Biotechnology — Analytical methods — General requirements and considerations for the testing and cha...
This document provides general requirements for the testing of cellular therapeutic products intended for human use.
This document also provides considerations for the characterization of cellular therapeutic products, including approaches to select and design analytical methods that are fit for purpose.
Such considerations can be used to establish critical quality attributes for a cellular…
Biotechnologie — Méthodes analytiques — Exigences et considérations générales pour les essais et la ...
Le présent document fournit les exigences générales applicables aux essais de produits de thérapie cellulaire à usage humain.
Il fournit également des considérations applicables à la caractérisation de produits de thérapie cellulaire, y compris les approches de sélection et de conception de méthodes analytiques adaptées à l’usage prévu.
Ces considérations peuvent être utilisées pour établir les…
Flexible cellular polymeric materials — Determination of antibacterial effectiveness
This document specifies a method of determining the antibacterial effectiveness of open-cell flexible cellular polymeric antibacterial treated materials, including their intermediate and final products.
This document is suitable for flexible cellular polymeric materials because the test procedure enables the test inoculum to efficiently contact with the surface of open cell in the flexible…
Molecular biomarker analysis — Method for the statistical evaluation of analytical results obtained ...
This document describes general requirements, procedures and performance criteria for evaluating the content of genetically modified (GM) seeds/grains in a lot by a group testing strategy that includes qualitative analysis of sub-sampled groups followed by statistical evaluation of the results.
This document is applicable to group testing strategy estimating the GM content on a percentage seed/…
Tissue paper and tissue products — Part 7: Determination of optical properties — Measurement of brig...
This document specifies testing procedures for the instrumental determination of brightness and colour of tissue paper and tissue products viewed under outdoor daylight conditions. It also gives specific instructions for the preparation of test pieces (single-ply, multi-ply products) and for the optical measurements of products, where special precautions can be necessary.
NOTE The…
Meat and meat products — Determination of chloramphenicol content — Reference method
This document specifies the liquid chromatographic (LC) method for the determination of chloramphenicol content of muscle tissue of meat, including livestock and poultry.
This document specifies the liquid chromatography tandem mass spectrometry method (LC-MS/MS) for the determination of chloramphenicol content of muscle tissue, casing, liver of meat and meat products, including livestock and…
Nickels, ferronickels and nickel alloys — Standards for the determination of chemical composition
This document lists the International Standards which are currently available for the determination of the chemical composition of nickels, ferronickels and nickel alloys (see Clause 4).
It provides details on the range of application and gives the principle of the method described in each International Standard (see Clause 5).
Annex A shows graphical representations of the content ranges of the…
Nickels, ferronickels et alliages de nickel — Normes pour la détermination de la composition chimiqu...
Le présent document répertorie les normes internationales actuellement disponibles pour la détermination de la composition chimique des nickels, des ferronickels et des alliages de nickel (voir Article 4).
Il détaille le domaine d’application et donne le principe de la méthode décrite dans chaque norme internationale (voir Article 5).
L’Annexe A montre les représentations graphiques des domaines…
Information technology - Service management - Part 11: Guidance on the relationship between ISO/IEC ...
This document provides guidance on the relationship between ISO/IEC 20000–1 and a commonly used service management framework, ITIL 4. It can be used by any organization or person wishing to understand how ITIL can be used with ISO/IEC 20000–1, including:
a) an organization that has claimed or demonstrated or intends to claim or demonstrate conformity to the requirements specified in ISO/IEC 20000…
