#297985
An chuid sin de roinn IIb nach bhfuil suite laistigh d'fhoroinn IIb 1.
That part of division IIb not falling within subdivision IIb 1.
Scag na torthaí
Bailiúcháin
121 toradh in 26 doiciméad
#297844
Foroinn ICES IIb 1
ICES subdivision IIb 1
#297845
Foroinn ICES IIb 2
ICES subdivision IIb 2
#297978
- Roinn staidrimh ICES IIb
- ICES statistical division IIb,
#297982
- Foroinn staidrimh ICES IIb 1
- ICES statistical subdivision IIb 1,
#297983
An chuid sin de roinn IIb atá teorannaithe leis na comhordanáidí seo a leanas:
That part of division IIb confined by the following coordinates:
#297984
- Foroinn staidrimh ICES IIb 2
- ICES statistical subdivision IIb 2,
#508826
IARSCRÍBHINN IIb
ANNEX IIb
#687444
Grúpa IIB
Group IIB
#744653
aicme IIb má bhaineann riosca íseal den nochtadh inmheánach leo; agus
class IIb if they present a low potential for internal exposure; and
#744662
is in aicme IIb atá siad i ngach cás eile,.
class IIb in all other cases.
#744723
Measúnú faireachais is infheidhme maidir le feistí in aicme IIa, aicme IIb agus aicme III
Surveillance assessment applicable to class IIa, class IIb and class III devices
#744771
Nós imeachta um measúnú le haghaidh feistí áirithe in aicme III agus in aicme IIb
Assessment procedure for certain class III and class IIb devices
#1680271
IARSCRÍBHINN IIb
ANNEX IIb
#1750527
IARSCRÍBHINN IIb
ANNEX IIb
#1751118
Iarscríbhinn IIb
Annex IIb
#1886630
feistí in aicme IIa agus in aicme IIb ón 26 Bealtaine 2025;
class IIa and class IIb devices from 26 May 2025;
#2059780
Iarscríbhinn IIb
Annex IIb
#2317273
Nochtadh: IAS 36.130 f (ii), Nochtadh: IAS 36.134 e (iiB)
Disclosure: IAS 36.130 f (ii), Disclosure: IAS 36.134 e (iiB)
#2449579
cuirtear Iarscríbhinn II a ghabhann leis an Treoirlíne seo in ionad Iarscríbhinn IIb.
Annex IIb is replaced by Annex II to this Guideline.
#2449605
IARSCRÍBHINN IIb
ANNEX IIb
#2569851
Dá bhrí sin, ba cheart na táirgí sin a aicmiú mar aicme IIb.
Those products should therefore be classified as class IIb.
#2593190
Nochtadh: IAS 36.130 f (ii), Nochtadh: IAS 36.134 e (iiB)
Disclosure: IAS 36.130 f (ii), Disclosure: IAS 36.134 e (iiB)
#2693631
cuirtear Iarscríbhinn II a ghabhann leis an Treoirlíne seo in ionad Iarscríbhinn IIb.
Annex IIb is replaced by Annex II to this Guideline.
#2693655
IARSCRÍBHINN IIb
ANNEX IIb
#2803652
IARSCRÍBHINN IIb
ANNEX IIb
#2803818
Leithdháilfear na cistí a chomhfhreagraíonn don mhéid sin lamháltas i gcomhréir le Cuid B d’Iarscríbhinn IIb.’;
The funds corresponding to that amount of allowances shall be distributed in accordance with Part B of Annex IIb.’;
#3036280
‘Forálacha sonracha is infheidhme maidir le deontais nach ndámhtar ar bhonn Chaibidlí IIa, IIb nó IIc’;
‘Specific provisions applicable to grants that are not awarded on the basis of Chapters IIa, IIb or IIc’;
#3036370
cuirtear Caibidil IIb seo a leanas isteach:
the following Chapter IIb is inserted:
#3036371
‘CAIBIDIL IIb
‘CHAPTER IIb
#3112298
‘Caibidil IIb
‘Chapter IIb
#742529
I gcás ina bhfuil bonn cirt leis toisc go bhfuil teicneolaíochtaí seanbhunaithe á n-úsáid i bhfeistí eile so-ionchlannaithe in aicme IIb, atá comhchosúil leis na teicneolaíochtaí siúd a úsáidtear sna feistí díolmhaithe atá sa liosta sa dara fomhír de mhír 4 den Airteagal seo, nó i gcás ina bhfuil bonn cirt leis d'fhonn sláinte agus sábháilteacht othar, úsáideoirí agus daoine eile a chosaint nó d'fhonn gnéithe eile den tsláinte phoiblí a chosaint, tugtar de chumhacht don Choimisiún gníomhartha tarmligthe a ghlacadh i gcomhréir le hAirteagal 115 chun an liosta sin a leasú trí chineálacha eile feistí so-ionchlannaithe in aicme IIb a chur leis nó trí fheistí a bhaint as.
Where justified in view of well-established technologies, similar to those used in the exempted devices listed in the second subparagraph of paragraph 4 of this Article, being used in other class IIb implantable devices, or where justified in order to protect the health and safety of patients, users or other persons or other aspects of public health, the Commission is empowered to adopt delegated acts in accordance with Article 115 to amend that list by adding other types of class IIb implantable devices to that list or removing devices therefrom.
#744618
Na feistí gníomhacha ar fad a beartaíodh chun feidhmíocht feistí teiripeacha gníomhacha in aicme IIb a rialú nó faireachán a dhéanamh orthu, nó a beartaíodh chun tionchar a imirt go díreach ar fheidhmíocht feistí den sórt sin, tá siad aicmithe mar aicme IIb.
All active devices intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices are classified as class IIb.
#508814
cuirtear isteach Iarscríbhinní IIb go IIg mar a leagtar amach iad san Iarscríbhinn a ghabhann leis an Rialachán seo.
Annexes IIb to IIg, as set out in the Annex to this Regulation, are inserted.
#741601
I gcás feistí in aicme IIa, in aicme IIb agus in aicme III, ba cheart leibhéal iomchuí rannpháirtíochta ó chomhlacht dá dtugtar fógra a bheith éigeantach.
For class IIa, class IIb and class III devices, an appropriate level of involvement of a notified body should be compulsory.
#742522
Roinnfear feistí ina n-aicmí I, IIa, IIb agus III, agus an chríoch a beartaíodh do na feistí agus na rioscaí dosheachanta a bhaineann leo á gcur san áireamh.
Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks.
#742557
Nós imeachta maidir le comhairliúchán i ndáil le meastóireacht chliniciúil le haghaidh feistí áirithe in aicme III agus in aicme IIb
Clinical evaluation consultation procedure for certain class III and class IIb devices
#742560
feistí gníomhacha in aicme IIb arb í an chríoch a beartaíodh dóibh táirge íocshláinte a riaradh agus/nó a bhaint, amhail dá dtagraítear i Roinn 6.4 d'Iarscríbhinn VIII (Riail 12).
class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).
#742574
Sásra maidir le grinnscrúdú a dhéanamh ar mheasúnuithe comhréireachta i gcás feistí áirithe in aicme III agus in aicme IIb
Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
#743008
Déanfaidh monaróirí feistí in aicme IIb agus in aicme III TTNS a nuashonrú agus ar bhonn bliantúil ar a laghad.
Manufacturers of class IIb and class III devices shall update the PSUR at least annually.
#743957
i gcás feistí in aicme IIa, in aicme IIb nó in aicme III: Na Ballstáit ina bhfuil an fheiste ar fáil nó ina bhfuil an fheiste le cur ar fáil,
in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available,
#744358
i gcás feistí in aicme IIa nó in aicme IIb, measúnú a dhéanamh ar dhoiciméadacht theicniúil na bhfeistí a roghnaítear ar bhonn ionadaíoch,
in the case of class IIa or class IIb devices, assess the technical documentation of devices selected on a representative basis,
#744570
i gcás inar féidir iad a nascadh le feiste ghníomhach in aicme IIa, in aicme IIb nó in aicme III; nó
if they may be connected to a class IIa, class IIb or class III active device; or
#744595
má beartaíodh iad chun fuinneamh a sholáthar i bhfoirm radaíochta ianúcháin, agus sa chás sin tá siad aicmithe mar aicme IIb;
are intended to supply energy in the form of ionising radiation in which case they are classified as class IIb;
#744596
má tá éifeacht bhitheolaíoch acu nó má ionsúitear iad ina n-iomláine nó den chuid is mó, agus sa chás sin tá siad aicmithe aicme IIb; nó
have a biological effect or are wholly or mainly absorbed in which case they are classified as class IIb; or
#744600
má beartaíodh iad chun fuinneamh a sholáthar i bhfoirm radaíochta ianúcháin, agus sa chás sin tá siad aicmithe mar aicme IIb;
are intended to supply energy in the form of ionizing radiation in which case they are classified as class IIb;
#744602
má beartaíodh iad le dul faoi athrú ceimiceach sa cholainn, agus sa chás sin tá siad aicmithe mar aicme IIb, seachas má chuirtear na feistí sna fiacla; nó
are intended to undergo chemical change in the body in which case they are classified as class IIb, except if the devices are placed in the teeth; or
#744603
má beartaíodh iad le cógais a thabhairt, agus sa chás sin tá siad aicmithe mar aicme IIb.
are intended to administer medicines, in which case they are classified as class IIb.
#744605
Tá na feistí so-ionchlannaithe agus na feistí máinliachta ionraí fadtéarmacha ar fad aicmithe mar aicme IIb ach amháin:
All implantable devices and long-term surgically invasive devices are classified as class IIb unless they:
#744630
meath tromchúiseach ar an staid sláinte duine nó idirghabháil mháinliach, agus sa chás sin tá siad aicmithe mar aicme IIb.
a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.