Manufacturing requirements for respiratory ventilators - clean room required?

#1
Hello Elsmar Cove community,

Does anybody here know if you are required to manufacture respiratory ventilators in a clean room? I could not find any specific requirements aside form ISO 13485 and CFR 820. I was asked by somebody who is interested in manufacturing emergency ventilators.

Thank you!
 
Elsmar Forum Sponsor

blackholequasar

Involved In Discussions
#2
It would be best to check with the FDA directly (if they are manufacturing in the US). There doesn't seem to be a lot of information out there just yet on this. I certainly wish whoever it is well in their endeavor, I know we are in dire need of them!
 

Johnnymo62

Haste Makes Waste
#6
I don' think clean rooms are necessary, but following the Good Manufacturing Practices should be sufficient. They are not used internally.
 
Thread starter Similar threads Forum Replies Date
M Description of the requirements of clause 9.2.2.3 manufacturing process audit- needs your feedback IATF 16949 - Automotive Quality Systems Standard 0
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
G QMS requirements for legal manufacturer when outsourcing manufacturing process Other Medical Device Regulations World-Wide 22
J Manufacturing Process Auditor Requirements - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 9
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
Q 21 CFR Part 111 - Requirements for Dietary Supplement Manufacturing Water Quality Document Control Systems, Procedures, Forms and Templates 1
W Requirements for Contract Manufacturing of a Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
M Orthopedic Devices and Implants Manufacturing Cleanliness Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
C Financial Records Retention Requirements for a Manufacturing Company Records and Data - Quality, Legal and Other Evidence 3
G Temperature Requirements for a Manufacturing Inspection Lab General Measurement Device and Calibration Topics 5
D PPE Requirements in Manufacturing Area of Class IIa Medical Device Other Medical Device and Orthopedic Related Topics 3
A Product Realization Requirements in a Non-Manufacturing Environment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Steam Sanitization Requirements for Parts for Medical Device Manufacturing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Medical Device Manufacturing Environmental Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M 7.2.2 Review of Requirements Related to the Product (Design-Manufacturing Service) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
V Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
C International Supplier Audit (ISO9001:2008 + Manufacturing Requirements) Supplier Quality Assurance and other Supplier Issues 4
A Temporary Change of Manufacturing Site - Notified Body Notification Requirements EU Medical Device Regulations 3
S TS 16949 Requirements for Remote Manufacturing Sites IATF 16949 - Automotive Quality Systems Standard 7
R 7.2.1 Customer Requirements Checklist for a Small Contract Manufacturing Machine Shop AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
G Medical Device Contract Manufacturing Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
M Manufacturing Equipment Pressure Gages Calibration Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30
L FDA Manufacturing Site Requirements Other US Medical Device Regulations 4
W Requirements of Contract Manufacturing in respect to GMP? ISO 13485:2016 - Medical Device Quality Management Systems 13
A Re-Validation criteria and Requirements for Manufacturing equipment on site ISO 13485:2016 - Medical Device Quality Management Systems 8
K ISO 13485 Audit requirements - Manufacturing requirements in draft? ISO 13485:2016 - Medical Device Quality Management Systems 12
G Medical Device 510k Requirements - Plan to expand the manufacturing site in Malaysia US Food and Drug Administration (FDA) 11
P Legal Requirements for Electrical Panel Manufacturing Industry Various Other Specifications, Standards, and related Requirements 3
A What is the expectation of Lean manufacturing plans in Visteon specific requirements Customer and Company Specific Requirements 0
Q Quality vs. manufacturing personnel requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Watchcat Best Regulatory Oversight for Off-Shore Device Manufacturing? Other Medical Device Regulations World-Wide 1
DuncanGibbons Manufacturing Plan vs Material Specification vs Control Plan Manufacturing and Related Processes 4
Q Automation in manufacturing - Print Shop ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Operational (free) simulation games for manufacturing and quality Lean in Manufacturing and Service Industries 5
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
P Manufacturing equipment (e.g.: Dental Welder): medical device or not? US Food and Drug Administration (FDA) 5
S Contagious Diseases in Medical Device Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 5
C Manufacturing overages & nonconforming material documentation ISO 13485:2016 - Medical Device Quality Management Systems 3
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
J Manufacturing procedure / work instruction depth ISO 13485:2016 - Medical Device Quality Management Systems 12
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
C Looking for China Good manufacturing practice China Medical Device Regulations 1
Watchcat Does 820.30 include the manufacturing process? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
Similar threads


















































Top Bottom