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ISO 13485 Sterilization Clause Applicability

#1
Hi, I am a manufacturer of medical face mask and currently my face mask is a type IIR medical face mask under BS EN14683.

Just would like your kind advice whether the sterilization clause in ISO13485:2016 can be "non-applicable" ?

If the sterilization is non-applicable to us, then what is the cleanliness and contamination control procedure details required? Only the cleanroom verification and validation will be sufficient?

Please share your kind advice.

Thank you and have a nice day!
 
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John C. Abnet

Teacher, sensei, kennari
Staff member
#2
Just would like your kind advice whether the sterilization clause in ISO13485:2016 can be "non-applicable"
Good day @amelol ;
There is no requirement in ISO 13485 for sterilization (unless sterilization is required).

Is your device... "sterile medical device" per term and definition 3.20 ?
Are there not statutory or regulatory requirements for your product to be sterile?

In regards to the "sterilization clause", sterilization is mentioned numerous times throughout the standard regarding documentation, and validation of ny sterilization that occurs. In particular, clause 7.5.2 requires your organization to identify and document "requirements for cleanliness". I would start there and as result, understand exactly what "requirements for cleanliness" do, or do not, exist.

Hope this helps.

Be well.
 
#3
Thanks John for sharing your thoughts. ;)

Good day @amelol ;
There is no requirement in ISO 13485 for sterilization (unless sterilization is required).

Is your device... "sterile medical device" per term and definition 3.20 ?
Are there not statutory or regulatory requirements for your product to be sterile?

Checked the face mask is not required to be sterile under the Malaysia medical device regulation. However, we do UV radiation oven sterilization on the face mask.

In regards to the "sterilization clause", sterilization is mentioned numerous times throughout the standard regarding documentation, and validation of ny sterilization that occurs. In particular, clause 7.5.2 requires your organization to identify and document "requirements for cleanliness". I would start there and as result, understand exactly what "requirements for cleanliness" do, or do not, exist.

Hope this helps.

Be well.
Checked the face mask is not required to be sterile under the Malaysia medical device regulation. However, we do UV radiation oven sterilization on the face mask. In this case, do I need to comply with the sterilization requirements?

Is cleanroom infrastructure and it’s cleanroom performance certified by NEBB considered fulfilling the “requirements for cleanliness”?
 

John C. Abnet

Teacher, sensei, kennari
Staff member
#4
In this case, do I need to comply with the sterilization requirements?
Good day @amelol ;
I want first issue the disclaimer that I do not know what regulatory or statutory requirement or ethics require your organization to sterilize or not to sterilize.

Having said that, you said in your prior post that "...the face mask is not required to be sterile under the Malaysia medical device regulation."

Remember, ISO 13485 is NOT a legal or regulatory requirement.

Do you have a copy of ISO 13485 and have you familiarized yourself with it? What is required by ISO 13485 is only what is stated within ISO 13485.

Hope this helps.
Be well.
 
#6
Good day @amelol ;
I want first issue the disclaimer that I do not know what regulatory or statutory requirement or ethics require your organization to sterilize or not to sterilize.

Having said that, you said in your prior post that "...the face mask is not required to be sterile under the Malaysia medical device regulation."

Remember, ISO 13485 is NOT a legal or regulatory requirement.

Do you have a copy of ISO 13485 and have you familiarized yourself with it? What is required by ISO 13485 is only what is stated within ISO 13485.

Hope this helps.
Be well.
Yes, I have the copy of standard and attended awareness training for it. Just that certain requirements like sterilization is vague to be included or excluded with justification. So to certify with ISO13485, I am not sure if the sterilization requirements can be “non applicable” or not.
Thanks a lot for your inputs.
 
#7
Sterilization requirements only apply if one of the following exists:
  1. Regulatory Requirement
  2. Customer Requirement
  3. Internal Requirement
Thanks Pjservan for sharing your thoughts.
Internal requirement means it is depends on the organization’s decision to implement the sterilization process or not right? If implement sterilization process in the production of face mask, then the ISO13485 system will need to establish all the sterilization process control, verification and validation procedures n records. Correct?
 

planB

Super Moderator
#8
amelol,

you typically only talk about "sterilisation" when you render your product free of viable micro-organism with typically at least a sterility assurance level (SAL) of 10exp(-6). Is your UV irradiation process capable of providing this minimum SAL? Or is it more sort of a decontamination process (i.e. no real defined and validated microbial log reduction)

EN 14683:2019 specifies the microbial cleanliness in section 5.2.5: "[...]the bioburden of the medical mask shall be≤ 30 CFU/g [...]". There are no other defined cleanliness requirements in this standard other than stating "In the selection of the filter and layer materials, attention shall be paid to cleanliness." in section 5.1.1. Controlled environmental manufacturing conditions are surely favourable to meet this requirement. There

Hope this helps,
 
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