Article R5211-40-1
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…
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Showing 7561–7570 of 18062 articles for “Art. 5 Oct 2004”
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…
…own or in conjunction with other health establishments, direct access to a network of specialised doctors and to specialised medical technical platforms capable of dealing with foreseeable complicati…
…regardless of the method of administration, taken during a one-to-one interview by a prescribing doctor, as well as any decision, taken under the same conditions, to make significant changes to this…
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…
…y 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 on-call doctor specialising in the discip…
I. - In addition to the equipment mentioned in II of article D. 6124-27-1, the haematology intensive care unit includes at least the equipment required for radiology and ultrasound examinations to be…
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