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Testing service
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Test object
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Item/Parameters
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Test standard (method)
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Serial Number
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name
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Medical Instruments
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1
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Microbial count
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Microbiological examination of non-sterile products: microbiological count examination USP41 USP41(61)
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Microbial limit test for non-sterile products: |
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2
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Bioburden
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Sterilization of healthcare products Microbiological method Part 1：
Determination of the number of microorganisms on the product ISO11737.1-2018 / |
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Sterilization of medical devices Microbiological method Part 1：
Determination of microbial populations on products GB/T 19973.1-2015 |
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3
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Sterility test/sterility
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Sterility test 2015 edition 《The Chinese pharmacopoeia》 2015 edition 《The China pharmacopoeia》 Part IV general principles 1101
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USP41 USP41(71) Sterility test USP41 USP41(71)
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Sterilization of medical devices -- microbiological methods -- part 2:
aseptic tests for the definition, validation, and maintenance of the sterilization process ISO11737.2-2009 |
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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 |
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4
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Endotoxin
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Bacterial endotoxin test 2015 edition 《The Chinese pharmacopoeia》 Part IV general principles 1143
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Bacterial endotoxin test USP41 USP41(85)
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Bacterial endotoxin - test methods, routine monitoring and batch selection ANSI/AAMIST72:2011/(R)2016 8, 9
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Methods of test for medical infusion, transfusion and infusion apparatus - part 2:
biological test methods GB/ t14233.2-2005 4 |
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5
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Biological monitoring of ethylene oxide sterilization
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Hospital disinfection supply centers - part 3:
Monitoring standard for cleaning, disinfection and sterilization effect Appendix CWS 310.3-2016 |
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Guide for biological indicator selection, use, and result determination GB/ t19972-2018 12.2 12.3 5
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Guidelines for the selection, use and determination of biological indicators ISO 14161:2009 12.2 12.3
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6
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Biological indicator test - determination of microbial quantity
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Biological indicator - resistance test USP41 USP41(55)
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Sterilization of healthcare products bioindicator part 1: general principles GB 18281.1-2015 6,7
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Sterilization of healthcare products Bioindicator part 1: general requirements ISO 11138-1:2007 6, 7
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7
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Residues of ethylene oxide
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Biological evaluation of medical devices-part 7:
ethylene oxide sterilization residue GB/T 16886.7-2015 appendix K |
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Biological evaluation of medical devices - part 7:
ethylene oxide sterilization residue ISO10993.7-2008 appendix K |
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8
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Residues of ethylene chlorohydrin
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Biological evaluation of medical devices - part 7:
ethylene oxide sterilization residue GB/T 16886.7-2015 appendix K |
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Biological evaluation of medical devices - part 7:
ethylene oxide sterilization residue iso10993.7-2008 appendix K |
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9
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Film thickness
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Determination of the thickness of plastic film and sheet
Mechanical measurement GB/ t6672-2001 |
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10
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Visually inspection for package integrity
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Aseptic medical device packaging test method Part 11:
Visual inspection of medical packaging seal integrity YY/T 0681.11-2014 |
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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 |
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11
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Resistance to internal pressure failure for unrestrained package
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Sterility medical device packaging test method Part 3:
Unrestrained packaging is resistant to internal pressure failure YY/ t0681.3-2010 |
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Test method for resistance of unrestrained packaging to internal pressure damage
ASTM F1140/F1140M-2013 ASTM F1140/ f1140m-2013 |
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12
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Internal pressure method detects gross leakage（Bubble method）
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Aseptic medical device packaging test method Part 5：
Internal pressure method detects gross leakage（Bubble method）YY/T 0681.5-2010 |
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Test method for detecting total leakage in medical packaging by internal pressurization（bubble method)
ASTM F2096-2011 ASTM f2096-2011 |
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13
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Burst test of flexible packing seal
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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 |
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Test method for rupture test of flexible packaging seal by gas pressurization method in barrier plate
ASTM F2054/F2054M-2013 ASTM F2054/F2054M-2013 |
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14
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Seal strength
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Aseptic medical device packaging test method Part 2：
Seal strength of soft barrier material YY/T 0681.2-2010 |
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Test method for sealing strength of flexible barrier materials ASTM F88/F88M-2015
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15
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Dye penetration
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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 |
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Test method for detecting porous water permeable medical packaging seal leakage by dye permeation test
ASTM F1929-2015 ASTM f1929-2015 |
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16
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Accelerated aging test
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Aseptic medical device packaging test method Part 1：
Guidelines for accelerated aging tests YY/T0681.1-2009 |
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Guidelines for accelerated aging testing of sterile barrier systems for medical devices
ASTM f1980 - 2016 ASTM f1980 - 2016 |
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Clean oom (area) of Pharmaceutical Industry
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1
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Intensity of illumination
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The design specification of clean workshop GB 50073-2013 9.2
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Code for cleanroom construction and acceptance GB 50591-2010 E.7
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2
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Noise
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The design specification of clean workshop GB 50073-2013 4.4
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Code for cleanroom construction and acceptance GB 50591-2010 E.6
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3
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Suspended particles test
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Methods for the determination of suspended particles in the pharmaceutical industry GB/T 16292-2010
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Clean room and related controlled environment Part1： |
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Clean room and related controlled environment Part1：
Air cleanliness class GB/T 25915.1-2010 Appendix B |
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4
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Planktonic bacteria
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Test method for phytoplankton in clean rooms (zones) of pharmaceutical industry GB/T 16293-2010
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Clean room and related controlled environment Biological pollution control Part 1 ：
General principles and methods ISO 14698.1-2003 Appendix A |
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Microbiological control and monitoring of sterile environment USP41(1116)
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5
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Settlement of bacteria
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Test method for settling bacteria in clean room (area) of pharmaceutical industry GB/T 16294-2010
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Clean room and related controlled environment Biological pollution control Part 1：
General principles and methods ISO 14698.1-2003 Appendix A |
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Microbiological control and monitoring of sterile environment USP41(1116)
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6
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Air changes
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Clean rooms and associated controlled environments - part 3: test method ISO 14644.3-2005 B
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Clean room and related controlled environment part 3: test methods GB/T 25915.3-2010 B4
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7
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Static pressure difference
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Clean room and related controlled environment part 3: test method ISO 14644.3-2005 B
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Clean room and related controlled environment part 3: test method GB/T 25915.3-2010 B5
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8
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The temperature
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Clean room and related controlled environment part 3: test method ISO 14644.3-2005 B
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Clean room and related controlled environment part 3: test method GB/T 25915.3-2010 B8
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9
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Relative humidity
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Clean room and related controlled environment part 3: test method ISO 14644.3-2005 B
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Clean room and related controlled environment part 3:test method GB/T 25915.3-2010 B9
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