BS EN ISO 4945:2018 Ferrous alloys, Steel. Determination of nitrogen. Spectrophotometric method

BS EN ISO 4945:2018

Steel. Determination of nitrogen. Spectrophotometric method

Status : Current   Published : December 2018



What is this standard about?

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.

NOTE 1 The decision chart in Figure 1 illustrates the rationale underlying the scope of this document.

However, diverse biological sources, including plants, insects and marine organisms, can also be used in the development of a cellular therapeutic product. Therefore the fundamental principles of risk management also apply for these sources of AMs.

This document does not cover the selection, assessment or control of starting materials and excipients. However, it is anticipated that these are still covered by general risk management procedures.

This document is applicable for users at all stages of clinical development and supply; however maximum benefits can be gained by the implementation of the recommendations in the early stages of development.

NOTE 2 International, regional or national regulations or requirements can also apply to specific topics covered in this document.

Standard NumberBS EN ISO 4945:2018
TitleSteel. Determination of nitrogen. Spectrophotometric method
Publication Date05 December 2018
Normative References(Required to achieve compliance to this standard)ISO 3696, ISO 14284, ISO 1042, ISO 648
Informative References(Provided for Information)ISO 5725-3:1994, ISO 5725-2:1994
ReplacesBS EN ISO 4945:2009
International RelationshipsEN ISO 4945:2018,ISO 4945:2018
Draft Superseded By17/30312516 DC
DescriptorsCalibration, Ferrous alloys, Chemical analysis and testing, Steels, Spectrophotometry, Determination of content, Distillation methods of analysis, Unalloyed steels, Complexing methods, Alloy steels, Nitrogen, Test equipment, Low-alloy steels
Title in FrenchAcier. Détermination de l'azote. Méthode spectrophotométrique
Title in GermanStahl. Bestimmung des Stickstoffgehalts. Spektralphotometrisches Verfahren
ISBN978 0 580 87942 5
File Size1.022 MB

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