Medical Devices QC Testing Procedure - Flexible Medical Solution Bags

K

kbng82

#1
hi,

i'd like to know if there's any website or good sourse of information to know about QC procedure or testing method conducted on medical devices, e.g. flexible medical solution bags, blood bags, etc....

thanks.
 
Elsmar Forum Sponsor
K

kbng82

#3
we wish to test the welding quality of the IV bags and blood bags, but i'd like to know what else QC test can we carry out on the production of this 2 products, perhaps drop test, bar code test, which i am not so sure which is important, which is not, and perhaps there're many other tests not to my knowledge which is important...

wish some expertise in this field can give me some guidance.. thanks
 
G

Gert Sorensen

#4
I think you would do well by looking at this, that's money well spent!

EN ISO3826-1:2004
Plastics collapsible containers for human blood and blood components
- Part 1: Conventional containers

The requirements for blood bags are rather high, and the equipment you need to test it is a bit specialized, so start by reading the standard. Perhaps, I can give you a little more feedback then :bigwave:
 
K

kbng82

#5
thanks for your suggestion. i will buy this standard to read first. is EN ISO 3826:2004 equivalent to ISO 3826:2003?

in the mean time while i order this standard, any opinion or suggestions from all expertise are most welcomed.

thanks first.
 
G

Gert Sorensen

#6
thanks for your suggestion. i will buy this standard to read first. is EN ISO 3826:2004 equivalent to ISO 3826:2003?

in the mean time while i order this standard, any opinion or suggestions from all expertise are most welcomed.

thanks first.
As far as I can see it should be the same. The 2004 version is the localized version in Denmark. Perhaps you should consider aquiring 3826-2 and 3826-3 as well.

As for suggestions of the top of my head? I would seriously contemplate measuring the hight of the welding. You should aim for a total height of the welding equal to 60-70% of the combined height of the foils. :bigwave:
 
Thread starter Similar threads Forum Replies Date
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
B Stability testing of medical devices as per ASTM F1980-16 CE Marking (Conformité Européene) / CB Scheme 0
M Sampling Plan for for Chemical Analysis Testing of Medical Devices EU Medical Device Regulations 3
JoCam Portable Appliance Testing of Medical Devices EU Medical Device Regulations 4
T Testing bluetooth medical devices against Japan Radio Law requirements Japan Medical Device Regulations 2
P Serial Testing of Bioburden for Medical Devices Other Medical Device Related Standards 2
C Safety Tests Required for In-Process Testing of Medical Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
P Testing Standards - Regulatory agency doing Enforcement Testing of Medical Devices EU Medical Device Regulations 5
M Stability Testing of Medical Devices - Ambient Temperature and Long Term Storage 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A Sample Size for Design Verification (Prototype Testing) for Medical Devices Qualification and Validation (including 21 CFR Part 11) 12
D Stability (Accelerated Life) Testing of Medical Devices for Home Use ISO 13485:2016 - Medical Device Quality Management Systems 3
P Regulations concerning Calibration of Stop Watches used for Testing Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D Information on Heavy Metal testing in Medical Devices Other Medical Device and Orthopedic Related Topics 6
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
W Supplier / contract testing facility audits - Small start-up - Medical devices Supplier Quality Assurance and other Supplier Issues 8
K 2021/2226 on Electronic Instructions for Use (IFU) for medical devices Article 22 Packs EU Medical Device Regulations 1
C Is there a definition of accessories for medical devices in China? China Medical Device Regulations 1
A Registration of medical devices in Greece EU Medical Device Regulations 0
I Customer Feedback Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 6
L Non Applicability of Clauses in ISO13485 for Medical Devices Medical Device and FDA Regulations and Standards News 4
M Medical Devices - DFM Medical Device and FDA Regulations and Standards News 5
B Transport Validation For Non-sterile Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
S Post Market Surveillance Report (PMSR) for Medical Devices EU Medical Device Regulations 6
A Mandatory Languages Requirements for Medical Devices CE Marking (Conformité Européene) / CB Scheme 2
N Shelf life guidance EU MDR, class 1 and class 2 Medical Devices EU Medical Device Regulations 2
B Do I need a Cleanroom to manufacture Medical Devices? ISO 13485:2016 - Medical Device Quality Management Systems 2
Derrick Yang 各国医疗器械上市流程的区别 (Differences in the listing process of medical devices in various countries) Service Industry Specific Topics 3
Judy Abbott Guideline as for devices utilizing plants and their derivatives in medical device US Food and Drug Administration (FDA) 6
Q Finding Independent License Holder (Medical devices) in Philippines Other Medical Device Regulations World-Wide 1
M Custom made class 1 Medical devices EU Medical Device Regulations 3
G Need Help with Run @ Rate for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 0
S ISO 14644 Cleanrooms: Industry-Specific Requirements for Medical Devices Other Medical Device Related Standards 0
I Post-market surveillance and Post-market performance follow-up for in vitro diagnostic medical devices EU Medical Device Regulations 0
JoCam Accessories for medical devices EU Medical Device Regulations 5
M Prescription Form - Medical Devices US Food and Drug Administration (FDA) 1
XRAY_3121 Drop Shipping Legend Medical Devices Other Medical Device Related Standards 0
A Production line for medical devices Other Medical Device Related Standards 1
S Design & Development records for Medical Devices Packaging and Labelling ISO 13485:2016 - Medical Device Quality Management Systems 9
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
U Medical Devices Labeling Medical Device and FDA Regulations and Standards News 0
K Guidance on X-Ray Medical Devices for Animal Use - FDA US Food and Drug Administration (FDA) 0
dgrainger Informational Good news: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation EU Medical Device Regulations 3
dgrainger Informational MDCG 2021-24 - Guidance on classification of medical devices EU Medical Device Regulations 0
S State Licensing requirements for Medical Devices sold in the US directly to hospitals and tissue banks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Q Best country to import medical devices into Europe Other Medical Device and Orthopedic Related Topics 0
dgrainger Informational Consultation on the future regulation of medical devices in the United Kingdom UK Medical Device Regulations 4
JoCam On-product labels for Medical Devices EU Medical Device Regulations 3
V Taiwan - Veterinary medical devices Other Medical Device Regulations World-Wide 1
K System of medical devices EU Medical Device Regulations 0

Similar threads

Top Bottom