SIST EN ISO 10993-14:2009

Oznaka standarda: SIST EN ISO 10993-14:2009
Koda projekta: 00206054
Organizacija: SIST
Naslov (angleški): Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
Naslov (slovenski): Biološko ovrednotenje medicinskih pripomočkov - 14. del: Prepoznavanje in ugotavljanje količine razgradnih produktov iz keramike (ISO 10993-14:2001)
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SIST EN ISO 10993-14:2009 angleški jezik Active SIST-F: 59.40 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 two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. Because of the generalized nature of this part of ISO 10993, product specific standards, when available, that address degradation product formation under more relevant conditions of use, should be considered first. This part of ISO 10993 considers only those degradation products generated by a chemical dissociation of ceramics during in vitro testing. No degradation induced by mechanical stress or external energy is covered. It is noted that while ISO 6872 and ISO 9693 cover chemical degradation tests, they do not address the analysis of degradation products. Because of the range of ceramics used in medical devices and the different requirements for accuracy and precision of the results, no specific analytical techniques are identified. Further, this part of ISO 10993 provides no specific requirements for acceptable levels of degradation products.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN ISO 10993-14:2002 - Biološko ovrednotenje medicinskih pripomočkov – 14. del: Prepoznavanje in ugotavljanje količine razgradnih produktov iz keramike (ISO 10993-14:2001) 01-jul-2009


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