Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Chirurgické implantáty
Komise : CEN/CLC/JTC 16 (CEN/CENELEC Joint Working Group on Active Implantable Medical Devices)
Původce: CEN
K připomínkám do: 2.03.2019
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This document specifies requirements for safety and performance of active implantable circulatory support devices, including type tests, animal studies and clinical evaluation requirements.

NOTE          The device that is commonly referred to as an active implantable medical device can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify main requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

The tests that are specified in document are type tests and are to be carried out on a sample of a device to assess device behavioural responses and are not intended to be used for the routine testing of manufactured products.

Included within the scope of this document are:

—    ventricular assist devices (VAD), left or right heart support;

—    total artificial hearts (TAH);

—    biventricular assist devices (biVAD);

—    percutaneous assist devices;

—    paediatric assist devices.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 3.03.2019
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This document specifies stainless steel commonly used in manufacturing dental instruments.

It is applicable to single-use and reusable dental instruments, connected to a power-driven system or not.

This document is not applicable to devices and instruments used for long-time in the mouth of the patient (e.g. crown, bridges, implants).

It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.

Oblast zaměření: Ergonomie
Komise : CEN/TC 122 (Ergonomics)
Původce: CEN
K připomínkám do: 5.03.2019
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This International Standard specifies design guidelines for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind.

Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, and layout.

This document addresses household and home appliances. It excludes electronic displays presenting characters and graphics, machinery, and appliances in special use for professional, technical, and industrial applications.

Oblast zaměření: Ergonomie
Komise : CEN/TC 122 (Ergonomics)
Původce: CEN
K připomínkám do: 5.03.2019
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This International Standard specifies ergonomic requirements and recommendations of spoken instructions for consumer products that are used as a means of instructions for operations or feedback of the status of products when used by a person with or without visual impairments.

NOTE 1       Spoken instructions are also useful for some users who have difficulty in reading and those with cognitive impairment.

The requirements and recommendations described in this standard do not depend on the language of guides and are applicable to conventional, stand-alone consumer products in general whose function is limited by characteristics that prevent the user from attaching, installing or using assistive technology. They are not applied to machines and equipment used for professional work.

This document is applicable to spoken instructions of both recorded human speech and synthesized speech from text.

This document does not apply to products for which the instructional content and/or the means of presentation are regulated by law or specified in other standards (e.g. medical devices, fire alarms). It also does not provide recommendations or requirements for spoken instructions of Interactive Voice Response (IVR) systems or digital assistants on personal computers or similar devices.

NOTE 2       ISO 9241‑154 provides recommendations or requirements for IVR systems.

NOTE 3       ISO/TS 9241‑126 provides generic guidance for the auditory presentation of information in interactive systems.

This document does not specify voice sounds of text-to-speech systems or narrative