Surgical masks ( type IIR) - Cleanroom Requirements

#1
Hi to all.

My manager wants to put the company manufacturing surgical masks ( type IIR), classied as medical devices, class I.

I have experience with medical devices and I know we need to create a technical file for the produt.

We have the standard (ISO 14683:2019), so we are aware of the tests requirements.

But I have one doubt and I can't find an answer. Is mandatory to have a cleanroom (ISO 8) to produce the surgical masks?

Thanks in advance.
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
As long as you can meet the required cleanliness requirements (including, but not limited to microbial cleanliness), it is to mandatory to produce in a cleanroom. Note that ISO 14683:2019 does not cover requirements for the manufacturing process (at least for the purpose of the European MDD): DIN EN 14683:2019-10 says in Table ZA.1 "Die Gestaltung des Herstellungsprozesses ist nicht abgedeckt."

HTH,
 
#3
Thanks for the reply.

To be clear, you meant to say "it is not mandatory to produce...", right? I think there is a typo.

Also, I made some research and the information I got is that for non sterile devices, the GMP indicates that is not mandatory a cleanroom.

Again, thanks for the information.
 

planB

Trusted Information Resource
#4
Sorry for the misleading typo - you are correct: "[...] it is not mandatory to produce in a cleanroom."
 
Thread starter Similar threads Forum Replies Date
J Guidance on manufacturing non-surgical face masks US Food and Drug Administration (FDA) 3
M Regulatory clearance pathways for surgical masks/N95 respirators Other US Medical Device Regulations 3
E MRI and Surgical Needle Other Medical Device Related Standards 0
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 1
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
A Is there any Light for a surgical microscope? Other ISO and International Standards and European Regulations 3
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
M Are Electrical Laparoscopic Surgical Devices ME equipment? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
B ISO 11607-1 for surgical instruments sterilized by end user Other Medical Device Related Standards 1
M Informational Is my device a Reusable Surgical Instrument under the EU MDR(2017/745)? Medical Device and FDA Regulations and Standards News 0
M Informational US FSA – Surgical staples – Guidance and proposed rules Medical Device and FDA Regulations and Standards News 0
M Informational FDA order – All manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distr Medical Device and FDA Regulations and Standards News 0
J0anne Implantable Devices - The effects of surgical scaffold implanted into the human body Other Medical Device and Orthopedic Related Topics 8
M FDA News FDA announces panel meeting on surgical mesh placed transvaginally to treat pelvic organ prolapse Medical Device and FDA Regulations and Standards News 0
J IEC60601-2-18 - Endoscopic Surgical Monitor System Images IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Strength verification of surgical instruments ISO 13485:2016 - Medical Device Quality Management Systems 5
J IEC 60601-2-2 - EMC Requirements - Surgical instrument manufacturer IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
E Canada classification of surgical displays, MDL needed? Canada Medical Device Regulations 2
C Class I Reusable Surgical Instruments - CE Mark with the Notified Body number EU Medical Device Regulations 14
P IFU for Sterling Silver Surgical devices ISO 13485:2016 - Medical Device Quality Management Systems 3
C What is the most appropriate Bioburden Test Method for Surgical Gloves ISO 13485:2016 - Medical Device Quality Management Systems 10
R FDA Biocompatibility questions for Surgical Gown 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R FDA Shelf Life Requirements for EO Surgical gown 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
I Defending "No Essential Performance" for a Surgical Video Camera IEC 60601 - Medical Electrical Equipment Safety Standards Series 13
S Is double packaging obligatory for surgical single-use scalpels? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
H Stainless Steel Surface Quality for Ophthalmic Surgical Device Other Medical Device Related Standards 11
E Vaccinations for Repair of Returned Surgical Devices US Food and Drug Administration (FDA) 3
T Electrical Surgical Tool with Big Metal Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Open Sourced Surgical Tray Sterilization Database and Software wanted Medical Information Technology, Medical Software and Health Informatics 2
K Regulations for sending Veterinary Surgical Instruments to Qatar Other Medical Device Regulations World-Wide 4
L Does IEC 61010-1 apply for Surgical Microscopes? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
1 Reprocessing of Surgical Instrument Sets Other Medical Device and Orthopedic Related Topics 4
N Reusable Surgical Instruments - Definition per Annex IX of Directive 93/42/EEC EU Medical Device Regulations 5
N Declaration of Conformity from the Notified Body for our Surgical Glove Class IIa CE Marking (Conformité Européene) / CB Scheme 6
I Dielectric Test for HF Surgical Equipment (IEC 60601-2-2 clause 201.8.5.1.2) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S Modification of Class I and Class IIa Surgical Medical Devices EU Medical Device Regulations 1
S Followups to ASTM F2554-10? Surgical Navigation System Accuracy Other Medical Device Related Standards 1
M Definition Surgical or Surgical Intervention - ISO 13485 Definition of "Surgical" Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
D Surgical Techniques - What are the requirements? EU Medical Device Regulations 4
B Can returned goods go back into inventory? (EO Sterilized Surgical Sponges) Misc. Quality Assurance and Business Systems Related Topics 4
somashekar Label Details and Contents for Reusable Surgical Instruments EU Medical Device Regulations 7
R Risks involved with Nitrogen Pressurized Equipment for Surgical Use ISO 13485:2016 - Medical Device Quality Management Systems 4
S Surgical Instrument Luminaries Standards - Single Use Disposable Surgical Instrument IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
L Stainless Steel Grades - Nomenclature for Surgical Instrument Stainless Steel ISO 13485:2016 - Medical Device Quality Management Systems 2
H Reusable Soft Tissue Surgical Laser Fiber Sterilization Method US Food and Drug Administration (FDA) 3
A Materials for Single Use Surgical Devices with Metal and Plastic Components ISO 13485:2016 - Medical Device Quality Management Systems 12
T Weight Load Testing Methods for Surgical Operating Tables ISO 13485:2016 - Medical Device Quality Management Systems 8

Similar threads

Top Bottom