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)

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