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  1. #743655

    Feistí a astaíonn radaíocht ianúcháin agus a beartaíodh lena n-úsáid sa raideolaíocht theiripeach, dearfar agus monarófar iad sa chaoi go bhféadfar faireachán agus rialú iontaofa a dhéanamh ar an dáileog atáthar a thabhairt, ar chineál an léis, ar fhuinneamh léis agus, i gcás inarb iomchuí, ar cháilíocht na radaíochta.

    Devices that emit ionising radiation and are intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type, energy and, where appropriate, the quality of radiation.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )

  2. #744626

    Tá feistí gníomhacha a beartaíodh le radaíocht ianúcháin a astú agus a beartaíodh don raideolaíocht dhiagnóiseach nó theiripeach, lena n-áirítear feistí don raideolaíocht idirghabhálach agus feistí lena rialaítear feistí den sórt sin nó lena ndéantar faireachán orthu, nó a bhfuil tionchar díreach acu ar a bhfeidhmíocht aicmithe mar aicme IIb.

    Active devices intended to emit ionizing radiation and intended for diagnostic or therapeutic radiology, including interventional radiology devices and devices which control or monitor such devices, or which directly influence their performance, are classified as class IIb.

    Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. )