Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the National Medical Products Administration of the People’s Republic of China.
This standard is under the jurisdiction of the National Technical Committee on Sterilization Techniques and Equipments of Standardization Administration of China (SAC/TC 200).
Drafting organizations of this standard: Guangdong Medical Devices Quality Surveillance and Test Institute, Suzhou Branch of Beijing Hua Guang Certification of Medical Devices Co., Ltd., Johnson & Johnson Medical (Suzhou) Ltd., Hangzhou Wei Qiang Medical Technology Co., Ltd., Suzhou Linhwa Medical Devices Co., ltd., and Terumo Medical Products (Hangzhou) Co., Ltd.
Chief drafters of this standard: Liang Zexin, Guo Xinhai, Liu Xuemei, Liu Zhenjian, Zhou Zhilong, Gao Ying, Lin Yuqing, Weng Hui and Lin Manting.
Introduction
A sterile medical device is the product that is free of microbial survivors. Standards specify requirements for validation and routine control of sterilization processes. If the medical devices must be served in sterile, the adventitious microbial contamination of a medical device shall be minimized before sterilization. This also explains that medical device regulations of all countries require the bioburden control of products before sterilization.
Both Medical Devices Manufacturing Quality Management Regulations Annex — Sterile Medical Devices and Medical Devices Manufacturing Quality Management Regulations Annex — Implantable Medical Devices in China specify that “the control level of initial contaminated microorganism and particulate contamination of products shall be determined according to the product quality requirements and documented, and the storage environment requirements and storage period of intermediate products shall be confirmed. It shall be tested and recorded regularly according to the requirements of the documents. The test records shall be regularly summarized and analyzed on trend”. Therefore, medical device manufacturers are in urgent need of relevant standards to provide analytical methods for quality control of bioburden.
Medical device manufacturers need to establish bioburden monitoring plan and evaluate it regularly to verify that their production process can continuously meet the established control requirements and ensure that the products meet the intended design requirements. Generally, the established data limits, which are evaluated and compared with the product bioburden test values, are called as alert level and acting level. The alert level and acting level reflect the risk control requirements of the manufacturer's production process. The limit value is established based on the data collected under normal operation of the production process. The alert level and acting level are helpful to monitor the continuity of production process. Generally, products beyond the alert level indicate that the product quality (microorganism risk) may have deviated from the baseline. Products beyond the acting level mean that the clean production conditions are out of control, and the risk of microbial contamination exposed to products is high.
Internationally, microbial contamination level of products is reflected by the bioburden test which is usually carried out according to ISO 11737-1. The standard takes into account the expected microbial species of target products and the nutritional conditions required for microorganism culture. In the standard, the collection method is confirmed by investigating the recovery efficiency of microorganisms of products, and finally the microbial contamination level of products is comprehensively evaluated through the evaluation of the suitability of microorganism counting (including culture conditions and microorganism counting technology, etc.). ISO 11737-1 is equivalent to GB/T 19973.1 which applies on the collection of bioburden data of medical device products, and the establishment of corresponding control level of microbial contamination under the guidance of statistics method. Through the statistics method, the risk of microbial contamination in the production process of medical devices is reduced to the lowest level as possible, which can guide the production practice.
Analytical method for bioburden control level of medical device
1 Scope
This standard specifies the analytical method for bioburden control level of medical device.
This standard is applicable to the analysis for bioburden control level of sterile and implantable medical devices.
This standard is not applicable to the analysis for bioburden test value in verification and development stage.
2 Normative references
The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19971 Sterilization of health care products — Vocabulary
GB/T 19973.1 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
YY/T 0287 Medical devices — Quality management systems — Requirements for regulatory purposes
YY/T 0316 Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB/T 19971 and the following apply.
3.1
colony forming unit; CFU
microbial colony formed by the reproduction of one or several microorganisms after microbial culture, referred to as CFU, which is usually expressed by number
3.2
correction factor
data used to compensate the data that cannot be completely collected from the product and/or microbial culture
3.3
alert level
microorganism content level for products requiring microorganism control, which is established by the users; if the test result exceeds established level, the monitoring procedure shall be started to track the microbial contamination of the products
3.4
acting level
microorganism content level for products requiring microorganism control, which is established by the users; if the test result exceeds established level, the investigation procedure shall be started to investigate the microbial contamination of the products
3.5
bioburden
total microbial survivors on or in the products and/or sterile barrier system
3.6
product
result of process
Note: Product is visible and may be raw materials, intermediates, components, and medical devices.
3.7
biological indicator; BI
test system with microbial survivor available, which is certainly resistant to the specified sterilization process
3.8
D value
time or dose required in 90% of population of inactivated microorganism under specified conditions
4 Factors affecting bioburden of products
There are many factors affecting bioburden of products, in which the risk source of bioburden is identified according to YY/T 0316, including but not limited to the following aspects:
——personnel dress, personal hygiene and habits;
——equipment and worktable surface;
——raw materials, packaging materials and components;
——cleaning, assembly, packaging, transporting and other operation ways;
——environmental conditions, storage conditions and storage time;
——process medium (process gas, process water, detergent, disinfectant, etc.);
——monitoring and test equipment and methods, etc.
Foreword i
Introduction ii
1 Scope
2 Normative references
3 Terms and definitions
4 Factors affecting bioburden of products
5 Bioburden risk of products
6 Bioburden monitoring
7 Acting processing
8 Evaluation of change
9 Periodic review
Annex A (Informative) Examples of statistical methods of alert level and acting level
Annex B (Informative) Example of establishing alert level and acting level without historical data
Bibliography
