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Other Medical Device Related Standards

Medical Device Related Standards not listed in the above sub-forums.
FAQs
M
  • Sticky
Informational Links to recognized / harmonised / consensus Standards for each market
Replies
5
Views
356
Ellison
Sam Lazzara
  • Sticky
February 2013 Medical Device "State-of-the-Art" updates
Replies
6
Views
5,103
Ronen E
Marc
  • Sticky
Medical Device Standards - Difference between IEC and EN Standards
2
Replies
13
Views
19,398
rob73
Discussions
I
ISO 10993 Biocompatibility Requirements - manufacturing process chemicals
Replies
7
Views
114
QM_123
R
Biocompatibility - ISO 10993 and SVHC Requirements
Replies
4
Views
1,540
Ronen E
TechnicalGuy
Colour of symbols on Medical Device labelling and packaging
Replies
1
Views
56
craiglab
F
Class I Device under MDD, reclassified to Class II under MDR
Replies
5
Views
102
Frypot
chris1price
Cleanroom Monitoring Plan - ISO14644-2:2015 - Risk Assessment
Replies
3
Views
227
indubioush
Q
UDI and Standalone Software - UDI per installation?
Replies
6
Views
2,310
RL-WANG
D
What is your Sterile Medical Device Pouch Peel Strength Spec?
Replies
3
Views
563
frank
N
Technical File Reviewer has requested more testing to ISO 10993
2
Replies
10
Views
273
Ronen E
lilybef
FDA and Biocompatability Testing - Reviewer has requested implantation testing
2
Replies
11
Views
679
lilybef
K
Bioburden 0 cfu for Dose Setting using the VDmax25
Replies
9
Views
1,849
Kees Fremerij
Z
In which country is essential to have and IEC 60601 CB Report?
Replies
0
Views
137
zhenlee0605
M
FDA Guidance - general wellness products - wearables
Replies
1
Views
168
yodon
J
ISO 15223-1: Keep dry vs. humidity limitation label symbol
Replies
2
Views
220
Ronen E
M
Medical Devices and ASD-STE100 (Simplified Technical English)
Replies
0
Views
139
Mountainview
H
Frequency of shelf life/sterilization/bench studies conducted on a medical device
Replies
1
Views
179
chris1price
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