List of drafts

prEN 2084 Archived

Comment end date 2025-11-25

Aerospace series - Cables, electrical, general purpose, with conductors in copper or copper alloy - Technical specification

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prEN ISO 16958 Archived

Comment end date 2025-11-25

Milk, milk products, infant formula and adult nutritionals - Determination of fatty acids composition - Capillary gas chromatographic method (ISO/FDIS 16958:2025)

ISO 16958:2015 specifies a method for the quantification of individual and/or all fatty acids in the profile of milk, milk products, infant formula and adult nutritional formula, containing milk fat and/or vegetable oils, supplemented or not supplemented with oils rich in long chain polyunsaturated fatty acids (LC-PUFA). This also includes groups of fatty acids often labelled [i.e. trans fatty acids (TFA), saturated fatty acids (SFA), monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), omega-3, omega-6 and omega-9 fatty acids] and/or individual fatty acids [i.e. linoleic acid (LA), α-linolenic acid (ALA), arachidonic acid (ARA), eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)]. The determination is performed by direct transesterification in food matrices, without prior fat extraction, and consequently it is applicable to liquid samples or reconstituted powder samples with water having total fat ≥ 1,5 % m/m. The fat extracted from products containing less than 1,5 % m/m fat can be analysed with the same method after a preliminary fat extraction using methods referenced in Clause 2. Dairy products, like soft or hard cheeses with acidity level ≤ 1 mmol/100 g of fat, can be analysed after a preliminary fat extraction using methods referenced in Clause 2. For products supplemented or enriched with PUFA with fish oil or algae origins, the evaporation of solvents should be performed at the lowest possible temperature (e.g. max. 40 °C) to recover these sensitive fatty acids.

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prEN ISO 11615 Archived

Comment end date 2025-11-25

Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of regulated medicinal product information (ISO/DIS 11615:2025)

ISO 11615:2017 establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of Medicinal Products. Taken together, the standards listed in the Introduction define, characterise and uniquely identify regulated Medicinal Products for human use during their entire life cycle, i.e. from development to authorisation, post-marketing and renewal or withdrawal from the market, where applicable. Furthermore, to support successful information exchange in relation to the unique identification and characterisation of Medicinal Products, the use of other normative IDMP messaging standards is included, which are to be applied in the context of ISO 11615:2017.

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prEN ISO 21762 Archived

Comment end date 2025-11-25

Medical devices utilizing non-viable human materials - Risk management (ISO/DIS 21762:2025)

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

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prEN ISO 15136-1 Public enquiry

Comment end date 2025-11-30

Petroleum and natural gas industries - Progressing cavity pump systems for artificial lift - Part 1: Pumps (ISO/DIS 15136-1:2025)

ISO 15136-1:2009 provides requirements for the design, design verification and validation, manufacturing and data control, performance ratings, functional evaluation, repair, handling and storage of progressing cavity pumps for use in the petroleum and natural gas industry. ISO 15136-1:2009 is applicable to those products meeting the definition of progressing cavity pumps (PCP) included herein. Connections to the drive string and tubulars are not covered in ISO 15136-1:2009. ISO 15136-1:2009 establishes requirements for characterization and testing of stator elastomer material, design validation and functional evaluation and provides information for PCP elastomer selection and testing, installation, start-up and operation guidelines, equipment selection and application guidelines, functional specification form, used pump evaluation, drive string selection and use, repair and reconditioning procedures and auxiliary equipment. Equipment not covered by the requirements of ISO 15136-1:2009 includes bottom-drive systems except for the PCP components, drive-string components and auxiliary equipment such as tag bars, gas separators and torque anchors.

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prEN 17161 Archived

Comment end date 2025-11-20

Design for All approach - Managing accessibility of products and services

This document specifies requirements and recommendations that can enable an organization to design, develop and provide products and services so that they can be accessed, understood and used by the widest range of users, including persons with disabilities. This document specifies requirements and recommendations that can enable an organization to widen their range of users by identifying diverse needs, characteristics, capabilities, and preferences, by directly or indirectly involving users, and by using knowledge about accessibility in its procedures and processes. This document specifies requirements that can enable an organization to meet applicable statutory and regulatory requirements as related to the accessibility of its products and services. The requirements and recommendations set out in this document are generic and are intended to be applicable to all relevant parts of all organisations, regardless of type, size or products and services provided. This document promotes accessibility following a Design for All approach in mainstream products and services and interoperability of these with assistive technologies.

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prEN ISO/ASTM 52922 Archived