+Artikolu 11 2.

Artikolu 11 2.

B’deroga mill-paragrafu 1, il-prodotti li ġejjin li jinkorporaw batteriji portabbli jistgħu jiġu ddisinjati b’tali mod li l-batterija tkun tista’ titneħħa u tiġi sostitwita biss minn professjonisti indipendenti:

(a) 

apparat iddisinjat speċifikament biex jaħdem primarjament f’ambjent li huwa regolarment soġġett għat-titjir tal-ilma, flussi tal-ilma jew immersjoni tal-ilma, u li huwa maħsub biex ikun jista’ jinħasel jew jitlaħlaħ;

(b) 

apparati mediċi professjonali ta’ immaġni u radjoterapija, kif definit fl-Artikolu 2, il-punt (1), tar-Regolament (UE) 2017/745, u apparati mediċi dijanjostiċi in vitro, kif definit fl-Artikolu 2, il-punt (2), tar-Regolament (UE) 2017/746.

Id-deroga stipulata fil-punt (a) ta’ dan il-paragrafu għandha tkun applikabbli biss meta tali deroga tkun meħtieġa biex tiġi żgurata s-sikurezza tal-utent u tal-apparat.

1. Ħarsa ġenerali

,

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
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