SIST EN ISO 10993-12:2021

Oznaka standarda: SIST EN ISO 10993-12:2021
Koda projekta: 00206085
Organizacija: SIST
Naslov (angleški): Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Naslov (slovenski): Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:2021)
Če kupite standardizacijski dokument v .pdf formatu prek spletne prodaje, vam nudimo 10% popust pri spodnji ceni brez DDV. Cenik SIST
Dokumenti
Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 10993-12:2021 angleški jezik Active SIST-G: 72.60 EUR
PDF
Papir
Tehnični odbor: VAZ - Varovanje zdravja
ICS: 11.100.20
Status: Objavljen
Objavljen: 01-Sep-2021
Refer. št. objave: Sporocila 2021-09
Referenčna oznaka: EN ISO 10993-12:2021
Področje projekta (angleško): This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: — test sample selection; — selection of representative portions from a medical device; — test sample preparation; — experimental controls; — selection of, and requirements for, reference materials; — preparation of extracts. This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
Povezava na standarde
Povezava Ime Datum
Nadomešča SIST EN ISO 10993-12:2012 - Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:2012) 01-Sep-2021
Nadomešča SIST EN ISO 10993-12:2012 - Biološko ovrednotenje medicinskih pripomočkov - 12. del: Priprava vzorcev in referenčni materiali (ISO 10993-12:2012) 08-Jun-2022


• 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