Ní áirithítear infhaighteacht ionadach d’fheistí sonracha den sórt sin toisc nach bhfuil na hionaduithe luaidhe atá ann faoi láthair iontaofa i gcás gach paraiméadair (mar shampla, créitínín agus nítrigin úiré sanfhuil) nó toisc go bhfuil cruinneas íseal acu maidir leis na paraiméadair sin.
The availability of substitutes for such specific devices is not ensured as current lead substitutions are not reliable for all parameters (for example, creatinine and blood urea nitrogen) or have a low accuracy for such parameters.
#2805215
Study to assess request for one (-1-) exemption, for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of creatinine and blood urea nitrogen (BUN) in whole blood, in Annex IV of Directive 2011/65/EU (Pack 26) [Staidéar chun measúnú a dhéanamh ar iarraidh ar dhíolúine amháin (-1-), maidir le luaidhe mar chobhsaitheoir teirmeach i gclóiríd pholaivinile (PVC) a úsáidtear mar bhunábhar i mbraiteoirí leictriceimiceacha aimpéarméadracha, poitéinsiméadrach agus seoladhmhéadracha a úsáidtear i bhfeistí leighis diagnóiseacha in vitro chun anailís a dhéanamh ar chréitínín agus nítrigin úiré sanfhuil (BUN) i lánfhuil, in Iarscríbhinn IV de Threoir 2011/65/AE (Pacáiste 26)]
Study to assess request for one (-1-) exemption, for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of creatinine and blood urea nitrogen (BUN) in whole blood, in Annex IV of Directive 2011/65/EU (Pack 26).
#2805219
Luaidhe mar chobhsaitheoir teirmeach i gclóiríd pholaivinile (PVC) a úsáidtear mar bhunábhar i mbraiteoirí leictriceimiceacha aimpéarméadracha, poitéinsiméadracha agus seoladhmhéadracha a úsáidtear i bhfeistis leighis diagnóiseacha in vitro chun anailís a dhéanamh ar chréitínín agus nítrigin úiré sanfhuil i lánfhuil.
Lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in vitro diagnostic medical devices for the analysis of creatinine and blood urea nitrogen in whole blood.