Évaluation biologique des dispositifs médicaux — Partie 17: Appréciation du risque toxicologique des...
Le présent document spécifie le processus et les exigences pour l'appréciation du risque toxicologique des constituants des dispositifs médicaux. Les méthodes et les critères utilisés pour évaluer si l'exposition à un constituant ne présente pas de dommages significatifs sont également spécifiés. L'appréciation du risque toxicologique peut faire partie de l'évaluation…
Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device ...
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1.
The process described in…
Wood-based panels — Determination of formaldehyde release — Part 3: Gas analysis method
This document specifies a procedure for determination of accelerated formaldehyde release from uncoated and coated wood-based panels using the gas analysis method. The procedure is also suitable for the testing of other materials (e.g. edge bands, floor coverings, foams, foils, laminated wood products, veneered wood products, coated wood products).
Automation systems and integration — Industrial data — Nuclear digital ecosystem specifications
This document provides:
— a review and summary of the adoption of digital methods and technology in the national nuclear sectors;
— a summary of the state of the art of some of the standards supporting the digital representation and interoperability of industrial data;
— orientation on the use of these standards for model-based systems engineering (MBSE) in order to achieve a nuclear…
Sintered metal materials, excluding hardmetals — Tensile test pieces
This document is applicable to all sintered metals and alloys, excluding hardmetals.
This document specifies:
— the die cavity dimensions used for making tensile test pieces by pressing and sintering, and by metal injection moulding (MIM) and sintering;
— the dimensions of tensile test pieces machined from sintered and powder forged materials.
