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iTeh together with SIST has developed and compiled a comprehensive collection of standard packages to support your standard requirements. Our packages cover an array of content that includes quality management, risk management, road vehicles, machine safety, and much more. With over 200 packages to choose from, you are sure to find a collection to suit your standard needs.

Latest Standards

This document specifies the requirements for the production and quality control of synthesized double-stranded DNA. It describes requirements for quality management, resource management, biosafety and biosecurity, quality control in production, product quality, and delivered product specifications for synthesized gene fragments, genes and genomes. This document is applicable to synthetic gene fragments, genes and genomes with a length below 10 Mbp (base pairs) in the forms of non-clonal fragments (linear) and clonal genes in plasmids (circular). This document does not provide specific requirements for materials used solely for diagnostic purposes. When the synthesized nucleic acids are procured and used for diagnostic purposes, the user can take ISO 15189, ISO 13485 and other related clinical standards into account.

  • Standard
    29 pages
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  • Draft
    29 pages
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    29 pages
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This document defines a reference architecture of knowledge engineering (KE) in artificial intelligence (AI). The reference architecture describes KE roles, activities, constructional layers, components and their relationships amongst themselves and other systems from systemic user and functional views. This document also provides a common KE vocabulary by defining KE terms.

  • Standard
    42 pages
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  • Draft
    43 pages
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  • Draft
    43 pages
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This document establishes general principles of presentation to be applied to construction drawings for general arrangement and assembly, mainly within the field of building and architectural drawings.

  • Standard
    26 pages
    English language
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  • Standard
    27 pages
    French language
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  • Draft
    26 pages
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    26 pages
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This document provides guidance on assessing the effect or compatibility of an additional or personal lubricant with synthetic male condoms (excluding synthetic polyisoprene condoms). It also applies to topical medicines and any other substances that come into contact with such condoms. It describes the measurement of changes in physical properties of the condoms after exposure to the test substance (i.e. lubricant, topical medicine, etc.) and specifies the pass/fail criteria for such changes. This document is intended to be used for evaluating the compatibility of chosen additional lubricants or topical medicines with chosen synthetic condoms. Each lubricant type is evaluated specifically against each condom material for which compatibility is claimed. This document is not applicable to the assessment of the compatibility of lubricants applied to a condom at the time of manufacture. It is not directly applicable to female condoms, although similar principles can apply.

  • Technical specification
    16 pages
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  • Draft
    14 pages
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    14 pages
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This document specifies a procedure for determining the loading level of a qualification test of a launch vehicle structure and takes into account all the minimum allowable strength characteristics necessary for these structures.

  • Standard
    6 pages
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    6 pages
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    6 pages
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This document specifies the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum chuanxiong Hort.). This document applies to Ligusticum chuanxiong rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.

  • Standard
    14 pages
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    14 pages
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    14 pages
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This document specifies the designation, dimensions and load ratings of metric-series tyres primarily intended for passenger cars.

  • Standard
    57 pages
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    57 pages
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    57 pages
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The proposed project is a revision of ISO/IEC/IEEE 24748-2:2018, Systems and software engineering — Life cycle management — Part 2: Guidelines for the application of ISO/IEC/IEEE 15288 (System life cycle processes). There are no scope changes. ISO/IEC/IEEE 24748-2 is a guideline for the application of ISO/IEC/IEEE 15288. It addresses system, life cycle, organizational, project, and process, concept application, principally through reference to ISO/IEC/IEEE 24748-1 and ISO/IEC/IEEE 15288. It gives guidance on applying ISO/IEC/IEEE 15288 from the aspects of strategy, planning, application in organizations, and application on projects. It also provides comparison of the differences between ISO/IEC/IEEE 15288 current revision and the prior version, ISO/IEC 15288:2015.

  • Standard
    63 pages
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    64 pages
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    64 pages
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This document provides accompanying reference software for ISO/IEC 23090-9. The use of this reference software is not required for making an implementation of an encoder or decoder in conformance to ISO/IEC 23090-9. Requirements established in ISO/IEC 23090-9 take precedence over the behaviour of the reference software.

  • Standard
    2 pages
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    2 pages
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    2 pages
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This document specifies the general requirements for the radiography of steel and iron castings by means of X-rays or gamma-rays.

  • Standard
    13 pages
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    13 pages
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    13 pages
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This document specifies the functionality, position, constraints and control of a magnetic track brake system (MTB system) installed in bogies for use in emergency braking and in low adhesion conditions on Mainline Trains with speeds up to 280 km/h. It covers high suspension types of MTB only and not high/low and low suspension type of MTB.
This document also contains test methods and acceptance criteria for an MTB system. It identifies interfaces with electrical equipment, bogie, track and other brake systems.
On the basis of the existing international and national standards, additional requirements are defined for:
-   conditions of application for the MTB system;
-   retardation and brake forces;
-   functional and design features;
-   strength requirements;
-   type, series and vehicle implementation tests.
For design and calculation a "reference surface" is established.

  • Standard
    42 pages
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This part specifies fire safety requirements for railway vehicle design to cover the objectives defined in EN 45545-1.
The measures and requirements specified in this part of EN 45545 aim to protect passengers and staff in railway vehicles in the event of a fire on board by minimizing the risk of a fire starting, delaying the fire development and controlling the spread of fire products through the railway vehicle, thus aiding evacuation.
It is not within the scope of this part to describe measures which ensure the preservation of the railway vehicles in the event of a fire.

  • Standard
    17 pages
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    15 pages
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IEC 60794-2-24:2024 is a detail specification and specifies indoor multiple multi-fibre unit cables for use in MPO (multi-fibre push on) connector terminated breakout cable assemblies.

  • Standard
    21 pages
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    17 pages
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This document specifies requirements for vascular device-drug combination products (VDDCPs).
With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not permanent implants.
NOTE 1        Due to variations in the design of combination products covered by this document and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this document can be necessary.
This document applies to delivery systems or parts of the delivery system that are an integral component of the vascular device and that are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).
This document does not apply to devices whose PMOA provide a conduit for delivery of a drug (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter).
This document does not apply to procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) that do not affect the drug-related aspects of the device.
This document does not provide a comprehensive pharmacological evaluation of VDDCPs.
NOTE 2        Some information about the requirements of certain national and regional authorities is given in Annex B.
The connection of absorbable components of VDDCPs (e.g. coatings) with drug-related aspects of the device are addressed in this document. This document does not provide an exhaustive list of the degradation and other time-dependent aspects of absorbable implants and coatings.
NOTE 3        For more information on absorbable coatings, refer to ISO/TS 17137 and ASTM F3036-13.
This document does not address issues associated with viable or non-viable biological materials such as tissues, cells or proteins.
This document does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).

  • Standard
    57 pages
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    55 pages
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REN/ERM-TGMAR-616

  • Standard
    21 pages
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  • Standard
    21 pages
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    21 pages
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This document describes a test procedure for sampling, elution, detection, and quantification of N-nitrosamines in air samples derived from a test chamber according to EN 16516:2017+A1:2020. The following N-nitrosamines are covered:
-Nitrosodimethylamine, CAS No. 62-75-9,
- N-Nitrosomethylethylamine, CAS No. 10595-95-6,
- N-Nitrosodiethylamine, CAS No. 55-18-5,
- N-Nitrosodipropylamine, CAS No. 621-64-7,
- N-Nitrosodiisopropylamine, CAS No. 601-77-4,
- N-Nitrosodibutylamine, CAS No. 924-16-3,
- N-Nitrosopiperidine, CAS No. 100-75-4,
- N-Nitrosopyrrolidine, CAS No. 930-55-2 and
- N-Nitrosomorpholine, CAS No. 59-89-2.

  • Technical specification
    19 pages
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    19 pages
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This CENELEC Guide establishes useful guidelines for the preparation and use of standards in the field of electromagnetic compatibility (EMC) in general, and in particular for the implementation of the EMC Directive and the Radio Equipment Directive (RED). This Guide is intended to be used by Technical Committees.
The purpose of this guide is to give advice on:
-  the preparation of dedicated Product and Product Family Standards;
-  the application of EMC Standards.
Certification aspects are not covered by this Guide.
NOTE Certification is the action by a third party demonstrating that adequate confidence is provided that a duly identified product, process or service is in conformity with a standard or with other normative documents.

  • Guide
    40 pages
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This standard describes two methods for determining the content of polycyclic aromatic hydrocarbons (PAH) and one method for determining the content of benzene, toluene, ethylbenzene and xylene (BTEX) in construction products with gas chromatography with mass spectrometric detection (GC-MS).

  • Standard
    39 pages
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    38 pages
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1.1   This European Standard applies to patented cold drawn unalloyed steel wire of circular cross-section for the manufacture of mechanical springs for static duty and dynamic duty applications.
1.2   In addition to this European Standard, the general technical delivery requirements of EN 10021 are applicable.

  • Standard
    30 pages
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    33 pages
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