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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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Medical Device Related Standards not listed in the above sub-forums.
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FAQs
M
Sticky
Informational
Links to recognized / harmonised / consensus Standards for each market
Mark Meer
Feb 25, 2019
Replies
5
Views
3,109
Feb 26, 2019
Ellison
Sticky
February 2013 Medical Device "State-of-the-Art" updates
Sam Lazzara
Feb 2, 2013
Replies
6
Views
7,784
Feb 26, 2019
Ronen E
Sticky
Medical Device Standards - Difference between IEC and EN Standards
Marc
Oct 27, 2011
2
Replies
13
Views
25,440
Oct 28, 2011
rob73
Discussions
M
Medical device substance based-leachables
Manel Mou
Jan 18, 2021
Replies
2
Views
103
Yesterday at 5:58 AM
Manel Mou
B
Free Sales Certificate for Non Medical Devices
Bella97
Jan 19, 2021
Replies
1
Views
91
Sunday at 3:20 PM
J0anne
R
Clinical accuracy and repeatability of IR(infrared) thermometer, no maximum error criteria is recommended in ISO
Rayjade Ko
Jan 18, 2021
2
Replies
10
Views
196
Thursday at 10:10 PM
indubioush
Q
The scope of ISO 21534
QuaffReg
Jan 14, 2021
Replies
0
Views
102
Jan 14, 2021
QuaffReg
C
ETO (Ethylene Oxide) Sterilization Audit Question
CarlyH
Jul 15, 2014
Replies
9
Views
2,595
Jan 9, 2021
planB
A
ANSI/AAMI versions of 60601-1-2 and related testing requirements
akp060
Aug 26, 2020
Replies
3
Views
382
Jan 4, 2021
jdoran
M
IEC 61010-1 requirements for motors
MrMech
Dec 31, 2020
Replies
0
Views
91
Dec 31, 2020
MrMech
Z
Is Op Amp Common-Mode Rejection Ratio (CMRR) test applicable to battery operated devices?
Zameer
Dec 21, 2020
Replies
0
Views
122
Dec 21, 2020
Zameer
Ethylene Oxide Sterilization Validation question
Sam Lazzara
Oct 10, 2013
2
Replies
11
Views
5,637
Dec 14, 2020
Hawkeye
T
B2C Medical Device Shipping across the US
The Friar
Dec 14, 2020
Replies
0
Views
112
Dec 14, 2020
The Friar
B
What regulates DICOM Viewer? Wat are the mandatory info that shall be displayed on the screen?
BargeSim
Dec 2, 2020
Replies
1
Views
197
Dec 3, 2020
yodon
L
Shelf life of medical devices
Lari1808
Dec 2, 2020
Replies
4
Views
273
Dec 2, 2020
William55401
B
ISO 11607-2 "Critical Parameter" vs. "Process Parameter"
bsgoldschmidt
Aug 17, 2020
Replies
6
Views
478
Nov 27, 2020
SligoRover37
A
Class I (exempt) testing requirements
Amit Bechar
Nov 23, 2020
Replies
0
Views
221
Nov 23, 2020
Amit Bechar
B
Sterilization Validation Plan
beltrans
Oct 8, 2020
Replies
3
Views
386
Nov 19, 2020
Alice
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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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