EWG/42/93 ﻣﻌﺘﻤﺪﺓ ﺣﺴﺐ ﺍﳌﻮﺍﺻﻔﺔ
ﻭﻳﺤﻖ ﻟﻬﺎ ﻭﺿﻊ ﻋﻼﻣﺔ )ﺍﻟﻬﻴﺌﺔEN ISO 13485 ﻭﺍﳌﻮﺍﺻﻔﺔ
EN 60601-1 • ﺷﺮﻭﻁ ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻘﻴﺎﺳﻴﺔ ﻟﻠﻨﻮﺭﻡ
+ ﻟﻸﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ – ﺍﻟﺠﺰﺀ 1: ﺍﻟﻤﻮﺍﺻﻔﺎﺕA1
.ﺍﻟﻌﺎﻣﺔ ﻟﻸﻣﺎﻥ ﺑﻤﺎ ﻓﻴﻬﺎ ﻣﻴﺰﺍﺕ ﺍﻟﻮﻇﺎﺋﻒ ﺍﻟﺮﺋﻴﺴﻴﺔ
– ﻟﻸﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔIEC/EN 60601-1-11 •
ﺍﻟﺠﺰﺀ 11-1: ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻌﺎﻣﺔ ﻟﻸﻣﺎﻥ ﺑﻤﺎ ﻓﻴﻬﺎ ﻣﻴﺰﺍﺕ
ﺍﻟﻮﻇﺎﺋﻒ ﺍﻟﺮﺋﻴﺴﻴﺔ.- ﻣﻌﺎﻳﻴﺮ ﺗﻜﻤﻴﻠﻴﺔ: ﺍﻟﻤﺘﻄﻠﺒﺎﺕ
.ﻭﺍﻟﻨﻈﻢ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ ﻟﻼﺳﺘﺨﺪﺍﻣﺎﺕ ﺍﻟﻤﻨﺰﻟﻴﺔ
:1 ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ
ﻳﺤﻘﻖ ﻣﺘﻄﻠﺒﺎﺕ ﻭﺷﺮﻭﻁ ﻋﻤﻠﻴﺎﺕ ﻓﺤﺺ ﺍﻷﺟﻬﺰﺓ ﻏﻴﺮ
:2 ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ
ﻳﺤﻘﻖ ﻣﺘﻄﻠﺒﺎﺕ ﻭﺷﺮﻭﻁ ﻋﻤﻠﻴﺎﺕ ﻓﺤﺺ ﺍﻷﺟﻬﺰﺓ ﻏﻴﺮ
ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂEN 1060-3 • ﻣﻌﻴﺎﺭ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻲ
ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ 3: ﻣﻠﺤﻖ ﺑﻤﺘﻄﻠﺒﺎﺕ ﺃﺟﻬﺰﺓ
AR
.(TÜV Rheinland LGA Products GmbH ﺍﳌﺬﻛﻮﺭﺓ
ﺍﻟﻤﻔﺮﻭﺽ ﺗﻮﻓﺮﻫﺎ ﻓﻲ ﺍﻷﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ
DIN EN ISO 81060-1 • ﻣﻌﺎﻳﻴﺮ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻴﺔ
DIN EN ISO 81060-2 • ﻣﻌﺎﻳﻴﺮ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻴﺔ
ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﺍﻹﻟﻜﺘﺮﺭﻭﻣﻐﻨﺎﻃﻴﺴﻴﺔ
ﺿﻤﺎﻥ ﺍﳉﻮﺩﺓ
®
Geratherm ﺷﺮﻛﺔ
ﺷﺎﺷﺔ ﻗﻴﺎﺱ ﺍﻟﻀﻐﻂ ﺗﺤﻘﻖ
(ISO 81060-1) ﺍﻟﻤ ﹸ ﺆ ﹶ ﺗ ﹾ ﻤ ﹶ ﺘ ﹶ ﺔ
(ISO 81060-2) ﺍﻟﻤﺆﺗﻤﺘﺔ
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