Yhteinen Toimialaliitto

 

This document defines a method of determining bulk density of solid recovered fuels by the use of a standard measuring container. This method is applicable to all SRFs with a nominal top size of particle less than 1/3 of the container diameter specified in this document.

 

 

 

This document specifies common requirements for transportable liquid oxygen systems and specific requirements for base units. Base units are used as a store for liquid oxygen for recharging portable units. They may also, if fitted with a flow outlet and flow selector, be used as a source for the supply of oxygen direct to the patient.

 

This document specifies requirements for portable units which are part of a transportable liquid oxygen system. These are used as a supply source for oxygen therapy in home-care and in health-care facilities. Portable units are intended to be carried by patients whilst moving around and during their off-site activities and can be refilled from a base unit through a transfilling connector. Portable units are used without professional supervision.

 

This document specifies requirements and provides recommendations for the pre-examination phase of cell free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, pleural effusions, ascites, cerebrospinal fluid (CSF), and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen purification and isolation of cfDNA. This document is applicable to medical laboratories, health institutions including facilities collecting and handling specimens, laboratory customers, in vitro diagnostic examination developers and manufacturers, biobanks, institutions and organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this document, neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving circulating cell free DNA (ccfDNA) from blood. These are not described in this document, but are covered in ISO 20186-3.

 

This document is a product specification, giving performance requirements for emergency safety body showers connected to the water supply. It is applicable to plumbed-in body showers only, located in laboratory facilities. Requirements are given in respect of the performance, installation, adjustment and marking of the showers as well as installation, operation and maintenance instructions to be given by the manufacturer. NOTE Attention is drawn to national regulations which might apply in respect of the installation and use of emergency safety showers.

 

This document is a product specification, giving performance requirements for emergency safety eye-wash units connected to the water supply. It is applicable to plumbed-in eye-wash units only. Requirements are given in respect of the performance, installation, adjustment and marking of the eye-wash units, as well as installation, operation and maintenance instructions to be given by the manufacturer. NOTE Attention is drawn to national regulations which can apply in respect of the installation and use of eye-wash units.

 

This international standard defines a method of determining bulk density of solid recovered fuels by the use of a standard measuring container.

 

This document specifies requirements and provides recommendations for the pre-examination phase of cell free DNA (cfDNA) from body fluid specimens other than blood, including but not limited to the collection, handling, storage, transport, processing and documentation of human body fluids, such as urine, cerebrospinal fluid (CSF), pleural effusions and saliva, intended for cfDNA examination. Processing includes multiple steps, such as centrifugation for specimen cleaning and isolation of cfDNA. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by health institutions including facilities collecting and handling specimen, laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for cytohistological analysis of body fluid derived nucleated cells are not described in this document. Neither are measures for preserving and handling of pathogens, and other bacterial or whole microbiome DNA in body fluids described. Different dedicated measures need to be taken for preserving circulating cell free DNA (ccfDNA) from blood. These are not described in this document, but are covered in ISO 20186-3. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

 

This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred as ‘assistive product’ within the standard) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability. The standard specifies safety, functional and ergonomic requirements for both persons with disability and assistants that apply during normal use and foreseeable misuse and failure. This document specifies requirements and test methods for assistive products within the following divisions of EN ISO 9999:2022. There are no specific requirements and test methods for products marked with *. Only the relevant general requirements apply when these products are considered to be medical devices. This document does not apply for:

 

 

This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred as ‘assistive product’ within the document) and which are considered to be medical devices, intended by the manufacturer to alleviate or compensate for disability. NOTE Assistive products are considered to be medical devices in some jurisdictions but not in others. The work environment and safety aspects for assistants are also included. It specifies safety and performance requirements that apply during normal use and foreseeable misuse and failure. It also specifies methods of measurement of the forces necessary to operate controls and specifies limits on the forces needed for some operations. This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999: 09 12 03 Commode chairs; 09 12 06 Toilets; 09 12 09 Toilet seats; 09 12 10 Toilet splash guards; 09 12 12 Raised toilet seats mounted on frame; 09 12 15 Toilet seats inserts; 09 12 18 Raised toilet seats fixed to toilet; 09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down; 09 12 24 Toilet arm supports and toilet back supports mounted on toilet; 09 12 25 Toilet arm supports and toilet back supports, free standing; 09 12 36 Douches and air dryers for attachment to a toilet; 09 33 04 Bath boards 09 33 05 Bath seats 09 33 07 Shower chairs with and without wheels 09 33 08 Back supports for bath or shower 09 33 12 Bathing stretchers, shower tables and diaper-changing tables; NOTE: Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered by EN 12221-1 and EN 12221-2. 09 33 15 Wash basins NOTE: General requirements for wash basins are covered by EN 14688. 09 33 18 Bidets 09 33 21 Bathtubs 09 33 36 Assistive products for drying oneself 18 15 06 Height adjustable plinths and brackets; 18 18 03 Handrails and support rails; 18 18 06 Fixed grab bars and handgrips; 18 18 10 Removable grab rails and handgrips; 18 18 11 Hinged rails and arm supports; This document does not encompass requirements regarding: — safe mounting in building structures; — fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to excretion-disposal and -wrapping systems; — 12 36 15 bathtub hoists that are covered by ISO 10535; — 09 33 21 Bathtubs — stability and friction issues in relation to slippery surfaces due to soap; — products that have been customised or custom-made for an individual user. NOTE: this list is based on ISO 9999:2016, however in the revision process, this will be updated to corresponding codes of ISO 9999:2022

 

This document specifies the conditions for the visual inspection of domestic articles made from ceramic, glass, glass ceramic, decorated glass, vitreous enamel, coatings, rubber, silicones, metal, and plastics after testing its dishwashing resistance according to the procedures described in the relevant parts of the EN 12875 series.

 

This European Standard specifies a method for testing the resistance of domestic articles made from ceramic, glass, glass ceramic, vitreous enamel, metal and plastics under the combined chemical, thermal and mechanical stresses of mechanical dishwashing in domestic dishwashers. It specifies a reference test method for domestic dishwashing only. It does not define the number of dishwashing cycles which any given product shall withstand.

 

This document specifies requirements for the contents of a technical file to demonstrate the fulfilment of regulatory requirements for an endosseous dental implant that may include: This document includes requirements for intended use and performance, design attributes, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labelling and information supplied by the manufacturer. The following devices are not included within the scope of this document:

 

This document provides general terms and definitions for systems, products and services as used in standards related to the railway applications. Excluded from the scope of this document are terms and definitions related to those electrotechnical and electronic products and services for railways which are within the scope of standards of IEC/TC 9.

 

This document specifies expected field loads for functions provided by the braking system actuator and modulator and applies to passenger cars and light commercial vehicles (classes M1 and N1, according to UNECE). Functions addressed in this document are: This document only covers functions where data of appropriate maturity are available. There are additional functions of a braking system, which are not covered by this document. By describing the expected field loads, this document specifies representative manoeuvres and occurrences for different functions. These serve as an orientation for the derivation of test procedures. This document applies to vehicles up to conditional automation (SAE J 3016 level 3).

 

This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices. This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

 

This document specifies the test suite structure (TSS) and test purposes (TP) to evaluate the conformity of on-board equipment (OBE) and roadside equipment (RSE) to ISO 13141. It provides a basis for conformance tests for dedicated short-range communication (DSRC) equipment to support interoperability between different equipment supplied by different manufacturers. ISO 13141 specifies requirements for the localization augmentation communication (LAC) interface level, but not for the RSE or OBE internal functional behaviour. Consequently, tests regarding OBE and RSE functional behaviour remain outside the scope of this document.