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Testing service

Testing service

Test object
Item/Parameters
Test standard (method)
Serial Number
name
Medical Instruments
1
Microbial count
Microbiological examination of non-sterile products: microbiological count examination USP41 USP41(61)

Microbial limit test for non-sterile products:
microbial counting method 2015 edition 《The Chinese pharmacopoeia》

2
 
Bioburden
 
Sterilization of healthcare products Microbiological method Part 1:
Determination of the number of microorganisms on the product ISO11737.1-2018 /
Sterilization of medical devices Microbiological method Part 1:
Determination of microbial populations on products GB/T 19973.1-2015
3
 
Sterility test/sterility
Sterility test 2015 edition 《The Chinese pharmacopoeia》 2015 edition 《The China pharmacopoeia》 Part IV general principles 1101
USP41 USP41(71) Sterility test USP41 USP41(71)
Sterilization of medical devices -- microbiological methods -- part 2:
aseptic tests for the definition, validation, and maintenance of the sterilization process ISO11737.2-2009
Sterilization of medical devices Microbiological methods part 2:
aseptic tests for the definition, validation, and maintenance of the sterilization process GB/T 19973.2-2018
4
 
Endotoxin
Bacterial endotoxin test 2015 edition 《The Chinese pharmacopoeia》 Part IV general principles 1143
Bacterial endotoxin test USP41 USP41(85)
Bacterial endotoxin - test methods, routine monitoring and batch selection ANSI/AAMIST72:2011/(R)2016 8, 9
Methods of test for medical infusion, transfusion and infusion apparatus - part 2:
biological test methods GB/ t14233.2-2005 4
5
 
Biological monitoring of ethylene oxide sterilization
Hospital disinfection supply centers - part 3:
Monitoring standard for cleaning, disinfection and sterilization effect
Appendix CWS 310.3-2016
Guide for biological indicator selection, use, and result determination GB/ t19972-2018 12.2 12.3 5
Guidelines for the selection, use and determination of biological indicators ISO 14161:2009 12.2 12.3
6
Biological indicator test - determination of microbial quantity
Biological indicator - resistance test USP41 USP41(55)
Sterilization of healthcare products bioindicator part 1: general principles GB 18281.1-2015 6,7
Sterilization of healthcare products Bioindicator part 1: general requirements ISO 11138-1:2007 6, 7
7
 
Residues of ethylene oxide
Biological evaluation of medical devices-part 7:
ethylene oxide sterilization residue GB/T 16886.7-2015 appendix K
Biological evaluation of medical devices - part 7:
ethylene oxide sterilization residue ISO10993.7-2008 appendix K
8
 
Residues of ethylene chlorohydrin
Biological evaluation of medical devices - part 7:
ethylene oxide sterilization residue GB/T 16886.7-2015 appendix K
Biological evaluation of medical devices - part 7:
ethylene oxide sterilization residue iso10993.7-2008 appendix K
9
Film thickness
Determination of the thickness of plastic film and sheet
Mechanical measurement GB/ t6672-2001
10
Visually inspection for package integrity
Aseptic medical device packaging test method Part 11:
Visual inspection of medical packaging seal integrity YY/T 0681.11-2014
Standard test method for determining the integrity of seals in pharmaceutical packaging by visual inspection
ASTM F1886/F1886M-2016 ASTM F1886/ f18866-2016 ASTM F1886/ f18866-2016
11
 
Resistance to internal pressure failure for unrestrained package
Sterility medical device packaging test method Part 3:
Unrestrained packaging is resistant to internal pressure failure YY/ t0681.3-2010
Test method for resistance of unrestrained packaging to internal pressure damage
ASTM F1140/F1140M-2013 ASTM F1140/ f1140m-2013
12
 
Internal pressure method detects gross leakage(Bubble method)
Aseptic medical device packaging test method Part 5:
Internal pressure method detects gross leakage(Bubble method)YY/T 0681.5-2010
Test method for detecting total leakage in medical packaging by internal pressurization(bubble method)
ASTM F2096-2011 ASTM f2096-2011
13
 
Burst test of flexible packing seal
Aseptic medical device packaging test method Part 9:
Bursting test of flexible packaging by air pressure method inside restraint plate YY/T 0681.9-2011
Test method for rupture test of flexible packaging seal by gas pressurization method in barrier plate
ASTM F2054/F2054M-2013 ASTM F2054/F2054M-2013
14
 
Seal strength
Aseptic medical device packaging test method Part 2:
Seal strength of soft barrier material YY/T 0681.2-2010
Test method for sealing strength of flexible barrier materials ASTM F88/F88M-2015
15
 
Dye penetration
Aseptic medical device packaging test method Part 4:
Dye penetration method was used to determine seal leakage of breathable packaging YY/T 0681.4-2010
Test method for detecting porous water permeable medical packaging seal leakage by dye permeation test
ASTM F1929-2015 ASTM f1929-2015
16
 
Accelerated aging test
Aseptic medical device packaging test method Part 1:
Guidelines for accelerated aging tests YY/T0681.1-2009
Guidelines for accelerated aging testing of sterile barrier systems for medical devices
ASTM f1980 - 2016 ASTM f1980 - 2016
Clean oom (area) of Pharmaceutical Industry
1
 
Intensity of illumination
The design specification of clean workshop GB 50073-2013 9.2
Code for cleanroom construction and acceptance GB 50591-2010 E.7
2
 
Noise
The design specification of clean workshop GB 50073-2013 4.4
Code for cleanroom construction and acceptance GB 50591-2010 E.6
3
 
Suspended particles test
Methods for the determination of suspended particles in the pharmaceutical industry GB/T 16292-2010

Clean room and related controlled environment Part1:
Air cleanliness class ISO 14644.1-2015 Appendix A

Clean room and related controlled environment Part1:
Air cleanliness class GB/T 25915.1-2010 Appendix B
4
 
Planktonic bacteria
Test method for phytoplankton in clean rooms (zones) of pharmaceutical industry GB/T 16293-2010
Clean room and related controlled environment Biological pollution control Part 1 :
General principles and methods ISO 14698.1-2003 Appendix A
Microbiological control and monitoring of sterile environment USP41(1116)
5
 
Settlement of bacteria
Test method for settling bacteria in clean room (area) of pharmaceutical industry GB/T 16294-2010
Clean room and related controlled environment Biological pollution control Part 1:
General principles and methods ISO 14698.1-2003 Appendix A
Microbiological control and monitoring of sterile environment USP41(1116)
6
 
Air changes
Clean rooms and associated controlled environments - part 3: test method ISO 14644.3-2005 B
Clean room and related controlled environment part 3: test methods GB/T 25915.3-2010 B4
7
 
Static pressure difference
Clean room and related controlled environment part 3: test method ISO 14644.3-2005 B
Clean room and related controlled environment part 3: test method GB/T 25915.3-2010 B5
8
 
The temperature
Clean room and related controlled environment part 3: test method ISO 14644.3-2005 B
Clean room and related controlled environment part 3: test method GB/T 25915.3-2010 B8
9
 
Relative humidity
Clean room and related controlled environment part 3: test method ISO 14644.3-2005 B
Clean room and related controlled environment part 3:test method GB/T 25915.3-2010 B9