Hälso- och sjukvård

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 6 jul 2020
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ISO 21606:2007 is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 7 jul 2020
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This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.

This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation.

This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility).

EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document.

This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document.

This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34.

Ämnesområden: Tandvårdsmaterial
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: ISO
Svarsdatum: den 13 jul 2020
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This International Standard is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.

Ämnesområden: Tandvårdsutrustning
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 17 jul 2020
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This document specifies general requirements and test methods for diamond rotary instruments used in dentistry, including designation, colour code and grit sizes and a quality control for these instruments.

It applies to all types of diamond rotary instruments independent of type and shape with exception to diamond discs which are defined in ISO 7711-2.

Kommittébeteckning: SIS/TK 330 (Förbrukningsmaterial inom sjukvården)
Källa: CEN
Svarsdatum: den 10 aug 2020
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This document applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 25 aug 2020
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This part of ISO 11199 specifies requirements and test methods of walking frames being used as assistive products for walking, manipulated by both arms, without accessories, unless specified in the particular test procedure. This part of ISO 11199 also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer including marking and labelling.

The requirements and tests are based on every-day use of walking frames as assistive products for walking for a maximum user mass as specified by the manufacturer. This part of ISO 11199 includes walking frames specified for a user mass of no less than 35 kg.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 25 aug 2020
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This part of ISO 11199 specifies requirements and test methods of rollators being used as assistive products for walking with wheels, manipulated by both arms, without accessories, unless specified in the particular test procedure. This part of ISO 11199 also gives requirements relating to safety, ergonomics, performance and information supplied by the manufacturer including marking and labelling.

The requirements and tests are based on every-day use of rollators as assistive products for walking for a maximum user mass as specified by the manufacturer. This part of ISO 11199 includes rollators specified for a user mass of no less than 35 kg.

This part of ISO 11199 is not applicable to rollators with horizontal forearm supports, classified as walking tables, for which ISO 11199-3 is applicable.

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 28 aug 2020
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This International Standard establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability.

Assistive products used by a person with disability, but which require the assistance of another person for their operation, are included in the classification.

The following items are specifically excluded from this International Standard:

— items used for the installation of assistive products;

— solutions obtained by combinations of assistive products that are individually classified in this International Standard;

— medicines;

— assistive products and instruments used exclusively by healthcare professionals or by teachers;

— non-technical solutions, such as personal assistance, guide dogs or lip-reading;

— implanted devices;

— financial support.