Amendements minéraux basiques carbonatés — Détermination de la réactivité — Méthode par titration au...
Le présent document spécifie une méthode pour la détermination de la réactivité des amendements minéraux basiques à base de carbonate de calcium ou à base de carbonate de calcium et de magnésium. Il évalue la rapidité et l'efficacité de leur potentiel de neutralisation par titration automatique à l'acide citrique.
Cette méthode s'applique uniquement aux amendements minéraux…
Implants chirurgicaux — Hydroxyapatite — Partie 2: Revêtements à base d'hydroxyapatite, obtenus...
Le présent document spécifie les exigences relatives aux revêtements monocouches à base d'hydroxyapatite obtenus par projection thermique, appliqués sur les implants chirurgicaux métalliques.
Ces exigences visent à décrire les propriétés du matériau et à les communiquer entre différents organismes. Ces exigences ne sont pas rédigées en vue de remplacer les exigences de fonctionnement et d…
Carbonate liming materials — Determination of reactivity — Automatic titration method with citric ac...
This document specifies a method for determining the reactivity of calcium carbonate and calcium magnesium carbonate liming materials. It assesses the speed and effectiveness of their neutralising potential by automatic titration with citric acid.
This method is applicable only to liming materials with a maximum particle size of 6,3 mm determined in accordance with ISO 20977.
NOTE For…
Non-destructive testing of welds — Ultrasonic testing — Use of automated phased array technology for...
This document specifies the application of phased array technology for the semi- or fully automated ultrasonic testing of fusion-welded joints in steel parts with thickness values between 3,2 mm and 8,0 mm. This meets the typical range of tube wall thickness values in boilers, which is an important application of this testing technology. The minimum and maximum value of the wall thickness range…
Biotechnology — Ancillary materials present during the production of cellular therapeutic products —...
This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products.
This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.
This document does not cover the selection, assessment or…
Biotechnology — Ancillary materials present during the production of cellular therapeutic products —...
This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation.
This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to…
Biotechnology — Ancillary materials present during the production of cellular therapeutic products —...
This document provides guidance for ancillary material (AM) users. It is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells.
This document focuses primarily on ancillary materials (AMs) of biological (human and animal) origin and their potential impurities and contaminants.…
