SBS - The best value in QMS software

What class of Compressed Air (ISO 8573) for Medical Devices

I

ifserav

Involved In Discussions
#1
#1
Hi to everibody?

I want to know what class of compressed air (ISO 8573) is suggested in the manufacture of medical devices?

Thanks in advance

Sergio ?vila
 
Last edited by a moderator:
QMS for Medical Device Companies
Elsmar Forum Sponsor
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
ifserav said:
Hi to everibody?

I want to know what class of compressed air (ISO 8573) ist duggested in the manufacture of medical devices?

Thanks in advance

Sergio ?vila
Click to expand...

I guess it depends on the specific type of medical device...
 
somashekar

somashekar

Staff member
Super Moderator
#3
#3
ifserav said:
Hi to everibody?

I want to know what class of compressed air (ISO 8573) ist duggested in the manufacture of medical devices?

Thanks in advance

Sergio ?vila
Click to expand...
If you are sterilizing your medical device, then the best is class 1,2 or 3. They are called ultra dry air.
The best will be class 1 for it also has controlled solid particles of 0.1 to 0.5 micron size within 100.
Between class 1,2,3 you take a technical and risk based decision.
Remember that moisture which is in the air is a home for bacteria and this an enemy to medical devices.
 
Last edited:
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
C Compressed Air coming into contact with Class II Medical Device Design and Development of Products and Processes 10
L Class IIb devices marked EC according to the 93/42/CE - Portugal CE Marking (Conformité Européene) / CB Scheme 3
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
J Reusable surgical Instrument is under class IIa? EU Medical Device Regulations 3
H EU CE marking for Medical Device Class I EU Medical Device Regulations 0
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
G Voluntary Class I Device Filing Other US Medical Device Regulations 4
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
D Can a diagnostic device be class I? EU Medical Device Regulations 1
A AMSQQP416E Class 2 type 2 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S IVD risk class II devices for Brazil and MDSAP Other Medical Device Regulations World-Wide 0
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 7
A Class I (exempt) testing requirements Other Medical Device Related Standards 0
Z Class I marketing regulation and supply chain Other Medical Device Regulations World-Wide 0
S We are looking for EU authorised Representative for both Class I and Class IIb devices EU Medical Device Regulations 7
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
R Class 1 Convenience kits for home teeth impression, NOT smile direct or other for alignment purposes Canada Medical Device Regulations 0
J Confusing on Harmonic Emissions/Voltage Fluctuations/Flicker test for CISPR 11 Class A Equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Intervertebral body fusion cage, MDR Class II or Class III? EU Medical Device Regulations 4
T Do I need a qualified compiler for class B software? IEC 62304 - Medical Device Software Life Cycle Processes 3
R Nanomaterials used as coating on class I MD - rule 19 EU Medical Device Regulations 4
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
D Class IIB Medical Device Accessories - OTS Tablets Other Medical Device Regulations World-Wide 1
K Doubt on insulation class of a device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Where to find Guidance Class II Amendment Canada Medical Device Regulations 1
A First CE-mark class III implantable device under MDD EU Medical Device Regulations 8
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
I IVD - 98/79EC - class IIa - Annex to the EC from the NB states the CM as one of the facilities? CE Marking (Conformité Européene) / CB Scheme 2
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
D Adding a Class I to a sample box Canada Medical Device Regulations 5
T Class A PRTD beyond 300°C General Measurement Device and Calibration Topics 0
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
K Sterile barrier system symbols - Label redlines for a Class III device (Kit Box) EU Medical Device Regulations 0
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
A FDA Class Classification for a cabinet 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
W Protective earth for Class I ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K Class III Kit Box - Are translations mandatory under EU MDR? EU Medical Device Regulations 5
Edward Reesor FDA DM and /or Class I Life Saving US Food and Drug Administration (FDA) 0
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4

Similar threads

Top Bottom