Ämnesområden

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 25 jun 2024
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This document specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as single-use sterile barrier systems and/or single-use packaging systems for terminally sterilized medical devices by the means of low temperature sterilization processes. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 [2], this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 12 jul 2024
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This standard defines an object-oriented abstract information model to represent a PHD and the observations generated by a PHD. It specifies what information needs to be present and the relationships between the informational elements in the model. It models observations in a generic way by focusing on the information content contained in the presentation of health measurements. The modeling follows the practice of ISO/IEEE 11073-20601 [B12] where Unified Modeling Language (UML) is used to describe a set of objects and the relationship between the objects.7 Tables provide descriptions of the attributes in the objects. IEEE 11073-10101™ nomenclature terms are used to express clinical content. This standard provides guidance as to what an exchange protocols needs to communicate to properly represent health observations, but is not, in itself, sufficient to be an exchange protocol. However, the content model defined herein does have sufficient detail to help organizations validate that there is no loss of the semantic content induced by data exchanges in a protocol adhering to this standard. This standard does not define a security framework.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 12 jul 2024
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Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of communication is established in ISO/IEEE 11073-10421:2012 between personal telehealth peak expiratory flow monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. The use of specific term codes, formats, and behaviors is specified in telehealth environments restricting optionality in base frameworks in favor of interoperability. A common core of communication functionality is defined for personal telehealth peak expiratory flow monitor devices.

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Detta dokument har följande omfattning:

a) riktlinjer och vägledning för att säkerställa korrekt planering och skydd av träd vid arbeten samt främja träds överlevnad och kondition.

b) utformning av trädskyddsåtgärder, bedömning, planering och åtgärder för att minska negativ inverkan på träd som direkt eller indirekt berörs av arbeten.

c) rekommendationer för att undvika eller minimera skador på trädens rötter, stammar och kronor under byggaktiviteter och andra arbeten.

d) definitioner av relevanta termer och begrepp som används inom området arbeten vid träd. 

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 9 aug 2024
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This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 9 aug 2024
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ISO/IEEE 11073-10471:2010 establishes a normative definition of the communication between independent living activity hubs and managers (e.g., cell phones, personal computers, personal health appliances and set top boxes) in a manner that enables plug-and-play (PnP) interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology and information models. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting ambiguity in base frameworks in favour of interoperability. ISO/IEEE 11073-10471:2010 defines a common core of communication functionality for independent living activity hubs. In this context, independent living activity hubs are defined as devices that communicate with simple situation monitors (binary sensors), normalize information received from the simple environmental monitors, and provide this normalized information to one or more managers. This information can be examined (for example) to determine when a person's activities/behaviour have deviated significantly from what is normal for them such that relevant parties can be notified. Independent living activity hubs will normalize information from the following simple situation monitors (binary sensors) for the initial release of the proposed standard: fall sensor, motion sensor, door sensor, bed/chair occupancy sensor, light switch sensor, smoke sensor, (ambient) temperature threshold sensor, personal emergency response system (PERS), and enuresis sensor (bed-wetting). ISO/IEEE 11073-10471:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and managers

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 9 aug 2024
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Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10472:2012 establishes a normative definition of communication between personal telehealth medication monitor devices and compute engines (e.g. cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. ISO/IEEE 11073-10472:2012 defines a common core of communication functionality for personal telehealth medication monitor devices.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 9 aug 2024
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This standard specifies a set of Participant Key Purposes (PKPs) pertaining to metric data exchange for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 9 aug 2024
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This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.