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
7K
Ellison
E
Sam Lazzara
  • Sticky
February 2013 Medical Device "State-of-the-Art" updates
Replies
6
Views
12K
Ronen E
Ronen E
Marc
  • Sticky
Medical Device Standards - Difference between IEC and EN Standards
2
Replies
13
Views
39K
rob73
rob73
Discussions
O
Maximum Force for Crushing Hazard?
Replies
4
Views
250
OccamMan
O
B
How to integrate risk assessment of a medical device to a SOP for ISO 14155:2020
Replies
0
Views
49
bill.Kal
B
S
  • Locked
Medical Device Registration Process in Russia
2
Replies
13
Views
11K
abc57
A
Dirk S
Cytotoxicity of instrument oil
Replies
2
Views
125
planB
planB
C
ISO 19227 Validation Cost
Replies
4
Views
1K
Chrisx
C
humoor
Urgent: Gamma Sterilization Re-validation
Replies
6
Views
251
Philip B
P
M
Temperature limit for storage/transport
Replies
3
Views
206
Med_eng22
M
L
Test Method Validation requirement in 11607-2
Replies
2
Views
166
planB
planB
S
Labelling of sterile barrier systems (sterilisation pouches)
Replies
1
Views
131
planB
planB
R
ISO 11137 Gamma sterilization validation, dose setting, dose audit
Replies
2
Views
2K
humoor
humoor
shimonv
A question about storage condition for shelf life validation
Replies
5
Views
256
indubioush
I
B
Sample size sterile barrier validation
Replies
1
Views
150
planB
planB
I
ISO 10933-10:2023 vs ISO 10933-10:2010
Replies
1
Views
133
planB
planB
M
Confusion about the Fatigue testing, Ageing and Durability in ISO 5840
Replies
0
Views
124
Mandy0528
M
S
ISO 10993-1:2018 Clause 4.11 - New testing of historical devices?
Replies
2
Views
178
Stephan
S
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