Article R5211-18
Medical devices which comply with the standards applicable to them, transposing the harmonised European standards, the references of which have been published in the Journal officiel de la République…
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Showing 1961–1970 of 32116 articles for “Art. 25-12 to 25-18”
Medical devices which comply with the standards applicable to them, transposing the harmonised European standards, the references of which have been published in the Journal officiel de la République…
For a new device, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may, at any time and for a period of two years following the declaration provided for…
…dvisory Board with specific expertise in the field of healthcare products, particularly in relation to medical devices, in vitro diagnostic medical devices and epidemiology. The chairmen of the commit…
The provisions of this section apply to health care organisations with an in-house pharmacy and to health cooperation groups managing an in-house pharmacy which provide their own sterilisation of medi…
…who is responsible for receiving and organising patient care. This nurse implements the referral protocols delegated by the doctor present in the facility and coordinates the patient's care, if necess…
The staff of the labour inspection system carry out their duties impartially, without expressing any prejudices in their behaviour, words or actions. They ensure that users in identical situations, wh…
The authorisation holder must ensure, in the context of exposure to ionising radiation, that staff and patients have access to the tools needed to optimise radiation protection. A dedicated echocardio…
I.-The holder of a "B" nuclear medicine authorisation pursuant to Article R. 6123-135 has an in-house pharmacy authorised to carry out the activity provided for in 6° of Article R. 5126-9 and, where a…
…medical and paramedical team identifies and regularly updates the recommendations for good practice to be applied, and sets up a system for assessing compliance with these standards. The registration…
I.-The holder of the "A" authorisation pursuant to Article R. 6123-135 shall have a team comprising: 1° At least one doctor specialising in nuclear medicine present on site during patient care; 2° At…
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