SIST EN ISO 10993-17:2009

Oznaka standarda: SIST EN ISO 10993-17:2009
Koda projekta: 00206057
Organizacija: SIST
Naslov (angleški): Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
Naslov (slovenski): Biološko ovrednotenje medicinskih pripomočkov - 17. del: Postavitev dopustnih mej za izlužene snovi (ISO 10993-17:2002)
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Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 10993-17:2009 angleški jezik Active SIST-H: 71.50 EUR
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Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.100.20
Status: Objavljen
Objavljen: 01-jul-2009
Refer. št. objave: Sporočila 2009-07
Področje projekta (angleško): This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN ISO 10993-17:2003 - Biološko ovrednotenje medicinskih pripomočkov - 17. del: Postavitev dopustnih mej za izlužene snovi (ISO 10993-17:2002) 01-jul-2009


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