Hälso- och sjukvård

Kommittébeteckning: SIS/TK 344 (Hjälpmedel)
Källa: CEN
Svarsdatum: den 31 maj 2024
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This document 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 document 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 document includes rollators specified for a user mass of no less than 35 kg. This document 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 10 jun 2024
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This document defines standards for the training of assistance dogs. Assistance dogs may be trained by structured programmes/schools, owner-trained under supervision or ownertrainers. Specifically, this document deals with the following topics: - Preparation of assistance dogs - Socialization and puppy raising of assistance dogs - Training of assistance dogs - Guide Dogs - Hearing Dogs - Mobility Assistance Dogs - PTSD Assistance Dogs - Medical Alert Response Assistance Dogs - Autism and Developmental Disorder Assistance Dogs - Dual Purpose Assistance Dogs

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 sterilization wrap made of - single-use creped paper - single-use nonwoven materials - reusable woven textile materials used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 25 jun 2024
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This document specifies test methods and values for paper used in the manufacture of single-use paper bags (specified in EN 868-4) and in the manufacture of single-use pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices by means of sterilization processes that require properties specific to higher temperature sterilization, such as moist heat sterilization used in healthcare facilities. 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 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 25 jun 2024
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This document specifies test methods and values for single-use paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems for terminally sterilized medical devices. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2, this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this document.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 25 jun 2024
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This document specifies test methods and values for paper used in the manufacture of single-use preformed sterile barrier systems and/or packaging systems for terminally sterilized medical devices by 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 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 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 19 jul 2024
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This European Standard specifies a test method and the minimum requirements for mycobactericidal 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. 

This European Standard applies to products that are used in the veterinary area – i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. 

NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. 

NOTE 2 This method corresponds to a phase 2 step 1 test. 

Ämnesområden: Tandvård: allmänt
Kommittébeteckning: SIS/TK 327 (Tandvård)
Källa: CEN
Svarsdatum: den 7 aug 2024
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This document specifies an extensible markup language (XML) format to facilitate the transfer of dental case data and CAD/CAM data between software systems.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 12 aug 2024
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This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C). This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities, and in dental institutions; - in clinics of schools, of kindergartens, and of nursing homes; and could occur in the workplace and in the home. It could also include services such as laundries and kitchens supplying products directly for the patients. The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.