SIST - Slovenian Institute for Standardization

This document specifies the requirements for solid wall pipes with smooth internal and external surfaces, extruded from the same formulation throughout the wall, fittings and the piping system of unplasticized poly(vinyl chloride) (PVC-U) intended for soil and waste discharge applications (low and high temperature)
-   above ground inside the building, or outside buildings fixed onto the wall; which is reflected in the marking by “B”;
-   for both inside buildings and buried in ground within the building structure, which is reflected in the marking by “BD”. This intended use is only applicable for components with nominal outside diameters equal to or greater than 75 mm.
NOTE 1   Multilayer pipes with different formulations throughout the wall and foamed core pipes are covered by EN 1453-1[1].
PVC-U pipes, fittings and the system complying with this document are also suitable for the following purposes:
-   ventilating part of the pipework in association with discharge applications;
-   rainwater pipework within the building structure.
This document covers a range of nominal sizes, a range of pipes and fittings series and gives recommendations concerning colours.
Pipes, fittings and other components conforming to any of the plastics product standards listed in Annex B can be used with pipes and fittings conforming to this document, provided they conform to the requirements for joint dimensions given in Clause 7 and to the requirements of Table 26.
NOTE 2   EN 476[2] specifies the general requirements for components used in discharge pipes, drains and sewers for gravity systems. Pipes and fittings conforming to EN 1329-1 fully meet the EN 476 requirements.

IEC 62841-3-11:2024 applies to transportable combined mitre and bench saws intended to be used with a toothed saw blade for cutting wood and analogous materials, plastics and nonferrous metals except magnesium with a saw blade diameter not exceeding 315 mm, which hereinafter is simply referred to as saw or tool.
This document does not apply to:
- saws intended to cut other metals, such as magnesium, steel and iron, or food;
- saws with an automatic feeding device;
- saws designed for use with abrasive wheels;
- saws designed for use with dado blades;
- single function bench or table saws;
- single function mitre saws;
- combined mitre and bench saws other than transportable.
NOTE 101 Transportable saws intended to cut ferrous metals will be covered by a future part of IEC 62841-3.
NOTE 102 Transportable tools designed for use with abrasive wheels are covered by IEC 62841-3-10:2015.
NOTE 103 Transportable table saws are covered by IEC 62841-3-1:2014.
NOTE 104 Transportable mitre saws are covered by IEC 62841-3-9:2020.
NOTE 105 In Europe (EN IEC 62841-3-11), the following additional NOTE applies:
NOTE Z101 Combined mitre and bench saws other than transportable are covered by EN 1870-3:2014.
This document is to be used in conjunction with IEC 62841-1:2014. This document supplements or modifies the corresponding clauses in IEC 62841-1, so as to convert it into the IEC Standard: Particular requirements for transportable combined mitre and bench saws.

This document specifies the requirements for the rescue coupler for train sets compliant with the Technical Specification for Interoperability Locomotives and Passenger rolling stock (TSI Loc & Pas).
This document defines the rescue coupler foreseen to connect rescue vehicle equipped with draw hook, according to EN 15566 together with the train to be rescued equipped with Type 10 automatic coupler according to EN 16019.

This document specifies a test method for the verification of the resistance to hydrostatic pressure of explosives for blasting and a test method for the verification of the resistance to hydrostatic pressure of explosives for boosters.
This document does not apply to black powder.
This document does not apply to explosive substances.

2021-12-07: This prAA includes CMs to prEN IEC (PR=75392)
DOW=DOR+48 months

This document specifies a procedure to determine the release of metals from metallic materials used in products intended to come into contact with drinking water.
The test can be used for three purposes:
a)   To assess a material as a reference material for a new category of materials by metal release testing using the results of several investigations in different waters covering a broad range of water compositions;
b)   To assess a material for an existing category for approval by way of metal release testing using the water defined in part 2, which exhibited the highest metal release when the reference material of the category was tested;
c)   To obtain data on the interaction of local water with a material.

This document specifies requirements for the respiratory tubing and connectors used to convey respirable gases to a patient in the healthcare and homecare environments and provide a safe connection between the gas supply device and the patient interface. Respiratory tubing and connectors are mainly used for delivery of oxygen but can also be used for respirable air or oxygen/air mixtures and breathable medicinal gas mixtures such as oxygen/nitrous oxide or oxygen/helium mixtures. This document also specifies requirements for respiratory therapy extension tubing.
NOTE 1        The gas supply devices referred to in this document do not include anaesthetic machines/workstations and ventilators.
NOTE 2        This document does not cover breathing tubes for breathing systems. These are specified in ISO 5367.
This document is written following the format of ISO 18190, General standard for airways and related equipment. The requirements in this device-specific standard take precedence over any conflicting requirements in the General standard

IEC 60669-2-4:2024 applies to manually operated general purpose isolating switches with a rated voltage not exceeding 440 V and a rated current not exceeding 125 A, intended for household and similar fixed electrical installations, either indoors or outdoors. This second edition cancels and replaces the first edition published in 2004. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
a) revision of the present edition with reference to the published IEC 60669-1:2017 Edition 4 with its amendments and references to clauses and tables;
b) introducing the values for isolating switches with ratings from 6 A to 13 A;
c) introducing a circuit motor load with a rated current not exceeding 10 A and a power factor not less than 0,6 in the scope;
d) modification of Table 1 and Table 5.

This document specifies definitions, principles of construction (but not dimensions) and design, requirements on performance and operation as well as methods for testing the performance of adjustable chemical dosing systems for conditioning water intended for human consumption inside buildings (see [1]) which are permanently connected to the mains supply.

This document applies to portable residual current devices (PRCDs) for household and similar uses, consisting of a plug, a residual current device (RCD) and one or more socket-outlets or a provision for connection. They do not incorporate overcurrent protection. They are intended for single- and two-phase systems for rated currents not exceeding 16 A for rated voltages not exceeding 250 V AC. They are intended to provide protection against shock hazard in case of direct contact, in addition to the protection provided by the fixed installations for the circuit downstream. PRCDs have a rated residual operating current not exceeding 0,03 A. The plug and socket-outlet parts of a PRCD are covered by the national standard of the country where the PRCD is placed on the market. This document applies to portable devices performing simultaneously the functions of detection of the residual current, of comparison of the value of this current with the residual operating value and of opening of the protected circuit when the residual current exceeds this value. PRCDs providing an additional function of detecting faults on the supply side with a defined behaviour in case of supply failures or miswiring (PRCD-S) are also covered by this document. PRCDs are not intended to be used as parts of fixed installations. Their connecting means can be plugs, socket-outlets, terminals or cords. NOTE 1 The requirements for PRCDs are in compliance with the general requirements of IEC 60755. PRCDs are essentially intended to be operated by ordinary persons and designed not to require maintenance. NOTE 2 An integral fuse is used, if necessary, for the relevant plug and socket-outlet system. The switching contacts of the PRCDs are not intended to provide isolation, as isolation can be ensured by disconnecting the plug. The requirements of this document apply for environmental conditions as defined in 7.1. Additional requirements can be necessary for PRCDs used in locations having more severe environmental conditions. PRCDs including batteries are not covered by this document. This document does not contain additional requirements for PRCDs without earthing contacts for which specific requirements can apply. This document can, however, be used as a guide for such devices which are intended to be used with Class II appliances only.

This document is applicable to calcium carbonate used for treatment of water intended for human consumption. It describes the characteristics of calcium carbonate and specifies the requirements and the corresponding test methods for calcium carbonate. It gives information on its use in water treatment.

This document specifies a procedure for obtaining a migration water to determine odour, flavour, colour and turbidity for products made from organic materials intended to come in contact with water for human consumption (drinking water) and used in piping and storage systems. Such products include pipes, tanks, reservoirs, fittings, ancillaries and their coatings both for site applied and factory-made products.
This document is applicable to products to be used under various conditions for the transport, storage and distribution of water intended for human consumption and raw water used for the manufacture of water intended for human consumption.
This document specifies a test method comprising a set of procedures. The use may be dependent on the relevant national regulations and/or the Commission Implementing Decision (EU) 2024/368.

This document specifies a test method for the verification of the resistance to water of explosives for blasting and boosters.
NOTE   This test method applies to situations where an explosive for blasting or a booster is subjected to high humidity and contact with water.
This document does not apply to black powder.
This document does not apply to explosive substances.

IEC 62196-2:2025 applies to EV plugs, EV socket-outlets, vehicle connectors and vehicle inlets with pins and contact-tubes of standardized configurations, herein referred to as "accessories". These accessories have a nominal rated operating voltage not exceeding 480 V AC, 50 Hz to 60 Hz, and a rated current not exceeding 63 A three phase or 70 A single phase, for use in conductive charging of electric vehicles.
This fourth edition cancels and replaces the third edition published in 2022. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) addition of new tests for latching devices;
b) corrections to standard sheets.

IEC 62196-1:2025 is applicable to EV plugs, EV socket-outlets, vehicle connectors, vehicle inlets, herein referred to as "accessories", and to cable assemblies for electric vehicles (EV) intended for use in conductive charging systems which incorporate control means, with a rated operating voltage not exceeding
- 690 V AC 50 Hz to 60 Hz, at a rated current not exceeding 250 A, and
- 1 500 V DC at a rated current not exceeding 800 A.
This fifth edition cancels and replaces the fourth edition published in 2022. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) addition of new tests for latching devices and retaining means;
b) inclusion of type 4 accessories.

This document provides guidance to the food industry, service providers and control laboratories on methodologies to be used for sample preparation, detection, identification and measurement of nano objects in inorganic food additives incorporated in food matrices.
Electron microscopy combined with energy dispersive X-ray spectroscopy (EM-EDX) and inductively coupled plasma mass spectrometry (ICP-MS) operated in single particle mode (spICP-MS) are the selected measurement methodologies to provide information on (i) the chemical composition and (ii) number-based particle size distribution of the nano-objects.
Special attention is given to the sample preparation, including matrix digestion, sample extraction and dilution steps to be used according to the combination of (i) the chemical nature of the food additive, (ii) the type of food matrix and (iii) the analytical technique of choice (EM-EDX or spICP-MS).

IEC 62133-1:2026 specifies requirements and tests for the safe operation of portable sealed secondary nickel cells and batteries containing alkaline electrolyte, under intended use and reasonably foreseeable misuse. This second edition cancels and replaces the first edition of IEC 62133-1 published in 2017. It constitutes a technical revision.
This edition includes the following significant technical changes with respect to IEC 62133 1:2017:
a) removal of the definition "secondary battery";
b) removal of the definition "portable battery";
c) "removal of the definition "portable cell";
d) replacement of the single term "room temperature" with 20 °C ± 5 °C in 7.2.3;
e) modification of Figure 1.

This document provides guidance for users in the correct selection and usage of routinely available techniques for the determination of the aggregation and agglomeration state of nano-objects in powders, aerosols and suspensions. It provides guidance on measurands and measurement methods to use along with guidance on sample preparation.

This document gives guidance on the labelling and information folder of potentially permanent magnet containing products in the context of information exchange between supply chain actors to improve recyclability of permanent magnets.
This document can be used by any natural or legal person that will place into the EU market products containing permanent magnets. The document is horizontal by nature and can potentially be applied to any type of permanent magnet containing product. Explicitly in scope are the product- and component groups mentioned in the introduction, as soon the total mass of permanent magnets is above the reporting level threshold specified 4.1 of this document.
The document specifies:
1.   the graphical format, application, and location of the labels, so they are easily located, legible, and scannable in the end-of-life state of the products in a way that is suitable for products of different sizes and complexity;
2.   the specifications of the data carrier, both in its physical format as placed on the product, and the accessibility, security, and verifiability of information;
3.   the access rights of relevant stakeholders to information;
4.   the information to be supplied regarding the location and composition of the permanent magnets;
5.   the information to be supplied regarding adjacent materials like coatings and fixation features, including adhesives;
6.   how to create step-by-step instructions for accessing and safely removing the permanent magnets, specifying the tools and technologies required, providing the recyclers a practically useful, unequivocal guide on how the disassembly of the magnets can be done most efficiently, and
7.   the format of the data to be supplied as per the previous points 4. – 6.
Labelling is employed for products which encompass at least one component mentioned above or a singular magnet, including segmented magnets, which holds a total mass of magnetic material as described in Table 1. Other magnet-holding components within a product that fall below that threshold are exempt from declaration and labelling. The purpose of these thresholds is to establish a sensible balance between the efforts required by both the responsible entities for labelling, as well as the efforts by the dismantlers and recyclers, and the output of recycled material. By excluding potential scrap sources where the yield would not warrant the effort, the work can be simplified for both sides.

This document specifies a method for determining the total content (solvent extractable) of melamine in chemicals for the leather tanning industry.
This method requires the use of liquid chromatography (LC) with a triple quadrupole mass spectrometer (MS/MS), an ultraviolet (UV) detector, or diode array detector (DAD) to identify and quantify the melamine.

This document defines Product Category Rules (PCR) providing guidelines and rules for developing a type III environmental declaration (as in EN 15804:2012+A2:2019) for ceramic tiles produced by extrusion and dry-pressing techniques, mainly used for internal and/or external floorings and walls coverings, facade cladding.
The c-PCR:
-   define the indicators to be declared, information to be provided and the way in which they are collated and reported;
-   describe which stages of ceramic tiles’ life cycle are considered in the EPD and which processes are to be included in the life cycle stages;
-   define rules for the development of scenarios;
-   include the rules for calculating the Life Cycle Inventory and the Life Cycle Impact Assessment underlying the EPD, including the specification of the data quality to be applied;
-   include the rules for reporting predetermined, environmental and health information, that is not covered by LCA for a ceramic tile, construction process and construction service where necessary;
-   define the conditions under which ceramic tiles can be compared based on the information provided by EPD;
-   include Annex A to Annex E in alignment to EN 15804:2012+A2:2019.
This PCR is intended to be used for cradle to grave and module D assessment.

This part of IEC 63522 is used for testing along with the appropriate severities and conditions for measurements and tests designed to assess the ability of DUTs to perform under expected conditions of transportation, storage and all aspects of operational use.
The objective of this test is to ensure that the properties of the relay coil(s) are within the specified limits.

The present document provides an overview of the Recommendation ITU-T X.509 | ISO/IEC 9594-8 [i.3] based certificate profiles and the statements for EU Qualified Certificates specified in other parts of ETSI EN 319 412 ([i.4] to [i.7]). It specifies common data structures that are referenced from other parts of ETSI EN 319 412 ([i.4] to [i.7]). The profiles specified in this multi-part deliverable aim to support both Regulation (EU) No 910/2014 [i.9] and the use of certificates in a wider international context. Within the European context, it aims to support both EU Qualified Certificates and other forms of certificate.

This document specifies requirements for the optical and geometrical properties of semi-finished blanks.

This document specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. It is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.
This document helps an organization to achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. The intended outcomes of an environmental management system include:
enhancing environmental performance;
meeting compliance obligations;
achieving environmental objectives.
This document is applicable to any organization, regardless of size, type or nature, and applies to the environmental aspects of its activities, products and services that the organization determines it can either control or influence considering a life cycle perspective. This document does not state specific environmental performance criteria.
This document can be used in whole or in part to systematically improve environmental management. Claims of conformity to this document, however, are not acceptable unless all its requirements are incorporated into an organization’s environmental management system and fulfilled without exclusion.

NeTEx is dedicated to the exchange of scheduled data (network, timetable and fare information). It is based on Transmodel V6.2 (EN 12896 series) and SIRI (CEN/TS 15531-4/-5 and EN 15531-1/-2/-3) and supports the exchange of information of relevance for passenger information about public transport services and also for running Automated Vehicle Monitoring Systems (AVMS).
NOTE Many NeTEx concepts are taken directly from Transmodel. The definitions and explanation of these concepts are extracted directly from the respective standard and reused in NeTEx, sometimes with adaptions in order to fit the NeTEx context.
Although the data exchanges targeted by NeTEx are predominantly oriented towards provisioning passenger information systems and AVMS with data from public transport scheduling systems, it is not restricted to this purpose. NeTEx can also provide an effective solution to many other use cases for transport data exchange.

This document specifies the dimensions of empty paper sacks and specifies a method of measuring those dimensions.

This document specifies procedures for detecting the presence of porosity in a protective paint system of any thickness on a steel or other metallic substrate. The procedures given in this document are based on methods using two different types of test equipment, the choice of equipment depending on the dry-film thickness. These procedures are only applicable to the testing of electrically non-conductive parts of a paint system.
The test methods specified are mainly intended for use with new coatings, but can also be used for coatings which have been in service for some time. In the latter case, it is important to bear in mind that the coating can have been penetrated by substances in contact with the coating during service.

This document establishes a framework and specifies electronic fee collection (EFC) functions for the personalization process of on-board equipment (OBE) used for EFC.
The personalization process takes place within the domain of the entity that is responsible for the application in the OBE.
This document is applicable to the EFC interface, e.g. using dedicated short-range communication or integrated circuit(s) card, between the personalization equipment (PE) and OBE as shown in Figure 1.
This document does not cover the following:
whether the personalization functionality resides completely in the PE or whether this functionality instead resides in a central system, where the PE is more or less “transparent”;
the exact application command or message structures for the EFC personalization functionality (these are dependent on the communication media and are described in subsequent parts of the ISO 21719 series);
the test procedures for evaluation of an implementation for conformity to the requirements in this document;
setting-up of operating organizations (e.g. toll service provider, personalization agent, trusted third party).
NOTE            Some of the issues listed above are subject to separate documents prepared by ISO/TC 204, CEN/TC 278 and the European Telecommunications Standards Institute – Electromagnetic compatibility and Radio Spectrum Matters (ETSI ERM).

IEC 61757:2026 defines, classifies, and provides a framework of generic tests or measurement methods for characterizing and specifying fibre optic sensors, including their specific components and subassemblies. The requirements of this document apply to all related fibre optic sensor standards that are part of the IEC 61757 series. Other parts of the IEC 61757 series contain requirements that are specific to sensors that measure particular quantities, and to a particular style or variant of such a fibre optic sensor. This second edition cancels and replaces the first edition published in 2018. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) expansion of the list of metrological parameters;
b) updates of the terms and definitions;
c) updates of the normative references and bibliography;
d) updates of the technical descriptions in Annex A.

This document is a profile of CEN/TS 16614 series. It focuses on information relevant to feed passenger information services and excludes operational and fares information.
NeTEx is dedicated to the exchange of scheduled data (network, timetable and fare information) based on Transmodel V6 (EN 12986) and SIRI (CEN/TS 15531-4/5 and EN 15531-1/2/3) and supports information exchange of relevance to public transport services for passenger information and AVMS systems.
As for most data exchange standards, defining subsets of data and dedicated rules for some specific use case is of great help for implementers and for the overall interoperability. This subset is usually called profile and this profile targets passenger information as only use case.

The present document specifies technical requirements, limits and test methods for Tilted Level Probing Radar (LPR) equipment using a downward tilted orientation of the LPR antenna in the three tilting ranges ±15°, ±30° and ±45° in relation to the strictly vertical downward direction and operating in the frequency range 75 GHz to 85 GHz in outdoor as well as indoor environments. Tilted LPR equipment in the scope of the present document consist of a combined transmitter and receiver and are equipped with an integral or dedicated antenna provided also by the equipment manufacturer. Equipment intended to be equipped with antennas from a third-party are not covered by the scope of the present document. Equipment exhibiting a receive only mode or a standby mode are also not covered by the scope of the present document. Furthermore, the present document is limited to tilted LPR equipment with FMCW modulation. Tilted LPR equipment and the related categorization is further specified in clause 4.2. NOTE: The relationship between the present document and essential requirements of article 3.2 of Directive 2014/53/EU [i.1] is given in Annex A.

This document presents Part 2 of the European Technical Specification known as “NeTEx”. NeTEx provides a framework for specifying communications and data exchange protocols for organisations wishing to exchange scheduled Information relating to public transport operations. As defined by Transmodel, 'Public transport' has to be understood as services advertised and available for use by the general public carried out by any means of transport.
This Technical Specification is made up of six parts defining a single European Standard, which provides a complete exchange format for public transport networks, timetable description and fare information.
Part 1 is the description of the public transport network topology exchange format. It also contains use case shared with part 2, and modelling rules and the description of a framework shared by all parts.
Part 2 is the description of the scheduled timetables exchange format.
Part 3 is the description of the fare information exchange format.
Part 4 is the description of the European passenger information profile.
Part 5 is the description of the alternative modes exchange format.
Part 6 is the description of the European passenger information accessibility profile.
Part 1 is fully standalone, and parts 2, 3, 4, 5 and 6 rely on Part 1 and possibly any previous part..
The XML schema can be downloaded from http://netex-cen.eu (or directly from https://github.com/NeTEx-CEN/NeTEx), along with available guidance on its use, example XML files, and case studies of national and local deployments.
This document is highly technical, and a special care has been taken to keep the text readable. In particular a set of formatting conventions is followed that enhances the usual CEN writing rules in order to distinguish references to elements of the formal models within text:
Transmodel terms and NeTEx conceptual model elements are in capital letters (JOURNEY PATTERN for example).
NeTEx physical model names are in bold italic font and use CamelCase style with no spaces (JourneyPattern, for example).
NeTEx physical model attribute types are in italic font and use CamelCase style with no spaces (TypeOfEntity, for example).

The present document defines a dictionary of parameters that are commonly used in multiple TC LI specifications. Aside from defining a dictionary, the present document aims to provide technical means for other specifications to use. It is encouraged to use the present document in the development of new specifications. It is foreseen that regular maintenance of the present document is required. As such, release management requirements will be defined. Before accepting any new common parameter, the present document will provide a set of requirements the parameter has to comply to in order to become a common parameter.

The present document specifies the general aspects of HI2 and HI3 interfaces for handover via IP based networks. The present document:
• specifies the modular approach used for specifying IP based handover interfaces;
• specifies the header(s) to be added to IRI and CC sent over the HI2 and HI3 interfaces respectively;
• specifies protocols for the transfer of IRI and CC across the handover interfaces;
• specifies protocol profiles for the handover interface.
The present document is designed to be used where appropriate in conjunction with other deliverables that define the service-specific IRI data formats (including ETSI TS 102 227 [i.1], ETSI TS 101 909-20-1 [33], ETSI TS 101 909-20-2 [34], ETSI TS 102 232-2 [5], ETSI TS 102 232-3 [6], ETSI TS 102 232-4 [32], ETSI TS 102 232-5 [37], ETSI TS 102 232-6 [36] and ETSI TS 102 232-7 [38]). Where possible, the present document aligns with 3GPP TS 33.108 [9] and ETSI TS 101 671 [4] and supports the requirements and capabilities defined in ETSI TS 101 331 [i.9] and ETSI TR 101 944 [i.4]. For the handover of intercepted data within GSM/UMTS PS and CS domains, the present document does not override or supersede any specifications or requirements in 3GPP TS 33.108 [9]. For the handover of services defined in 3GPP TS 33.128 [46], in the event of conflict between the present document and 3GPP TS 33.128 [46], the terms of 3GPP TS 33.128 [46] apply.

Within the field of health informatics, the DICOM (digital imaging and communication in medicine) standard addresses the exchange of digital images, and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information, such as Picture Archiving anc Communication System (PACS), Hospital Information System (HIS) and Radiology Information System (RIS).
This document is equivalent to part 1 of DICOM. As such, it normatively describes the content of DICOM (Clause 6) and the requirements to make a claim of conformance (Clause 5).
The DICOM standard is applicable to diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. It is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments.

This document covers the design of any rigid packaging with the main body of the packaging unit predominantly made of PS or XPS and the design of separate components predominantly made of rigid PS or XPS with respect to compatibility of the design with state-of-the-art collecting, sorting and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than PS and XPS are also covered by this document as they need to be evaluated on compatibility with PS or XPS polymer recycling.

This document specifies requirements for high chromium white cast iron grit, as supplied for blast-cleaning processes. It specifies ranges of particle sizes, together with corresponding grade designations. Values are specified for hardness, density, defect/structural requirements, metallographic structure and chemical composition.
The requirements specified in this document apply to abrasives supplied in the new condition only. They do not apply to abrasives either during or after use.
High chromium white cast iron grits are used in both static and site blasting equipment. They are most often selected where there is a possibility for the recovery and re-use of the abrasive.
NOTE 1 Although this document has been developed for preparation of steelwork, these materials are predominantly used for non-ferrous substrates. The properties specified will generally be appropriate for use when preparing other material surfaces, or components, using blast-cleaning techniques, and can be used for applications where no subsequent coating is applied.
NOTE 2 Whenever dissimilar metals are used together, galvanic corrosion can occur.

This document provides requirements for the evaluation process for bottles predominantly made of PET with respect to compatibility of the design with recycling processes.
Packaging components and ancillary elements made of other materials than PET are also covered by this document as they need to be evaluated for compatibility with the recycling processes.

This document covers the design of any rigid packaging which has its main component, in weight, predominantly made of EPS, with respect to compatibility of the design with state-of-the-art collecting, sorting, and recycling processes and useability of the recyclates in an application.
Packaging constituents and packaging components made of other materials than EPS are also covered by this document as they need to be evaluated on compatibility with polymer recycling.
Unless otherwise stated, in the interests of better readability, ‘EPS packaging’ always includes ‘EPS white goods packaging and fish boxes’.

This document specifies good clinical practice (GCP) for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies the general requirements intended to
protect the rights, safety and well-being of human subjects, users or other persons,
ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
define the responsibilities of the sponsor and principal investigator, and
assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
Other standards or national requirements can also apply to the investigational device(s) under consideration or the clinical investigation(s).
NOTE            For Software as a Medical Device (SaMD), where appropriate, demonstration of the analytical validity (the SaMD’s output is accurate for a given input), the scientific validity (the SaMD’s output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD’s output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [5]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document can consider whether either specific sections or requirements of this document, or both, can be applicable.

IEC 61512-1:2026 applies to systems, specifications, and their use for implementing batch and related procedure-oriented manufacturing controls in the process industries. This document establishes a reference model framework for procedure-oriented control, defines terms to help explain the model relationships and usage, and describes general criteria for evaluating conformance. This follows the principle of separation between recipe procedural elements and equipment procedural elements enabling operations to define recipes without the need of changes in equipment procedures.
This second edition cancels and replaces the first edition published in 1997. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) Models and text are modified to provide more detail and clarity. Key clarifications are:
1) Two types of equipment modules are defined: generic and recipe-aware. All recipe-aware equipment modules contain procedural control and can be used as phases in the recipe.
2) Execution of all procedural control contained directly in units is part of the Unit Supervision activity.
3) The relationships between types of recipes, recipe components, and equipment control are more fully described and illustrated.
4) Entity relationship diagrams have been replaced with more intuitive UML instance diagrams, except for the equipment entity model.
5) The transition diagram for the procedural states example has been updated with a more intuitive and complete UML state diagram.
6) References to other standards in the series and to IEC 62264 are included to provide direction for further clarification of selected topics.
7) Activity names are capitalised to help prevent confusion with similar terms, such as their underlying functions.
b) Previous Clauses 4 through 6 (now Clauses 4 through 8) were rearranged to provide a clearer top-down organisation of the document. Key changes are:
1) Removing the lower levels of the physical (role-based equipment) model (see 4.4.2) to eliminate redundancy because their groupings are defined by the associated functionality in the equipment entity model and are not meaningful for batch control without those associations.
2) Describing equipment control and the equipment entity model immediately after the physical (role-based equipment) model and describing each level as completely as possible without excessive use of forward references (see 4.4.3).
3) Combining the descriptions of basic, procedural, and coordination control with their usage in each type of equipment entity, providing a single consolidated discussion of each type of control (see Clause 5)
4) Additional considerations to support application of the models have been grouped in Clause 7 to clarify their supporting relationship to the core models.
c) Clause 9 was added to define completeness, compliance, and conformance in relation to this document.
d) Annex B was added to provide a more expansive procedural state reference model. The model found in Clause 7 can be considered a collapsed version of this more general model.
e) Annex C was added to clarify a number of points concerning the models, their application, and the new Clause 9 on conformance and compliance.
f) Annex E was added to more fully describe the changes in this update to IEC 61512-1:1997.

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.
This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier.
EXAMPLE 1           Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers).
NOTE 2        Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1.
NOTE 3        ISO 5367 specifies other safety and performance requirements for breathing tubes.
This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients.
NOTE 4        A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier.
EXAMPLE 2           Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12 also applies.
EXAMPLE 3           Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2‑72 also applies.
EXAMPLE 4           Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70 also applies.
EXAMPLE 5           Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79 or ISO 80601-2-80 also apply.
EXAMPLE 6           Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90 also applies.
This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture.
NOTE 5        ISO 9360‑1 and ISO 9360‑2 specify safety and performance requirements for a passive HME.
NOTE 6        If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.
NOTE 7        Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2.
This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789.
This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators to humidify the chamber