SIST EN ISO 10993-18:2020/oprA1:2021

SLOVENSKI STANDARD
SIST EN ISO 10993-18:2020/oprA1:2021
01-oktober-2021
Biološko ovrednotenje medicinskih pripomočkov - 18. del: Kemična opredelitev
lastnosti materialov za medicinske pripomočke znotraj procesov obvladovanja
tveganja - Dopolnilo 1: Določitev faktorja negotovosti (ISO 10993-18:2020/DAM
1:2021)

Biological evaluation of medical devices - Part 18: Chemical characterization of medical

device materials within a risk management process - Amendment 1: Determination of the

Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung

Évaluation biologique des dispositifs médicaux - Partie 18: Caractérisation chimique des

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

Partie 18: Caractérisation chimique des matériaux des dispositifs médicaux au sein d'un processus de

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This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of

In the columns “Qualitative” and “Quantitative” for the example methods “HPLC, with UV, CAD, ELSD and/or

In the column “Anti-solvents” for “Polymer” Polystyrene and Styrenics (ABS), replace “can” by “ACN”

Quantification in extractables profiling is achieved by various means which differ with respect to

the accuracy of the estimated and reported concentration, where the accuracy can vary significantly

depending on the quantification means employed. For example, quantification could involve the use

of an internal standard to normalize the responses obtained for all relevant analytes. In such an

approach, one estimates the concentration of each analyte based on the simplifying assumption that

all analytes respond similarly, among themselves and with respect to the internal standard (i.e. all

substances have the same response factor). Depending on the validity of this simplifying assumption,

the concentration estimates thus obtained can have widely differing uncertainties and degrees of