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ﺞﺗﻧﻣﻟﺍ ﺕﺎﻔﺻﺍﻭﻣ
(ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 108-93,2) ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 42,2-34 :ﺔﺿﻭﺭﻌﻣﻟﺍ ﺓﺭﺍﺭﺣﻟﺍ ﺔﺟﺭﺩ ﻕﺎﻁﻧ
(ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 104-50) ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 40-10 :ﻝﻳﻐﺷﺗﻟﺍ ﻁﻳﺣﻣ ﺓﺭﺍﺭﺣ ﺔﺟﺭﺩ ﻕﺎﻁﻧ
(ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 131–13-) ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 55–25- :ﻥﻳﺯﺧﺗﻟﺍ ﺓﺭﺍﺭﺣ ﺔﺟﺭﺩ ﻕﺎﻁﻧ
(ﻑﻳﺛﻛﺗ ﻥﻭﺩ) %95-10 ﺔﻳﺑﺳﻧ ﺔﺑﻭﻁﺭ : ﻥﻳﺯﺧﺗﻟﺍﻭ ﻝﻳﻐﺷﺗﻠﻟ ﺔﻳﺑﺳﻧﻟﺍ ﺔﺑﻭﻁﺭﻟﺍ
ﺕﻳﺎﻬﻧﺭﻬﻓ ﻭﺃ ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 0.1 :ﺽﺭﻌﻟﺍ ﺔﻗﺩ
ﻱﺭﺑﺧﻣﻟﺍ ﺄﻁﺧﻠﻟ ﻰﺻﻗﻷﺍ ﺩﺣﻟﺍ ﺔﺿﻭﺭﻌﻣﻟﺍ ﺓﺭﺍﺭﺣﻟﺍ ﺔﺟﺭﺩ ﻕﺎﻁﻧ ﺔﻗﺩ
ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ
42-ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 35
(ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 0,4 ±) ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 0,2 ± :(ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 107,6-ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 95)
(ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 0,5 ±) ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 0,3 ± :ﻕﺎﻁﻧﻟﺍ ﺍﺫﻫ ﺝﺭﺎﺧ
(ﺕﻳﺎﻬﻧﺭﻬﻓ ﺔﺟﺭﺩ 0,26 ±) ﺔﻳﻭﺋﻣ ﺔﺟﺭﺩ 0,14 ± :ﻲﻛﻳﻧﻳﻠﻛﻹﺍ ﺩﺩﺭﺗﻟﺍ
ﺱﺎﻳﻗ
600/ﻥﺎﻣﺎﻋ :ﺔﻳﺭﺎﻁﺑﻟﺍ ﺭﻣﻋ
ﺕﺍﻭﻧﺳ
5 :ﺔﻣﺩﺧﻟﺍ ﺭﻣﻋ
ﻱﻭﺟ ﻁﻐﺿ 1 ﻰﻟﺇ ﻝﺻﻳ ﻱﻭﺟ ﻁﻐﺿ ﺕﺍﺫ ﺕﺎﻋﺎﻔﺗﺭﺍ ﺩﻧﻋ ﻭﺃ ﻱﻭﺟ ﻁﻐﺿ 1 ﺩﻧﻋ ﻝﻣﻌﻠﻟ ﺹﺻﺧﻣ ﺍﺫﻫ ﺓﺭﺍﺭﺣﻟﺍ ﺱﺎﻳﻘﻣ
.(ﻝﺎﻛﺳﺎﺑ ﻭﺗﻛﻫ 1060 700)
ﻡﺍﺩﺧﺗﺳﻻﺍ ﺕﺎﻣﻳﻠﻌﺗ ﺭﻅﻧﺍ
ﺔﻘﺑﻁﻣ ﻊﻁﻗ ﻊﻣ ﺯﺎﻬﺟﻟﺍ
BF ﻉﻭﻧﻟﺍ ﻥﻣ
10 °C
40 °C
ﻝﻳﻐﺷﺗﻟﺍ ﺓﺭﺍﺭﺣ ﺔﺟﺭﺩ
ً
ﻓﺎﺟ ﻪﻘﺑﺃ
ﻥﻳﺯﺧﺗﻟﺍ ﺓﺭﺍﺭﺣ ﺔﺟﺭﺩ
.ﺭﺎﻌﺷﺇ ﻥﻭﺩ ﺭﻳﻳﻐﺗﻠﻟ ﺔﺿﺭﻋ
:ﺔﻳﻟﺎﺗﻟﺍ ﺭﻳﻳﺎﻌﻣﻠﻟ ﺯﺎﻬﺟﻟﺍ ﺍﺫﻫ ﻝﺛﺗﻣﻳ
Standard Reference Edition Title:
EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with
maximum device).
EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for basic safety and essential
performance.
EN ISO 14971: 2014 Medical devices – Application of risk management to medical devices.
EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process.
EN 60601-1-2: 2007 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests.
EN 980: 2008 Symbols for use in labeling of medical devices.
EN 1041: 2008 Information supplied by the manufacturer of medical devices.
EN 60601-1-11: 2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and
essential performance -- Collateral standard: Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment.
ﺔﻳﺑﻭﺭﻭﻷﺍ ﺔﻧﺟﻠﻟﺍ ﺔﻘﻳﺛﻭ ﻁﻭﺭﺷﻟ ﺞﺗﻧﻣﻟﺍ ﺍﺫﻫ ﻝﺛﺗﻣﻳ
ﺕﺎﺑﻠﻁﺗﻣﻟ ﻲﻠﻳﺻﻔﺗ ﻑﺻﻭﻟ .ﻲﺳﻳﻁﺎﻧﻐﻣﻭﺭﻬﻛﻟﺍ ﻕﻓﺍﻭﺗﻟﺎﺑ ﻕﻠﻌﺗﻳ ﺎﻣﻳﻓ ﺔﺻﺎﺧ ﺔﻳﺋﺎﻗﻭ ﺭﻳﺑﺍﺩﺗ ﻰﻟﺇ ﺝﺎﺗﺣﺗ ﺔﻳﺋﺎﺑﺭﻬﻛﻟﺍ ﺔﻳﺑﻁﻟﺍ ﺓﺯﻬﺟﻷﺍ
.(ﻥﺎﻣﺿﻟﺍ ﺔﻗﺎﻁﺑ ﺭﻅﻧﺍ) ﻙﺑ ﺹﺎﺧﻟﺍ ﺩﻣﺗﻌﻣﻟﺍ ﻲﻠﺣﻣﻟﺍ ﺔﻣﺩﺧﻟﺍ ﺯﻛﺭﻣﺑ ﻝﺎﺻﺗﻻﺎﺑ ﻝﺿﻔﺗ (
EMC) ﻲﺳﻳﻁﺎﻧﻐﻣﻭﺭﻬﻛﻟﺍ ﻕﻓﺍﻭﺗﻟﺍ
.ﺔﻳﺑﺭﻬﻛﻟﺍ ﺔﻳﺑﻁﻟﺍ ﺓﺯﻬﺟﻷﺍ ﻰﻠﻋ ﺭﺛﺅﺗ ﻥﺃ ﻱﻭﻳﺩﺍﺭﻟﺍ ﺩﺩﺭﺗﻟﺍ ﺕﺍﺫ ﺔﻠﻘﻧﺗﻣﻟﺍ ﻝﺎﺻﺗﻻﺍ ﺓﺯﻬﺟﺃﻭ ﺔﻟﻭﻣﺣﻣﻟﺍ ﻝﺎﺻﺗﻻﺍ ﺓﺯﻬﺟﻷ ﻥﻛﻣﻳ
.ﻪﻣﺍﺩﺧﺗﺳﺍ ﺭﻣﻋ ﺔﻳﺎﻬﻧ ﻲﻓ ﺔﻳﻟﺯﻧﻣﻟﺍ ﺕﺎﻳﺎﻔﻧﻟﺍ ﻲﻓ ﺞﺗﻧﻣﻟﺍ ﻥﻣ ﺹﻠﺧﺗﻟﺍ ﻡﺩﻋ ﻰﺟﺭﻳ
.ﺔﻳﻠﺣﻣﻟﺍ ﻭﺃ ﺔﻳﻧﻁﻭﻟﺍ ﺢﺋﺍﻭﻠﻟ
ً
ﻘﺑﻁ ﺔﻣﺋﻼﻣﻟﺍ ﻊﻣﺟﻟﺍ ﻊﻗﺍﻭﻣ ﻲﻓ ﺔﻏﺭﺎﻔﻟﺍ ﺕﺎﻳﺭﺎﻁﺑﻟﺍ ﻥﻣ ﺹﻠﺧﺗ ،ﺔﺋﻳﺑﻟﺍ ﺔﻳﺎﻣﺣﻟ
ﺔﻳﺳﻳﻁﺎﻧﻐﻣﻭﺭﻬﻛﻟﺍ ﺕﺎﺛﺎﻌﺑﻧﻻﺍ - ﺔﻌ
ﻧﺻ
ُ
ﻣﻟﺍ ﺔﻛﺭﺷﻟﺍ ﻥﺎﻳﺑﻭ ﻱﺩﺎﺷﺭﻹﺍ ﻝﻳﻟﺩﻟﺍ
.ﻩﺎﻧﺩﺃ ﺓﺩﺩﺣﻣﻟﺍ ﺔﻳﺳﻳﻁﺎﻧﻐﻣﻭﺭﻬﻛﻟﺍ ﺔﺋﻳﺑﻟﺍ ﻲﻓ ﻡﺍﺩﺧﺗﺳﻼﻟ ﺩﻌ
ُ
ﺍﺫﻫ
IRT 6520/6020 ﻲﺋﺎﺑﺭﻬﻛﻟﺍ ﻲﺑﻁﻟﺍ ﺯﺎﻬﺟﻟﺍ
.ﺔﺋﻳﺑﻟﺍ ﻩﺫﻫ ﻲﻓ ﻪﻣﺍﺩﺧﺗﺳﺍ ﻰﻠﻋ IRT 6520/6020 ﻲﺋﺎﺑﺭﻬﻛﻟﺍ ﻲﺑﻁﻟﺍ ﺯﺎﻬﺟﻟﺍ ﻡﺩﺧﺗﺳﻣ ﻭﺃ ﻝﻳﻣﻌﻟﺍ ﺹﺭﺣﻳ ﻥﺃ ﺏﺟﻳ
ﺕﺎﺛﺎﻌﺑﻧﻻﺍ ﺭﺎﺑﺗﺧﺍﻕﻓﺍﻭﺗﻟﺍﻱﺩﺎﺷﺭﻹﺍ ﻝﻳﻟﺩﻟﺍ - ﺔﻳﺳﻳﻁﺎﻧﻐﻣﻭﺭﻬﻛﻟﺍ ﺔﺋﻳﺑﻟﺍ
ﺩﺩﺭﺗﻟﺍ ﺕﺍﺫ ﺕﺎﺛﺎﻌﺑﻧﻻﺍ
CISPR 11 ،ﻱﻭﻳﺩﺍﺭﻟﺍ
1 ﺔﻋﻭﻣﺟﻣﻟﺍ
ءﺍﺩﻷ ﻱﻭﻳﺩﺍﺭ ﺩﺩﺭﺗ ﺕﺍﺫ ﺔﻗﺎﻁ ﻲﺋﺎﺑﺭﻬﻛﻟﺍ ﻲﺑﻁﻟﺍ ﺯﺎﻬﺟﻟﺍ ﺍﺫﻫ ﻡﺩﺧﺗﺳﻳ
ﻱﻭﻳﺩﺍﺭﻟﺍ ﺩﺩﺭﺗﻟﺍ ﺕﺍﺫ ﺕﺎﺛﺎﻌﺑﻧﻻﺍ ﻥﺈﻓ ﻡﺛ ﻥﻣﻭ .ﻁﻘﻓ ﺔﻳﻠﺧﺍﺩﻟﺍ ﻪﺗﻔﻳﻅﻭ
ﺯﺎﻬﺟ ﻱﺃ ﻊﻣ ﻝﺧﺍﺩﺗ ﻱﺃ ﺏﺑﺳﺗ ﻥﺃ ﺢﺟﺭﻳ ﻻﻭ
ً
ﺩﺟ ﺔﻠﻳﻠﻗ ﻥﻭﻛﺗ ﻪﻧﻣ ﺔﻘﻠﻁﻧﻣﻟﺍ
.ﺏﻳﺭﻗ ﻲﻧﻭﺭﺗﻛﻟﺇ
ﺩﺩﺭﺗﻟﺍ ﺕﺍﺫ ﺕﺎﺛﺎﻌﺑﻧﻻﺍ
CISPR 11 ،ﻱﻭﻳﺩﺍﺭﻟﺍ
ﺔﺋﻔﻟﺍﻕﻓﺍﻭﺗﻣ
ﺔﺳﻧﺎﺟﺗﻣﻟﺍ ﺕﺎﺛﺎﻌﺑﻧﻻﺍ
IEC 61000-3-2
ﻕﺑﻁﻧﻳ
.ﺔﻗﺎﻁﻠﻟ ﺭﺩﺻﻣﻛ ﻁﻘﻓ ﺕﺎﻳﺭﺎﻁﺑﻟﺍ ﻰﻠﻋ ﻲﺋﺎﺑﺭﻬﻛﻟﺍ ﻲﺑﻁﻟﺍ ﺯﺎﻬﺟﻟﺍ ﺍﺫﻫ ﺩﻣﺗﻌﻳ
ﺕﺎﺛﺎﻌﺑﻧﻻﺍ/ﺩﻬﺟﻟﺍ ﺕﺎﺑﻠﻘﺗ
ﺔﺿﻣﺍﻭﻟﺍ
ﻕﺑﻁﻧﻳ
ﺓﺎﻳﺣﻠﻟ ﺔﻣﻋﺍﺩﻟﺍ ﺭﻳﻏ ﺓﺯﻬﺟﻸﻟ ﺔﻠﺻﺎﻔﻟﺍ ﺔﻓﺎﺳﻣﻟﺍ ﺏﺎﺳﺣ
(ﺭﺗﻣ/ﺕﻟﻭﻓ 3 / ﻊﺑﺭﻣ ﻁﺳﻭﺗﻣ ﺭﺫﺟ ﺕﻟﻭﻓ 3 ﻕﻓﺍﻭﺗ)
ﺔﺟﺭﺎﺧﻟﺍ ﺔﻗﺎﻁﻠﻟ ﺭﻳﺩﻘﺗ ﻰﺻﻗﺃ
(ﺕﺍﻭﻟﺎﺑ) ﻝﺎﺳﺭﻹﺍ ﺯﺎﻬﺟ ﻥﻣ
(ﺭﺗﻣﻟﺎﺑ) ﻝﺎﺳﺭﻹﺍ ﺯﺎﻬﺟ ﺩﺩﺭﺗﻟ
ً
ﻘﻓﻭ ﺔﻠﺻﺎﻔﻟﺍ ﺔﻓﺎﺳﻣﻟﺍ
80 ﻰﻟﺇ ﺯﺗﺭﻫ ﻭﻠﻳﻛ 150
ﻲﻓ ﺯﺗﺭﻫ ﺎﺟﻳﻣ
ﺔﻳﻛﻠﺳﻼﻟﺍ ﺕﺎﻗﺎﻁﻧﻟﺍ
ﺔﻳﻣﻠﻌﻟﺍﻭ ﺔﻳﻋﺎﻧﺻﻟﺍ
(ISM) ﺔﻳﺑﻁﻟﺍﻭ
ﺯﺗﺭﻫ ﺎﺟﻳﻣ 80
ﺎﺟﻳﻣ 800 ﻰﻟﺇ
ﺯﺗﺭﻫ
ﺯﺗﺭﻫ ﺎﺟﻳﺟ 2,5 ﻰﻟﺇ ﺯﺗﺭﻫ ﺎﺟﻳﻣ 800
0,01
0,120,120,23
0,1
0,370,370,74
1
1,171,172,33
10
3,693,697,38
100
11,6711,6723,33
d = [
3,5
] P
V
1
d = [
3,5
] P
E
1
d = [
7
] P
E
1
48


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