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Showing 7481–7490 of 17987 articles for “Art. 5 avr. 1978”
…s must have at least six months' professional experience under the conditions set out in article R. 5142-16 before taking on this role.
For Class IIa devices, the authorized body must, as part of the assessment of the quality system, assess the technical documentation for at least one representative sample of each device subcategory i…
…this device to be understood and its conformity with the essential requirements defined in section 5 of this chapter to be assessed. For the purposes of assessing such conformity, the authorized body…
…ned assessment. In addition, for a device included in list A of the order referred to in article R. 5221-6, the manufacturer submits an application for examination of the design of this device to the…
When providing systemic cancer treatment by immunotherapy or innovative therapeutic medicinal products, the holder of the authorisation for systemic cancer treatment has a patient care organisation wh…
…e management of foreseeable aplasia lasting more than eight days induced by intensive chemotherapy; 5° Patient follow-up during treatment and after the episode of systemic cancer drug treatment. II-Pe…
I. - Establishments authorised for systemic medicinal treatments for cancer with designation B or C must have on site : 1° The organisation of a medical permanence at least by means of operational on-…
…s of authorisations for medicine caring for children and adolescents mentioned in articles R. 6123-151 and R. 6123-158.
The non-medical team in a haematology intensive care unit comprises at least: 1° One nurse for every four open beds ; 2° During the day, one nursing assistant for every four open beds and, at night, o…
The medical permanence of the haematology intensive care unit is ensured, outside day services, by at least : 1° The presence on site of a doctor with training or experience in critical care ; 2° An o…
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