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Bioburden Testing - Non Sterile Product / Tapes - ISO 11737-1

Olgamargarita

Involved In Discussions
#1
Goog day!

The tapes is class I and have mark CE.

I have the following doubts::bigwave:

1. Tapes can follow the bioburden testing procedure described in ISO 11737?? even if the ISO indicate that is applied to sterile product? why?

2. The EU has established the tests must develop in non sterile product?

3. The certificate of analysis tapes, only mention bioburden test and no performs specific bacterias (pathogen), why a product with marck CE do not develop a specific bacterias test(pathogen)???

Thank you very much, in advance

Olga
 
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Ajit Basrur

Staff member
Admin
#3
Goog day!

The tapes is class I and have mark CE.

I have the following doubts::bigwave:

1. Tapes can follow the bioburden testing procedure described in ISO 11737?? even if the ISO indicate that is applied to sterile product? why?

2. The EU has established the tests must develop in non sterile product?

3. The certificate of analysis tapes, only mention bioburden test and no performs specific bacterias (pathogen), why a product with marck CE do not develop a specific bacterias test(pathogen)???

Thank you very much, in advance

Olga
Olga, could you tell what tapes are these ?
 

Olgamargarita

Involved In Discussions
#4
Thank you very much for you kindly reply,

Adhesive tapes are composed by backing material (PE film or acetate fabric or cellulosic bleached virgen fibers or cotton fabric) and adhesive (Acrylic or hot melt adhesive or Rubber/Zno/resin).

They are used for dressing and medical device retention on the skin.

Thanks

Olga
 

Ajit Basrur

Staff member
Admin
#5
The ISO 11737-1 is "Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products"

This standard applies only when your product is labeled "STERILE" and from your device descriptionb, understand its a non sterile product.

Since the ISO 11737-1 is specifically to address the sterile medical devices, there should be no pathogens. Even the presence of a single cfu renders the article "NON STERILE".
 

Olgamargarita

Involved In Discussions
#6
I am going to explain more about these products (non sterile products) certified by notified body, a indian company sent us a certificate of analysis where indicate in the microbiological part, bioburden test based under ISO 11737-1.

1. I want to know if is correct the bioburden test to non sterile product can be based in ISO 11737-1 ?

2. The certificate of analysis do not report another microbiological (only bioburden test) test as pathogen test. It is correct, a non sterile product did not perform a pathogen test?

3.There are any regulation in the European comunity that regulates to non sterile products (aseptic products) regarding microbiological test (bioburden and pathogen test)?

4 If the company do not performed a pathogen test how ensures that the product do not contain pathogen bacterias?

I would appreciate you help me to understand the point aforementioned.
 

Olgamargarita

Involved In Discussions
#9
The manufacturer do not perform the test pathogen. It is confirm.
The only microbiological test they report in the certificate of analysis is:

Bioburden test based in ISO 11737-1
acepptance criteria: <10cfu/1gm

The manufacture process is automatically

:yes:
 

bio_subbu

Super Moderator
#10
Hi Olga

The first point which I observed is “class I non-sterile product certified by notified body. Normally, Notified Body intervention is not required for Class I devices sold as non-sterile.

Can you please tell me that what is the intention of verify pathogen contamination on the product “adhesive tapes”?. Because, the product itself “non- sterile” and the intended use/claim of the product declared as “used for dressing and medical device retention on the skin”. I assume that the product not directly touch with wound surface and won’t be an any high risk.

The manufacturer might have followed this standard ISO 11737-1 as a good practice, to enumerate the bacterial load on the non-sterile product.
 
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