GB 16383-2014 English PDF

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GB 16383-2014: Quality control standards for radiation sterilization of medical and hygienical products
Status: Valid

GB 16383: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 16383-2014	189	Add to Cart	3 days	Quality control standards for radiation sterilization of medical and hygienical products	Valid
GB 16383-1996	279	Add to Cart	3 days	Quality control standards for radiation sterilization of medical and hygienical products	Obsolete

Similar standards

GB/T 26367   GB/T 26368   GB/T 26370   GB/T 43247   GB/T 39873   GB 27951   

Basic data

Standard ID: GB 16383-2014 (GB16383-2014)
Description (Translated English): Quality control standards for radiation sterilization of medical and hygienical products
Sector / Industry: National Standard
Classification of Chinese Standard: C50
Classification of International Standard: 11.080
Word Count Estimation: 8,896
Date of Issue: 12/12/2014
Date of Implementation: 7/1/2015
Older Standard (superseded by this standard): GB 16383-1996
Quoted Standard: GB 18280; GB 18871; JJG 591
Regulation (derived from): National Standards Bulletin 2014 No. 30
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary: This standard specifies the medical and health supplies radiation sterilization and disinfection of terms and definitions, radiation sterilization and disinfection requirements, the product of radiation processing requirements, microbiological monitoring

GB 16383-2014: Quality control standards for radiation sterilization of medical and hygienical products

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Quality control standards for radiation sterilization of medical and hygienical products ICS 11.080 C50 National Standards of People's Republic of China Replacing GB 16383-1996 Medical and health supplies radiation sterilization quality control Issued on. 2014-12-22 2015-07-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Introduction Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 radiation sterilization and disinfection requirements 2 5 product radiation processing requirements 2 6 3 microbiological monitoring methods and requirements 7 product release radiation to claim 3 Managed 8 medical and health supplies radiation after claim 3 Appendix A (normative) Initial bacteria contamination detection 4

Foreword

Chapter 6 of this standard are recommendatory, the rest are mandatory provisions. This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard replaces GB 16383-1996 "medical and health supplies radiation sterilization quality control standards." This standard and GB 16383-1996 comparison, major technical changes are as follows. --- Standard name from "medical and health supplies radiation sterilization quality control standards" to "medical and health supplies radiation sterilization QC"; --- A reference to the standard version has been updated and added GB 18280, GB 18871, "People's Republic of China Pharmacopoeia (two)" (2010 edition); --- According to GB 18280 terms and definitions on the part of the sterilization dose is determined, remove the medical supplies production plant production requirements; --- Remove the sterilization and disinfection dose and sterility assurance level requirements; --- Increases may affect product quality should take corrective and preventive actions; --- The "microbiological monitoring methods and requirements" as an independent Chapter 6, "Radiation product release requirements" as Chapter 7. Proposed for The quality of our country demands. This standard is proposed and managed by the National Health and Family Planning Commission People's Republic of China. This standard by the Jiangsu Provincial Disease Prevention and Control Center is responsible for drafting, Suzhou Municipal Center for Disease Control and Prevention, Chinese Center for Disease Control parameters Plus draft. The main drafters of this standard. Xu Yan, Tan Zhi, Chen Xueliang, Zhang stream wave, Zhang Jun, Lixin Wu, Sun Jun, Wu Xiaosong, Chen Wensen, Chenyue Ying. This standard was first released in May 1996. Medical and health supplies radiation sterilization quality control

1 Scope

This standard specifies the medical and health supplies radiation sterilization and disinfection of terms and definitions, radiation sterilization and disinfection requirements, the product of radiation treatment to Requirements, microbiological monitoring methods and requirements, requirements and release management requirements radiation after radiation products. This standard applies to all units to carry out radiation sterilization and disinfection.

2 Normative references

The following documents for the application of this document is essential. Any application document dated, dated version only suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 18280 Sterilization of health care products Requirements for validation and routine control of radiation sterilization GB 18871 ionizing radiation protection and safety of radiation sources basic standards JJG591 γ-ray radiation (Radiation Processing) People's Republic of China Pharmacopoeia (two) (2010 Edition)

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Sterility assurance level Sterilizationassurancelevel; SAL There is a single probability of viable microorganisms on the product after sterilization, usually expressed as a 10-n. 3.2 D value Dvalue In setting the exposure conditions, required to kill 90% of the total absorbed dose of radiation specific test organisms. 3.3 Bioburden bioburden A product or activity on the total number of microorganisms present in a package. 3.4 Biological indicators biologicalindicator It has a definite resistance to specific sterilization or disinfection procedures for monitoring the use of sterilization effect of microbiological testing equipment. 3.5 Absorbed dose absorbeddose Unit mass of the material of the magnitude of the energy absorbed. Note. The unit of absorbed dose is Gy (Gy), 1Gy = 1J/kg. 3.6 Absorbed dose unevenness unevenress Radiation product box, different parts of the measured maximum absorbed dose (Dmax) divided by the minimum absorbed dose (Dmin) of the provider, see equation (1). U = Dmax Dmin (1) Where. Dmax --- the maximum absorbed dose; Dmin --- minimum absorbed dose. 3.7 Dosimeter dosimeter Dosimeter One kind can measure the radiation dose received by the instrument in time to be determined. 3.8 Working dosimeter workingdosemeter After standard dosimeter calibrated for calibration of radiation field and dose rate measurement of absorbed dose products for regular dose monitoring of agent Meter. 3.9 Sterilization dose sterilizationdose To achieve a specified sterilization requirements of the minimum dose required.

4 radiation sterilization and disinfection requirements

4.1 In the medical and health supplies radiation sterilization before requirements 4.1.1 medical and health supplies and packaging materials should be resistant to radiation sterilization dose of material. Bioburden 4.1.2 medical supplies should be carried out testing to ensure the effectiveness of the use of radiation sterilization. 4.1.3 respect for anomalies that may affect product quality, technology, production and other corrective actions should occur. 4.1.4 should take appropriate precautions to potential hazards that may affect the product quality of technology, production environment. 4.2 pairs of radiation sterilization and disinfection unit requirements 4.2.1 radiation sterilization and disinfection unit of radiation facilities installation, identification, operation, officers should reach JJG591, GB 18871 and GB 18280 Requirements, and shall obtain radiation safety license and the state department issued a qualified radiation processing measurement permits; the operator should go through training Training, technology assessment certificate holders posts. 4.2.2 radiation sterilization and disinfection unit should have sufficient detection capability to radiation sterilization bioburden and sterility testing of products to be based on, Establish and validate the sterilization dose, to ensure the effectiveness of radiation processing. 4.2.3 radiation sterilization and disinfection unit for abnormal situation should be the appropriate corrective and preventive actions. 4.3 to establish the sterilization dose Conducted in accordance with GB 18280 requirements.

5 Product radiation processing requirements

5.1 absorbed dose measurement 5.1.1 radiation sterilization unit used dosimeter must be regularly calibrated. 5.1.2 Working dosimeters should be placed on pre-determined point of the conventional dose, after radiation dose measurement, recording and analysis of results. 5.2 Product radiation sterilization and disinfection 5.2.1 The product packaging size, density and distribution of the product in the package, the product of the radiation container loading pattern detailed description. 5.2.2 Each should do to be radiation dose distribution map to determine the maximum dose and minimum dose position and size, and to determine the maximum dose Relationship between dose and conventional dose minimum dose point. 5.2.3 radiation to be irradiated product should be evenly filled container, unevenness absorbed dose should be less than 1.5.

6 microbiological monitoring methods and requirements

6.1 The initial detection of bacterial contamination Each production batch of at least 10 randomly selected samples in accordance with the requirements of GB 18280 of initial detection of bacterial contamination. 6.2 sterilization effect test Each batch of products should be done to monitor the effect of disinfection or sterilization. At the minimum dose for at least 10 laying biological indicators. Removed after radiation Chip indicator bacteria according to "People's Republic of China Pharmacopoeia (two)" (2010 edition) sterility test requirements. Release claim 7 radiation products After 7.1 Product radiation treatment, packaging intact, radiation dose monitoring results meet the technological requirements of the products to be released; for dose monitoring Test results qualified to meet the requirements of the packaging is damaged product, only to be re-radiation treatment damaged packaging, other packaging intact products It was released; for radiation dose monitoring results do not meet process requirements and should be scrapped or re-radiation treatment. Before the 7.2 release, each batch of products shall be issued by irradiation processing certificate.

8 management requirements of medical and health supplies radiation after

8.1 Radiation sterilization (disinfection) after the medical supplies shall be affixed to the packaging instruction card radiation chemistry, sterilization (disinfection) certificate, the qualification certificate Should batch number, sterilization date, expiry date, sterilization units. 8.2 Radiation sterilization (disinfection) shall be accompanied by a list of products after radiation sterilization (disinfection) process by sterilization (disinfection) operator, review signatures And quality management audit, its product code, batch number, and the number of products and storage should be consistent records. 8.3 to be radiation sterilization (disinfection) product depot and depot sterilized products must be strictly separated. 8.4 product radiation treatment, transportation and storage process, if the packaging and sealing damaged destruction, should be scrapped.

Appendix A

(Normative) The initial detection of bacterial contamination A.1 reagents, equipment A.1.1 eluent. 0.1% Tween 80, 1% peptone saline. A.1.2 media. nutrient agar. A.1.3 filter (pore size 0.45μm). A.2 Sampling Method A.2.1-destructive method for the sampling of available medical supplies, such as infusion (blood), syringes, needles, dialyzers and various types of pipes and so on, press "People's Republic of China Pharmacopoeia (two)" (2010 edition) regulations. A.2.2-destructive method can not be used for sampling of special medical supplies to use sterile saline cotton swab smear samples, quarried surface Take the entire surface of less than 100cm2, 100cm2 quarried surface greater than or equal to take 100cm2. A.2.3 dressings available aseptic take 10g into 100mL sterile saline, thoroughly shaking after sampling. A.2.4 number of samples. a variety of products each batch randomly selected 10 samples. A.3 detection method A.3.1 pour plate method. respectively take 1mL processing eluent inoculated five plates, pour melted nutrient agar 45 ℃'s, 35 ℃ ± 2 ℃ culture 48h, while for parallel samples and blank control. A.3.2 membrane filter method. For the low concentration of microorganisms eluent, available membrane filtration eluate through 0.45μm membrane, the membrane paste Nutrient agar surface culture in 35 ℃ ± 2 ℃ culture 48h. A.4 Calculation Results A.4.1 pour plate method, see the calculation formula (A.1). Bacteria (CFU/member or CFU/g) = The average number of bacteria × dilution Pieces or mass (g) (A.1) A.4.2 membrane filtration method to calculate Eq. (A.2). Bacteria (CFU/member or CFU/g) = The number of bacteria on the filter Pieces or mass (g) (A.2) ......

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