Surgical mask stability testing (CE mark)

#1
Hi all!
I am supporting a company in obtaining the CE mark for surgical masks. The masks are three layers of non-woven fabric. In relation to stability of the product I have seen that some competitors set an expiration date of 5 years while in other cases I found nothing about it on the labeling.
What is the approach in these cases? What kind of stability tests have to be done?

Thank you in advance for any tips and advice!!!!
 
Elsmar Forum Sponsor

monoj mon

Involved In Discussions
#2
I don't have any experience with surgical masks. But, I am just wondering, will it be appropriate to conduct package integrity testing along with the performance testing after a certain point of accelerated aging (say after 1 year, 3 years & 5 years) within the expected shelf life (say 5 years) just like other medical devices!
 
Thread starter Similar threads Forum Replies Date
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
P CE technical file - Buying Surgical Mask from China ISO 13485:2016 - Medical Device Quality Management Systems 16
D Surgical Instrument Tray Classification EU Medical Device Regulations 1
E MRI and Surgical Needle Other Medical Device Related Standards 0
Z MDR Class Ir deadline (Reusable surgical instruments) EU Medical Device Regulations 27
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
A Is there any Light for a surgical microscope? Other ISO and International Standards and European Regulations 3
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
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

Similar threads

Top Bottom