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prEN ISO 27799 Public enquiry
Comment end date 2025-03-27
Health informatics - Information security management in health using ISO/IEC 27002 (ISO/DIS 27799:2025)

ISO 27799:2016 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s). It defines guidelines to support the interpretation and implementation in health informatics of ISO/IEC 27002 and is a companion to that International Standard. ISO 27799:2016 provides implementation guidance for the controls described in ISO/IEC 27002 and supplements them where necessary, so that they can be effectively used for managing health information security. By implementing ISO 27799:2016, healthcare organizations and other custodians of health information will be able to ensure a minimum requisite level of security that is appropriate to their organization's circumstances and that will maintain the confidentiality, integrity and availability of personal health information in their care. It applies to health information in all its aspects, whatever form the information takes (words and numbers, sound recordings, drawings, video, and medical images), whatever means are used to store it (printing or writing on paper or storage electronically), and whatever means are used to transmit it (by hand, through fax, over computer networks, or by post), as the information is always be appropriately protected. ISO 27799:2016 and ISO/IEC 27002 taken together define what is required in terms of information security in healthcare, they do not define how these requirements are to be met. That is to say, to the fullest extent possible, ISO 27799:2016 is technology-neutral. Neutrality with respect to implementing technologies is an important feature. Security technology is still undergoing rapid development and the pace of that change is now measured in months rather than years. By contrast, while subject to periodic review, International Standards are expected on the whole to remain valid for years. Just as importantly, technological neutrality leaves vendors and service providers free to suggest new or developing technologies that meet the necessary requirements that ISO 27799:2016 describes. As noted in the introduction, familiarity with ISO/IEC 27002 is indispensable to an understanding of ISO 27799:2016. The following areas of information security are outside the scope of ISO 27799:2016: a) methodologies and statistical tests for effective anonymization of personal health information; b) methodologies for pseudonymization of personal health information (see Bibliography for a brief description of a Technical Specification that deals specifically with this topic); c) network quality of service and methods for measuring availability of networks used for health informatics; d) data quality (as distinct from data integrity).

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prEN ISO 80601-2-70 Public enquiry
Comment end date 2025-02-20
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO/DIS 80601-2-70:2024)

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. 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 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]. This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8]. This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9]. This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12]. This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601‑2‑80[11].

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prEN 1656 Public enquiry
Comment end date 2025-02-20
Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area - Test method and requirements (phase 2, step 1)

This document specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance. The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. This document applies to products that are used for equipment disinfection by immersion, surface disinfection by wiping, spraying, flooding or other means and teat disinfection in the veterinary area - e.g. in the breeding, husbandry, production, veterinary care facilities, transport and disposal of all animals except when in the food chain following death and entry into processing industry. This document also applies to products used for teat disinfection in these veterinary areas. This method is not applicable to evaluate the activity of hand hygiene products. For these products reference is made to EN 14885, which specifies in detail the relationship of the various tests to one another and to "use recommendations". NOTE This method corresponds to a phase 2 step 1 test.

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prEN IEC 60601-2-91:2024 Archived
Comment end date 2025-01-31
Particular requirement for basic safety and essential performance of non-thermal plasma wound treatment equipment
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prEN ISO 17510 Public enquiry
Comment end date 2025-02-13
Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO/DIS 17510:2024)

ISO 17510:2015 applies to masks and their accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient-connection port of sleep apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing therapy (e.g. nasal masks, exhaust ports and headgear).

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prEN ISO 12487 Public enquiry
Comment end date 2025-02-11
Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO/DIS 12487:2024)

This document specifies the requirements and methods for the clinical investigation of ME equipment used to measure the body temperature in indirect measurement mode. This document covers both intermittently and continuously measuring clinical thermometers. NOTE           For clinical thermometers in direct measurement mode determining the technical accuracy in accordance with IEC 80601-2-56 is typically sufficient. This document specifies additional disclosure requirements. This document is not applicable to the clinical investigation of a screening thermographs for human febrile temperature screening whose laboratory accuracy requirements are described in IEC 80601-2-59.

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prEN ISO 80601-2-74 Public enquiry
Comment end date 2025-02-06
Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO/DIS 80601-2-74:2024)

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system. This document is also applicable to those accessories intended by their manufacturer to be connected to a humidifier where the characteristics of those accessories can affect the basic safety or essential performance of the humidifier. EXAMPLE 1         Heated breathing tubes (heated-wire breathing tubes) or ME equipment intended to control these heated breathing tubes (heated breathing tube controllers). NOTE 1        Heated breathing tubes and their controllers are ME equipment and are subject to the requirements of IEC 60601‑1. NOTE 2        ISO 5367 specifies other safety and performance requirements for breathing tubes. This document includes requirements for the different medical uses of humidification, such as invasive ventilation, non-invasive ventilation, nasal high-flow therapy, and obstructive sleep apnoea therapy, as well as humidification therapy for tracheostomy patients. NOTE 3        A humidifier can be integrated into other equipment. When this is the case, the requirements of the other equipment also apply to the humidifier. EXAMPLE 2         Heated humidifier incorporated into a critical care ventilator where ISO 80601‑2-12[10] also applies. EXAMPLE 3         Heated humidifier incorporated into a homecare ventilator for dependent patients where ISO 80601‑2-72[12] also applies. EXAMPLE 4         Heated humidifier incorporated into sleep apnoea therapy equipment where ISO 80601‑2‑70[11] also applies. EXAMPLE 5         Heated humidifier incorporated into ventilatory support equipment where either ISO 80601-2-79[13] or ISO 80601-2-80[14] also apply. EXAMPLE 6         Heated humidifier incorporated into respiratory high-flow therapy equipment where ISO 80601‑2‑90[15] also applies. This document also includes requirements for an active HME (heat and moisture exchanger), ME equipment which actively adds heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. This document is not applicable to a passive HME, which returns a portion of the expired moisture and heat of the patient to the respiratory tract during inspiration without adding heat or moisture. NOTE 4        ISO 9360‑1 and ISO 9360‑2[4] specify safety and performance requirements for a passive HME. NOTE 5        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+AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1. NOTE 6        Additional information can be found in IEC 60601‑1:2005+AMD1:2012+AMD2:2020, 4.2. This document does not specify the requirements for cold pass-over or cold bubble-through humidification devices, the requirements for which are given in ISO 20789[6]. This document is not applicable to equipment commonly referred to as “room humidifiers” or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. This

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prEN ISO 80601-2-90 Public enquiry
Comment end date 2025-02-06
Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment (ISO/DIS 80601-2-90:2024)

This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: —   intended for use with patients who can breathe spontaneously; and —   intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities. NOTE 1        In the home healthcare environment, the supply mains is often not reliable. Respiratory high-flow therapy equipment can be: —   fully integrated ME equipment; or —   a combination of separate items forming a ME system. This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2  This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4         Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. 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 the general standard, 7.2.13 and 8.4.1. NOTE 3        Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: —    ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12[14]; —    ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[15]; —    ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84[20]; —    ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72[17]; —    ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601‑2‑79[18]; —    ventilatory support equipment or accessories intended for patients with ven

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ISO/DIS 9829 Public enquiry
Comment end date 2025-02-03
Healthcare organization management — Pandemic response — Contact tracing

This document specifies contact tracing procedures for the highly contagious respiratory infectious disease cases including both symptomatic and asymptomatic infections for pandemic response. The scope of the document includes: — overview and general procedures of contact tracing — requirements and privacy protection guidance in contact tracing

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prEN 17180 Archived
Comment end date 2025-02-01
Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing

This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent. These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical devices. This document specifies minimum requirements • for the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices; • for the equipment and controls of these sterilizers needed for operation, control and monitoring, and which can be used for validation of the sterilization processes; • for the test equipment and test procedures used to verify the sterilizer performance specified by this document. This document does not specify requirements for equipment intended to process liquids, biological waste, or human tissues. This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. This document does not specify requirements and tests for decontamination systems for use in rooms, enclosures, or environmental spaces. NOTE 1 Attention is drawn to the standards for quality management, e.g. EN ISO 13485. NOTE 2 Environmental aspects of this standard are addressed in Annex H.

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prEN ISO 20417 Archived
Comment end date 2025-01-30
Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024)

NOTE 1        There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied. NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory. Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

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prEN ISO 6876 Archived
Comment end date 2025-01-30
Dentistry - Endodontic sealing material (ISO/DIS 6876:2024)

ISO 6876:2012 specifies requirements and test methods for root canal (endodontic) sealing materials which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It only covers sealers intended for orthograde use, i.e. a root filling placed from the coronal aspect of a tooth.

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ISO/DIS 16473 Archived
Comment end date 2025-01-26
Healthcare organization management — Pandemic response — Response resource information management

This document specifies the information and communication technology (ICT) perspective requirements to manage the information of response resources for a public health emergency (PHE) response. The scope of the document includes:  overview of response resource information management;  requirements for managing response resource information including: - information collection; - information storage; - information disposal; - information distribution. The requirements defined in this document can only be effectively applied, if information exchange described in clause 5 is supported at both municipal and national levels.

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