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SIS: Swedish Standards Institute

SIS, the Swedish Standards Institute, is a nonprofit organization that develops and publishes standards on a wide variety of topics. Headquartered in Stockholm, Sweden, SIS is Sweden's national standards organization and its representative in the European CEN and the international ISO. In 2010, SIS involved over 4,800 experts from 1,500 member companies, agencies and organizations, all contributing to the development and assimilation of SIS standards. Cover page in Swedish with English title, and the full text is in English. Standards from SIS are available both individually, directly through the ANSI webstore, and as part of a Standards Subscription. If you or your organization are interested in easy, managed, online access to standards that can be shared, a Standards Subscription may be what you need - please contact us at: or 1-212-642-4980 or Request Proposal Price.

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SIS-ISO/TS 22002-4:2016

Prerequisite programmes on food safety - Part 4: Food packaging manufacturing (ISO/TS 22002-4:2013, IDT) (Swedish Standard)

This Technical Specification specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs) to assist in controlling food safety hazards in the manufacture of food packaging.This Technical Specification is applicable to all organizations, regardless of size or complexities that manufacture food packaging and/or intermediate products. This Technical Specification is not designed or intended for use in other parts or activities of the food supply chain.NOTE 1 The organization producing its own food packaging (e.g. self-blowing of bottles and forming/filling/sealing of aseptic cartons/pouches) can decide whether or not this Technical Specification should be applied.Food packaging manufacturing organizations are diverse in nature, and not all of the requirements specified in this Technical Specification apply to an individual organization. Each organization is required to conduct a documented food safety hazard analysis that includes each requirement. Where exclusions are made or alternative measures are implemented, these need to be justified by the food safety hazard analysis.This Technical Specification is not a Management system Standard, and is intended to be used by food packaging manufacturing organizations wishing to implement PRPs in such a way as to address the requirements specified in ISO 22000.This Technical Specification is intended to be used in conjunction with ISO 22000.NOTE 2 For the purpose of this Technical Specification, the term food includes beverages.

SS-EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices (Swedish Standard)

This European Standard specifies requirements for information to be supplied by a manufacturer for medical devices regulated by Council Directive 90/385/EEC relating to active implantable medical devices and Council Directive 93/42/EEC concerning medical devices. It does not specify the language to be used for such information, nor does it specify the means by which the information is to be supplied. It is also intended to complement the specific requirements of the cited EU Directives on medical devices by providing guidance on means by which certain requirements can be met. If a manufacturer follows these means, they will provide a presumption of conformity with the relevant Essential Requirements regarding information to be supplied. This standard does not cover requirements for provision of information for in vitro diagnostic medical devices, which are covered by other labelling standards (see Bibliography). NOTE When national transpositions of the Directives specify the means by which information shall be supplied, this standard does not provide derogation from these requirements for that country.

SS-EN ISO 13485:2012

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (Swedish Standard)

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.

SS-EN 15194:2017

Cycles - Electrically power assisted cycles - EPAC Bicycles (Swedish Standard)

This European Standard applies to EPAC bicycles for private and commercial use with exception of EPAC intended for hire from unattended station. This European Standard is intended to cover all common significant hazards, hazardous situations and events (see Clause 4) of electrically power assisted bicycles, when used as intended and under condition of misuse that are reasonably foreseeable by the manufacturer. This European Standard is intended to cover electrically power assisted bicycles of a type which have a maximum continuous rated power of 0,25 kW, of which the output is progressively reduced and finally cut off as the EPAC reaches a speed of 25 km/h, or sooner, if the cyclist stops pedalling. This European Standard specifies requirements and test methods for engine power management systems, electrical circuits including the charging system for the design and assembly of electrically power assisted bicycles and sub-assemblies for systems having a rated voltage up to and including 48 V d.c. or integrated battery charger with a nominal 230 V a.c. input. This European Standard specifies safety and safety related performance requirements for the design, assembly, and testing of EPAC bicycles and subassemblies intended for use on public roads, and lays down guidelines for instructions on the use and care of such bicycles. This European Standard applies to EPAC bicycles that have a maximum saddle height of 635 mm or more and that are intended for use on public roads. This European Standard is not applicable to EPACs which are manufactured before the date of its publication as EN.

SS-EN 388:2016

Protective gloves against mechanical risks (Swedish Standard)

This European Standard specifies requirements, test methods, marking and information to be supplied for protective gloves against the mechanical risks of abrasion, blade cut, tear, puncture and, if applicable, impact. This standard is intended to be used in conjunction with EN 420. The test methods developed in this standard may also be applicable to arm protectors.

SS-EN 614-1:2006+A1:2009

Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles (Swedish Standard)

This European Standard establishes the ergonomic principles to be followed during the process of design of machinery.

This European Standard applies to the interactions between operators and machinery when installing, operating, adjusting, maintaining, cleaning, dismantling, repairing or transporting equipment, and outlines the principles to be followed in taking the health, safety and well-being of the operator into account. This European Standard provides a framework within which the range of more specific ergonomics standards and other related standards relevant to machinery design should be applied.

The ergonomic principles given in this European Standard apply to all ranges of human abilities and characteristics to ensure safety, health and well-being and overall system performance. Information will need to be interpreted to suit the intended use.

NOTE Although the principles in this European Standard are orientated towards machinery for occupational use, they are also applicable to equipment and machinery for private use.

SS-ISO 31000:2009

Risk management - Principles and guidelines (ISO 31000:2009, IDT) (Swedish Standard)

This International Standard provides principles and generic guidelines on risk management.

This International Standard can be used by any public, private or community enterprise, association, group or individual. Therefore, this International Standard is not specific to any industry or sector.

NOTE For convenience, all the different users of this International Standard are referred to by the general term ôorganizationö.

This International Standard can be applied throughout the life of an organization, and to a wide range of activities, including strategies and decisions, operations, processes, functions, projects, products, services and assets.

This International Standard can be applied to any type of risk, whatever its nature, whether having positive or negative consequences.

Although this International Standard provides generic guidelines, it is not intended to promote uniformity of risk management across organizations. The design and implementation of risk management plans and frameworks will need to take into account the varying needs of a specific organization, its particular objectives, context, structure, operations, processes, functions, projects, products, services, or assets and specific practices employed.

It is intended that this International Standard be utilized to harmonize risk management processes in existing and future standards. It provides a common approach in support of standards dealing with specific risks and/or sectors, and does not replace those standards.

This International Standard is not intended for the purpose of certification.

SS-ISO/IEC 27005:2013

Information technology - Security techniques - Information security risk management (ISO/IEC 27005:2011, IDT) (Swedish Standard)

Denna internationella standard innehσller riktlinjer f÷r hantering av informationssΣkerhetsrisker.

Denna internationella standard st÷djer de allmΣnna koncept som specificeras i SS-ISO/IEC 27001 och den Σr utformad f÷r att st÷dja ett lyckat inf÷rande av informationssΣkerhet med utgσngspunkt frσn riskhantering.

Kunskap om de koncept, modeller, processer och den terminologi som beskrivs i SS-ISO/IEC 27001 och SS-ISO/IEC 27002 Σr av betydelse f÷r en fullstΣndig f÷rstσelse av denna internationella standard.

Denna internationella standard Σr tillΣmplig f÷r alla typer av organisationer (t.ex. kommersiella f÷retag, statliga myndigheter, ideella organisationer) vilka avser att hantera risker som skulle kunna Σventyra organisationens informationssΣkerhet.

SS-EN 15468:2016

Laminate floor coverings - Elements with directly applied printing and resin surface layer - Specifications, requirements and test methods (Swedish Standard)

This European Standard specifies characteristics, states requirements and gives test methods for laminate floor coverings (as defined in 3.1). It includes a classification system, based on EN ISO 10874, providing practical requirements for areas of use and levels of use, to indicate where laminate floor coverings will give satisfactory service and to encourage the consumer to make an informed choice. It also specifies requirements for marking and packaging.Laminate floor coverings are considered for domestic and commercial levels of use, e.g. in domestic kitchens. This standard does not specify requirements relating to areas that are subject to frequent wetting, such as bathrooms, laundry rooms or saunas.


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