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EN ISO 4135:2022/prA1 New
Comment end date 2026-04-14
Anaesthetic and respiratory equipment - Vocabulary - Amendment 1 (ISO 4135:2022/DAM 1:2026)
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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.

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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.

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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.

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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.

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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.

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prEN 868-8 Public enquiry
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).

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prEN 868-10 Public enquiry
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.

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prEN 868-9 Public enquiry
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.

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prEN 868-5 Public enquiry
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.

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prEN ISO 18730 Public enquiry
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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prEN ISO 17256 Public enquiry
Comment end date 2026-03-17
Anaesthetic and respiratory equipment - Respiratory therapy tubing and connectors (ISO 17256:2024)

This document specifies requirements for the respiratory tubing and connectors used to convey respirable gases to a patient in the healthcare and homecare environments and provide a safe connection between the gas supply device and the patient interface. Respiratory tubing and connectors are mainly used for delivery of oxygen but can also be used for respirable air or oxygen/air mixtures and breathable medicinal gas mixtures such as oxygen/nitrous oxide or oxygen/helium mixtures. This document also specifies requirements for respiratory therapy extension tubing. NOTE 1        The gas supply devices referred to in this document do not include anaesthetic machines/workstations and ventilators. NOTE 2        This document does not cover breathing tubes for breathing systems. These are specified in ISO 5367. This document is written following the format of ISO 18190, General standard for airways and related equipment. The requirements in this device-specific standard take precedence over any conflicting requirements in the General standard

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prEN ISO 11737-3 Public enquiry
Comment end date 2026-03-17
Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing (ISO 11737-3:2023)

This document specifies general criteria to be applied in the determination of bacterial endotoxins on or in health care products, components or raw materials using bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. This document is not applicable to the evaluation of pyrogens other than bacterial endotoxins. Other endotoxin detection methodologies are not included. This document does not address setting specific endotoxin limit specifications.

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prEN ISO 18969 Public enquiry
Comment end date 2026-02-24
Clinical evaluation of medical devices (ISO/DIS 18969:2025)

This document specifies terminology, principles and a process for the clinical evaluation of medical devices. The process described in this document aims to assist manufacturers of medical devices to estimate the clinical risks associated with a medical device and evaluate the acceptability of those risks in the light of the clinical benefits achieved when the device is used as intended. The requirements of this document are applicable throughout the life cycle of a medical device. The process described in this document applies to the assessment of risks and benefits from clinical data obtained from the use of medical devices in humans. This document specifies general requirements intended to — verify the safety of medical devices when used in accordance with their instructions for use; — verify that the clinical performance or effectiveness of a medical device meet the claims of the manufacturer in relation to its intended use; — verify that there is sufficient clinical evidence to demonstrate the achievement of a positive benefit/risk balance when a medical device is used in the intended patient population in accordance with its intended use; — ensure the scientific conduct of a clinical evaluation and the credibility of conclusions drawn on the safety and performance of a medical device; — define the responsibilities of the manufacturer and those conducting or contributing to a clinical evaluation; and — assist manufacturers, clinicians, regulatory authorities and other bodies involved in the conformity assessment of medical devices. Note 1 This standard can be used for regulatory purposes. Note 2 This document does not apply to in vitro diagnostic medical devices. However, there may be situations, dependent on the device and national or regional requirements, where sections and/or requirements of this document might be applicable.

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prEN ISO 80601-2-56 Public enquiry
Comment end date 2026-02-19
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO/DIS 80601-2-56:2025)

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment. Me equipment that measures a body temperature is inside the scope of this document. ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4]. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1. NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.

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prEN ISO 10993-16 Public enquiry
Comment end date 2026-02-17
Biological evaluation of medical devices - Part 16: Toxicokinetic evaluation for degradation products and leachables (ISO/DIS 10993-16:2025)

ISO 10993-16:2017 provides principles on designing and performing toxicokinetic evaluation relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic evaluation in the biological evaluation of medical devices.

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prEN ISO 8537 New
Comment end date 2026-02-10
Sterile single-use syringes, with or without needle, for insulin (ISO/DIS 8537:2025)

ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations. The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time. ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).

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