC62D
La presente Norma si applica alla sicurezza fondamentale e alle prestazioni essenziali dei dispositivi di riscaldamento quali COPERTE, CUSCINI e MATERASSI termici ad uso medico. I dispositivi destinati a preriscaldare un letto ad uso medico sono inclusi nello scopo di questo documento.
Essa non si applica a:
- DISPOSITIVI DI RISCALDAMENTO destinati alla fisioterapia;
- RISCALDATORI RADIANTI PER NEONATI, che rientrano negli scopi della Norma
CEI EN 60601-2-21;
- INCUBATRICI PER NEONATI, che rientrano negli scopi della Norma CEI EN 60601-2-19;
- INCUBATRICI PER IL TRASPORTO NEONATI, che rientrano negli scopi della Norma
CEI EN 60601-2-20;
- dispositivi di raffreddamento.
La Norma in oggetto sostituisce completamente la Norma CEI EN 80601-2-35:2011-04 , che rimane applicabile fino al 16-07-2024.
Questa Norma viene pubblicata dal CEI in una prima fase nella sola lingua inglese, per consentirne l'immediato utilizzo da parte degli utenti interessati, nel rispetto della data di pubblicazione fissata dagli Enti Normatori internazionali.
Successivamente il CEI pubblicherà, in un nuovo fascicolo, la versione solo italiana; tale versione avrà la stessa validità della presente.
La presente Norma recepisce il testo originale inglese della Pubblicazione IEC.

Relations

Replaces: CEI EN 80601-2-35/A11
Replaces: CEI EN 80601-2-35/Ec1
Replaces: CEI EN 80601-2-35/A1
Replaces: CEI EN 80601-2-35/A1
Replaces: CEI EN 80601-2-35/EC
Replaces: CEI EN 80601-2-35

See also

EN IEC 60601-2-35:2021
IEC 60601-2-35:2020

International Coding Standard (ICS)

11.040.01
Medical equipment in general
11.140
Hospital equipment
* Including hospital beds, surgical tables, medical garments, medical gloves, containers for sharp disposal, etc.

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.

Search also in the summary/description of the standard

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.

This way, you will get more results.

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.