Class I Shelf-life requirements

#1
Hi Everyone,

I am just doing some work on the tech files of some of our new products. They are all class I theatre wear products which have function as medical devices but don’t need to meet any standards.

An example would be disposable operating theatre caps where their only function is to prevent hair fall during procedures to maintain the sterile field. They do not need to confirm to any standard and they are not tested on properties such as tensile strength, water resistance etc.

They are made from Spunbond polypropylene and Spunlace fabric which is fairly resistant to environmental effects.. especially when stored under standard storage conditions in packaging. There are many similar devices on the market that have a 5 year shelf life.

Am I required to carry out proper accelerated ageing tests and real life ageing tests on these products to claim a specific shelf-life? The problem is I wouldn’t even know how to test them after accelerated ageing as they don’t have any physical properties to meet other than still be the right shape and stitching still intact. (Note that I will do real life ageing anyway however I have to wait 5 years so it’s of no help now)

Or.. could I write a report of some kind regarding the simplicity of the product (just some PP fabric stitched together), the properties of the raw material and comparison to similar devices on the market in order to justify a shelf life of say 3-5 years?

I would be very appreciative of any help with this?

Thanks!
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
I wouldn't automatically assume that just because the devices are simple and common they're not subject to any published standards. On the contrary, published standards often consolidate long accumulated knowledge to ensure broad application of proven best practices. Additionally, for the OT caps don't think just "OT caps" - there may be broader PPE standards that may apply. Essentially anything that comes into an OT / sterile field needs to meet certain standards, many times regardless of what it actually is/does.

Regarding shelf life - you don't necessarily have to do testing, but you do need a solid (preferably engineering) rationale on file. A careful analysis of how it compares with equivalent competitors' products that have had a long failure/problem-free use history can be a contributing element (but you have to do it properly and rely on real data; no BS). Accelerated ageing becomes relevant after you've concluded that you need real time ageing, to allow you to not wait 5 years to start selling... but again, you might not need to age at all in the first place. STOP and THINK before you TEST.

Start with the device's requirements specification (if there is one) and with your risk analysis - think of everything that can go wrong with/about/around the device, as simple/modest as it might be, so you can capture everything required of it ("bad" things that might happen map individually onto preventative requirements). Once you know the requirements you can start working out how to justify (engineering wise) that they will still be met 5 years later.
 
Last edited:
#3
I wouldn't automatically assume that just because the devices are simple and common they're not subject to any published standards. On the contrary, published standards often consolidate long accumulated knowledge to ensure broad application of proven best practices. Additionally, for the OT caps don't think just "OT caps" - there may be broader PPE standards that may apply. Essentially anything that comes into an OT / sterile field needs to meet certain standards, many times regardless of what it actually is/does.

Regarding shelf life - you don't necessarily have to do testing, but you do need a solid (preferably engineering) rationale on file. A careful analysis of how it compares with equivalent competitors' products that have had a long failure/problem-free use history can be a contributing element (but you have to do it properly and rely on real data; no BS). Accelerated ageing becomes relevant after you've concluded that you need real time ageing, to allow you to not wait 5 years to start selling... but again, you might not need to age at all in the first place. STOP and THINK before you TEST.

Start with the device's requirements specification (if there is one) and with your risk analysis - think of everything that can go wrong with/about/around the device, as simple/modest as it might be, so you can capture everything required of it ("bad" things that might happen map individually onto a preventative requirements). Once you know the requirements you can start working out how to justify (engineering wise) that they will still be met 5 years later.
Thanks Ronen for your detailed reply. I am fairly certain there are no PPE standards that apply to this product since it’s intended purpose has nothing to do with protection of the wearer. There are some other standards that do apply to the product as a medical device but I was referring to an industry standard which applies to a group of properties essential to its performance (such as EN13795 for gowns or EN14683 for masks).

Thank you, this makes a lot of sense when it comes to shelf life. When you say preferably engineering what exactly do you mean? My plan is to do a literature search for data on shelf life of the raw materials and how they degrade over time and then consider these when looking at the products function.
In terms of other products on the market, we have 100% identical products which have been on the market for 10 years plus which are claiming 5 year shelf-lives.. There is no medical device reporting of issues for these products within Europe. I can write a rationale behind the equivalency of the products.

I do not think ageing is required for these products (however I will reserve judgement until I have finished my analysis) but does that mean I can not claim a shelf-life of 3-5 years without proper studies being done? Could I base it on the evaluation and rationale document I am proposing to complete?

Thank you that is a good idea to start with the requirements and risk analysis first and then tailor the evaluation around that.
 

Ronen E

Problem Solver
Moderator
#4
I am fairly certain there are no PPE standards that apply to this product since it’s intended purpose has nothing to do with protection of the wearer.
IMO this distinction is unproductive in this case. While it may be the case that you are not bound to comply with any published standards, you might still benefit from voluntary application of standards that are only tangent/adjacent to your particular application. Further, in my understanding PPE means Protective Equipment that is Personal, not necessarily for the protection of the wearer. Surgical masks are typically referred to as PPE though they are the same - unless otherwise specified, they are not intended to protect the surgeon but rather to protect the patient "from the surgeon".
When you say preferably engineering what exactly do you mean?
I mean based on quantitative data and solid application of physics/mathematics. It doesn't have to be complicated or fancy, but it needs to be more than word shuffling.
In terms of other products on the market, we have 100% identical products which have been on the market for 10 years plus which are claiming 5 year shelf-lives..
Can you back up the "100% identical" claim with facts? If this is the case I'm a little confused - whose products are you referring to, yours or competitors'? In case it's the latter, are you merely distributing these products?...
There is no medical device reporting of issues for these products within Europe.
I didn't expect there to be one... But sometimes there are indications from other sources that there were/are problems. I'm not saying that this should be the case here - I wouldn't know; I'm only saying that you have to make a real effort to look into this, and document your search in detail (even if you found nothing). This will support a statement along "The product has been around for many years and yet there are no known issues with it."
does that mean I can not claim a shelf-life of 3-5 years without proper studies being done? Could I base it on the evaluation and rationale document I am proposing to complete?
If your evaluation is solid enough you might be able to claim a certain shelf life (as backed by your documented rationale), perhaps in the absence of test data. It might at least allow you to start placing a new product on the market while you wait for test results that might come in later. Such later test results may not be required at all, however you might be required to conduct the testing nonetheless, "just in case" - authorities tend to be risk averse and would sometimes require something regardless of reason or burden to the manufacturer. The OT cap example seems a very low risk so I would have started with an engineering rationale and escalated to testing only upon a firm requirement from the authorities (unlikely IMO, but who knows).
 

Junn1992

Quite Involved in Discussions
#5
If the caps are not provided sterile...shelf life is not a big issue right?

It's just a simple matter to say that the materials are not expected to degrade under specified conditions of storage and transport. And the reason is..1 2 3
 

Ronen E

Problem Solver
Moderator
#6
If the caps are not provided sterile...shelf life is not a big issue right?
Define "big issue"...?
If a claim is made in the labelling it needs to be backed by objective evidence. That's true for any and all claims.
It's just a simple matter to say that the materials are not expected to degrade under specified conditions of storage and transport. And the reason is..1 2 3
What would make all the difference is what's in 1, 2, 3 etc.
You can say that things are or aren't expected to happen, but unless you have a solid rationale (preferably based on evidence) to back it, that's all it is. You said it, so what?
 
Thread starter Similar threads Forum Replies Date
N Class III PMA shelf life extension US Medical Device Regulations 2
N Shelf life guidance EU MDR, class 1 and class 2 Medical Devices EU Medical Device Regulations 2
D Shelf life of non sterile class IIb product. ISO 13485:2016 - Medical Device Quality Management Systems 1
Edward Reesor Class I non-sterile "Shelf Life" labeling (EU/UK) CE Marking (Conformité Européene) / CB Scheme 4
T Class III device and shelf life data requirements US Medical Device Regulations 7
L "Shelf-Life" Class I Non-Sterile Products Expiration Date? CE Marking (Conformité Européene) / CB Scheme 3
M Shelf Life of Combination Sets for Class II Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
J EU Medical Device Class I - Stability (Shelf Life) Test EU Medical Device Regulations 2
D Class II Sterile Product Shelf Life Labeling - Should we do a recall? Nonconformance and Corrective Action 4
J Non-Sterile Class 2 Medical Device Shelf Life Other Medical Device Related Standards 5
N Does Class I (exempt) device have requirements of Shelf Life and Expiration Dating ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
U Shelf Life Requirement for Class II Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 26
Q Expiry Dates on a Non-Sterile Class 1 Medical Device (5 Year Shelf Life). Other Medical Device and Orthopedic Related Topics 11
B IEC 60825-1 Class 3R Laser Off-The-Shelf or Custom Label Needed Other ISO and International Standards and European Regulations 3
K Use of off the shelf hardware in Medical Devices class II IEC 60601 - Medical Electrical Equipment Safety Standards Series 10
R Class I MDSW CE Mark CE Marking (Conformité Européene) / CB Scheme 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
A Class 2a CE Mark Regulatory Pathway CE Marking (Conformité Européene) / CB Scheme 1
normhowe Surprising shoe policies for Class 7 Cleanrooms US Medical Device Regulations 5
L Class I under MDD EU Medical Device Regulations 1
C Legacy device under Class A sterile devices EU Medical Device Regulations 0
N FDA class 1 US Food and Drug Administration (FDA) 6
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
M UDI IVD Medical Device Class III US Food and Drug Administration (FDA) 1
M Class Exempt Medical Device Recall Question US Food and Drug Administration (FDA) 3
J Clinical Evaluation For Instruments - Class I, Class Ir, Class Im, and Class IIa - EU MDR EU Medical Device Regulations 4
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
T Testing for proving food safety on USP class vi material RoHS, REACH, ELV, IMDS and Restricted Substances 0
N FDA class 2 Device QS Requirements US Food and Drug Administration (FDA) 2
K Class I Medical Device Registration EU Medical Device Regulations 11
dgrainger Informational Common Specifications for certain class D IVDs EU Medical Device Regulations 0
S BASIC UDI-DI for a class IIa device marketed in a Procedure kit EU Medical Device Regulations 1
M From Class 1 to Acessory EU Medical Device Regulations 4
Q Class I Medical Device with measuring function (UK MDR 2002 / MDD) UK Medical Device Regulations 3
R Class II Active Medical Device SYSTEMS and COMPONENTS Canada Medical Device Regulations 2
S Drawing Requirements for Catalog Items (Class II Medical Device) US Food and Drug Administration (FDA) 3
M Labeling IVD Class III Medical Device and FDA Regulations and Standards News 0
L Class II Accessory Labeling Conundrum US Medical Device Regulations 19
H Mapping QMS+business processes in a medical device with class I and IIa+b Process Maps, Process Mapping and Turtle Diagrams 3
S Labeling requirements for class 1, fashion sunglasses US Food and Drug Administration (FDA) 0
B Can a software that receive data from a MD be classified as Class I?or is not a MD? EU Medical Device Regulations 5
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
D Class III license: Add new device to the license system Canada Medical Device Regulations 1
P Servicing of Class IIb devices under MDD EU Medical Device Regulations 2
marmotte Help with Surgical Class I + 510(k) exemption US Food and Drug Administration (FDA) 0
R Is "SAFE" permitted in class 1 medical device marketing claims? US Medical Device Regulations 1
ChrisM Class 1 non-sterile device, need certified QMS or not? EU Medical Device Regulations 2
S Reintroduce packaging component/med device from white room back to class 7 clean room Manufacturing and Related Processes 1
Steve Prevette I need a template to solve world hunger, a world class Quality Program, and make lots of money Coffee Break and Water Cooler Discussions 5
D Is sampling allowed for MDR Class III products? EU Medical Device Regulations 0

Similar threads

Top Bottom