List of drafts

prEN IEC 60335-2-49:2026/prAA:2026 Public enquiry

Comment end date 2026-08-05

Household and similar electrical appliances - Safety - Part 2-49: Particular requirements for commercial electric appliances for keeping food and crockery warm

This European Standard deals with the safety of electrically operated commercial appliances for keeping food and crockery warm, their rated voltage being not more than 250 V for single-phase appliances connected between one phase and neutral, and 480 V for other appliances.They are used for commercial purposes, processing of food, also in areas open to the public, for example in kitchens of restaurants, canteens, hospitals and in commercial enterprises, such as bakeries and butcheries. The electrical part of appliances making use of other forms of energy is also within the scope of this standard.

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prEN IEC 60335-2-42:2026/prA1:2026 Public enquiry

Comment end date 2026-08-05

Household and similar electrical appliances - Safety - Part 2-42: Particular requirements for commercial electric forced convection ovens, steam cookers and steam-convection ovens

This European Standard deals with the safety of electrically operated commercial forced convection ovens, steam cookers, steam-convection ovens and, exclusive of any other use, steam generators, not intended for household use. The rated voltage being not more than 250 V for single-phase appliances connected between one phase and neutral and 480 V for other appliances. Appliances within the scope of this standard are typically used in restaurants, canteens, hospitals and commercial enterprises such as bakeries, butcheries, etc

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prEN IEC 60335-2-38:2026/prAA:2026 Public enquiry

Comment end date 2026-08-05

Household and similar electrical appliances - Safety - Part 2-38: Particular requirements for commercial electric griddles and griddle grills

This standard deals with the safety of electrically operated commercial griddles and griddle grills, their rated voltage being not more than 250 V for single-phase appliances connected between one phase and neutral and 480 V for other appliances. These appliances are not intended for household and similar purposes. They are used for commercial processing of food in areas not open to the public, for example in kitchens of restaurants, canteens, hospitals and in commercial enterprises such as bakeries and butcheries. The electrical part of appliances making use of other forms of energy is also within the scope of this standard.

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prEN IEC 60335-2-38:2026/prA1:2026 Public enquiry

Comment end date 2026-08-05

Household and similar electrical appliances - Safety - Part 2-38: Particular requirements for commercial electric griddles and griddle grills

This standard deals with the safety of electrically operated commercial griddles and griddle grills, their rated voltage being not more than 250 V for single-phase appliances connected between one phase and neutral and 480 V for other appliances. These appliances are not intended for household and similar purposes. They are used for commercial processing of food in areas not open to the public, for example in kitchens of restaurants, canteens, hospitals and in commercial enterprises such as bakeries and butcheries. The electrical part of appliances making use of other forms of energy is also within the scope of this standard.

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prEN IEC 60335-2-42:2026 Public enquiry

Comment end date 2026-08-05

Household and similar electrical appliances - Safety - Part 2-42: Particular requirements for commercial electric forced convection ovens, steam cookers and steam-convection ovens

This European Standard deals with the safety of electrically operated commercial forced convection ovens, steam cookers, steam-convection ovens and, exclusive of any other use, steam generators, not intended for household use. The rated voltage being not more than 250 V for single-phase appliances connected between one phase and neutral and 480 V for other appliances. Appliances within the scope of this standard are typically used in restaurants, canteens, hospitals and commercial enterprises such as bakeries, butcheries, etc

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prEN IEC 60335-2-49:2026 Public enquiry

Comment end date 2026-08-05

Household and similar electrical appliances - Safety - Part 2-49: Particular requirements for commercial electric appliances for keeping food and crockery warm

This European Standard deals with the safety of electrically operated commercial hot cupboards not intended for household use. The rated voltage being not more than 250 V for single-phase appliances connected between one phase and neutral, and 480 V for other appliances. Hot cupboards with heated tops, heated display cases, heated crockery dispensers and heated shelves and tables are also within the scope of this standard. The appliances within the scope of this standard are typically used in restaurants, canteens, hospitals and similar commercial enterprises.

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prEN IEC 60335-2-38:2026 Public enquiry

Comment end date 2026-08-05

Household and similar electrical appliances - Safety - Part 2-38: Particular requirements for commercial electric griddles and griddle grills

This standard deals with the safety of electrically operated commercial griddles and griddle grills, their rated voltage being not more than 250 V for single-phase appliances connected between one phase and neutral and 480 V for other appliances

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prEN 485-1 Public enquiry

Comment end date 2026-08-04

Aluminium and aluminium alloys - Sheet, strip and plate - Part 1: Technical conditions for inspection and delivery

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.

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prEN ISO/IEC 27555 Public enquiry

Comment end date 2026-08-04

Information security, cybersecurity and privacy protection - Guidelines on personally identifiable information deletion (ISO/IEC DIS 27555:2026)

This document contains guidelines for developing and establishing policies and procedures for deletion of personally identifiable information (PII) in organizations by specifying: — a harmonized terminology for PII deletion; — an approach for defining deletion rules in an efficient way; — a description of required documentation; — a broad definition of roles, responsibilities and processes. This document is intended to be used by organizations where PII is stored or processed. This document does not address: — specific legal provision, as given by national law or specified in contracts; — specific deletion rules for particular clusters of PII that are defined by PII controllers for processing PII; — deletion mechanisms; — reliability, security and suitability of deletion mechanisms; — specific techniques for de-identification of data.

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prEN 18229-1 Public enquiry

Comment end date 2026-08-02

AI trustworthiness framework - Part 1: Logging

This document provides terminology, concepts, requirements, and guidance for logging of AI systems. It is primarily intended for organizations placing on the market or putting into service AI systems and is not specific to any particular sector.

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prEN ISO 2553 Public enquiry

Comment end date 2026-08-02

Welding and allied processes - Symbols for welding - Welded joints (ISO/DIS 2553:2026)

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.

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prEN IEC 61621:2026 Public enquiry

Comment end date 2026-07-31

Dry, solid insulating materials - Resistance test to high-voltage, low-current arc discharges

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prEN IEC 60384-1:2026 Public enquiry

Comment end date 2026-07-31

Fixed capacitors for use in electronic equipment - Part 1: Generic specification

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ISO/DIS 23565 Public enquiry

Comment end date 2026-07-31

Biotechnology — Bioprocessing — General requirements and considerations for equipment systems used in the manufacturing of cellular therapeutic products

This document specifies minimum requirements and general considerations for equipment, consisting of hardware, software and consumables, used in the manufacturing of cellular therapeutic products. This includes equipment for processing cellular therapeutic products starting from cell isolation/selection, expansion, washing, volume reduction, final formulation and preparation prior to cryopreservation for storage of cellular therapeutic products. This document provides guidance on the design, use and maintenance of equipment and equipment systems to both equipment suppliers and equipment users including aspects such as the target parties, i.e. equipment supplier or equipment user, and the phase of the involved task, i.e. design, use, or maintenance. This document is applicable to any unit operation system, that is intended to be used, either alone or in combination, for the manufacture of cellular therapeutic products by meeting equipment user requirements. It is applicable to equipment used for the purpose of monitoring the equipment status. This document does not apply to: — processing equipment for cellular therapeutic products used at the point of care; — equipment used for analytical purposes; — biosafety cabinets, general cell culture equipment (such as CO2 incubators, etc.); — software to control multiple equipment systems or multiple unit operations.

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prEN 12814-2 Public enquiry

Comment end date 2026-07-31

Testing of welded joints of thermoplastics semi-finished products - Part 2: Tensile test

This document specifies the dimensions, the method of sampling, the preparation of the test specimens and the conditions for performing the tensile test in order to determine the short-term tensile welding factor. A tensile test can be used in conjunction with other tests (e.g. bend, tensile creep, macro) to assess the performance of welded assemblies, made from thermoplastics materials. The test is applicable to welded semi-finished products made from thermoplastics materials filled or unfilled, but not reinforced, irrespective of the welding process used.

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prEN 50206-1:2026 Public enquiry

Comment end date 2026-07-31

Railway applications - Rolling stock - Pantographs: Characteristics and tests - Part 1: Pantographs for main line vehicles

This document specifies the general assembly characteristics applied to pantographs and their control unit, to enable current collection from the overhead contact line system. It also specifies the tests the pantographs and their control unit need to perform. This document is not applicable to pantograph dielectric tests performed on the pantograph installed on the vehicle roof. Insulation coordination is covered in EN 50124 1. This document is not applicable to pantographs used on isolated metros and light rail systems. These pantographs are considered in EN 50206 2. This document is not applicable to third and fourth rail current collectors used on isolated metros and light rail systems. These pantographs are considered in EN 50702.

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EN 1993-1-13:2024/prA1 Public enquiry

Comment end date 2026-07-30

Eurocode 3 - Design of steel structures - Part 1-13: Beams with large web openings

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 121ε. The local checks at and between adjacent openings apply to web slenderness up to this limit. The material parameter ε is defined in EN 1993-1-1:2022, 5.2.5 (2). NOTE The limit of 121ε 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.

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EN 1993-1-10:2025/prA1 Public enquiry

Comment end date 2026-07-30

Eurocode 3 - Design of steel structures - Part 1-10: Material toughness and through-thickness properties

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.

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EN 1993-1-4:2025/prA1 Public enquiry

Comment end date 2026-07-30

Eurocode 3 - Design of steel structures - Part 1-4: Stainless steel structures

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.

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EN 1993-1-9:2025/prA1 Public enquiry

Comment end date 2026-07-30

Eurocode 3 - Design of steel structures - Part 1-9: Fatigue

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).

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EN 1992-1-2:2023/prA1 Public enquiry

Comment end date 2026-07-30

Eurocode 2 - Design of concrete structures - Part 1-2: Structural fire design

1.1 Scope of prEN 1992 1 2 (1) This document deals with the design of concrete structures for the accidental situation of fire exposure and is intended to be used in conjunction with prEN 1992 1 1 and EN 1991 1 2. This document identifies differences from, or supplements to, normal temperature design. (2) This document applies to concrete structures required to fulfil a loadbearing function, separating function or both. (3) This document gives principles and application rules for the design of structures for specified requirements in respect of the aforementioned functions and the levels of performance. (4) This document applies to structures, or parts of structures, that are within the scope of prEN 1992 1 1 and are designed accordingly. (5) The methods given in this document are applicable to normal weight concrete up to strength class C100/115 and lightweight concrete up to strength class LC50/60. 1.2 Assumptions (1) In addition to the general assumptions of prEN 1990 the following assumptions apply: - the choice of the relevant design fire scenario is made by appropriate qualified and experienced personnel or is given by the relevant national regulation; - any fire protection measure taken into account in the design will be adequately maintained.

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EN 1992-1-1:2023/prA1 Public enquiry

Comment end date 2026-07-30

Eurocode 2 - Design of concrete structures - Part 1-1: General rules and rules for buildings, bridges and civil engineering structures

1.1 Scope of FprEN 1992-1-1 (1) This document gives the general basis for the design of structures in plain, reinforced and prestressed concrete made with normal weight, lightweight and heavyweight aggregates. It gives specific rules for buildings, bridges and civil engineering structures, including temporary structures; additional requirements specific to bridges are given in Annex K. The rules are valid under temperature conditions between −40 °C and +100 °C generally. This document complies with the principles and requirements for the safety, serviceability, durability and robustness of structures, the basis of their design and verification that are given in EN 1990. (2) This document is only concerned with the requirements for resistance, serviceability, durability, robustness and fire resistance of concrete structures. Other requirements, e.g. concerning thermal or sound insulation, are not considered. (3) This document does not cover: - resistance to fire (see EN 1992 1 2); - fastenings in concrete (see EN 1992 4); - seismic design (see EN 1998 (all parts)); - particular aspects of special types of civil engineering works (such as dams, pressure vessels); - structures made with no-fines concrete, aerated or cellular concrete, lightweight aggregate concrete with open structure components; - structures containing steel sections considered in design (see EN 1994 (all parts)) for composite steel and concrete structures; - structural parts made of concrete with a smallest value of the upper sieve aggregate size Dlower < 8 mm (or if known Dmax < 8 mm) unless otherwise stated in this Eurocode. 1.2 Assumptions (1) The assumptions of EN 1990 apply to FprEN 1992-1-1. (2) It is assumed that the requirements for execution and workmanship given in EN 13670 are complied with.

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prEN 14492-1 Public enquiry

Comment end date 2026-07-30

Cranes - Power driven winches and hoists - Part 1: Power driven winches

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.

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prEN ISO 1924-2 Public enquiry

Comment end date 2026-07-30

Paper and board - Determination of tensile properties - Part 2: Constant rate of elongation method (20 mm/min) (ISO/DIS 1924-2:2026)

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.

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prEN ISO 7198 Public enquiry

Comment end date 2026-07-30

Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO/DIS 7198:2026)

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

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