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EVS-EN ISO 11608-7:2017

Nõelinfusiooni süsteemid meditsiiniliseks kasutamiseks. Nõuded ja katsemeetodid. Osa 7: Nägemispuudega inimestele mõeldud rakendused

Üldinfo
Kehtiv alates 16.08.2017
Alusdokumendid
ISO 11608-7:2016; EN ISO 11608-7:2017
Direktiivid või määrused
93/42/EEC Meditsiinivahendid

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
16.08.2017
Põhitekst
ISO 11608-7:2016 specifies particular requirements to make needle-based drug delivery systems or NIS (needle-based injection system) accessible for persons with visual impairments. It applies to devices intended for patient or caregiver administration of medicinal products to humans.
It covers requirements to allow for safe and correct handling of the NIS, including labelling, packaging, and instructions for use. It also includes requirements for training programs, if applicable.
It covers requirements for NIS that are claimed to be appropriate for use by persons with visual impairments.
It does not address requirements for use of sharps containers by persons with visual impairments.
Although specifically intended to apply to needle-based injection systems within the ISO 11608 series, ISO 11608-7:2016 can be applied to NIS outside the ISO 11608 series as well, if they might be used by persons with visual impairments.
It is written to address the needs of persons with all levels of visual limitations, including low, moderate, or severe visual impairment; legal, functional, or total blindness; and colour vision deficiencies.
Therefore, ISO 11608-7:2016 includes the requirement to provide information in visual formats that can be perceived and understood by people with moderate visual impairment and in non-visual formats (e.g. tactile or auditory) that can be perceived and understood by people with no useful vision.
For simplicity's sake, this range is described in ISO 11608-7:2016 as addressing the needs of individuals with moderate visual impairment or blindness.
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EVS-EN ISO 11608-2:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012)
Kehtetu alates 17.05.2022
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EVS-EN ISO 11608-3:2012

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)
Kehtetu alates 17.05.2022
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EVS-EN ISO 11608-5:2012

Nõelinfusiooni süsteemid meditsiiniliseks kasutamiseks. Nõuded ja katsemeetodid. Osa 5: Automatiseeritud funktsioonid
Kehtetu alates 03.04.2023
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EVS-EN ISO 11608-1:2015

Nõelinfusiooni süsteemid meditsiiniliseks kasutamiseks. Nõuded ja katsemeetodid. Osa 1: Nõelinfusiooni süsteemid
Kehtetu alates 17.05.2022