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This document specifies test methods and values for single-use sealable pouches and reels constructed of a porous material as specified in EN 868 part 2, 3, 6, 7, 9 or 10 and a plastic film. These sealable pouches and reels are intended to be used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

 

This document specifies test methods and values for re-usable containers used as sterile barrier systems for terminally sterilized medical devices. These containers are intended to be used in large steam sterilizers as specified in EN 285. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document. This document does not cover additional materials and/or accessories inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device).

 

This document defines the minimum requirements to ensure the interoperability of hydrogen refuelling points, including refuelling protocols that dispense liquid hydrogen to road vehicles that comply with legislation applicable to such vehicles. This document focuses on heavy-duty vehicles as defined in Regulation (EU) 2023/1804. The safety and performance requirements for the entire hydrogen fuelling station, addressed in accordance with existing relevant European and national legislation, are not included in this document. This document applies to hydrogen refuelling points and dispensing systems providing liquid hydrogen to vehicles compliant with Regulation (EU) 2019/2144. NOTE Guidance on considerations for hydrogen fuelling stations is provided in ISO 13984:-.

 

Smart Cards • Definition of a Smart Card that is in the scope of the Regulation (EU) 2024/2847, Annex 4, Category 41 o In reference to TC47X/WG3 work on Security MCU/MPU • Distinction between applicative part and general part of the architecture that is essential for composite evaluation • Expectation on applicative and composite evaluation in accordance with EUCC scheme Similar Devices • Definition of similar devices that are in- or out-of-scope of this standardisation category – for example: o Products in-scope that fully comply with architectural description of a compliant Smart Card but do come in different packaging (e.g. SIM-card form factors, key fobs, tokens, IoT embedded ID elements), etc. o Products out-of-scope that come packaged as a smart card but contain microcontrollers with security functions or tamper resistance appropriate for evaluation under other categories Secure Elements • Definition of a Secure Element that is on the scope of the Regulation (EU) 2024/2847, including description of possible architectures and required security capabilities, in alignment with TC47X • Distinction between applicative part and general part of the architecture that is essential for composite evaluation • Expectation on applicative and composite evaluation in accordance with EUCC scheme • Alignment of security capabilities of secure elements with microcontrollers and microprocessors with security functions and/or tamper resistance capabilities Related remote data processing • Technical criteria characterizing a remote data processing • Identification of remote data processing e.g. life cycle management, security update services…. • Standardized expectations on lifecycle management of Smart Cards and Secure Elements As part of the work, the group will cover at least the types of PwDE and their intended purposes in relation to use cases described in the list below. In addition, for some types of PwDE, expertise from external organizations which are recognized will be leveraged to ensure the project is relevant and in line with the reality of markets. Type of the Product with Digital Elements: 1. Secure element, Smart Cards and similar devices for critical use cases – high risk profile 2. Secure element, Smart Cards and similar devices for critical use cases – low risk profile 3. Remote data processing systems / services The list above is not finite, it represents initial state. The work of the group will first focus on delivering precise scope related to intended purpose and dependant use cases, in collaboration with other standardisation workgroups and industry representatives. Note on the use cases - Standard may cover specific aspects of particular use cases Note on risk profile - The mapping of compliance criteria with EUCC may be given - Standard may cover aspects of newer version of Common Criteria CC:2022, and other established schemes

 

The aim of this amendment is to modify some terms in definitions included in clause 3 and a paragraph of 5.2, according to EN 18601:2024

 

This document defines the assessment of endurable longitudinal compressive force (LCF) of a vehicle. The endurable longitudinal compressive force is a parameter depending on the vehicle design. It is used to estimate the risk of derailment of a vehicle as a result of being subjected to longitudinal compressive force, under operating conditions. NOTE 1 As operating conditions can vary in several aspects (infrastructure, train configurations etc.), this document defines uniform assessments of endurable longitudinal compressive force per vehicle in specific operating conditions. The main assessment of endurable longitudinal compressive force for conventional trains is derived from UIC 530-2:2011, which is based on practical tests performed in ERRI-B12. Assessments of endurable longitudinal compressive force for high-capacity trains in this document are required by the methodology of IRS 40421. IRS 40421 assesses operational train parameters. This document applies to the following types of vehicles: - single wagons; - permanently coupled units with standard ends between the vehicles; - permanently coupled units with diagonal buffers and screw couplers between the vehicles; - permanently coupled units with a bar coupler between the vehicles; - articulated units with 2-axle bogies; - wagons with 3-axle bogies; - low-floor wagons with eight or more axles (e.g. rolling road wagon); - vehicles with centre couplers; - railbound construction and maintenance machines as defined in EN 14033-1:2017. NOTE 2 This document defines the acceptance process to be followed by vehicles that are operated in a way that high longitudinal compressive force occur in the trains due to their operational environment (e.g. train composition, brake mode, track layout). The following vehicles are not in the scope of this document: - locomotives and passenger rolling stocks; - vehicles that are only operated in passenger trains. NOTE 3 Locomotives, passenger rolling stocks and vehicles operated in passenger trains only are not in the scope of this document as they either are subject to low longitudinal compressive force in operation or have sufficient endurable longitudinal compressive force due to their axle load. Acceptance criteria and test conditions as well as conditions for simulation are defined in this document. Conditions for dispensation of the assessment of the endurable longitudinal compressive force are also defined in this document. This document applies principally to vehicles which operate without restrictions on tracks with a gauge of 1 435 mm in Europe. NOTE 4 The influence on railway systems using other gauges is not sufficiently understood to extend the scope of this document to gauges other than 1 435 mm. NOTE 5 For wagons with centre couplers, a need for assessment of derailment risk due to Longitudinal Forces on other gauges (1 524 mm, 1 600 mm, 1 668 mm) has been expressed. The influence on railway systems using other gauges is not sufficiently understood. This document only introduces some notions to assess it independently from the gauge.

 

This document specifies the characteristics of screws, pan head, offset cruciform recess, close tolerance normal shank, short thread, in alloy steel, cadmium plated. Classification: 1 100 MPa1/235 °C2.

 

This document establishes the widely accepted definitions and concepts of servitization and advanced services to facilitate communication between industry stakeholders. It provides a framework that explains the breadth of the organizational transformation process required to develop an advanced services business model. lt also provides guidance on how to envision advanced services and the requirements for their effective delivery through servitization. Case studies for advanced services and servitization are provided in Annex A and Annex B. Although the concepts of advanced services and servitization have originated in a manufacturing context, the standard is equally applicable to other product-based organizations of any size that seek to provide any type of advanced services.

 

This document specifies the procedure for the determination/calculation of the dry matter content of inorganic fertilizers for which the results of the performed analysis are expressed in relation to the dry residue.

 

This document specifies the procedure for the extraction of different organic and organo-mineral fertilizers with 2 % formic acid (20 g/l) to enable a subsequent determination of phosphorus, representing the amount of soft natural phosphates. This document is applicable to the fertilizing products blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants, and where the following category: organic fertilizers, organo-mineral fertilizers is the highest % in the blend by mass or volume, or in the case of liquid form by dry mass. If the organic fertilizer or the organo-mineral fertilizer is not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible.

 

This document specifies a method for the determination of the biuret content by high-performance liquid chromatography (HPLC) with ultraviolet (UV) detector. This document is applicable to organic and organo-mineral fertilizers containing urea. This document is applicable to fertilizing products blends where a blend is a mix of at least two of the following products: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants and where organic matter is present in at least one of the products in the blend. In case a fertilizing product blend is composed only of inorganic products, the European Standard for inorganic fertilizers applies. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible. NOTE 1 This method was tested only for one fertilizing product blend during the inter-laboratory study. The product tested was a liquid organo-mineral mixture of a liquid organic fertilizer, a growing medium and a non-microbial plant biostimulant. NOTE 2 Nowadays, there is a method standardized as EN 15479 that allows the determination of biuret in urea by spectrophotometric detection. Organic and organo-mineral fertilizers contain organic matter and other compounds apart from urea that would interfere in a spectrophotometric method. HPLC allows an accurate determination of biuret by separating it from possible interfering compounds [2] [5].

 

This document specifies the procedure for digestion of different organic and organo-mineral fertilizers with aqua regia to enable a subsequent determination of arsenic (As), cadmium (Cd), copper (Cu), chromium (Cr), lead (Pb), nickel (Ni), boron (B), cobalt (Co), iron (Fe), manganese (Mn), molybdenum (Mo), zinc (Zn), mercury (Hg), phosphorus (P), potassium (K), magnesium (Mg), calcium (Ca), sulfur (S) and sodium (Na)). This document is applicable to the component materials “by-products”, when used as components of fertilizing products, as well as the fertilizing products blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants, and where the following category: organic fertilizers, organo-mineral fertilizers is the highest % in the blend by mass or volume, or in the case of liquid form by dry mass. If the organic fertilizer or the organo-mineral fertilizer is not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible. The digests are suitable for analysis using prEN 17770 [11] and prEN 17769 [10]. This document is applicable and validated for several types of matrices as indicated in Annex A. NOTE 1 Digestates prepared by the procedure given in this document can also be applied for determination of other elements. NOTE 2 Alternatively, inductively coupled plasma mass spectrometry (ICP-MS) can be used for the measurement if the user proves that the method gives the same results.

 

This document specifies a method for determination of the content of mercury (Hg) using (cold) vapour generation apparatus coupled to an atomic absorption spectrophotometer and a method using a direct amalgamation technique. It is applicable to aqua regia digests prepared according to prEN 17768. It is applicable to organic fertilizers and organo-mineral fertilizers. This document is applicable to the fertilizing product blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants and where the following category: organic fertilizers or organo-mineral fertilizers is the highest % in the blend by mass or volume, or in case of liquid form by dry mass. If organic fertilizers and organo-mineral fertilizers are not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible. NOTE It is also possible to use other suitable methods for the determination of mercury described in Annex A if users prove that the method gives the same results as the methods described in this document.

 

This document specifies the procedure for the determination and calculation of the dry matter content of organic and organo-mineral fertilizers for which the results of the performed analysis are to be calculated to the dry matter content basis. This document is applicable and validated for several types of matrices as indicated in Annex A. This document is applicable to the component materials “by-products”, “thermal oxidation materials and derivatives”, or “recovered high-purity materials”, when used as components of fertilizing products, as well as the fertilizing products blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants and where the following category organic fertilizers, organo-mineral fertilizers is the highest % in the blend by mass or volume, or in the case of liquid form by dry mass. If the organic fertilizer or the organo-mineral fertilizers is not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible.

 

This document is applicable to the component materials by-products, thermal oxidation materials and derivatives, or recovered high-purity materials, when used as components of fertilizing products. This document provides an overview of relevant methods for the determination of specific properties of these components when used in fertilizing products, including: — for the component materials “by-products”: — determination of the total iron content; — determination of the total zinc content; — determination of the total copper content; — determination of the total cobalt content; — determination of the total manganese content; — determination of the dry matter content; — determination of the total organic carbon content; — for the component materials “thermal oxidation materials and derivatives”: — determination of the dry matter content; — for the component materials “recovered high-purity materials”: — determination of the dry matter content; — determination of the total organic carbon content.

 

This document specifies a method for the determination of boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo), phosphorous (P) and zinc (Zn) in organic and organo-mineral fertilizers using inductively coupled plasma-atomic emission spectrometry (ICP-AES). NOTE 1 Alternatively, inductively coupled plasma mass spectrometry (ICP-MS) can be used for the measurement if the user proves that the method gives the same results. This method is applicable to extracts prepared according to prEN 17766, prEN 17767 and prEN 17779. NOTE 2 The method can be used for the determination of other elements, provided the user has verified the applicability. This document is applicable to the fertilizing products blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants, and where the following category: organic fertilizers, organo-mineral fertilizers is the highest % in the blend by mass or volume, or in the case of liquid form by dry mass. If the organic fertilizer or the organo-mineral fertilizer is not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible.

 

This document specifies a method for the determination of total organic carbon (TOC) by elemental analysis using dry combustion. The method is applicable to organic and organo-mineral fertilizers containing more than 1 g carbon per kg of dry matter (0,1 %), with the exclusion of organo-mineral fertilizers containing urea-formaldehyde polymers or urea as long as there is no method available to assess carbon in urea-formaldehyde polymers or urea. This document is applicable to the component materials “by-products”, or “recovered high-purity materials”, when used as components of fertilizing products, as well as the fertilizing products blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants and where the following category: organic fertilizers, organo-mineral fertilizers is the highest % in the blend by mass or volume, or in the case of liquid form by dry mass. If the organic fertilizer or the organo-mineral fertilizer is not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible. This document is applicable and validated for several types of matrices as indicated in Annex B.

 

This document specifies the procedure for the extraction of different organic and organo-mineral fertilizers with a solution of neutral ammonium citrate to enable a subsequent determination of phosphorus. This document is applicable to the fertilizing products blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil Improvers, growing media, inhibitors, plant biostimulants, and where the following category: organic fertilizers, organo-mineral fertilizers is the highest % in the blend by mass or volume, or in the case of liquid form by dry mass. If the organic fertilizer or the organo-mineral fertilizer is not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible.

 

This document specifies a method for the titrimetric determination of the ammoniacal nitrogen content in inorganic fertilizers (including compound fertilizers), in which nitrogen is found exclusively either in the form of ammonium salts or ammonium salts together with nitrates. This document is applicable to the fertilizing products blends where a blend is a mix of at least two of the following components: fertilizers, liming materials, soil improvers, growing media, inhibitors, plant biostimulants and where the following category: inorganic fertilizers is the highest % in the blend by mass or volume, or in the case of liquid form by dry mass. If inorganic fertilizers are not the highest % in the blend, the European Standard for the highest % of the blend applies. In case a fertilizing product blend is composed of components in equal quantity, the user decides which standard to apply. Variations in analytical methods for fertilizing product blends can lead to differing results as some components or matrix interactions can affect the outcome. Validation procedures have shown that developed standard methods are robust and reliable across diverse product compositions, but possible interferences and unexpected results when analysing fertilizing product blends are possible. In the case of application to ammonium nitrate fertilizers of high nitrogen content, this document is not applicable to fertilizer product blends. This document is not applicable to fertilizers or fertilizer product blends containing urea, cyanamide, nutrient polymers or other organic nitrogenous compounds.

 

The scope of this proposal is to establish a methodology and analytical framework to determine the GHG emissions related to the production and transport of Ammonia up to the consumption gate and related to the conversion of Ammonia into hydrogen and its transport to consumption gate.