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
4,872
Ellison
Sam Lazzara
  • Sticky
February 2013 Medical Device "State-of-the-Art" updates
Replies
6
Views
9,527
Ronen E
Marc
  • Sticky
Medical Device Standards - Difference between IEC and EN Standards
2
Replies
13
Views
31,493
rob73
Discussions
A
Changes in ETSI EN 301-48-17 v3.2.4 2020
Replies
0
Views
117
akp060
E
Biocompatibility testing of our applied part seems redundant
Replies
2
Views
156
EMC_noob
E
Do I need test reports for all standards mentioned in my 510k application?
Replies
8
Views
348
EMC_noob
G
Fractional cycles during sterilisation requalification
Replies
4
Views
175
ganglai
S
In Field Validation Requirements
Replies
1
Views
121
levatorsuperioris
S
316 Stainless Steel Standards
Replies
3
Views
346
levatorsuperioris
R
Shelf life of product
Replies
4
Views
241
ganglai
chris1price
Irradiation site for dose audit
Replies
2
Views
107
chris1price
P
Demonstrate shelf life per ISO 11140-1
Replies
0
Views
104
Parsely
D
UV Absorption Test - What is it's purpose and what specifically is it looking for?
2
Replies
10
Views
2,845
PHAM H
S
ISO 14644 Cleanrooms: Industry-Specific Requirements for Medical Devices
Replies
0
Views
91
Schkund
Edward Reesor
ISO 19223 Discussion (Help)
Replies
1
Views
145
Ajit Basrur
V
EN ISO 10993-1, Category of surface device by nature of body contact
Replies
2
Views
170
Vicky Santos
M
Stability with min/max sealing parameters?
Replies
1
Views
126
planB
A
Production line for medical devices
Replies
1
Views
324
yodon
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