Hugtakasafn þýðingamiðstöðvar utanríkisráðuneytisins
Hugtakasafn : Eitt hugtak
- ÍSLENSKA
- stakbilunarástand
- ENSKA
- single fault condition
- DANSKA
- første fejlforekomst
- SÆNSKA
- första fel
- FRANSKA
- condition de premier défaut
- ÞÝSKA
- Erstauftreten eines Defekts
- Svið
- lyf
- Dæmi
-
[is]
Tæki skulu hönnuð og framleidd á þann hátt að komist sé, eins og framast er unnt, hjá því að sjúklingur, notandi eða annar einstaklingur fái rafstuð fyrir slysni, bæði við venjulega notkun tækisins og ef um er að ræða stakbilunarástand í tækinu, að því tilskildu að tækið sé sett upp og því viðhaldið samkvæmt tilsögn framleiðanda.
- [en] 18.7. Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer.
- Skilgreining
- [en] condition in which there is a fault of a single protection (but not a reinforced protection) or of a single component or a device ...
NOTE: If a single fault condition results unavoidably in another single fault condition, the two failures are considered as one single fault condition (IATE) - Rit
-
[is]
Reglugerð Evrópuþingsins og ráðsins (ESB) 2017/745 frá 5. apríl 2017 um lækningatæki, um breytingu á tilskipun 2001/83/EB, reglugerð (EB) nr. 178/2002 og reglugerð (EB) nr. 1223/2009 og um niðurfellingu á tilskipunum ráðsins 90/385/EBE og 93/42/EBE
- [en] 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
- Skjal nr.
- 32017R0745
- Athugasemd
-
[is]
Á við um öryggismál vegna rafmagns.
- [en] Tekið úr FDA. Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation. Samhengið er: The following paragraphs and diagrams describe the electrical safety tests commonly available on medical equipment safety testers. (...). 6.1 Normal condition and single fault conditions
A basic principle behind the philosophy of electrical safety is that in the event of a single abnormal external condition arising or of the failure of a single means of protection against a hazard, no safety hazard should arise. Such conditions are called "single fault conditions" (SFCs) and include such situations as the interruption of the protective earth conductor or of one supply conductor, the appearance of an external voltage on an applied part, the failure of basic insulation or of temperature limiting devices.
Where a single fault condition is not applied, the equipment is said to be in "normal condition" (NC).'' - Orðflokkur
- no.
- Kyn
- hk.
Takk fyrir
Ábendingin verður notuð til að bæta gæði þjónustu og upplýsinga á vef Stjórnarráðsins. Hikaðu ekki við að hafa samband ef þig vantar aðstoð.