Mar 19, 2020 11:44
4 yrs ago
21 viewers *
Spanish term
Esterilización de agrupación de productos
Spanish to English
Medical
Medical: Instruments
Medical devices
Hi folks! I hope you are all well. This is from a training manual for a Spanish company that produces medical devices in the section on what the technical coordinator is responsible for. "Agrupación", as I understand it, is grouping or clustering several products under the same CE mark, but how does one sterilize a grouping? I don't even get that. Maybe it means sterilization procedures for groups of devices with the CE mark?
Thanks
Preparación y supervisión de la documentación exigida para el registro de los responsables de
la puesta en el mercado de productos sanitarios:
– De la clase I.
– A medida.
– Agrupación de productos sanitarios con marcado CE.
– **Esterilización de agrupación de productos con marcado CE.**
– Esterilización de productos no estériles dispuestos para ser esterilizados antes del uso.
– De diagnóstico in vitro.
Thanks
Preparación y supervisión de la documentación exigida para el registro de los responsables de
la puesta en el mercado de productos sanitarios:
– De la clase I.
– A medida.
– Agrupación de productos sanitarios con marcado CE.
– **Esterilización de agrupación de productos con marcado CE.**
– Esterilización de productos no estériles dispuestos para ser esterilizados antes del uso.
– De diagnóstico in vitro.
Proposed translations
(English)
| 4 +2 | Sterilisation for product groups/groups of products |
liz askew
|
Proposed translations
+2
45 mins
Selected
Sterilisation for product groups/groups of products
Guidance on the Manufacture of Sterile ... - Pmdawww.pmda.go.jp › files
PDF
Sterile Pharmaceutical Products Produced by Terminal Sterilization. With the support ... sterilization processes established for groups of similar products already.
Sterile Pharmaceutical Products Produced by Terminal Sterilization. With the support ... sterilization processes established for groups of similar products already.
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Discussion
Products that need CE marking | nibusinessinfo.co.ukwww.nibusinessinfo.co.uk › content › products-need-ce-marking
CE marking applies to the following product groups: active implantable medical devices; appliances burning gaseous fuels; cableway installations designed to ...
so agrupacion de productos = product groups
Medical devices class I have the lowest perceived risk. The manufacturers of such devices can choose one out of three possible CE marking routes. In this regard, they should consider the following: if the medical device is sterile, e.g., a personal protection kit; if the medical device has measuring functions, e.g., stethoscope; and, if it’s not sterile, nor measuring, e.g., corrective glasses. If your product is class I, and it’s not a sterile or measuring device, then all you need to do is to self-certificate it, and formally declare its compliance with the applicable requirements of the MDD via a written statement. If it’s a sterile or a measuring medical device, then you will need a Notified body assessment.
Table 1: CE marking routes of Class I Medical Devices