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
 
Elsmar Forum Sponsor

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.
 
Thread starter Similar threads Forum Replies Date
F Bioburden Testing requirements for Non-Sterile Dental Products EU Medical Device Regulations 6
C ISO 11737 - Bioburden testing for non-sterile products Other ISO and International Standards and European Regulations 10
K When is Bioburden Testing Required? Other Medical Device Related Standards 4
D Sterility and BioBurden Testing for Plastics ISO 13485:2016 - Medical Device Quality Management Systems 5
C Sterility and Bioburden Testing - LAL passed under 0.5EU/mL Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
R Simulated product for bioburden testing Other ISO and International Standards and European Regulations 2
M Bioburden testing for Class 10000 (Grade C) clean room ISO 13485:2016 - Medical Device Quality Management Systems 1
P Serial Testing of Bioburden for Medical Devices Other Medical Device Related Standards 2
P Frequency of Bioburden Testing EU Medical Device Regulations 3
M Sterility Testing vs Bioburden Testing - Differences Qualification and Validation (including 21 CFR Part 11) 7
I Bioburden and Endotoxin (LAL) Testing proposal help 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Spinal Implant Testing Requirements - Bioburden, TGA & Ion Chromatography 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Microbiological Testing - Bioburden and Identification of Micro-Organisms ISO 13485:2016 - Medical Device Quality Management Systems 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
B Bioburden monitoring for surgical instrument provided non-sterile EU Medical Device Regulations 3
B Radiation Sterilization Dose Audit: Bioburden frequency Other Medical Device Related Standards 1
V Cleanliness/Bioburden for Non-Sterile Gas Path Medical Devices Other Medical Device Regulations World-Wide 7
K Bioburden 0 cfu for Dose Setting using the VDmax25 Other Medical Device Related Standards 9
N Must Bioburden Sampling Procedures be Documented? Other Medical Device Related Standards 5
C What is the most appropriate Bioburden Test Method for Surgical Gloves ISO 13485:2016 - Medical Device Quality Management Systems 10
M Bioburden numbers and ECA gloves 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Biological Monitoring Program Environmental Bioburden Test Method Needed ISO 13485:2016 - Medical Device Quality Management Systems 1
C What is an acceptable bioburden level or count when working in cleanroom ISO class7 ISO 13485:2016 - Medical Device Quality Management Systems 1
B BioBurden and EndoToxin Questions Other Medical Device Related Standards 6
S Bioburden Monitoring Sample Size Increase ISO 13485:2016 - Medical Device Quality Management Systems 4
I Bioburden Count Question - Bioburden is above the alert limit >1 CFU/component avg. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Bioburden Monitoring - 'Off the Shelf' Bioburden/Microbiological Monitoring Software ISO 13485:2016 - Medical Device Quality Management Systems 4
L GB15980-2003 Bioburden Count Trend on Operator Hands Other ISO and International Standards and European Regulations 1
0 Guideline/Method for Raw Material Roll Stock Bioburden Sampling Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Q Bioburden Requirements on Device used on Unbroken Skin Other Medical Device and Orthopedic Related Topics 4
A Microbial Limit (Bioburden)on dry nonwoven that used for making Hand sanitizing wipes ISO 13485:2016 - Medical Device Quality Management Systems 1
D Bioburden and Product Labels - VD Max studies on all the BOMs Other Medical Device and Orthopedic Related Topics 9
H Determining a New Product Bioburden Limit ISO 13485:2016 - Medical Device Quality Management Systems 11
L Validation of transfer materials - Bioburden of items from lab into cleanroom Other Medical Device and Orthopedic Related Topics 2
L Monitoring bioburden on clean room gloves Other Medical Device and Orthopedic Related Topics 1
C Establishing alert and action limits for clean room bioburden Other Medical Device and Orthopedic Related Topics 9
E Bioburden tests duration and Monitoring of gloves ISO 13485:2016 - Medical Device Quality Management Systems 6
S What is a reasonable Bioburden limit? ISO 13485:2016 - Medical Device Quality Management Systems 13
I IATF Lab Scope Testing Qualification and Competency Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 0
M Comparing data from destructive testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Flammability testing Reliability Analysis - Predictions, Testing and Standards 0
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
K IEC 62304 - Testing Independance IEC 62304 - Medical Device Software Life Cycle Processes 5
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
C Surgical mask stability testing (CE mark) EU Medical Device Regulations 1
Beliz Biocompatibility Testing for Laser Epilation Device EU Medical Device Regulations 2
C One Time Service Supplier - Temperature and Humidity Testing Service ISO 13485:2016 - Medical Device Quality Management Systems 5
D IEC 60601-1 - Service life testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
P Flammability Testing of Aircraft Interior Materials Federal Aviation Administration (FAA) Standards and Requirements 0

Similar threads

Top Bottom