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prEN ISO 8836 Public enquiry
Comment end date 2026-05-12
Anaesthetic and respiratory equipment - Suction catheters for use in the respiratory tract (ISO/DIS 8836:2026)

This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

prEN ISO 11737-1 Public enquiry
Comment end date 2026-05-12
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO/DIS 11737-1:2026)

ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.

prEN ISO 3630-1 Public enquiry
Comment end date 2026-04-30
Dentistry - Endodontic instruments - Part 1: General requirements (ISO/DIS 3630‑1:2026)

This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols.

prEN ISO 3843 Public enquiry
Comment end date 2026-04-28
Dentistry - Dental attachments - Measurement of placement and removal forces (ISO/DIS 3843:2026)

This document specifies a test method for measuring the forces needed for the placement and removal of dental attachments (frictional retention elements of ball head-, snap-on, prefabricated telescopic and bar systems used for the attachment, support and stabilization of crowns and bridges, single attachments, removable partial dentures, complete dentures, and other superstructures on dental implant systems (including monopart implants)and, if not other justified, on natural teeth and root post copings). If not otherwise justified, this document can also be used for tests on custom-made or patient matched devices (e.g. laboratory manufactured). This test method is not applicable to retention devices for which normal placement and removal requires any off-axis rotation for the path of least resistance. This test method is not applicable to dental magnetic attachments, these are specified in ISO 13017.

prEN ISO 10555-3 Public enquiry
Comment end date 2026-04-23
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters (ISO/DIS 10555-3:2026)

ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use.

prEN ISO 10555-5 Public enquiry
Comment end date 2026-04-23
Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle peripheral intravenous catheters (ISO/DIS 10555-5:2026)

ISO 10555-5:2013 specifies requirements for over-needle peripheral intravascular catheters, intended for accessing the peripheral vascular system, supplied in the sterile condition and intended for single use.

prEN IEC 60601-2-92:2026 Public enquiry
Comment end date 2026-04-22
Medical electrical equipment - Part 2-92: Particular requirements for the basic safety and essential performance of magnetic resonance guided radiotherapy equipment for use with external beam equipment
prEN ISO 3826-4 Public enquiry
Comment end date 2026-04-21
Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO/DIS 3826-4:2026)

This document specifies requirements including performance requirements for aphaeresis blood bag systems with integrated features. Aphaeresis blood bag systems need not contain all of the integrated features identified in this part of ISO 3826. The integrated features refer to: needle stick protection device, leucocyte filter, sterile barrier filter, pre-collection sampling device, red blood cell storage bag, plasma storage bag, platelet storage bag, polymorphonucleic (e.g. stem) cell storage bag, post-collection sampling devices, and connections for storage solutions, anticoagulant, and replacement fluid. This document specifies additional requirements for blood bag systems used to collect varying quantities of blood components or cells by apheresis. It can be used on automated or semi-automated blood collection systems.

prEN ISO 3826-3 Public enquiry
Comment end date 2026-04-16
Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO/DIS 3826‑3:2026)

ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). The integrated features refer to: leucocyte filter; pre-donation sampling device; top and bottom bag; platelet storage bag; needle stick protection device. In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units. Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.

prEN ISO 3826-2 Public enquiry
Comment end date 2026-04-16
Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO/DIS 3826‑2:2026)

This document addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in this document do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation.  As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This document is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. This document may also be of assistance to different stages of the blood supply chain, e.g.: distributors of blood collection devices (manual or automated) or other representatives of manufacturers; blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product. This document does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this document may be suitable for application in other areas of medical technology.

EN ISO 4135:2022/prA1 Public enquiry
Comment end date 2026-04-14
Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2026)
prEN ISO 9693 Public enquiry
Comment end date 2026-04-07
Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems (ISO/FDIS 9693:2026)

This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material. For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

prEN ISO 23401-2 Public enquiry
Comment end date 2026-04-07
Dentistry - Denture lining materials - Part 2: Soft type materials for short-term use (ISO/DIS 23401-2:2026)

This document specifies requirements for soft type denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis, and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. This document is not applicable to hard type denture lining materials or soft type denture lining materials for long-term use.

prEN ISO 23401-3 Public enquiry
Comment end date 2026-04-07
Dentistry - Denture lining materials - Part 3: Soft type materials for long-term use (ISO/DIS 23401-3:2026)

This document specifies requirements for soft type denture lining materials suitable for long-term use and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging, marking the products and for the instructions for use to be supplied by the manufacturer. These materials may also be used for maxillofacial prostheses. This document is not applicable to hard type denture lining materials or soft type denture lining materials for short-term use.

prEN ISO 17254 Public enquiry
Comment end date 2026-04-07
Dentistry - Coiled springs for use in orthodontics (ISO/DIS 17254:2026)

ISO 17254:2016 applies to coiled springs for use in orthodontic appliances. It gives details of methods to compare the physical and mechanical properties of coiled springs, the test methods by which they can be determined, as well as packaging and labelling requirements.

prEN ISO 19253 Public enquiry
Comment end date 2026-04-07
Sterilization of health care products - Moist heat - Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers (ISO/DIS 19253:2026)

Specifies the requirements and the relevant tests for sterilizers intended to be used for the terminal sterilization of health care products (medical devices or medicinal products) presented as aqueous liquid in sealed containers. The container can be rigid, semi rigid or flexible. The sterilizing agent, moist heat, is created internally from the product, heating being achieved by use of saturated steam, mixtures of steam and a pressure ballasting non-condensing gas such as air or super-heated water in the sterilizer chamber. The sterilizers can be used in both a health care and industrial setting. This standard does not apply to sterilizers using saturated steam for the sterilization of the surfaces of medical devices or sterilizers used in laboratories. NOTE 1 Sterilizers using saturated steam for sterilizing the surfaces of medical devices are covered by EN 285 and EN 13060. Laboratory sterilizers are covered by some national standards. NOTE 2 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of other aqueous liquid in sealed containers such as veterinary products or some foodstuffs. Note 3 Sterilizers conforming to NWIP ISO XXXXX can also be used for the sterilization of a contained product enclosed within a sterile barrier system conforming to the EN ISO 11607 series of standards.

prEN ISO 23401-1 Public enquiry
Comment end date 2026-03-31
Dentistry - Denture lining materials - Part 1: Hard type materials (ISO/DIS 23401-1:2026)

This document specifies the requirements for acrylic hard type materials used as chairside denture lining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer. Dentures which are relined by hard type denture lining materials specified by this document are limited to those of acrylic. This document is not applicable to soft type denture lining materials.

prEN 868-8 Archived
Comment end date 2026-03-24
Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

This document specifies test methods and values for re-usable containers used as sterile barrier systems for terminally sterilized medical devices. These containers are intended to be used in large steam sterilizers as specified in EN 285. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document. This document does not cover additional materials and/or accessories inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, indicators, packing lists, mats, instrument organizer sets, tray liners or an additional envelope around the medical device).

prEN 868-10 Archived
Comment end date 2026-03-24
Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefins - Requirements and test methods

This document specifies test methods and values for sealable adhesive coated nonwoven materials of polyolefins, manufactured from nonwovens specified in EN 868-9 used for single-use sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

prEN 868-9 Archived
Comment end date 2026-03-24
Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

This document specifies test methods and values for uncoated nonwoven materials of polyolefins used for single-use sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

prEN 868-5 Archived
Comment end date 2026-03-24
Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels constructed of porous materials and plastic film - Requirements and test methods

This document specifies test methods and values for single-use sealable pouches and reels constructed of a porous material as specified in EN 868 part 2, 3, 6, 7, 9 or 10 and a plastic film. These sealable pouches and reels are intended to be used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 series specifies materials, test methods and values that are specific to the products covered by this document.

prEN ISO 18730 Archived
Comment end date 2026-03-24
Anaesthetic and respiratory equipment - Waste volatile anaesthetic agent capture systems (ISO/DIS 18730:2026)

This document specifies requirements for waste volatile anaesthetic agent capture systems that may or may not include the recycling of the collected volatile anaesthetic agent for reuse. NOTE 1: Waste volatile agent capture systems, that are part of a medical gas pipeline system as specified in ISO 7396-1 [4], are outside the scope of this document. NOTE 2: Nitrous oxide is not considered to be a volatile anaesthetic agent.

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