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Medical Devices, Medical Information Technology, Medical Software and Health Informatics
Medical Device Related Standards
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Sticky
Informational
Links to recognized / harmonised / consensus Standards for each market
Mark Meer
Feb 25, 2019
Replies
5
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8K
Feb 26, 2019
Ellison
E
Sticky
February 2013 Medical Device "State-of-the-Art" updates
Sam Lazzara
Feb 2, 2013
Replies
6
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13K
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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40K
Oct 28, 2011
rob73
Discussions
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ISO 10993-1 Evaluation for commonly used materials
David1234
Wednesday at 8:39 PM
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0
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64
Wednesday at 8:39 PM
David1234
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A
Locked
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AlexisRuiz2772
Apr 4, 2024
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7
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309
Monday at 10:47 AM
Sidney Vianna
Retention time of test samples
MrTetris
Apr 13, 2024
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2
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243
Apr 24, 2024
v9991
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S
Labelling of sterile barrier systems (sterilisation pouches)
StepPCHen
Jul 27, 2023
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2
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409
Mar 21, 2024
erdal88
E
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ANSI/AAMI ST108 Water for processing medical devices
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Mar 4, 2024
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1
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230
Mar 4, 2024
planB
F
IP67 Rating on a class II wearable medical device question
Frank Katarow
Feb 7, 2024
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303
Feb 28, 2024
yodon
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ETO Sterilization Dunnage Calculation
Emma F
Feb 26, 2024
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191
Feb 26, 2024
Emma F
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ISO 15223-1 Do Not Reuse and Do Not Resterilize
Kat C
Jun 2, 2020
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6
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5K
Feb 13, 2024
StepPCHen
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Biological evaluation plan and report
beltrans
Oct 8, 2020
2
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8K
Jan 23, 2024
big boss
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In regard to ISO 10993-1, 6.3.2.13 Degradation
localpark
Jan 10, 2024
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399
Jan 11, 2024
localpark
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Seeking Guidance on Identifying Standards
Mkane
Dec 10, 2023
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598
Jan 8, 2024
DanMann
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EN 82304-1:2017 | EN 62304:2006/A1:2015
Vckytr
Dec 28, 2023
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421
Jan 3, 2024
Vckytr
Class 1 medtech start up and regulatory decisions
timbro
Dec 20, 2023
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331
Dec 22, 2023
timbro
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Quarterly dose audit and date of manufacture
Chrisx
Dec 21, 2023
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1
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211
Dec 22, 2023
chris1price
C
ISO 14708-5 Implants for surgery - AIMD_ Clause 6.3.1 Evidence Mapping
cobedangthuong
Dec 19, 2023
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0
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177
Dec 19, 2023
cobedangthuong
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