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
4,291
Ellison
Sam Lazzara
  • Sticky
February 2013 Medical Device "State-of-the-Art" updates
Replies
6
Views
8,964
Ronen E
Marc
  • Sticky
Medical Device Standards - Difference between IEC and EN Standards
2
Replies
13
Views
29,734
rob73
Discussions
S
Biocompatibility requirement for electrode adapters
Replies
1
Views
56
planB
A
Class I (exempt) testing requirements
Replies
1
Views
519
vavave
Sam Lazzara
Ethylene Oxide Sterilization Validation question
2
Replies
13
Views
6,174
planB
H
EO Sterilization Validation - Sterility Testing and Load Configuration
Replies
3
Views
1,268
planB
N
Cleanroom Classification Change
Replies
7
Views
190
John Predmore
M
FDA Guidance - general wellness products - wearables
Replies
5
Views
1,033
Ajit Basrur
B
Biological evaluation plan and report
Replies
7
Views
3,427
planB
Ajit Basrur
Any ISO standard or guidance documents on barcode and scanning?
Replies
1
Views
149
Sidney Vianna
M
ISO 20417 - Medical Devices — Information to be provided by the manufacturer
Replies
8
Views
5,360
ASteel
B
Gamma Sterilization
Replies
1
Views
87
chris1price
S
ISO 15223-1:2020 Symbols
Replies
6
Views
2,850
LUFAN
R
How to obtain OBL licence under Indian MDR, 2017
Replies
2
Views
196
Regulatory
U
EN 455-4 Accelerated Shelf Life tests for Medical Gloves
Replies
2
Views
112
UKCAtastrophe
F
Biocompatibility on aged devices
Replies
4
Views
2,566
Christie
C
ISO 80601-2-56 Laboratory accuracy
Replies
7
Views
317
Benjamin Weber
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