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Subject: surgically invasive for transient use med. Эндостеплер.The iDrive Ultra powered handle shaft is intended to be surgically invasive for transient use. немного не понял вот этого .... surgically invasive .... for transient use .... Разве хирургическая операция сама по себе не является инвазивной? И писать инвазивная хирургическая операция это масло-масленное ? Мой вариант: Поправьте пожалуйста. Заранее благодарен. |
| Инвазивная процедура может, например, быть при интервенционном вмешательстве. Может, авторы хотят подчеркнуть, что этот аппарат именно для большой хирургии |
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link 14.09.2013 14:21 |
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1.2. Invasive devices Invasive device A device which, in whole or in part, penetrates the body, either through a body orifice or through the surface of the body. Body orifice Any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening, such as a stoma. Surgically invasive device An invasive device that penetrates through the surface of the body with the aid or in the context of a surgical operation. Devices other than those referred to in the previous subparagraph, and which produce penetration other than through an established body orifice, shall be treated as surgically invasive devices for the purposes of this Directive. Implantable device Any device which is intended: -to be totally introduced into the human body, or -to replace an epithelial surface or the surface of the eye, by surgical intervention, and which is inten ded to remain in place after the procedure. Any device intended to be partally introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device |
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link 14.09.2013 14:23 |
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Rule 5 All invasive devices with respect to body orifices that are not surgically invasive devices and that are not intended for connection to an active medical device are: 1) in Cl as s I if they are intende d for transient u se; Examples: ♦ Handheld mirrors used in dentistry to aid in dental diagnosis and surgery, dental impression materials, tubes used for pumping the stomach, impression tray; enema devices, examination gloves and prostatic balloon dilation catheters. 2) or in Class Ha if they are intended for short-term use; |
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link 14.09.2013 14:25 |
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Rule 6 All surgically invasive devices intended for transient use are in Class IIa. Examples: ♦ Needles used for suturing, needles of syringes, lancets, suckers, single use scalpels, single use scalpel blades, support devices in ophthalmic surgery, staplers, surgical swabs, drill bits connected to active devices, surgical gloves, etchants, tester of artificial heart valves, heart valve occluder, heart valve sizers and holders, trial hip prosthesis heads or stems, swabs to sample exudates, single use aortic punches. All surgically invasive devices intended for transient use are in Class IE if they are intended specifically to diagnose, monitor, or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body. Examples: Cardiovascular catheters (e.g., angioplasty balloon catheters), including related guidewires and dedicated disposable cardiovascular surgical instruments e.g., electrophysiological catheters, electrodes for el ec trophy si olo gical diagnosis and ablation and catheters containing or incorporating sealed radioisotopes, where the radioactive isotope as such is not intended to be released into the body, if used in the central circulatory system. All surgically invasive devices that are intended for transient use are in Class I if they are reusable surgical instruments. |
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Спасибо Большое. :) |
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