Hälso- och sjukvård

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. This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.

ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993‑1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history of safe clinical use, additional testing according to this revision is not recommended.

I detta dokument anges krav och riktlinjer för FH-utbildning (första hjälpen). Dokumentet innehåller krav och rekommendationer för:

• utformning av FH-utbildning och prioriterade moment,
• innehåll i FH-utbildning,
• kompetens och utbildning för en FH-instruktör.

Detta dokument är avsett att användas av

• leverantörer av FH-utbildning,
• inköpare och upphandlare av FH-utbildning,
• skyddsombud och arbetsmiljöombud.

Detta dokument är utformat för att stödja arbetsgivares uppfyllande av kraven i Arbetsmiljölagen (AML 1977:1160) och Arbetsmiljöverkets föreskrifter, i synnerhet AFS 2023:2. Standarden avser FH-utbildning i arbetslivet och är inte avsedd att tillämpas på utbildningsinsatser riktade till allmänheten eller till civilsamhällesorganisationer.

Dokumentet belyser också specifika behov inom olika branscher och samhällssektorer i bilagor.

Detta dokument innehåller inte beskrivningar av vårdtekniker eller specifika metoder.

I detta dokument anges krav på tjänster som levereras till äldre med omfattande behov i ordinärt och särskilt boende.

I detta dokument anges även krav på utföraren. Dessa krav kopplar till utförarens dokumenterade rutiner för att säkerställa att servicenivån av ovan nämnda tjänster uppnås.

Detta dokument är avsett att användas vid kvalitetssäkring, uppföljning, utvärdering och utveckling av dessa tjänster samt som underlag vid, upphandling, utbildning, tillsyn och certifiering.

This document specifies a test method and the minimum requirements for virucidal activity of chemical disinfectant products that form a homogeneous, physically stable preparation when diluted with hard water – or in the case of ready-to-use products – with water. This document is applicable to products that are used in the medical area for disinfecting non-porous surfaces including surfaces of medical devices by wiping or mopping – regardless if they are covered by the Medical Device Regulation [1] or not. Due to the new methods of application of surface disinfectants like pre-impregnated wipes this document was established to cover the different application methods. This document is applicable for four methods of application of products for wiping and/or mopping: a) soaking any non-specified wipe or mop with product; b) spraying the product on any non-specified wipe and / or mop or a specified wipe or mop; c) impregnation of specified wipes or mops by the user with the product according to the manufacturer’s recommendation; d) pre-impregnation of specified wipes or mops by the manufacturer as ready-to-use wipes or mops. In all types of application the water control has to be conducted with the standard wipe (5.3.2.17 a), because it is process or method control. The contact time for the water control is no longer than 5 min. This document does not apply to products that are sprayed on or used for flooding of surfaces, without wiping or mopping during the contact time. In this case, the methods of phase 2/ step 2 without mechanical action apply. The test-surface (5.3.2.16) was selected as a standard surface and should cover all non-porous surfaces. It was not intended to cover the influence of each different surface. This document is applicable 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 can occur in the workplace and in the home. It can also include services such as laundries and kitchens supplying products directly for the patients. NOTE This method corresponds to a phase 2, step 2 test. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.