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EN ISO 1942:2020/prA1 Public enquiry
Comment end date 2025-06-03
Dentistry - Vocabulary - Amendment 1: Definitions for types of tests used in standards development (ISO 1942:2020/DAM 1:2025)
prEN ISO 23402-1 Public enquiry
Comment end date 2025-05-29
Dentistry - Portable dental equipment for use in non‐permanent healthcare environment - Part 1: General requirements (ISO/DIS 23402-1:2025)

This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments. Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator's stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments. NOTE Particular requirements for specific types of portable dental equipment for use in non-permanent healthcare environments are specified in subsequent parts of this document. This document does not apply to stationary dental equipment, wearable equipment (such as headlamps and loupes), mobile dental equipment or portable dental equipment that is not intended to be used in non-permanent healthcare environments or not designed to be disassembled, folded or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary dental equipment that can be installed in a dental mobile medical facility (e.g. vehicular or containerized mobile dental clinic) are not considered in this document.

prEN ISO 10993-11 Public enquiry
Comment end date 2025-05-29
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO/DIS 10993-11:2025)

ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

prEN ISO 12052 Public enquiry
Comment end date 2025-05-29
Health informatics - Digital imaging and communication in medicine (DICOM) including workflow and data management (ISO/DIS 12052:2025)

ISO 12052:2017, within the field of health informatics, addresses the exchange of digital images and information related to the production and management of those images, between both medical imaging equipment and systems concerned with the management and communication of that information. ISO 12052:2017 facilitates interoperability of medical imaging equipment by specifying: - for network communications, a set of protocols to be followed by devices claiming conformance to this document; - the syntax and semantics of Commands and associated information which can be exchanged using these protocols; - for media communication, a set of media storage services to be followed by devices claiming conformance to this document, as well as a File Format and a medical directory structure to facilitate access to the images and related information stored on interchange media; - information that is to be supplied with an implementation for which conformance to this document is claimed. ISO 12052:2017 does not specify: - the implementation details of any features of the DICOM standard on a device claiming conformance; - the overall set of features and functions to be expected from a system implemented by integrating a group of devices each claiming conformance to this document; - a testing/validation procedure to assess an implementation's conformance to this document. ISO 12052:2017 pertains to the field of medical informatics. Within that field, it addresses the exchange of digital information between medical imaging equipment and other systems. Because such equipment may interoperate with other medical devices and information systems, the scope of this document needs to overlap with other areas of medical informatics. However, this document does not address the full breadth of this field. ISO 12052:2017 has been developed with an emphasis on diagnostic medical imaging as practiced in radiology, cardiology, pathology, dentistry, ophthalmology and related disciplines, and image-based therapies such as interventional radiology, radiotherapy and surgery. However, it is also applicable to a wide range of image and non-image related information exchanged in clinical, research, veterinary, and other medical environments. ISO 12052:2017 facilitates interoperability of systems claiming conformance in a multi-vendor environment, but does not, by itself, guarantee interoperability.

EN IEC 80601-2-60:2020/prA1:2025 Public enquiry
Comment end date 2025-05-28
Amendment 1 - Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
prEN ISO 13504 Public enquiry
Comment end date 2025-05-27
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO/DIS 13504:2025)

ISO 13504:2012 specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants and further manipulations of connecting parts in the craniofacial area. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system.

prEN ISO 22532 Public enquiry
Comment end date 2025-05-20
Health informatics - Identification of medicinal products - Core vocabulary (terms and definitions) for the IDMP Standards (ISO/DIS 22532:2025)

This standard lists the terms and definitions to be used in the IDMP (Identification of medicinal products) standards and technical specifications, when terms and definitions as to be used in more than one of these standards.

prEN ISO 10524-3 Public enquiry
Comment end date 2025-05-20
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO/DIS 10524‑3:2025)

This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools. Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures. This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications. VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).

prEN ISO 10477 Public enquiry
Comment end date 2025-05-15
Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)
prEN ISO 16791 Public enquiry
Comment end date 2025-05-13
Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers (ISO/DIS 16791:2025)

This document provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product. This document outlines best practice for AIDC barcoding solutions for applications. Users can, however, consider the coding interoperability requirements for other AIDC technologies, e.g. Radio Frequency Identification (RFID).

prEN ISO 10873 Public enquiry
Comment end date 2025-05-13
Dentistry - Denture adhesives (ISO/DIS 10873:2025)

This document classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This document is applicable to denture adhesives for use by the consumer and excludes the dental lining materials prescribed or applied by dental professionals.

EN ISO 7551:2023/prA1 Public enquiry
Comment end date 2025-05-06
Dentistry - Endodontic absorbent points - Amendment 1 (ISO 7551:2023/DAM 1:2025)
prEN ISO 10650 Public enquiry
Comment end date 2025-04-29
Dentistry - Powered polymerization activators (ISO/DIS 10650:2025)

This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard. This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.

EN ISO 80601-2-13:2022/prA1:2025 Public enquiry
Comment end date 2025-04-22
Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation - Amendment 1 (ISO 80601-2-13:2022/DAmd1:2025)
prEN ISO 5832-2 Public enquiry
Comment end date 2025-04-22
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO/DIS 5832-2:2025)

This document specifies the characteristics of, and corresponding test methods for, unalloyed titanium for use in the manufacture of surgical implants. Six grades of titanium based on tensile strength are listed in Table 2. NOTE   The mechanical properties of a sample obtained from a finished product made of this metal do not necessarily comply with those specified in this document.

prEN IEC 80601-2-30:2025 Archived
Comment end date 2025-04-16
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
prEN ISO 15883-6 Archived
Comment end date 2025-04-15
Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noncritical medical devices and health care equipment (ISO/DIS 15883-6:2025)

ISO 15883-6:2011 specifies particular requirements for washer-disinfectors (WDs) intended for use when the level of assurance of disinfection that is necessary can be achieved by cleaning and thermal disinfection (A0 not less than 60) and does not require an independent automated record of critical processes to be kept. It is intended to be used in conjunction with ISO 15883-1, which gives general requirements for WDs. The range of products on which WDs of this particular type can be used is restricted to devices and equipment which are non-invasive and non-critical (i.e. not penetrating skin or contacting mucosal surfaces).

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