SIST - Slovenian Institute for Standardization
The Slovenian Institute for Standardization is recognized as the national standards body in the Republic of Slovenia. SIST develops, adopts and maintains Slovenian standards, and participates in the work of international (ISO, IEC, ITU-T) and European Standardisation Organisations (CEN, CENELEC, ETSI) where its experts represent national interests.
SIST represents Slovenia in European (CEN, CENELEC, ETSI) and international standards organizations (ISO, IEC). As part of the European Union, SIST adopts European standards, ensuring alignment and harmonization with broader European standards.
- Technical report12 pagesSlovenian languagee-Library read for1 day
IEC 60749-21:2025 establishes a standard procedure for determining the solderability of device package terminations that are intended to be joined to another surface using tin-lead (SnPb) or lead-free (Pb-free) solder for the attachment. This test method provides a procedure for “dip and look” solderability testing of through hole, axial and surface mount devices (SMDs) as well as an optional procedure for a board mounting solderability test for SMDs for the purpose of allowing simulation of the soldering process to be used in the device application. The test method also provides optional conditions for ageing. This test is considered destructive unless otherwise detailed in the relevant specification.
NOTE 1 This test method does not assess the effect of thermal stresses which can occur during the soldering process. More details can be found in IEC 60749‑15 or IEC 60749‑20.
NOTE 2 If a qualitative test method is preferred, the Wetting balance test method can be found in IEC 60068-2-69.
This edition includes the following significant technical changes with respect to the previous edition:
- revision to certain operating conditions in line with current working practices.
- Standard24 pagesEnglish languagee-Library read for1 day
The amendment to EN IEC 60601-2-22:2020 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered).
These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.
- Amendment8 pagesEnglish languagee-Library read for1 day
- Technical specification15 pagesSlovenian languagee-Library read for1 day
This document specifies chemical product safety requirements and reference test methods for the following child care articles:
— Safety barriers
— Bedguards
— Baby carriers and child carriers
— Pushchairs and prams
— Carry cots, baby nests and carry cot stands
— Bath tubs and bathing aids
— Reclined cradles and infant swings
— Chair mounted seats
— Table mounted chairs
— Childs seats for bicycle
— Baby bouncers
— Children's harnesses and reins
— Baby walking frames
— Changing units
See also Clause A.1.
- Standard17 pagesEnglish languagee-Library read for1 day
The eighth edition of ICAO Doc 9303 progresses from using the first edition of the ISO/IEC 19794 series for encoding biometric reference data in electronic machine-readable travel documents to using the ISO/IEC 39794 series for this purpose. This document specifies how to use ISO/IEC 39794-4 for fingerprint image data stored in electronic machine-readable travel documents.
- Technical specification26 pagesEnglish languagee-Library read for1 day
- Amendment9 pagesEnglish languagee-Library read for1 day
This document describes and specifies the requirements of products of natural origin and products from industrial processes of basic and fine quality to be used as liming materials in agriculture for raising the pH of soil (and water).
- Standard25 pagesEnglish languagee-Library read for1 day
1.1 This document specifies safety requirements for design, construction and manufacturing of permanently installed electrically powered vertical lifting appliances affixed to a building structure intended for use by persons, including persons with disability:
- travelling vertically between predefined levels along a guided path whose inclination to the vertical does not exceed 15°;
- supported or sustained by rack and pinion, rope traction drive, noncircular elastomeric-coated suspension means (hereafter called traction belts) traction drive, rope positive drive, chains, timing belts, screw and nut, guided chain or hydraulic jack (direct or indirect);
- with enclosed wells;
- with a rated speed not greater than 0,15 m/s;
- with the carrier completely enclosed;
- with a temperature in the well and in the machinery spaces between +5 °C and +40 °C.
1.2 This document does not specify additional requirements for:
- lightning protection;
- operation subject to ATEX rules;
- lifting appliances whose primary function is the transportation of goods;
- earthquakes, flooding;
- firefighting and evacuation;
- noise and vibrations;
- the transport of type-C wheelchairs as defined in EN 12183:2022 and/or EN 12184:2022;
- vertically sliding doors.
1.3 Components incorporated in a lifting appliance installation are:
a) designed in accordance with usual engineering practice and calculation codes, taking into account all failure modes;
b) of sound mechanical and electrical construction;
c) free of defects.
1.4 This document is not applicable to lifting appliances manufactured before the date of its publication.
- Standard183 pagesEnglish languagee-Library read for1 day
The amendment to EN IEC 60601-2-57 contains the Annexes ZA (Normative references to international publications with their corresponding European publications) and ZZ (Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered).
These two Annexes are necessary for the harmonization of the standard to the Regulation (EU) 2017/745.
- Amendment7 pagesEnglish languagee-Library read for1 day
- Corrigendum3 pagesEnglish and French languagee-Library read for1 day
This document provides the guidelines of CEN and CENELEC’s policy towards building partnerships with European organizations, associations and other recognized stakeholders who have an interest in European standardization and are willing and able to provide added-value knowledge and to actively contribute with inputs and proposals to CEN and/or CENELEC corporate and technical bodies.
- Guide18 pagesSlovenian languagee-Library read for1 day
This document describes the scientific background and rationale for the content of EN 17950, Protective helmets - Test methods - Shock absorption including measuring rotational kinematics.
- Technical report34 pagesEnglish languagee-Library read for1 day
- Amendment5 pagesEnglish languagee-Library read for1 day
The European Commission will in its project "VAT in the digital age" (ViDA) mandate that VAT reporting on intra-EU transactions is performed in near real-time and based on EN 16931-1. This Technical Report defines the impact of this legislation on the various deliverables of CEN/TC 434, with a focus on the subset to be sent to tax authorities and how EN 16931-1 needs to be changed. The ViDA package applies to all EU member states and specific territories where the VAT legislation applies (e.g. Northern Ireland in respect to goods).
This document does not define the content of the common electronic message based on the electronic invoice to be sent to the authorities. The definition of that common electronic message (DRR message) is a task of the European Commission, possibly with help of CEN. As the DRR message is not an invoice, but a VAT report, it is not to be regarded as a Core Invoice Usage Specification (CIUS). The DRR message therefore needs not to obey the rules for developing a CIUS. For example, not all mandatory elements in the invoice need to be part of the DRR message.
- Technical report31 pagesEnglish languagee-Library read for1 day
The present document specifies technical characteristics and methods of measurements for the following equipment used in ground-based ATC Surveillance for civil air navigation:
• Wide Area Multilateration (WAM) systems with Mode S capabilities which may include Mode A/C, transmitting at 1 030 MHz and at 1 090 MHz, and receiving at 1 090 MHz, used for air traffic control with or without 1 090 MHz phase overlay.
Antennas for this equipment are passive.
Remote Field Monitors (RFM) as described in ETSI EN 303 363-2 [i.6] as well as Vehicle transmitters as described in ETSI EN 303 213-5-2 [i.7] are not covered in the present document.
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.
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- Standard50 pagesEnglish languagee-Library read for1 day
- Corrigendum3 pagesEnglish languagee-Library read for1 day
This document specifies requirements for dosing systems for chlorine dioxide generation according to the chlorite-chlorine gas process, the chlorite-acid process and the chlorite-sodium peroxodisulphate process, which are used for the disinfection and oxidation of substances in water.
The chlorine dioxide (ClO2) solution is produced on site (in situ) by automated mixing of chemical precursors.
NOTE According to EN 12671, chlorine dioxide is suited for the use of the treatment of water intended for human consumption (drinking water).
- Standard54 pagesEnglish languagee-Library read for1 day
This document defines terms related to the functions, products, and properties in geosynthetics, and terms used in International Standards on geosynthetics.
- Standard17 pagesEnglish languagee-Library read for1 day
This document specifies the test method for assessing the propensity of textile floor coverings to soiling in the absence of abrasive wear and texture changes using a standard artificial soil composition.
This document applies to the testing of unused textile floor coverings of all types.
This document can also be extended to assess the effects of fibre finishes, cleaning chemicals and cleaning equipment (see Annex A).
- Standard15 pagesEnglish languagee-Library read for1 day
This document specifies methods for determining the density (dry density or fully impregnated density), oil content (related to test piece volume and related to open porosity) and open porosity of permeable sintered metal materials.
This document applies in particular to porous metal bearings and to structural parts produced by pressing and sintering metal powders.
- Standard19 pagesEnglish languagee-Library read for1 day
This document gives recommendations for the selection, use, care and maintenance of hearing protectors.
- Standard59 pagesEnglish languagee-Library read for1 day
IEC 63584-210:2025 is the OCPP version 2.1. Version 2.1 is an extension of OCPP 2.0.1. OCPP 2.1 has its own JSON schemas, but the schemas are OCPP 2.0.1 schemas that have been extended with optional fields that are used by OCPP 2.1 functionality. With the minor exceptions mentioned below, all application logic developed for OCPP 2.0.1 will continue to work in OCPP 2.1 without any changes. The new features of OCPP 2.1, of course, require new application logic.
- Standard934 pagesEnglish languagee-Library read for1 day
This document provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses.
Preservative uptake and release testing is not intended as a routine test of production contact lenses or contact lens care products nor are testing results meant to establish finished goods specifications in any way.
Such testing is carried out when developing new contact lens materials and/or contact lens care products.
NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses.
NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This document does not measure disinfection performance.
- Standard14 pagesEnglish languagee-Library read for1 day
This document specifies a methodology for describing and managing interactions and a format for digital communication between actors in any use case associated with the management of an asset during all life cycle stages.
It provides:
— a methodology that describes an interaction framework for a use case;
— an appropriate way to map responsibilities and interactions that provides a process context for information flow;
— a format in which the interaction framework is specified and executed.
This document is intended to promote secure, verifiable, traceable and high-quality digital IDM communication between actors during all phases of the life cycle of assets, facilitate interoperability between software applications used, and to provide a basis for data- and process-driven information exchange and traceability of communication.
- Standard90 pagesEnglish languagee-Library read for1 day
The quality of background noise transmission is an important factor, which significantly contributes to the perceived overall quality of speech. Both existing and, even more notably, the new generation of terminals, networks and system configurations, including broadband services, can be greatly improved when designed properly, with consideration and presence of background noise. The present document:
• describes a noise simulation environment using realistic background noise scenarios for laboratory use;
• contains a database including the relevant background noise samples for subjective and objective evaluation.
The present document provides information about the recording techniques needed for background noise recordings and discusses the advantages and drawbacks of existing methods. Additionally, the present document describes the requirements for laboratory conditions. The loudspeaker setup and the loudspeaker calibration and equalization procedure are described. The simulation environment specified can be used for the evaluation and optimization of terminals and of complex configurations including terminals, networks and other configurations. The main application areas should be: office, home and car environment. The setup and database as described in the present document are applicable for:
• Objective performance evaluation of terminals in different (simulated) background noise environments.
• Speech processing evaluation by using the pre-processed speech signal in the presence of background noise, recorded by a terminal.
• Subjective evaluation of terminals by performing conversational tests, specific double talk tests or talking and listening tests in the presence of background noise.
• Subjective evaluation in third party listening tests by recording the speech samples of terminals in the presence of background noise.
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- Standard64 pagesEnglish languagesale 15% off
- Standardization document64 pagesEnglish languagee-Library read for1 day
The present document defines a core set of features that enables multiple subscriber devices to gain access to operator provided high-speed data service independently of the underlying access network. This core set of features allows for both IPv4- and IPv6-enabled devices to gain connectivity to the Internet. The core set of features defined in the present document includes the ability to provision multiple CPE devices, a description of how to forward data to and from CPE devices, and also the ability to forward IP multicast traffic to and among CPE devices.
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- Standard93 pagesEnglish languagee-Library read for1 day
The present document specifies technical requirements, limits and test methods for UWB devices installed in motor and railway vehicles in the frequency range 6,0 GHz to 8,5 GHz, used for UWB radiodetermination applications. The present document covers only monostatic radar equipment. Further details of the covered UWB radiodetermination equipment installed in motor and railway vehicles and the related EUT categories can be found in clause 4.2 of the present document.
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.
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This document specifies test procedures for determining the stability of contact lenses once they are placed in their final packaging during storage and distribution.
NOTE The results obtained can be used for determining the expiry date.
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The IEC 63382 series specifies the management of distributed energy storage systems, composed of electrically chargeable vehicle batteries (ECV-DESS), which are handled by an aggregator/flexibility operator (FO) to provide energy flexibility services to grid operators.
Aggregator and flexibility operator have the same meaning in the context of this document and represent the entity which aggregates a number of other network users (e.g. energy consumers, prosumers, DERs) bundling energy consumption or generation assets into manageable sizes for the energy system.
The aggregator/FO communicates with the charging station (CS) backend system, which is typically the system platform (HW, SW and HMI) of either a charging station operator (CSO), or a charging service provider (CSP).
The purpose of the data exchange is to perform flexibility services, and it takes place between the aggregator/FO and a dedicated interface located in the CS backend system, which has been defined FCSBE, flexibility port at the charging station backend.
This part of IEC 63382 describes the technical characteristics and architectures of ECV-DESS, including:
– EV charging stations configurations, comprising several AC-EVSEs and/or DC-EVSEs;
– individual EVs connected to grid via an EVSE and managed by an aggregator/FO.
The focus of this document is on the interface between the FO and the FCSBE and the data exchange at this interface, necessary to perform energy flexibility services (FS).
The FO/aggregator converts grid services and/or grid support functions requested by the grid operators (DSOs or TSOs) into multiple flexibility services to be provided by a number of CSs, utilizing their own optimization and resource allocation algorithms.
Communication between FO and grid operators (DSO, TSO), optimization algorithms adopted by FO, flexibility service bidding procedures are out of scope of this document.
The data exchange between FO and FCSBE typically includes:
– flexibility service request and response;
– flexibility services parameters;
– EV charging station configuration and technical capabilities;
– credentials check of parties involved in the flexibility service;
– FS execution related notifications;
– event log, detailed service record, proof of work.
The exchange of credentials has the purpose to identify, authenticate and authorize the actors involved in the flexibility service transaction, to check the validity of a FS contract and to verify the technical capabilities of the system EV + CS, and conformity to applicable technical standards to provide the requested flexibility service.
This document also describes the technical requirements of ECV-DESS, the use cases, the information exchange between the EV charging station operator (CSO) and the aggregator/FO, including both technical and business data.
It covers many aspects associated to the operation of ECV-DESS, including:
– privacy issues consequent to GDPR application (general data protection regulation);
– cybersecurity issues;
– grid code requirements, as set in national guidelines, to include ancillary services, mandatory functions and remunerated services;
– grid functions associated to V2G operation, including new services, as fast frequency response;
– authentication/authorization/transactions relative to charging sessions, including roaming, pricing and metering information;
– management of energy transfers and reporting, including information interchange, related to power/energy exchange, contractual data, metering data;
– demand response, as smart charging (V1G).
It makes a distinction between mandatory grid functions and market driven services, taking into account the functions which are embedded in the FW control of DER smart inverters.
This document deals with use cases, requirements and architectures of the ECV-DESSs with the associated EV charging stations.
Some classes of energy flexibility services (FS) have been identified and illustrated in dedic
- Standard200 pagesEnglish languagee-Library read for1 day
This document specifies equipment and procedures for determining the pull-through resistance of plate and spiral anchors through thermal insulation.
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- Corrigendum3 pagesEnglish languagee-Library read for1 day
This document specifies the general requirements and provides guidance for the development and application of loop-mediated isothermal amplification (LAMP) to detect microorganisms and associated genetic markers (e.g. antimicrobial resistance genes, virulence genes) in the food chain.
This document is applicable to all LAMP methods, platforms, and items from the food chain and laboratories.
This document does not apply to the use of LAMP for quantification.
Validation and verification of LAMP methods as either alternative or reference methods are not covered in this document. Both validation and verification of microbiological methods are described in detail in the ISO 16140 series and ISO 17468.
General requirements for isothermal methods including LAMP for molecular biomarker analysis are given in ISO 22942-1, and general requirements and definitions for polymerase chain reaction (PCR) for the detection and quantification of microorganisms in the food chain are given in ISO 22174.
This document has been established for microorganisms in the food chain and is applicable to:
— products intended for human consumption;
— products for feeding animals;
— environmental samples in the area of food and feed production and handling;
— samples from the primary production stage for the above items.
- Standard24 pagesEnglish languagee-Library read for1 day
ISO 24516-1:2016 specifies guidelines for technical aspects, tools and good practices for the management of assets of drinking water networks to maintain value from existing assets.
ISO 24516-1:2016 does not apply to the management of assets of waterworks (including catchment and treatment, pumping and storage in the network), which are also physically part of the drinking water system and can influence the management of assets of the pipe network.
ISO 24516-1:2016 focuses on the assets typically owned or operated by drinking water utilities (networked drinking water systems) that are expected to meet customer needs and expectations over longer (multi-generational) periods.
ISO 24516-1:2016 includes examples for good practice approaches on the strategic, tactical and operational levels.
ISO 24516-1:2016 is applicable to all types and sizes of organization and/or utilities operating drinking water systems, and all different roles/functions for the management of assets within a utility (e.g. asset owner/responsible body, asset manager/operator, service provider/operator).
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IEC 62065:2025 specifies the minimum operational and performance requirements, test methods and required test results conforming to performance standards adopted by the IMO in resolution MSC.74(69) Annex 2 Recommendation on Performance Standards for Track Control Systems. In addition, it takes into account IMO resolution A.694(17) to which IEC 60945 is associated. It also takes into account IMO resolution MSC.302(87) on bridge alert management (BAM), to which IEC 62923-1 and IEC 62923-2 are associated.
This third edition cancels and replaces the second edition published in 2014. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) alert management has been brought in line with MSC.302(87), IEC 62923-1 and IEC 62923‑2, reducing the number of alerts for one situation and improving the information provided by alerts. An overview is provided in Annex F;
b) the previous Annex F has been removed as it was outdated and not instrumental in this document;
c) the requirements in Clause 5 have been further detailed:
d) the structure of Clause 6 has been updated.
- Standard113 pagesEnglish languagee-Library read for1 day
This part of IEC 61076 establishes uniform specifications and technical information for circular connectors. This document is to be used in conjunction with the generic specification IEC 61076-1 for product requirements as the basis for preparation of detail product specifications for circular connectors.
NOTE The quality assessment requirements for connectors whose product requirements are given in IEC 61076 series are detailed in IEC 62197-1. This can be used as the basis for preparation of detail quality assessment specifications for circular connectors.
In the event of conflict between this sectional product specification and the detail product specification, it is intended that the requirements of the detail product specification prevail.
- Standard30 pagesEnglish languagee-Library read for1 day
IEC 61252:2025 specifies
– performance specifications for personal sound exposure meters,
– details of the tests necessary to verify conformance to all mandatory specifications for the purpose of pattern evaluation, and
– procedures for periodic testing of a personal sound exposure meter.
Personal sound exposure meters conforming to the requirements of this document have a specified frequency response for sound incident on the microphone from all directions.
This document is applicable to instruments that are designed to be worn on a person in a configuration specified by the manufacturer for the measurement of sound immission resulting from steady, intermittent, fluctuating, irregular, or impulsive sounds. For reproducibility of results, specifications and tests for the response to sound waves apply without an operator present in the sound field.
Pattern evaluation tests and periodic tests described in this this document apply to personal sound exposure meters for which the manufacturer claims conformance to the specifications given in this document.
IEC 61252:2025 cancels and replaces the first edition published in 1993, Amendment 1:2000, and Amendment 2:2017. This edition constitutes a technical revision.
This edition includes the following significant technical changes with respect to the previous edition:
a) personal sound exposure meters are required to provide indications of time-averaged sound level and peak sound level;
b) sound exposure is an optional quantity for indication;
c) specifications for physical quantities that do not follow the principle of equal-energy exchange rate have been added;
d) specifications for directional response have been added;
e) specifications for frequency weightings apply to the relative diffuse-field frequency response;
f) determination of conformance to specifications takes account of uncertainties of measurement;
g) detailed requirements for pattern-evaluation tests and periodic testing have been added.
- Standard54 pagesEnglish languagee-Library read for1 day
This document is applicable to material testing and specifies the requirements for the tensile testing of metallic materials at ambient temperature for aerospace applications.
It is applied when referred to in the EN technical specification or material standard unless otherwise specified on the drawing, order or inspection schedule.
- Standard28 pagesEnglish languagee-Library read for1 day
IEC 61189-3-302:2025 describes a method for the detection of plating defects in unpopulated circuit boards using computed tomography (CT).
This document is applicable to non-destructive testing of metallized holes.
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IEC 62933-3-1:2025 is applicable to EES systems designed for grid-connected indoor or outdoor installation and operation. This document considers:
necessary functions and capabilities of EES systems; sizing and design of EES system; operation of EES system; test items and performance assessment methods for EES systems; requirements for monitoring and acquisition of EES system operating parameters; exchange of system information and control capabilities required; maintenance of EES system. Stakeholders of this document comprise personnel involved with EES systems, which include:
- planners of electric power systems and EES systems;
- owners of EES systems;
- operators of electric power systems and EES systems;
- constructors;
- suppliers of EES systems and its equipment;
- aggregators.
Use-case-specific technical documentation, including planning and installation specific tasks such as system design, monitoring, measurement, tests, operation and maintenance, are very important and can be found throughout this document.
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IEC 60749-24:2025 specifies unbiased highly accelerated stress testing (HAST). HAST is performed for the purpose of evaluating the reliability of non-hermetically packaged solid-state devices in humid environments. It is a highly accelerated test which employs temperature and humidity under non-condensing conditions to accelerate the penetration of moisture through the external protective material (encapsulant or seal) or along the interface between the external protective material and the metallic conductors which pass through it. Bias is not applied in this test to ensure that the failure mechanisms potentially overshadowed by bias can be uncovered (e.g. galvanic corrosion).
This test is used to identify failure mechanisms internal to the package and is destructive.
This edition includes the following significant technical changes with respect to the previous edition:
a) rearrangement of clauses to reposition requirements;
b) addition of two notes to the post-test electrical procedures.
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IEC 61249-2-53:2025 specifies requirements for properties of PTFE unfilled reinforced laminated sheet of a thickness 0,05 mm up to 10,0 mm of defined flammability (vertical burning test), copper-clad. This part of IEC 61249 is applicable to the design, manufacture, use of PTFE unfilled reinforced laminated sheet of defined flammability (vertical burning test), copper-clad. Its flame resistance is defined in terms of the flammability requirements of 8.4.
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IEC 60749-22-2:2025 establishes a means for determining the strength of a ball bond to a die or package bonding surface and can be performed on pre-encapsulation or post-encapsulation devices. This measure of bond strength is extremely important in determining two features:
a) the integrity of the metallurgical bond which has been formed, and
b) the quality of ball bonds to die or package bonding surfaces.
This test method covers thermosonic (ball) bonds made with small diameter wire from 15 µm to 76 µm (0,000 6" to 0,003").
This test method can only be used when the bonds are large enough to allow for proper contact with the shear test chisel and when there are no adjacent interfering structures that would hinder the movement of the chisel. For consistent shear results the ball height will be at least 4,0 µm (0,000 6 ") for ball bonds, which is the current state of the art for bond shear test equipment at the time of this revision.
This test method can also be used on ball bonds that have had their wire removed and on to which a second bond wire (typically a stitch bond) is placed. This is known as "stitch on ball" and "reverse bonding". See Annex A for additional information.
The wire bond shear test is destructive. It is appropriate for use in process development, process control, or quality assurance, or both.
This test method can be used on ultrasonic (wedge) bonds, however its use has not been shown to be a consistent indicator of bond integrity. See Annex B for information on performing shear testing on wedge bonds.
This test method does not include bond strength testing using wire bond pull testing. Wire bond pull testing is described in IEC 60749-22-1.
This first edition, together with the first edition of IEC 60749-22-1, cancels and replaces the first edition IEC 60749-22 published in 2002. This International Standard is to be used in conjunction with IEC 60749-22-1:2025.
This edition includes the following significant technical changes with respect to the previous edition:
a) Major update, including new techniques and use of new materials (e.g. copper wire) involving a complete rewrite as two separate subparts (this document and IEC 60749‑22‑1).
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This document specifies the control and approval of in vitro diagnostic reagents used in animal health for immunological analyses with a qualitative expression of test results.
This document is applicable to diagnostic reagents, as a priority for infectious (bacterial, viral, fungal or parasitic) or prion diseases and associated animal species for which harmonization of practices in this area is needed, i.e. those for which the national, regional or international regulatory framework provides for the control of trade in animals and/or animal products and/or the definition of a health status (absence of infection) of areas, establishments or individuals. While all reagents designated by the competent authorities fall under the scope of this document, the authorities or any other animal health stakeholder can choose to derogate in specific and exceptional situations such as emerging, exotic or rare diseases.
This document is not applicable to all existing diagnostic reagents, in particular those for which certain parameters described in this document cannot be validly evaluated in accordance with international requirements, due, e.g. to the absence of a specific reference method and/or accessible and duly validated reference materials (RMs).
This document does not cover the step in which the user verifies a reagent (analysis method adoption).
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