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Microbiological Testing

Microbiological Testing for Medical Devices

About HTW Lab:

HTW, as a leading one-stop testing and certification solution provider for medical device, supply a large range of testing items including biocompatibility test,  microbiological test, EMC test, safety test, Pathology test, physical and chemical performance test, wireless coexistence test both for active medical products and non-active medical products.

Communicate with our experts to determine your needs and we will provide you with an evaluation, proposal and quotation.


Why Choose Us?

HTW Lab, accredited by CNAS, CMA, consistently operates competently and generates accurate and valid results in accordance with ISO/IEC 17025. Our lab meets the requirements of GLP. We can supply test service in accordance with national and global standards for both active and non-active medical products. Our familiarity with these standards makes for a seamless and trustworthy testing process, and a full range of biocompatibility testing capability according to ISO 10993 .


Our global team of medical health and services professionals come from the medical industry with an average of about 8 years of experience. Their deep expertise underpins our astute understanding of global device safety and accreditation requirements, keeping us ahead of the latest developments and ensuring that all emerging regulatory needs are met.


Testing We Support

  • Cleaning, disinfection and sterilization verification

  • Antibacterial test

  • Establishing the sterilization dose

  • Radiation sterilization dose audit

  • Microbial Limit Test

  • Bioburden Test

  • Sterility Test


Your Benefits At A Glance:

1.20 Years Of Experience

HTW has extensive experience in all types of Medical devices and regulatory requirements across markets. 

2.Provide Free Modification Service Program

Together with our wealth of knowledge in complex regulations globally, HTW provides a complete suite of testing solutions according to your needs including free Modification service.

3.Save time to global markets

With over 7,000 square meters of labs, HTW offers the best testing cycles and you don't have to wait in line, HTW offers 1-on-1 service.With our in-depth insight of global product quality and regulatory requirements, HTW can optimize your costs and minimize your time to market.

4.Complete qualifications

ISO/IEC 17025 lab, accreditated by CNAS, CMA,A2LA,GLP.

5.Competitve price

located in China ,Testing costs are lower than other labs.


We're Here for You

We're based in China but regularly work with clients globally. We will get back to you in 1 working day.


Our Business Hours: 

8.30am - 5.00pm in CST (UTC/GMT+08:00) Monday - Friday 


Email:

sales@htwlab.com

Kindly tell us ‘how did you hear about us’.

HTW Testing and Certification Solutions.

Standards We Test To

1.Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-1:2006 

2.Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose ISO 11137-2:2013 

3.Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices GB 18280.1-2015 

4.Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose GB 18280.2-2015

5.CHP 2020 CHP 2020 PART4 1106  

6.A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices AAMI TIR30: 2011

7.Designing, Testing And Labeling Reusable Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers AAMI TIR12: 2010 

8.Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices ASTM 3208-20 

9.Central sterile supply department(CSSD)-Part 1:Management standard WS 310.1-2016 

10.Central sterile supply department(CSSD)-Part 2:Standard for operating of cleaning,disinfection and sterilization WS 310.2- 2016

11.Central sterile supply department(CSSD)-Part 3:Surveillance standard for cleaning,disinfection and sterilization WS 310.3- 2016 

12.Regulation of disinfection technique in healthcare settings WS/T 367-2012 

13.Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices ISO 17664:2017 

14.Sterilization of health care products — Moist heat ISO 17665[all parts]:2006

15.Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 20857:2010

16.Sterilization of medical devices — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices ISO 

25424:2018

17.Washer-disinfectors.Part 2:Requirements and tests for washer disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment,etc. YY/T 0734.2—2018 

18.Washer-disinfector—Part 3:Requirements and tests for washer disinfectors employing thermal disinfection for human waste containers YY/T 0734.3—2018 

19.Washer-disinfectors—Part 4:Requirements and tests for washer disinfectors employing thermal disinfection for non-invasive medical devices,etc. YY/T 0734.4—2016 

20.Sterilization of medical devices Microbiological methodsPart 1:Determination of a population of microorganisms on products GB/T 19973.1-2015 Annex A 

21.Sterilization of healthcare products -Microbiological methodsPart1:Determination of a population of microorganisms on products ISO 11737-1:2018 Annex A 

22.Hygienic standard for disposal sanitary products GB15979-2002 Annex B 

23.CHP 2020 CHP 2020 PART4 1105 

24.USP42 USP 43-NF38  

25.Sterilization of medical devices- Microbiological methods-Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process GB/T 19973.2-2018 Annex A

26.Sterilization of medical eies----Microbiological metos-..-Part 2: Tests of sterility performed in the definition, validation and maintenance ofa ISO 11737-2:2009 Annex A

27.Test methods for infusin trnsfusionsiecetio equipment for medical use-Part 2: Biological test methods GB/T 14233.2-2005 3 

28.USP USP 43-NF38

Sample Requirements

10 sets of complete samples

The samples should be provided according to the normal shipping status, if product is sold under sterilized conditions so that pls provide sample with sterilized package. 


Consulting Service

Consulting Service

Preliminary Product Development Regulatory Guidance

Product Technical Requirements Review Service

Clinical Evaluation

Plant Construction Consulting

Quality Management System Construction


Domestic Registration/Global Market Access

China NMPA (CFDA)

US FDA (Listing, 510k)

EU CE

Brazil ANVISA (INMETRO, ANATEL )

Australian TGA

Canadian CMACAS

UK UKCA


Product We Test

All reusable medical equipment, such as endoscopes, B-ultrasound, surgical equipment, household medical equipment, etc.

All the antibacterial /bacteriostatic products, such as gel dressing products, cleaning disinfectants, etc.

All products sterilized by ethylene oxide, irradiation, high pressure steam, low temperature plasma, etc., such as medical masks, protective clothing, disposable sterile surgical electrodes, disposable sterile implant products, etc.

Process of Certification Service

1. Provide us with product pictures, product brochures/manuals

2. Determine your needs(test report purpose/ test itmes/ standards)

3. Receive the testing/compliance service proposal and quotation 

4. Sign contract and make payment

5.Send samples (please contact us for address info.)

6.Informed project opening and test TAT(turn around time) via email

7.Testing 

8.Draft report for your confirmation

9. Formal reports endorsed by ILAC - CNAS (electronic version) 

10.Sample Discard or Return

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