Примери за използване на Class iia на Английски и техните преводи на Български
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Colloquial
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Official
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Medicine
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Ecclesiastic
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Ecclesiastic
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Computer
Sanitary product CE Class IIa.
Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII.
Niedermaier DETOX KUR is a Class IIa medicinal product.
To be placed in the teeth,in which case they are in Class IIa.
Mediloy S-Co is a Class IIa medical product in accordance with the European Medical Device Directive 93/42/EEC.
Are intended to be placed in the teeth,in which case they are classified as class IIa;
Are in class IIa in all other cases, including devices principally intended to manage the micro-environment of a wound.
BEMER is an officially authorised medical device in the EU(CE0483) of the class IIa(93/42/EEC).
Class IIa, IIb and III devices shall be accompanied by the statement referred to in Annex VIII, which shall be available to the particular patient identified byname, an acronym or a numerical code.
All devices intended specifically to be used for disinfecting medical devices are in Class IIa.
Moreover, in the case of class IIa and class IIb devices, the quality management system assessment shall be accompanied by the assessment of technical documentation for devices selected on a representative basis in accordance with Sections 4.4 to 4.8.
Are intended to be placed in the teeth,in which case they are classified as class IIa;
Lt; Disinfectants for non-invasive medical devices, class IIa Disinfectants for invasive and non-invasive medical devices,class IIb Disinfectants for non-invasive medical devices, class IIa Other products for medical devices, class I.
(ii) may be connected to an active medical device classified as Class IIa or higher.
In the case of devices falling within Class IIa, other than devices which are custom made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, followed by a procedure relating to the EC declaration of conformity set out in Annex VII with either.
If they may be connected to an active medical device in class IIa or a higher class, .
All active therapeutic devices intended to administer orexchange energy are classified as class IIa unless their characteristics are such that they may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy, in which case they are classified as class IIb.
Non-active devices specifically intended for recording of X-ray diagnostic images are in Class IIa.
In the case of devices falling within Class III and implantable andlong-term invasive devices falling within Class IIa or IIb, the manufacturer may commence the relevant clinical investigation at the end of a period of 60 days after notification, unless the competent authorities have notified him within that period of a decision to the contrary based on considerations of public health or public policy.
All surgically invasive devices intended for short-term use are in class IIa unless they.
( a) in the case of investigational class I devices orin the case of non-invasive class IIa and class IIb devices, unless otherwise stated by national law, immediately after the validation date of the application pursuant to paragraph 5, and provided that a negative opinion which is valid for the entire Member State, under national law, has not been issued by an ethics committee in the Member State concerned in respect of the clinical investigation;
Devices specifically intended for recording of diagnostic images generated by X-ray radiation are classified as class IIa.
The frequency and the sampling basis of the assessment of the technical documentation on a representative basis as set out inthe third paragraph of Section 2.3 and in Section 3.5 of Annex IX in the case of class IIa and class IIb devices, and in Section 10.2 of Annex XI in the case of class IIa devices;
All non- invasive devices intended to canalize or store blood, body fluids and tissues, liquids or gases intended for transfusion, subministration or introduction in the body,are classified as class IIa if:-.
All active devices intended to administer and/or remove medicines, body liquids or other substances to orfrom the body are in Class IIa, unless this is done in a manner.
All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration orintroduction into the body are classified as class IIa.
Lt; Other products for medical devices, class I Disinfectants for invasive and non-invasive medical devices,class IIb Disinfectants for non-invasive medical devices, class IIa Other products for medical devices, class I.
All non-invasive devices intended for channelling or storing blood, body liquids, cells or tissues, liquids or gases for the purpose of eventual infusion, administration orintroduction into the body are classified as class IIa.
All invasive devices with respect to body orifices, other than surgically invasive devices,intended for connection to an active medical device in Class IIa or a higher class, are in Class IIa.
All non-invasive devices intended for modifying the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids intended for implantation or infusion into the body are in class IIb, unless the treatment consists of filtration, centrifugation or exchanges of gas, heat,in which case they are in class IIa.