ﻭﻳﺤﻖ ﻟﻪ ﻭﺿﻊ ﺍﻟﻌﻼﻣﺔEN ISO 13485 ﻭEWG / 93/42 ﻃﺒﻘﺎ ﻟﻠﺘﻮﺟﻴﻪ
.ﺍﳌﻌﺪﺍﺕ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ - ﺍﳉﺰﺀ 1: ﺍﳌﺘﻄﻠﺒﺎﺕ ﺍﻟﻌﺎﻣﺔ ﻟﻠﺴﻼﻣﺔ ﺍﻷﺳﺎﺳﻴﺔ ﻭﺍﻷﺩﺍﺀ ﺍﻷﺳﺎﺳﻲ
-ﺍﳌﻌﺪﺍﺕ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ - ﺍﳉﺰﺀ 11-1: ﺍﳌﺘﻄﻠﺒﺎﺕ ﺍﻟﻌﺎﻣﺔ ﻟﻠﺴﻼﻣﺔ ﻭﻳﺘﻀﻤﻦ ﺍﻷﺩﺍﺀ ﺍﻟﻘﻴﺎﺳﻲ
ﺍﳌﻌﻴﺎﺭ ﺍﳉﺎﻧﺒﻲ: ﺍﳌﺘﻄﻠﺒﺎﺕ ﻟﻠﻤﻌﺪﺍﺕ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ ﻭﺍﻷﻧﻈﻤﺔ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ ﻟﻠﺤﺼﻮﻝ
ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻏﻴﺮ ﺍﻟﻐﺎﺯﻳﺔ - ﺍﳉﺰﺀ 1: ﺍﳌﺘﻄﻠﺒﺎﺕ ﻭﻃﺮﻕ ﺍﻻﺧﺘﺒﺎﺭ ﻟﻸﺟﻬﺰﺓ ﻏﻴﺮ ﺁﻟﻴﺔ
ﻣﻘﺎﻳﻴﺲ ﺿﻐﻂ ﺍﻟﺪﻡ ﻏﻴﺮ ﺍﻟﻐﺎﺯﻳﺔ - ﺍﳉﺰﺀ 2: ﺍﻟﺘﺤﻘﻴﻖ ﺍﻟﺴﺮﻳﺮﻱ ﻟﻸﺟﻬﺰﺓ ﺁﻟﻴﺔ ﺍﻟﺼﻨﻊ
ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻏﻴﺮ ﺍﻟﻐﺎﺯﻳﺔ ﺍﳉﺰﺀ 3: ﺍﻟﺸﺮﻭﻁ ﺍﻹﺿﺎﻓﻴﺔ ﻷﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ
.( LGA Products GmbH ﺭﺍﻳﻨﻼﻧﺪTÜV :) ﺍﻟﺸﺮﻛﺔ ﺍﳌﺬﻛﻮﺭﺓ
:ﻳﺘﻮﺍﻓﻖ ﺟﻬﺎﺯ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻊ
.ﻋﻠﻰ ﺍﻟﺮﻋﺎﻳﺔ ﺍﻟﻄﺒﻴﺔ ﻓﻲ ﺇﻃﺎﺭ ﺍﳌﻨﺰﻝ
ﺿﻤﺎﻥ ﺍﳉﻮﺩﺓ
®
ﻳﺘﻢ ﺍﻋﺘﻤﺎﺩ ﺟﻴﺎﺗﻴﺮﻡ
EN 60601-1 •
IEC/EN 60601-1-11 •
DIN EN ISO81060-1 •
(ISO 81060-1) ﺍﻟﺼﻨﻊ
DIN EN ISO81060-2 •
(ISO 81060-2)
EN1060-3 •
.ﺍﻟﻜﻬﺮﻭﻣﻐﻨﺎﻃﻴﺴﻴﺔ
ﻉ
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