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
8K
Ellison
E
Sam Lazzara
  • Sticky
February 2013 Medical Device "State-of-the-Art" updates
Replies
6
Views
14K
Ronen E
Ronen E
Marc
  • Sticky
Medical Device Standards - Difference between IEC and EN Standards
2
Replies
13
Views
42K
rob73
rob73
Discussions
P
New ISO 10993-1
Replies
3
Views
321
Jean_B
J
S
EO Sterile Validation Testing Parameters
Replies
1
Views
127
fox747
F
C
Device Shelf-Life Validation
Replies
2
Views
204
EmiliaBedelia
E
I
Change from BI release to parametrical release Experiences
Replies
1
Views
105
chris1price
chris1price
M
510(k) Vs LTF for a vital signs monitor direclty interfacing with EHR
Replies
1
Views
127
mihzago
mihzago
S
ISO 80601-2-56 Laboratory Accuracy Testing Method
Replies
4
Views
348
sun_shine
S
R
[EU REP] / [XX REP] Symbol - Where to buy?
Replies
2
Views
334
Al_Z1
A
Shanicehuo
French Medical device waste marking
Replies
2
Views
201
ethanwalker
E
austin_howell
11137-1 Test of Sterility and Dose Auditing
Replies
3
Views
392
planB
planB
S
How to write system requirements?
Replies
5
Views
535
Tidge
T
L
Blue man pictogram
Replies
3
Views
264
Tidge
T
F
Polymer Sample Retention Time Requirements?
Replies
4
Views
412
Bev D
Bev D
J
Explain clause 5.3.2.3 Analysis of process failure risk from ISO/TR 80002-2:2017
Replies
2
Views
282
Jeevan Jyoti
J
G
Number of Destructively Tested Devices Needed for Ethylene Oxide Validation
Replies
6
Views
2K
planB
planB
J
Device Classification Help
2
Replies
10
Views
1K
EmiliaBedelia
E
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