Information service
11 Health care technology
New standards
EVS-EN 18156:2026
Tactile lettering - Requirements on the presentation and application of Braille and raised characters
Scope:
This document specifies requirements and technical specifications for information presented in tactile lettering in the built environment.
NOTE For the definition of built environment see ISO 21542.
It sets out rules for content, design, arrangement and application of information elements so that blind and partially sighted people are able to locate, identify, fluently read and interpret this information.
This document does not specify technical methods for producing tactile lettering.
This document is only applicable to permanently installed tactile lettering.
NOTE For the definition of built environment see ISO 21542.
It sets out rules for content, design, arrangement and application of information elements so that blind and partially sighted people are able to locate, identify, fluently read and interpret this information.
This document does not specify technical methods for producing tactile lettering.
This document is only applicable to permanently installed tactile lettering.
Base documents:
EN 18156:2026
EVS-EN IEC 60601-2-28:2019/A1:2026
Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
Scope:
Amendment to EN IEC 60601-2-28:2019
Base documents:
IEC 60601-2-28:2017/AMD1:2026; EN IEC 60601-2-28:2019/A1:2026
ISO 25657:2026
Traditional Chinese medicine — Curculigo orchioides rhizome
Scope:
This document specifies the quality and safety requirements and test methods for the Curculigo orchioides rhizome, which is derived from the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae).
This document is applicable to Curculigo orchioides rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document is applicable to Curculigo orchioides rhizomes that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Base documents:
ISO 5833:2026
Implants for surgery — Acrylic resin cements
Scope:
This document specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly (methacrylic acid esters). This document applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.
All requirements in this document apply to, and all test methods are intended to be performed on, a sterile product.
The requirements in this document are not intended to apply to acrylic resin cements for other applications, such as stabilization of spinal fractures, fixation of bone screws, bone anchors or augments, etc., although the test methods described can be applicable.
This document does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.
All requirements in this document apply to, and all test methods are intended to be performed on, a sterile product.
The requirements in this document are not intended to apply to acrylic resin cements for other applications, such as stabilization of spinal fractures, fixation of bone screws, bone anchors or augments, etc., although the test methods described can be applicable.
This document does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.
Base documents:
Replaces:
ISO 5833:2002
ISO/TS 22358:2026
Traditional Chinese medicine — Procedure for reporting indoor air quality when combusting moxibustion devices
Scope:
This document aims to provide a procedure for reporting indoor air quality when combusting moxibustion devices. It is intended for use in business-to-business (B to B) transactions, subject to mutual agreement between parties. This document specifies the steps for preparing reports that compare indoor concentration values of target pollutants generated when combusting moxibustion device with international, regional, or national ambient and indoor air quality regulations, standards, or guideline values.
This document does not apply to moxibustion devices that do not involve combustion of moxibustion material, such as electric heating moxibustion equipment covered in ISO 21292:2020 and infrared moxibustion-like instruments covered in ISO 20493:2018.
This document does not apply to moxibustion devices that do not involve combustion of moxibustion material, such as electric heating moxibustion equipment covered in ISO 21292:2020 and infrared moxibustion-like instruments covered in ISO 20493:2018.
Base documents:
ISO 17966:2026
Assistive products for toileting, bathing and showering — Requirements and test methods
Scope:
This document specifies requirements and associated test methods for assistive products for toileting, bathing and showering (from herein referred to as ‘assistive product’ within this document).
NOTE 1 Some of the assistive products can be classified as medical devices.
This document 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 ISO 9999:2022.
09 12 03 Commode chairs;
chairs, with or without castors, with a collection receptacle used for toileting away from the bathroom.
09 12 06 Toilets;1)
included are, e.g. raised or height adjustable toilets, toilets with built-in douche and air dryers.
09 12 09 Toilet seats;1)
devices attached to the toilet bowl or toilet chair for a person to sit on, which can provide stability and comfort.
09 12 10 Toilet splash guards;1)
devices to keep bodily substances from splashing outside the toilet bowl.
09 12 12 Raised toilet seats, free-standing;
raised toilet seats (separate) standing on floor, where the seat can easily be removed from the toilet bowl;included are, e.g. over toilet frames.
09 12 15 Raised toilet seats, detachable;
raised toilet seats (loose attachments) placed directly on the toilet bowl/toilet seat where the seat insert can easily be removed from the toilet bowl/toilet seat.
09 12 18 Raised toilet seats fixed to toilet;
devices permanently fixed on to a toilet bowl to increase the height of the seat and to facilitate sitting down upon, and standing up from, the toilet; included are, e.g. plinths.
09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;
toilet seats that have a built-in lifting mechanism to assist a person to sit down on and get up from the toilet.
09 12 24 Toilet arm supports and toilet back supports mounted on toilet;
devices mounted on the toilet that provide support getting on or off the 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;1)
devices attached to a toilet to provide a water spray with or without air blowing afterwards to wash, and possibly dry, a person’s bottom while sitting on the toilet; included are, e.g. toilet seats with that function.
09 33 04 Bath boards;
seats without back support placed on the rim across the bathtub.
09 33 05 Bath seats;
seats hung from the rim of or placed in the bathtub; included are e.g. bath seats with or without backrest.
09 33 07 Shower chairs with and without wheels;
devices for supporting sitting during showering; included are, e.g. shower stools.
09 33 08 Back supports for bath or shower;
excluded are, e.g. back support cushions.
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
stationary or portable tables, with or without castors, on which a person lies during bathing, showering or changing.
NOTE 2 Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered by EN 12221-1.
09 33 15 Wash basins;1)
stationary or portable basins for water used when washing parts of the body.
09 33 18 Bidets;1)
stationary or portable basins primarily intended for washing genitals and bottom.
09 33 36 Assistive products for drying oneself;1)
devices and materials for enabling a person to dry their own body.
18 15 06 Height adjustable plinths and brackets;
height-adjustable surfaces or brackets on which furniture (e.g. wash basins) can be mounted.
18 18 03 Handrails and support rails;
bars, usually cylindrical, attached to a wall, floor or other stable structure that provide the means for a person to support or stabilize themselves using hands or arms while walking, e.g. up and down stairs or ramps or moving along corridors.
18 18 06 Fixed grab bars and handgrips;
devices, usually straight or angled bars, that are permanently attached to a wall, a wall and a floor, or a wall, ceiling and floor to provide support to a person while standing or changing position.
18 18 10 Removable grab rails and handgrips;
devices, usually straight or angled bars, that can be temporarily attached to walls, floors, ceilings or furniture using, e.g. clamps or suction pads and removed without tools providing support to a person while changing position.
18 18 11 Hinged rails and arm supports;
devices that provide support to a person when changing their position; they can be fixed to a wall or floor and can be folded up or sideways or lowered down to allow access or when they are not needed.
This document does not apply for:
— safe mounting in building structures;
— fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to excretion-disposal and wrapping systems;
— bathtub hoists that are covered by ISO 10535:2021, namely
-- 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats;
-- 12 36 09 Mobile hoists for transferring a person in lying position;
-- 12 36 12 Stationary hoists fixed to walls, floor or ceiling;
-- 12 36 15 Stationary hoists fixed to, or mounted in or on, another product;
— 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.
---------------------------------
1)There are no specific requirements and test methods for these products. Only the relevant general requirements apply when these products are considered to be assistive products.
NOTE 1 Some of the assistive products can be classified as medical devices.
This document 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 ISO 9999:2022.
09 12 03 Commode chairs;
chairs, with or without castors, with a collection receptacle used for toileting away from the bathroom.
09 12 06 Toilets;1)
included are, e.g. raised or height adjustable toilets, toilets with built-in douche and air dryers.
09 12 09 Toilet seats;1)
devices attached to the toilet bowl or toilet chair for a person to sit on, which can provide stability and comfort.
09 12 10 Toilet splash guards;1)
devices to keep bodily substances from splashing outside the toilet bowl.
09 12 12 Raised toilet seats, free-standing;
raised toilet seats (separate) standing on floor, where the seat can easily be removed from the toilet bowl;included are, e.g. over toilet frames.
09 12 15 Raised toilet seats, detachable;
raised toilet seats (loose attachments) placed directly on the toilet bowl/toilet seat where the seat insert can easily be removed from the toilet bowl/toilet seat.
09 12 18 Raised toilet seats fixed to toilet;
devices permanently fixed on to a toilet bowl to increase the height of the seat and to facilitate sitting down upon, and standing up from, the toilet; included are, e.g. plinths.
09 12 21 Toilet seats with built-in raising mechanism to help standing up and sitting down;
toilet seats that have a built-in lifting mechanism to assist a person to sit down on and get up from the toilet.
09 12 24 Toilet arm supports and toilet back supports mounted on toilet;
devices mounted on the toilet that provide support getting on or off the 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;1)
devices attached to a toilet to provide a water spray with or without air blowing afterwards to wash, and possibly dry, a person’s bottom while sitting on the toilet; included are, e.g. toilet seats with that function.
09 33 04 Bath boards;
seats without back support placed on the rim across the bathtub.
09 33 05 Bath seats;
seats hung from the rim of or placed in the bathtub; included are e.g. bath seats with or without backrest.
09 33 07 Shower chairs with and without wheels;
devices for supporting sitting during showering; included are, e.g. shower stools.
09 33 08 Back supports for bath or shower;
excluded are, e.g. back support cushions.
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
stationary or portable tables, with or without castors, on which a person lies during bathing, showering or changing.
NOTE 2 Mainstream diaper-changing tables for babies/toddlers are excluded. They are covered by EN 12221-1.
09 33 15 Wash basins;1)
stationary or portable basins for water used when washing parts of the body.
09 33 18 Bidets;1)
stationary or portable basins primarily intended for washing genitals and bottom.
09 33 36 Assistive products for drying oneself;1)
devices and materials for enabling a person to dry their own body.
18 15 06 Height adjustable plinths and brackets;
height-adjustable surfaces or brackets on which furniture (e.g. wash basins) can be mounted.
18 18 03 Handrails and support rails;
bars, usually cylindrical, attached to a wall, floor or other stable structure that provide the means for a person to support or stabilize themselves using hands or arms while walking, e.g. up and down stairs or ramps or moving along corridors.
18 18 06 Fixed grab bars and handgrips;
devices, usually straight or angled bars, that are permanently attached to a wall, a wall and a floor, or a wall, ceiling and floor to provide support to a person while standing or changing position.
18 18 10 Removable grab rails and handgrips;
devices, usually straight or angled bars, that can be temporarily attached to walls, floors, ceilings or furniture using, e.g. clamps or suction pads and removed without tools providing support to a person while changing position.
18 18 11 Hinged rails and arm supports;
devices that provide support to a person when changing their position; they can be fixed to a wall or floor and can be folded up or sideways or lowered down to allow access or when they are not needed.
This document does not apply for:
— safe mounting in building structures;
— fixed building installations e.g. water, electricity, drainage and sewerage, requirements in relation to excretion-disposal and wrapping systems;
— bathtub hoists that are covered by ISO 10535:2021, namely
-- 12 36 06 Mobile hoists for transferring a person in sitting position with solid seats;
-- 12 36 09 Mobile hoists for transferring a person in lying position;
-- 12 36 12 Stationary hoists fixed to walls, floor or ceiling;
-- 12 36 15 Stationary hoists fixed to, or mounted in or on, another product;
— 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.
---------------------------------
1)There are no specific requirements and test methods for these products. Only the relevant general requirements apply when these products are considered to be assistive products.
Base documents:
Replaces:
ISO 17966:2016
Replaced standards
ISO 5833:2002
Implants for surgery -- Acrylic resin cements
Scope:
Scope
This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.
This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.
All requirements apply to, and all tests are intended to be performed on, the sterile product.
This International Standard specifies the physical, mechanical, packaging and labelling requirements for curing polymerizing radio-opaque and non-radio-opaque resin cements based on poly(methacrylic acid esters). It applies to two types of cement, intended respectively for use with a syringe or in the dough state, for the fixation of internal orthopaedic prostheses and supplied as units containing premeasured amounts of sterile powder and of sterile liquid in forms suitable for mixing at the time of implantation.
This International Standard does not cover the hazards associated with the use of the cement in respect of either the patient or the user of the cement.
All requirements apply to, and all tests are intended to be performed on, the sterile product.
Base documents:
Replaced:
ISO 5833:2026
ISO 17966:2016
Assistive products for personal hygiene that support users -- Requirements and test methods
Scope:
ISO 17966:2016 specifies requirements and associated test methods for assistive products for personal hygiene (APPHs) that support users and which are intended by the manufacturer to alleviate or compensate for disability. 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 International Standard specifies requirements and test methods for assistive products within the following divisions of ISO 9999:2011:
09 12 03 Commode chairs;
NOTE This covers mobile and static products.
09 12 06 Toilets with built in raising and height adjustable mechanism;
NOTE This excludes toilets with built-in douche and air dryers.
09 12 09 Toilet seats;
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 03 Bath/shower chairs (with and without wheels), bath boards, stools, back supports and seats;
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
18 15 06 Height adjustable plinths and brackets;
NOTE Refers to height adjustable plinths and brackets when used as an assistive product for personal hygiene (APPH). Height adjustable mechanisms for other items such as basins may be included.
18 18 03 Handrails and support rails;
18 18 06 Fixed grab bars and handgrips;
18 18 10 Removable grab rails and handgrips;
NOTE This excludes removable grab rails and handgrips which are static as defined in 3.27.
18 18 11 Hinged rails and arm supports;
ISO 17966:2016 does not encompass requirements regarding:
- safe mounting in building structures;
- requirements regarding fixed building installations e.g. water and electricity;
- bathtub hoists that are covered by ISO 10535;
- 09 33 21 Bathtubs of ISO 9999:2011;
- stability and friction issues in relation to slippery surfaces due to soap;
- products that have been customised or custom-made for an individual user.
This International Standard specifies requirements and test methods for assistive products within the following divisions of ISO 9999:2011:
09 12 03 Commode chairs;
NOTE This covers mobile and static products.
09 12 06 Toilets with built in raising and height adjustable mechanism;
NOTE This excludes toilets with built-in douche and air dryers.
09 12 09 Toilet seats;
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 03 Bath/shower chairs (with and without wheels), bath boards, stools, back supports and seats;
09 33 12 Bathing stretchers, shower tables and diaper-changing tables;
18 15 06 Height adjustable plinths and brackets;
NOTE Refers to height adjustable plinths and brackets when used as an assistive product for personal hygiene (APPH). Height adjustable mechanisms for other items such as basins may be included.
18 18 03 Handrails and support rails;
18 18 06 Fixed grab bars and handgrips;
18 18 10 Removable grab rails and handgrips;
NOTE This excludes removable grab rails and handgrips which are static as defined in 3.27.
18 18 11 Hinged rails and arm supports;
ISO 17966:2016 does not encompass requirements regarding:
- safe mounting in building structures;
- requirements regarding fixed building installations e.g. water and electricity;
- bathtub hoists that are covered by ISO 10535;
- 09 33 21 Bathtubs of ISO 9999:2011;
- stability and friction issues in relation to slippery surfaces due to soap;
- products that have been customised or custom-made for an individual user.
Base documents:
Replaced:
ISO 17966:2026
Drafts
prEN ISO 24466
Dentistry - Designations for the parts and dimensions of an implant body or a monopart implant (ISO/DIS 24466:2026)
Scope:
This document defines the general labelling information required by the clinician for the selection of a suitable dental implant for the surgical procedure. This document designates the terms for the parts of an implant body or a monopart implant that are used in oral implantology and specifies the dimensions and their data on the packaging of a dental implant. This document does not apply to non-root form implants such as zygomatic implants or subperiosteal implants.
Base documents:
ISO/DIS 24466; prEN ISO 24466
prEN ISO 26782
Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO/DIS 26782:2026)
Scope:
This document specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg.
This document applies to a spirometer that measures timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.
Devices intended for continuously monitoring patients are outside the scope of this document.
NOTE
This document has been prepared to address the relevant essential principles [3] and labelling principles [4] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
(see Clause A.2)
This document applies to a spirometer that measures timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.
Devices intended for continuously monitoring patients are outside the scope of this document.
NOTE
This document has been prepared to address the relevant essential principles [3] and labelling principles [4] of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
(see Clause A.2)
Base documents:
ISO/DIS 26782; prEN ISO 26782
prEN ISO 24051-2
Medical laboratories - Part 2: Digital pathology and artificial intelligence (AI)-based image analysis (ISO/DIS 24051-2:2026)
Scope:
This document specifies requirements and gives recommendations for the digitalization of slide-mounted, stained sections, processing of digital whole slide images, and artificial intelligence (AI) based image analysis to support anatomical pathology examination. This document focuses on sections from formalin-fixed paraffin-embedded (FFPE) tissues (derived e.g. from surgical resection, biopsy or autopsy). It is also applicable to paraffin-embedded tissue fixed by fixatives other than formalin.
This document is applicable to in vitro diagnostic examinations using digital pathology and AI-based image analysis performed by medical laboratories, in particular but not limited to anatomical pathology laboratories. It is also intended to be used by health institutions, in vitro diagnostics developers and manufacturers, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
This document is applicable to in vitro diagnostic examinations using digital pathology and AI-based image analysis performed by medical laboratories, in particular but not limited to anatomical pathology laboratories. It is also intended to be used by health institutions, in vitro diagnostics developers and manufacturers, and regulatory authorities.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
Base documents:
ISO/DIS 24051-2; prEN ISO 24051-2