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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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Informational
Links to recognized / harmonised / consensus Standards for each market
Mark Meer
Feb 25, 2019
Replies
5
Views
7K
Feb 26, 2019
Ellison
E
Sticky
February 2013 Medical Device "State-of-the-Art" updates
Sam Lazzara
Feb 2, 2013
Replies
6
Views
12K
Feb 26, 2019
Ronen E
Sticky
Medical Device Standards - Difference between IEC and EN Standards
Marc
Oct 27, 2011
2
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13
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39K
Oct 28, 2011
rob73
Discussions
O
Maximum Force for Crushing Hazard?
OccamMan
Aug 29, 2023
Replies
4
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250
Tuesday at 4:36 PM
OccamMan
O
B
How to integrate risk assessment of a medical device to a SOP for ISO 14155:2020
bill.Kal
Tuesday at 7:41 AM
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0
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49
Tuesday at 7:41 AM
bill.Kal
B
S
Locked
Medical Device Registration Process in Russia
schorre
Aug 6, 2009
2
Replies
13
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11K
Sep 13, 2023
abc57
A
Cytotoxicity of instrument oil
Dirk S
Sep 5, 2023
Replies
2
Views
125
Sep 5, 2023
planB
C
ISO 19227 Validation Cost
Chrisx
Feb 9, 2021
Replies
4
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1K
Aug 15, 2023
Chrisx
C
Urgent: Gamma Sterilization Re-validation
humoor
Aug 8, 2023
Replies
6
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251
Aug 15, 2023
Philip B
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M
Temperature limit for storage/transport
Med_eng22
Aug 7, 2023
Replies
3
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206
Aug 9, 2023
Med_eng22
M
L
Test Method Validation requirement in 11607-2
Luis_777
Aug 2, 2023
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2
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166
Aug 8, 2023
planB
S
Labelling of sterile barrier systems (sterilisation pouches)
StepPCHen
Jul 27, 2023
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1
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131
Aug 8, 2023
planB
R
ISO 11137 Gamma sterilization validation, dose setting, dose audit
rmyjq
Apr 23, 2018
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2
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2K
Aug 8, 2023
humoor
A question about storage condition for shelf life validation
shimonv
Jul 14, 2023
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5
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256
Jul 14, 2023
indubioush
I
B
Sample size sterile barrier validation
bm3009
Jul 13, 2023
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1
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150
Jul 13, 2023
planB
I
ISO 10933-10:2023 vs ISO 10933-10:2010
indre.jur
Jul 11, 2023
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1
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133
Jul 11, 2023
planB
M
Confusion about the Fatigue testing, Ageing and Durability in ISO 5840
Mandy0528
Jul 7, 2023
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0
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124
Jul 7, 2023
Mandy0528
M
S
ISO 10993-1:2018 Clause 4.11 - New testing of historical devices?
Stephan
Jul 3, 2023
Replies
2
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178
Jul 4, 2023
Stephan
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