Medicinsk utrustning

Kommittébeteckning: SIS/TK 334 (Hälso- och sjukvårdsinformatik)
Källa: CEN
Svarsdatum: den 17 okt 2022
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Within the context of the ISO/IEEE 11073 family of standards for device communication, ISO/IEEE 11073-10420:2012 establishes a normative definition of the communication between personal body composition analyzing devices 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 appropriate portions of existing standards including ISO/IEEE 11073 terminology and IEEE 11073-20601 information models. 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 11073-10420:2012 defines a common core of communication functionality for personal telehealth body composition analyzer devices. In this context, body composition analyzer devices are being used broadly to cover body composition analyzer devices that measure body impedances, and compute the various body components including body fat from the impedance.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
Källa: CEN
Svarsdatum: den 8 nov 2022
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This document specifies performance requirements for voice prostheses including requirements for marking, packaging and information to be provided by the manufacturer as well as test methods for the evaluation of physical characteristics of voice prostheses.
NOTE There is guidance or rationale for this list item contained in A.2.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 20 nov 2022
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This part of ISO 8536 specifies the requirements for infusion sets that use light-protective agents in the fluid path materials (abbreviated as "light-protective infusion sets” henceforth).
This document also provides guidelines for performance and quality specifications of materials used in light-protective infusion sets.

Kommittébeteckning: SIS/TK 340 (Biologisk säkerhet för medicintekniska produkter)
Källa: CEN
Svarsdatum: den 30 nov 2022
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This document specifies general requirements for non-active surgical implants, hereafter referred to as implants. This document is not applicable to dental implants, dental restorative materials,
transendodontic and transradicular implants, intra-ocular lenses, the viable animal or human tissue components of implants containing viable animal or human tissue and implants intended to remain in place for less than 30 days after being implanted.
With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.
Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards.
NOTE 1 This document does not require that the manufacturer have a quality management system in place.
However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety.
NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.