SIST EN ISO 10993-18:2009

Oznaka standarda: SIST EN ISO 10993-18:2009
Koda projekta: 00206058
Organizacija: SIST
Naslov (angleški): Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
Naslov (slovenski): Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov (ISO 10993-18:2005)
Če kupite standardizacijski dokument v .pdf formatu prek spletne prodaje, vam nudimo 20% popust pri spodnji ceni brez DDV. Cenik SIST
Dokumenti
Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 10993-18:2009 angleški jezik Active SIST-G: 66.00 EUR
PDF
Papir
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 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example: - As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971). - Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17). - Judging equivalence of a proposed material to a clinically established material. - Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former. - Screening of potential new materials for suitability in a medical device for a proposed clinical application. This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003). This part of ISO 10993 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN ISO 10993-18:2005 - Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov (ISO 10993-18:2005) 01-jul-2009
Revidiran oSIST prEN ISO 10993-18:2018 - Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev lastnosti materialov znotraj procesov obvladovanja tveganja (ISO/DIS 10993-18:2018) 01-nov-2018


• Slovenski standardi SIST s cenovnim razredom AC so popravki standardov in so v večini primerov brezplačni.

• Slovenski standardi SIST s cenovnim razredom AP so privzeti tuji standardi, katerih sestavni del je izvirni standard, ki ga moramo pridobiti pri izdajatelju v tujini. Naročilo pošljite na: prodaja@sist.si.

Najbolje prodajani standardi