Toimialayhteisöt
The work item aims to differentiate between biodegradable and non-biodegradable plastic materials. Non-biodegradable plastics are defined as those plastics which do not biodegrade, even in conditions which are conducive to the process. In contrast, the biodegradation of biodegradable plastics occurs when they come into contact with active microorganisms, under conditions that are conducive to biodegradation. This process is analogous to the biodegradation of natural polymers. The plastic materials that are categorised as being intrinsically biodegradable can be utilised in the design of products with a high risk of dispersion. The test scheme is not intended to be applicable to any specific application. Instead, the objective is to develop a framework methodology that can be utilised across diverse industrial sectors for the identification of biodegradable plastics, with the subsequent application of these plastics in the manufacture of various products and for different purposes. The work item does not intend to characterise and evaluate the environmental impact of products containing plastics identified as biodegradable. The test scheme should address the definition of intrinsic biodegradability of plastic materials, without determining the hazard potential of the products, which necessitates a distinct assessment that extends beyond the scope of this particular work item. The rate of biodegradation of a plastic object is not the focus of this particular work item, as it is contingent on environmental conditions. The test scheme to be developed will not be sufficient to carry out an analysis of the ecological risk associated with the dispersal of products, as this requires an assessment of the intrinsic hazard, of the environmental fate, in addition to the assessment of biodegradability.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 150
(Industrial Trucks - Safety)
Alkuperä: CEN
Määräpäivä: 2026-07-25
This document is applicable to self-propelled and pedestrian propelled manual and semi-manual industrial trucks as defined in ISO 5053 1:2020 including their load handling devices and attachments (hereafter referred to as trucks) intended for use in potentially explosive atmospheres.NOTE 1 Attachments mounted on the load carrier or on fork arms which are removable by the user are not considered to be a part of the truck.This document specifies supplementary technical requirements for the prevention of the ignition of an explosive atmosphere of flammable gases, vapours, mists or dusts by industrial trucks of equipment group II and equipment category 2G, 3G, 2D or 3D.NOTE 2 The relationship between an equipment category (hereafter referred to as category) and the corresponding zone (area classification) is shown in informative Annex B.This document does not apply to:— trucks of equipment group I;— trucks of equipment group II, equipment category 1;— trucks intended for use in potentially explosive atmospheres with hybrid mixtures;— protective systems.This document does not apply to trucks intended for use in potentially explosive atmospheres of carbon disulfide (CS2), carbon monoxide (CO) and/or ethylene oxide (C2H4O) due to the special properties of these gases.Technical requirements relating to lithium-ion batteries and fuel cells as energy sources are not given in this document due to their specific hazards.
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Toimialayhteisö:
SFS Suomen Standardit
Komitea: ISO/TC 133
(Clothing sizing systems - size designation, size measurement methods and digital fittings)
Alkuperä: ISO
Määräpäivä: 2026-07-29
This document provides a description of anthropometric measurements that can be used as a basis for the creation of physical and digital anthropometric databases. The list of measurements specified in this part ISO 8559-6 is intended to serve as a guide for practitioners in the field of clothing who are required to apply their knowledge to select population market segments and to create size and shape profiles for the development of all contour fitting garment types which extend from the torso and shoulder to the breast and their equivalent fitness. The list provides a guide for how to take anthropometric measurements, as well as give information to clothing product development teams and innerwear manufacturers on the principles of measurement and their underlying anatomical and anthropometrical bases.
It is intended to use this part ISO 8559-6 in conjunction with national, regional or international regulations or agreements to ensure harmony in defining population groups and to allow comparison of anthropometric data sets.
Toimialayhteisö:
Kemesta
Komitea: ISO/TC 61/SC 9
(Thermoplastic materials)
Alkuperä: ISO
Määräpäivä: 2026-07-29
This document is a standard template for developing and revising integrated All-in-One material designation standards for virgin and recycled thermoplastic materials, and a mixture thereof. It establishes a designation system to ensure uniformity in structure, style, and terminology, preventing misinterpretation caused by using different wording for identical provisions in standard documents.
The code number for a designatory property range in Data block 4 for a thermoplastic material is assigned solely to provide a designation.
Data block 4 is not intended to provide a detailed specification for a particular application. Instead, the detailed specification agreed upon between the parties involved is linked to the document using Data block 5.
For cases where the corresponding recycled thermoplastic material is not present, (Template) 6 and 7 are not used.
When a material designation standard is revised using this template and introduces significant format changes or technical amendments, the revised standard is published under a new number. This is intended to prevent any potential issues arising from existing references in legal documents or contracts.
Toimialayhteisö:
Kemesta
Komitea: ISO/TC 6/SC 2
(Test methods and quality specifications for paper and board)
Alkuperä: ISO
Määräpäivä: 2026-07-29
This part of ISO 1924 specifies a method for measuring the tensile strength, strain at break and tensile energy absorption of paper and board, using a testing machine operating at a constant rate of elongation (20 mm/min). This part of ISO 1924 also specifies equations for calculating the tensile index, the tensile energy absorption index and the modulus of elasticity.
Testing in conformance with this part of ISO 1924 always includes the measurement of tensile strength. Measurement or calculation of other properties is subject to agreement between the parties concerned.
This part of ISO 1924 is applicable to all papers and boards, including papers with a high strain at break if the results are within the capacity of the testing machine. It also applies to the components of corrugated board but not, however, to corrugated board itself.
This part of ISO 1924 is not applicable to tissue paper and tissue products for which ISO 12625-4[2] is applicable. For the determination of tensile properties of laboratory sheets, ISO 5270[3] is recommended.
Toimialayhteisö:
Kemesta
Komitea: CEN/TC 172
(Pulp, paper and board)
Alkuperä: CEN
Määräpäivä: 2026-07-30
ISO 1924-2:2008 specifies a method for measuring the tensile strength, strain at break and tensile energy absorption of paper and board, using a testing machine operating at a constant rate of elongation (20 mm/min). ISO 1924-2:2008 also specifies equations for calculating the tensile index, the tensile energy absorption index and the modulus of elasticity.
Testing in conformance with ISO 1924-2:2008 always includes the measurement of tensile strength. Measurement or calculation of other properties is subject to agreement between the parties concerned.
ISO 1924-2:2008 is applicable to all papers and boards, including papers with a high strain at break if the results are within the capacity of the testing machine. It also applies to the components of corrugated board but not, however, to corrugated board itself.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 147
(Cranes - Safety)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document is applicable to the design, information for use, maintenance and testing of power-driven winches for which the prime mover is an electric motor, hydraulic motor, or pneumatic motor. Winches are designed for the movement or manipulation of loads supported on level or inclined planes in situations where risks resulting from a failure of the winding mechanism or pulling medium are mitigated by external measures.
This document is not applicable to devices which handle suspended loads.
Generally, a winch is used without any additional transport movement, except in cases where a winch is used on a stranded vehicle for self-recovery of the vehicle.
Applications of winches covered are for example, but not limited to:
a) rope winches;
b) belt winches, except steel belts used as pulling media;
c) traction winches, including double capstan and traction sheave winches.
These types of winches a) to c) also include the following specific applications:
— vehicle recovery winches;
— winches for boat trailers;
— winches for stationary offshore applications.
NOTE Examples are shown in Annex H.
This document does not apply to:
— power-driven hoists in accordance with EN 14492-2;
— forestry winches in accordance with EN ISO 19472-1;
— winches for seagoing vessels and mobile offshore units;
— winches for the lifting of persons;
— NGL building hoists in accordance with EN 14492-2;
— winches for the handling of hot molten masses.
This document deals with the significant hazards, hazardous situations or hazardous events relevant to power driven winches when used as intended and under conditions of misuse which are reasonably foreseeable, identified in Annex A.
This document does not specify additional requirements for hazards related to the use of power driven winches in explosive atmospheres in underground mines.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 438
(Additive Manufacturing)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document identifies common failure modes, which can occur within operations across additive manufacturing (AM) process categories defined in ISO/ASTM 52900. It lists state-of-the-art failure modes, which can lead to risks within AM parts and equipment, as well as providing informative examples of corresponding failure effects and mitigation actions.
This document can be used to aid manufacturers in their risk management. While doing so it supports the implementation of AM as a production method within critical applications and regulated industries. This document helps to address the requirements for risk management set by regulated industries for part and production method compliance.
Technology specific failure modes will be addressed in separate standards, including but not limited to PBF-LB/M, PBF-LB/P, MEX, MJT, BJT, and DED.
This document aims to close the existing gap between general risk management standards, such as ISO 31000 or ISO 14971 (medical), and the know-how gap of existing failure modes of the AM process category and their integrated workflow.
The standard maps risks according to AM processes defined within ISO/ASTM 52920.
This document does not cover environment, health and safety risks and will not measure, assess, or evaluate the risk impact on the AM part to be produced. It does not list the part specific input and output parameters, during the respective process steps. This task is dedicated to the risk management evaluation teams, which usually comprise quality managers and product domain specific experts.
The document enables all part owners and manufacturers to use it for the risk mapping activities, to support subsequent risk assessments, continuous improvement, validation planning, estimation of manufacturing efforts, and conformity audits.
For risk examples that are relevant only to specific AM machinery brands, manufacturers might consider use of the informative annex.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 121
(Welding and allied processes)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document defines the rules to be applied for symbolic representation of welded joints on technical drawings. This can include information about the geometry, manufacture, quality and testing of the welds. The principles of this document can also be applied to soldered and brazed joints.
It is recognized that there are two different approaches in the global market to designate the arrow side and other side on drawings. In this document:
— clauses, tables and figures which carry the suffix letter "A" are applicable only to the symbolic representation system based on a dual reference line;
— clauses, tables and figures which carry the suffix letter "B" are applicable only to the symbolic representation system based on a single reference line;
— clauses, tables and figures which do not have the suffix letter "A" or "B" are applicable to both systems.
The symbols shown in this document can be combined with other symbols used on technical drawings, for example to show surface finish requirements.
An alternative designation method is presented which can be used to represent welded joints on drawings by specifying essential design information such as weld dimensions, quality level, etc. The joint preparation and welding process(es) are then determined by the production unit in order to meet the specified requirements.
NOTE Examples given in this document, including dimensions, are illustrative only and are intended to demonstrate the proper application of principles.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 184
(Advanced technical ceramics)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document specifies two test methods for the determination of the resistance of the edges of brittle ceramic materials to be damaged by chipping.
This document is applicable to homogeneous monolithic ceramics with flat surfaces and straight sharp or chamfered edges.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 438
(Additive Manufacturing)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document specifies guidelines and recommendations to be followed prior to carrying out
dimensional measurements on three-dimensional (3D) volumetric X-ray Computed Tomographic (XCT)
images of additive manufacturing (AM) series production parts. It is applicable to cone beam XCT
systems. However, these guidelines and recommendations can easily be transposed to fan beam XCT
systems.
The process to be followed prior to performing dimensional measurement on 3D volumetric XCT
images of AM series production parts, in this standard, is divided into two steps:
Step 1: Quantification of an XCT system performance, in terms of image quality and basic
dimensional measurement accuracy, with a reference object and eventually a Representative Quality
Indicators (RQI), with the specific part (part chosen from the AM series production parts) XCT setting
under certain environmental conditions. This step leads to the determination of the image quality, the
voxel size and the basic dimensional measurement accuracy of an XCT system;
Step 2: Validation of the XCT system compliance, in terms of dimensional measurement accuracy,
with the specific part, with the chosen XCT setting under the specific environmental conditions. This
step leads to a simplified determination of the dimensional measurement uncertainty of each
measurand of the specific part.
If step 1 does not comply with the set requirements, the XCT system cannot be used for step 2.
This document does not claim to provide a definitive method to determine XCT dimensional
measurement accuracy, which, given the complexity of an XCT process, is not yet established. For the
same reason, it is addressed to qualified XCT operators with the support of metrology experts.
This document is dedicated to AM series production parts and its aim is to provide a methodology for
controlling the geometric specificities associated with AM (internal shapes, lattice structures). It is
applicable on parts that are fabricated by any type of AM categories of processes and material
provided the X-ray penetration lengths are sufficient to scan the test part.
These prior quantification and validation processes, which allow dimensional measurements to be carry
out on 3D volumetric XCT images of AM series production parts, are valid for a specific part geometry
in a given material associated with a chosen XCT setting (magnification & XCT acquisition and
reconstruction parameters of the specific part) under specific environmental conditions for the
measurands specified. The quantification and validation processes are reconsidered when different
geometry of the part or material or XCT setting or environmental conditions or measurands are taken
into account.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 132
(Aluminium and aluminium alloys)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document specifies the technical conditions for inspection and delivery of wrought aluminium and wrought aluminium alloy sheet, strip and plate for general applications. It also includes provisions for ordering and testing.
It applies to products with a thickness over 0,20 mm up to and including 400 mm.
For many special applications of aluminium strip, sheet and plate, specific European Standards exist, where different or additional requirements are formulated and the appropriate alloys and tempers are selected: see Annex A. Most of these special European Standards refer to provisions of this document.
The selection of the relevant special European Standards is under the responsibility of the purchaser.
Specific European Standards are available for applications involving special properties, such as corrosion resistance, toughness, fatigue strength, surface appearance or welding properties.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 250/SC 3
(Eurocode 3 - Design of steel structures)
Alkuperä: CEN
Määräpäivä: 2026-07-30
1.1 Scope of prEN 1993-1-4
This document provides supplementary rules for the structural design of steel structures that extend and modify the application of EN 1993-1-1, EN 1993-1-3, EN 1993-1-5 and EN 1993-1-8 to austenitic, duplex (austenitic-ferritic) and ferritic stainless steels.
NOTE 1 Austenitic-ferritic stainless steels are commonly known as duplex stainless steels. The term duplex stainless steel is used in this document.
NOTE 2 Information on the durability of stainless steels is given in Annex A.
NOTE 3 The execution of stainless steel structures is covered in EN 1090-2 and EN 1090-4.
1.2 Assumptions
Unless specifically stated, EN 1990, EN 1991 (all parts), EN 1993-1-1, EN 1993-1-3, EN 1993-1-5 and EN 1993-1-8 apply.
The design methods given in prEN 1993-1-4 are applicable if
- the execution quality is as specified in EN 1090-2 and EN 1090-4, and
- the construction materials and products used are as specified in EN 1993-1-1, EN 1993-1-3, EN 1993 1-5 and EN 1993-1-8, or in the relevant material and product specifications.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 250/SC 3
(Eurocode 3 - Design of steel structures)
Alkuperä: CEN
Määräpäivä: 2026-07-30
1.1 Scope of EN 1993-1-10
(1) EN 1993-1-10 specifies rules for the selection of steel grades and qualities related to fracture toughness to avoid brittle fracture.
NOTE Steel quality is also known as (Charpy) subgrade.
(2) EN 1993-1-10 specifies rules to specify through thickness properties for welded elements to reduce the risk of lamellar tearing.
(3) EN 1993-1-10 specifies additional toughness requirements for specific cases to ensure upper shelf toughness in relation to design ultimate resistance in tension and seismic design.
(4) EN 1993-1-10 specifies rules for structural steels as listed in EN 1993-1-1. This document applies to steel grades S235 to S700.
(5) EN 1993-1-10 specifies rules that apply to the selection of parent material only.
(6) EN 1993-1-10 specifies rules that apply to steel materials covered by EN 1993-1-1:2022, 5.1(3), provided that each individual piece of steel is tested in accordance with the requirements of EN 1993 1 1:2022, 5.2.1 and EN 1090-2:2018+A1:2024, 5.1.
(7) This document does not apply to material salvaged from existing steelwork subjected to fatigue or fire.
1.2 Assumptions
(1) Unless specifically stated, EN 1990, EN 1991 (all parts) and the other relevant parts of EN 1993-1 (all parts) apply.
(2) The design methods given in EN 1993-1-10 are applicable if:
- the execution quality is as specified in EN 1090-2 or EN 1090-4, and
- the construction materials and products used are as specified in the relevant parts of EN 1993 (all parts), or in the relevant material and product specifications.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 250/SC 3
(Eurocode 3 - Design of steel structures)
Alkuperä: CEN
Määräpäivä: 2026-07-30
1.1 Scope of EN 1993-1-13
1.1.1 General
(1) This document gives supplementary provisions that extend the application of EN 1993-1-1 and EN 1993-1-5 to the design of rolled and welded steel sections with various shapes of web openings. The following cases are considered:
- rolled or welded beams with single or widely spaced web openings;
- rolled or welded beams with closely spaced web openings;
- cellular beams with circular openings made by cutting and re-welding two parts of steel sections that may be different in dimensions;
- beams with hexagonal and sinusoidal openings made by cutting and re-welding two parts of steel sections that may be different in dimensions.
(2) This document applies to uniform members with I or H profiles, which are symmetric about the weak axis. It does not apply to non-prismatic or curved beams although the same principles can apply.
(3) This document applies to steel beams with web openings that are subjected to sagging (positive) or to hogging (negative) bending moments.
(4) This document covers the verification of the resistance at the openings and their effects on the global behaviour of the beam, including lateral torsional buckling.
(5) Alternative methods are presented for beams with circular openings and with sinusoidal openings in which the forces and resistances are calculated by increments around or along the openings and which are suitable for computer methods.
(6) This document applies to web slenderness, hw/tw, not exceeding 121e. The local checks at and between adjacent openings apply to web slenderness up to this limit. The material parameter e is defined in EN 1993-1-1:2022, 5.2.5 (2).
NOTE The limit of 121e is the limit of a Class 4 web for a steel section with equal flanges. It is used as a convenient limit for the application of this document, including mono-symmetric sections.
(7) This document does not cover fatigue. In case of fatigue, EN 1993-1-9 applies.
(8) This document does not cover fire design. For the design in case of fire, EN 1993-1-2 applies.
(9) This document does not cover the buckling verification of members with web openings under axial force.
1.1.2 Shapes of web openings
(1) The different shapes of web openings that are considered in this document are shown in Figure 1.1.
Figure 1.1 - Different shapes of web openings in steel beams
1.1.3 Stiffened openings
(1) This document also covers openings in the web of beams that are reinforced by longitudinal stiffeners and/or transverse stiffeners on one or both sides of the web, see Figure 1.2.
NOTE The National Annex can give rules for alternative types of stiffener.
Figure 1.2 - Stiffening of openings in beam webs
1.2 Assumptions
(1) Unless specifically stated, EN 1990, the EN 1991 series and EN 1993-1-1 apply.
(2) The design methods given in EN 1993-1-13 are applicable if:
- the execution quality is as specified in EN 1090-2, and
- the construction materials and products used are as specified in the relevant parts of the EN 1993 series, or in the relevant material and product specifications.
Toimialayhteisö:
Metalliteollisuuden Standardisointiyhdistys
Komitea: CEN/TC 250/SC 3
(Eurocode 3 - Design of steel structures)
Alkuperä: CEN
Määräpäivä: 2026-07-30
1.1 Scope of EN 1993-1-9
(1) EN 1993-1-9 gives design methods for the verification of the fatigue design situation of steel structures.
NOTE Steel structures consist of members and their joints. Each member and joint can be represented as a constructional detail or as several of the latter.
(2) Design methods other than the stress-based methods, such as the notch strain method or fracture mechanics methods, are not covered by EN 1993-1-9.
(3) EN 1993-1-9 only applies to structures made of all grades of structural steels and products within the scope of EN 1993-1 (all parts), in accordance with the provisions noted in the detail category tables or annexes.
(4) EN 1993-1-9 only applies to structures where execution conforms to EN 1090-2.
NOTE Supplementary execution requirements are indicated in the detail category tables.
(5) EN 1993-1-9 applies to structures operating under normal atmospheric conditions and with sufficient corrosion protection and regular maintenance. The effect of seawater corrosion is not covered.
(6) EN 1993-1-9 applies to structures with hot dip galvanizing in accordance with the provisions noted in the detail category tables or annexes.
(7) Microstructural damage from high temperature (> 150°C) that occurs during the design service life is not covered.
(8) EN 1993-1-9 gives guidance of how to consider post-fabrication treatments that are intended to improve the fatigue resistance of constructional details.
1.2 Assumptions
(1) Unless specifically stated, EN 1990, EN 1991 (all parts) and EN 1993 1 (all parts) apply.
(2) The design methods given in EN 1993-1-9 are applicable if:
- the execution quality is as specified in EN 1090-2, and
- the construction materials and products used are as specified in the relevant parts on EN 1993 (all parts), or in the relevant material and product specifications.
(3) The design methods of EN 1993-1-9 are generally derived from fatigue tests on constructional details with large scale specimens that include effects of geometrical and structural imperfections from material production and execution (e.g. the effects of tolerances and residual stresses from welding).
Toimialayhteisö:
Palvelualojen työnantajat PALTA
Komitea: CEN/TC 239
(Rescue systems)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
Toimialayhteisö:
Palvelualojen työnantajat PALTA
Komitea: CEN/TC 239
(Rescue systems)
Alkuperä: CEN
Määräpäivä: 2026-07-30
This document specifies minimum requirements for the design and performance of foldable patient transfer chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.
Toimialayhteisö:
Palvelualojen työnantajat PALTA
Komitea: CEN/TC 285
(Non-active surgical implants)
Alkuperä: CEN
Määräpäivä: 2026-07-30
ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.
NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary.
It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.
Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016.
While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.
Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016.
Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539-1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).
NOTE Requirements for endovascular prostheses are specified in ISO 25539-1.
The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.
Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016.
NOTE Requirements for vascular stents are specified in ISO 25539-2.
Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:201
Toimialayhteisö:
Palvelualojen työnantajat PALTA
Komitea: ISO/TC 106/SC 1
(Filling and restorative materials)
Alkuperä: ISO
Määräpäivä: 2026-07-30
This document specifies the requirements and test methods for dental amalgam alloy powder and dental mercury that are suitable for the preparation of dental amalgam together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking.
Note Two of the requirements apply only to dental mercury (as supplied) and two to dental mercury sachets. All of the other requirements apply to the dental amalgam alloy (as supplied) and dental amalgam.
This document is not applicable to dental amalgam alloy powder and dental mercury supplied in a pre-capsulated form.
This document is not applicable to other metallic materials in which an alloy powder reacts with an alloy that is liquid at ambient temperature to produce a solid metallic material intended for dental restoration.
This document applies to products used to make dental amalgam restorations, supplied to the user in the following forms: dental amalgam alloy as a fine free flowing powder, or as a fine powder compacted into tablets and dental mercury in dental mercury sachets (sometimes referred to as dental mercury pillows). The mass of dental mercury in these sachets is limited to the amount appropriate to make a small to medium-sized restoration in a single tooth.
This document is not applicable to dental mercury that is supplied in a primary container in an undivided mass that exceeds the amount suitable for a small to medium-sized restoration.