EWG/93/42 ﻣﻌﺘﻤﺪﺓ ﻭﻓﻘﹰ ﺎ ﻟﻠﻤﻮﺍﺻﻔﺔ ﺍﻟﻔﻨﻴﺔGeratherm
ﻭﻫﻲ ﻣﺨﻮﻟﺔ ﻟﺘﺮﻛﻴﺐ ﺍﳌﻨﺘﺠﺎﺕ ﺍﻟﺘﻲ ﲢﻤﻞ ﺍﻟﻌﻼﻣﺔEN ISO 13485 ﻭ
TÜV Rheinland LGA Products )ﺍﳌﻜﺎﻥ ﺍﳌﺬﻛﻮﺭ: ﺷﺮﻛﺔ
EN 60601-1 +A1 • ﺷﺮﻭﻁ ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻘﻴﺎﺳﻴﺔ ﻟﻠﻨﻮﺭﻡ
ﻟﻸﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ – ﺍﻟﺠﺰﺀ 1: ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻌﺎﻣﺔ
ﻟﻸﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ – ﺍﻟﺠﺰﺀIEC/EN 60601-1-11 •
11-1: ﺍﻟﻤﻮﺍﺻﻔﺎﺕ ﺍﻟﻌﺎﻣﺔ ﻟﻸﻣﺎﻥ ﺑﻤﺎ ﻓﻴﻬﺎ ﻣﻴﺰﺍﺕ ﺍﻟﻮﻇﺎﺋﻒ
ﺍﻟﺮﺋﻴﺴﻴﺔ.- ﻣﻌﺎﻳﻴﺮ ﺗﻜﻤﻴﻠﻴﺔ: ﺍﻟﻤﺘﻄﻠﺒﺎﺕ ﺍﻟﻤﻔﺮﻭﺽ ﺗﻮﻓﺮﻫﺎ
ﻓﻲ ﺍﻷﺟﻬﺰﺓ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ ﻭﺍﻟﻨﻈﻢ ﺍﻟﻄﺒﻴﺔ ﺍﻟﻜﻬﺮﺑﺎﺋﻴﺔ
ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ 1: ﻳﺤﻘﻖ
ﻣﺘﻄﻠﺒﺎﺕ ﻭﺷﺮﻭﻁ ﻋﻤﻠﻴﺎﺕ ﻓﺤﺺ ﺍﻷﺟﻬﺰﺓ ﻏﻴﺮ ﺍﻟﻤ ﹸ ﺆ ﹶ ﺗ ﹾ ﻤ ﹶ ﺘ ﹶ ﺔ
ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ 2: ﻳﺤﻘﻖ
ﻣﺘﻄﻠﺒﺎﺕ ﻭﺷﺮﻭﻁ ﻋﻤﻠﻴﺎﺕ ﻓﺤﺺ ﺍﻷﺟﻬﺰﺓ ﻏﻴﺮ ﺍﻟﻤﺆﺗﻤﺘﺔ
ﺃﺟﻬﺰﺓ ﻗﻴﺎﺱ ﺿﻐﻂEN 1060-3 • ﻣﻌﻴﺎﺭ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻲ
ﺍﻟﺪﻡ ﻣﻦ ﺧﺎﺭﺝ ﺍﻟﺠﺴﻢ – ﺟﺰﺀ 3: ﻣﻠﺤﻖ ﺑﻤﺘﻄﻠﺒﺎﺕ ﺃﺟﻬﺰﺓ
AR
.ﻟﻸﻣﺎﻥ ﺑﻤﺎ ﻓﻴﻬﺎ ﻣﻴﺰﺍﺕ ﺍﻟﻮﻇﺎﺋﻒ ﺍﻟﺮﺋﻴﺴﻴﺔ
DIN EN ISO 81060-1 • ﻣﻌﺎﻳﻴﺮ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻴﺔ
DIN EN ISO 81060-2 • ﻣﻌﺎﻳﻴﺮ ﺍﻟﻨﻮﺭﻡ ﺍﻟﻘﻴﺎﺳﻴﺔ
ﻗﻴﺎﺱ ﺿﻐﻂ ﺍﻟﺪﻡ ﺍﻹﻟﻜﺘﺮﺭﻭﻣﻐﻨﺎﻃﻴﺴﻴﺔ
158
ﺿﻤﺎﻥ ﺍﳉﻮﺩﺓ
.(ﻟﻠﻤﻨﺘﺠﺎﺕ ﺍﻟﻄﺒﻴﺔ، ﺵ.ﺫ.ﻡ.ﻡ
ﺷﺎﺷﺔ ﻗﻴﺎﺱ ﺍﻟﻀﻐﻂ ﺗﺤﻘﻖ
.ﻟﻼﺳﺘﺨﺪﺍﻣﺎﺕ ﺍﻟﻤﻨﺰﻟﻴﺔ
(ISO 81060-1)
(ISO 81060-2)
®
ﺷﺮﻛﺔ