Microbiological Testing - Bioburden and Identification of Micro-Organisms

I

ISO MAN

#1
Micrbiological Testings

Dear All,
I am looking for practical easy to use test methods for:

1. Bioburden of the finished product (Est. size is 250 gm and 6m length) for the
whole product and not only fluid bath,
2. Identification of micro-organisms on settle plates

Thanks
 
Elsmar Forum Sponsor
C

CNSue

#2
ISO 10993 or EN 30993

Hi,

it depends on your application. The minimum requirements for plates (electrodes) are defined in ISO 10993-5 (biocompatibility): cytotoxicity and ISO 10993-10: dermal irritation and sensitization.

But, as mentioned before, it depends on the indented use.

Chris
 
Thread starter Similar threads Forum Replies Date
M Microbiological Testing Lab - Layout & Standards Other Medical Device Regulations World-Wide 0
T Microbiological Testing of Packaging Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Ensuring Randomness in Collecting Chicken Samples for Microbiological Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
B R&R Study in Microbiological Testing - Aerobic Plate Count, Coliform, and Salmonella Food Safety - ISO 22000, HACCP (21 CFR 120) 4
S Why is Microbiological (viable) monitoring not part of ISO 14644 ? Manufacturing and Related Processes 5
V Deviating from USP Method for Microbiological Assay Qualification and Validation (including 21 CFR Part 11) 2
I Microbiological Monitoring for Surfaces - Switching from Swab to Contact Plates Other Medical Device Related Standards 2
A Microbiological Audits Required by CB under ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
B How to set Cleanroom Alert and Action Limits as part of Microbiological Evaluation Quality Assurance and Compliance Software Tools and Solutions 8
J Bioburden Monitoring - 'Off the Shelf' Bioburden/Microbiological Monitoring Software ISO 13485:2016 - Medical Device Quality Management Systems 4
A Microbiological Laboratory Waste Disposal Procedure(s) do you follow? General Measurement Device and Calibration Topics 4
Q How to Establish Microbiological Limits in Foods Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
N General Microbiological Laboratory Layout and Required Equipment General Measurement Device and Calibration Topics 6
G Is Microbiological Monitoring required for Clean Room? Other Medical Device Regulations World-Wide 8
K Microbiological State of a Reagent Kit - Enquiry Regarding ISO 18113 Other Medical Device Related Standards 1
A ISO 11737 - Sterilization of Medical Devices - Microbiological Methods EU Medical Device Regulations 1
M Microbiological Limits of Polyethylene Packaging Film Food Safety - ISO 22000, HACCP (21 CFR 120) 4
R Microbiological Cleaning Validation of Tablet Press Machine Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
M Microbiological Standards (Limits) for Hand Swabs for Coliforms and S. Aureus Food Safety - ISO 22000, HACCP (21 CFR 120) 15
S HACCP on Time and Temperature Control - Microbiological Contamination Food Safety - ISO 22000, HACCP (21 CFR 120) 3
V Microbiological Criteria Food Safety - ISO 22000, HACCP (21 CFR 120) 1
S Pharmaceutical Shelf Life Testing Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
D How to testing of Pressure relief valve as per API 6D ? Oil and Gas Industry Standards and Regulations 1
J Impact Testing--Is conversion between Izod and Sharpy Possible? General Measurement Device and Calibration Topics 3
O Should a Covid vaccine and testing policy be included as part of ISO9001 or AS9100 risk management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V How to select the tests for proficiency testing Measurement Uncertainty (MU) 0
B Customer Preference Testing Customer and Company Specific Requirements 2
N Pre-Clinical Performance Testing Design and Development of Products and Processes 3
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
I How to find required testing for a specific device? Other US Medical Device Regulations 3
J CQI-9v4 Alternative TUS Testing Methods Various Other Specifications, Standards, and related Requirements 0
M ASTM F1717 Static and Dynamic Testing 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T Mold Limits for Microbiology Testing Other Medical Device Related Standards 3
S Orthopedic implant sterility testing Medical Device and FDA Regulations and Standards News 1
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
M Issues with leakage current testing for a CLASS II device since no PE and FE is present IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
M Testing criteria - where to place Design and Development of Products and Processes 2
E 60601-1 - Tilt testing - Tensile safety factor IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Setup for testing against ISO14708 clause 16 (protection of the patient from herms caused by heat) Other Medical Device Related Standards 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M Bacteriostasis/Fungistasis Testing Other Medical Device and Orthopedic Related Topics 6
P Sample Size for Distribution Simulation Testing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
D Essential performance and EMC immunity testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
J Biocompatbility testing on Class 1 device requirements Other US Medical Device Regulations 12
Q Summative Usability Evaluation Testing: prior or during Clinical Investigation? Human Factors and Ergonomics in Engineering 10
B NIOSH Approval for Surgical N95 Respirators - Required testing US Food and Drug Administration (FDA) 2
M ECG lead leakage currents - How to specify ECG leads during electrical safety testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom