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EVS-EN ISO 11199-1:2021

Assistive products for walking manipulated by both arms - Requirements and test methods - Part 1: Walking frames (ISO 11199-1:2021)

Üldinfo
Kehtiv alates 01.07.2021
Alusdokumendid
ISO 11199-1:2021; EN ISO 11199-1:2021
Tegevusala (ICS grupid)
11.180.10 Abivahendid liikumiseks
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
01.07.2021
Põhitekst
01.01.2000
Põhitekst
This document specifies requirements and test methods for walking frames used as assistive products for walking, 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 everyday use of walking frames as assistive products for walking for a maximum user mass as specified by the manufacturer. This document includes walking frames specified for a user mass of no less than 35 kg.
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Standardi monitooring
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Põhitekst

EVS-EN ISO 11199-2:2021

Assistive products for walking manipulated by both arms - Requirements and test methods - Part 2: Rollators (ISO 11199-2:2021)
Uusim versioon Kehtiv alates 03.08.2021
Põhitekst

EVS-EN ISO 14971:2019

Meditsiiniseadmed. Riskihalduse rakendamine meditsiiniseadmetele
Uusim versioon Kehtiv alates 02.01.2020
Põhitekst

CEN ISO/TR 24971:2020

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)
Uusim versioon Kehtiv alates 03.08.2020
Põhitekst

EVS-EN ISO 10993-1:2020

Meditsiiniseadmete bioloogiline hindamine. Osa 1: Hindamine ja katsetamine riskihaldusprotsessis
Uusim versioon Kehtiv alates 31.12.2020