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Service Items

Inspection and Test

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The laboratory which was written authorized by the legal representative of Shenzhen King Medical Packaging Sterilization Service Co., Ltd. is an independent testing institution. It is not affected by any superior and external pressure of the company.The laboratory operates strictly according to the quality management system of ISO/IEC 17025/ CNAS- -CL01.

 

Test items of the laboratory

So far, 11 test items are carried out for the medical devices field, and 7 test items are carried out for the cleaning room(area) of the pharmaceutical industry. The items and its relevant testing standards are as the followings.

 

NO.

Testing items

Standard No.

Standard title

1

Microbial enumeration tests

2015 of ChinesePharmacopoeia

Vol.IVgeneral chapter1105 Microbiological examination of nonsterile products:microbial enumeration tests

2

Bioburden

ISO 11737.1-2018

Sterilization of health care products - Microbiological methods- Part 1:Determination of population of microorganisms on products

GB/T 19973.1-2015

Sterilization of medical devices- Microbiological methods- Part 1:Estimation ofpopulation of microorganisms on products

3

Sterilitytest of sterility

2015 of ChinesePharmacopoeia

VolIVgeneral chapter1101 Sterility test

GB/T 19973.2-2005

Sterilization of medical devices-Microbiological methods--Part 2:Tests of sterility performed in the validation of a sterilization process

IS011737.2-2009

Sterilization of medical devices -Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

4

Biologicalmonitoring of ethylene oxide sterilization

WS 310.3-2016

Central sterile supply department (CSSD) - Part 3: Surveillance standard forcleaning, disinfection and sterilization

IS014161-2009

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

GB/T 19972-2005

Sterilization of health care products-- Biological indicators--Guidance for the selection, use and interpretation of results

5

Bacterial endotoxin test

2015 of ChinesePharmacopoeia

Vol.IVgeneral chapter 1143 Bacterial endotoxin test

GB/T14233.2- 2005

Test method of medical infusion, blood transfusion and injection equipment - Part2: Biological test method

6

Determination of ethylene oxide residuals

GB/T 16886.7-2015

Biological evaluation of medical devices-Part 7:Ethylene oxide sterilization residuals

IS010993.7-2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

7

Determination of ethylene chlorohydrin residuals

GB/T 16886.7-2015

Biological evaluation of medical devices-Part 7:Ethylene oxide sterilization residuals

IS010993.7-2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

8

Film thickness

GB/T6672-2001

Plastics film and sheeting - Determination of thickness by mechanical scanning

9

Seal Strength

YY/T 0681.2-2010

Test methods for sterile medical device package. Part 2:Seal strength of flexible battier materials

ASTM F88/F88M-2015

Standard Test Method for Seal Strength of Flexible Barrier Materials

10

Dye penetration

YY/T 06814-2010

Test methods for sterile medical device package-Part 4:
Detecting seal leaks in porous packages by dye penetration

ASTM F1929-2015

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

11

Accelerated aging

YY/T 0681.1-2009

Test methods for sterile medical device package-Part 1:Test guide for accelerated aging

ASTM F1980-2016

Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

12

Temperature

GB/T 25915.3-2010

Cleanrooms and associated controlled environments - Part 3: Test methods

13

Relative humidity

GB/T 25915.3-2010

Cleanrooms and associated controlled environments - Part 3: Test methods

14

Static pressure difference

GB/T 25915.3-2010

Cleanrooms and associated controlled environments - Part 3: Test methods

15

Air change rate

GB/T 25915.3-2010

Cleanrooms and associated controlled environments - Part 3: Test methods

16

Airborne particles

GB/T 16292-2010

Test method for airborne particles in clean room(area) of the pharmaceutical industry

17

Airborne microbe

GB/T 16293 2010

Test method for airborne microbe in clean room(zone) of the pharmaceutical industry

18

Settling microbe

GB/T 16294-2010

Test method for setting microbe in clean room(area) of the pharmaceutical industry

 

 

All of the following standards will be regularly updated by ISO. When you find the following standards are not thelatest version, the latest version released by ISO shall prevail.

 

No.

Testing items

Standard No.

Standard title

1

Quality management system

ISO 13485-2016

Medical devices一Quality management systems - -Requirements for regulatory purposes

YY/T 0287-2017

Medical devices-Quality Management Systems -Requirements for Regulatory Purposes

CFR Title 21QSR820

21 CFR 820 QUALITY SYSTEM REGULATION

ISO 14971:2012

Medical devices -- Application of risk management to medical devices

2

Packaging for terminally sterilized medical devices

ISO 11607.1-2006

Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems

ISO 11607.2-2006

Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes

ISO/TS 16775-2014

Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

3

Ethylene oxide sterilization

ISO 11135-2014

Sterilization of health care products --- Ethylene oxide --- Requirements for development, validation and routine control of a sterilization process for medical devices

GB 18279.1-2015

Sterilization of health care products - Ethylene oxide-Part 1:Requirements for development , validation and routine control of a sterilization process for medical devices

GB/T182792-2015

Sterilization of health care products -Ethylene oxide- Part 2:Guidence on the application of GB 18279.1

4

Biological indicator

ISO 1138.1-2017

11138-1 Sterilization of health care product一Biological indicators- Part 1:General requirements, 2nd edition

ISO 111382-2017

11138-2 Sterilization of health care products一Biological indicators Part 2:
Biological indicators for ethylene oxide sterilization processes, 3rd edition

ISO14161-2009

Sterilization of health care products - Biological indicators - Guidance for theselection, use and interpretation of results

5

Chemistry indicator

lSO 11140.1-2014

Sterilization of health care products - Chemical indicators -- Part 1: Generalrequirements

6

Cleanrooms and Associated Controlled Environments

ISO 146441-2015

Cleanrooms and associated controlled environments - Part 1: Classification ofair cleanliness by particle concentration

ISO 146442-2015

Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

ISO 146443- 2005

Cleanrooms and associated controlled environments - Part 3: Cleanrooms and associated controlled environments - Part 3: Test methods

ISO 146444-2001

Cleanrooms and associated controlled environments - Part 4: Design,construction and start-up

ISO 146445-2004

Cleanrooms and associated controlled environments - Part 5: Operations