What Is Involved in Medical Device Assembly?

In order to strengthen the supervision and management of medical device production, guide the supervision department to implement on-site inspection and evaluation of the inspection results of Medical Device Manufacturing Quality Management Standards and related appendixes to medical device manufacturing enterprises. Relevant appendix, the State Food and Drug Administration has formulated the "Guidelines for On-site Inspection of Medical Device Production Quality Management Specifications", "Guidelines for On-site Inspection of Sterile Medical Devices for Medical Device Production Quality Management Guidelines", and "Implantability for Medical Device Production Quality Management Specifications "Guiding Principles for On-site Inspection of Medical Devices" "Guiding Principles for On-site Inspection of In Vitro Diagnostic Reagents for Medical Device Manufacturing Quality Management Specifications." Is issued to you, please follow.

Guiding principles for on-site inspection of sterile medical devices

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In order to strengthen the supervision and management of medical device production, guide the supervision department to implement on-site inspection and evaluation of the inspection results of Medical Device Manufacturing Quality Management Standards and related appendixes to medical device manufacturing enterprises. Relevant appendix, the State Food and Drug Administration has formulated the "Guidelines for On-site Inspection of Medical Device Production Quality Management Specifications", "Guidelines for On-site Inspection of Sterile Medical Devices for Medical Device Production Quality Management Guidelines", and "Implantability for Medical Device Production Quality Management Specifications "Guiding Principles for On-site Inspection of Medical Devices" "Guiding Principles for On-site Inspection of In Vitro Diagnostic Reagents for Medical Device Manufacturing Quality Management Specifications." Is issued to you, please follow.
The guiding principles are used to guide the regulatory authorities on the implementation of on-site inspections and evaluation of inspection results of Medical Device Manufacturing Quality Management Standards and related appendixes for medical device manufacturers, and are applicable to on-site verification of medical device registration, medical device production licenses (including renewal or (Changes) On-site inspections, and various types of supervision and inspections carried out by medical device manufacturers based on work needs. [1]
1.1.1 A management organization that is compatible with the production of medical devices should be established with an organization chart.
Check the quality manual provided, whether it includes the organization chart of the enterprise, and whether the relationship between the various departments is clear.
* 1.1.2 The responsibilities and authority of each department should be clear, and the quality management function should be clear.
Check the company's quality manual, procedure files or related documents, whether the responsibilities and authority of each department have been stipulated; the quality management department should be able to exercise its functions independently, check the documents of the quality management department, and clearly stipulate that it has responsibility for related issues of product quality The right to make decisions.
1.1.3 The persons in charge of the production management department and the quality management department shall not serve concurrently.
Check the company's employment documents or authorization documents, and check the relevant production, inspection and other performance responsibilities records to verify that they are consistent with the authorization.
1.2.1 The person in charge of the enterprise shall be the main person responsible for the quality of the medical device product.
1.2.2 The person in charge of the enterprise shall organize and formulate the quality policy and quality objectives.
Review the quality policy and quality target development procedures and approve personnel.
1.2.3 The person in charge of the enterprise shall ensure the human resources, infrastructure and working environment required for the effective operation of the quality management system.
1.2.4 The person in charge of the enterprise shall organize the implementation of management review, regularly evaluate the operation of the quality management system, and continuously improve it.
Check the management review documents and records, and verify whether the person in charge of the organization has organized a management review.
* 1.2.5 The person in charge of the enterprise shall ensure that the enterprise organizes production in accordance with the requirements of laws, regulations and rules.
1.3.1 The person in charge of the enterprise shall determine a representative of the manager.
View appointment documents for manager representatives.
* 1.3.2 The management representative shall be responsible for establishing, implementing and maintaining a quality management system, reporting on the operation of the quality management system and improvement needs, and increasing staff awareness of meeting regulations, rules and customer requirements.
See if the responsibilities are clearly stated. View the management representative's report on the operation and improvement of the quality management system.
1.4.1 Persons in charge of technology, production, and quality management departments should be familiar with medical device laws and regulations, have practical experience in quality management, and have the ability to make correct judgments and handle actual problems in production management and quality management.
Check the qualification requirements of the person in charge of the relevant department, and whether there are regulations on professional knowledge, work skills, and work experience; check the assessment and evaluation records, and ask on site to determine whether they meet the requirements.
1.5.1 Professional technical personnel, management personnel and operating personnel shall be provided to suit the production products.
Review the eligibility requirements for the person.
* 1.5.2 There should be a corresponding quality inspection agency or full-time inspection personnel.
Check the organization chart, department responsibility requirements, post appointments and other documents to confirm compliance.
* 1.6.1 Personnel engaged in work affecting product quality shall be trained in accordance with the requirements of their positions, and have relevant theoretical knowledge and practical skills.
Positions that affect the quality of medical devices should be identified, and the level of professional knowledge (including academic qualifications), work skills, and work experience that personnel in these positions must have. Check whether the training content, training records and assessment records meet the requirements.
1.7.1 All personnel working in clean rooms (areas) shall be regularly trained in basic knowledge of hygiene and microbiology, and clean operations.
Check training plans and records: whether it can be confirmed that personnel working in clean rooms (areas) are regularly trained in basic knowledge of hygiene and microbiology, clean technology, etc.
1.7.2 Personnel who temporarily enter the clean room (area) shall instruct and supervise them.
Check to see if relevant documents have been prepared, and provide guidance and supervision for personnel (including outsiders) who temporarily enter the clean room to enter and exit the clean area.
1.8.1 The cleaning requirements for personnel shall be established, and the hygiene rules for staff in clean rooms (areas) shall be formulated.
Check the staff hygiene rules to see if there are regulations on personnel cleaning, access procedures, and the wearing of clean clothes.
1.8.2 Personnel entering clean rooms (areas) should be purified in accordance with procedures and wear work caps, masks, clean work clothes, and work shoes.
Observe on-site personnel whether to enter the clean room (area) to purify in accordance with the procedures, and properly wear work caps, masks, clean work clothes, work shoes or shoe covers in accordance with regulations.
1.8.3 Operators who touch the product with their bare hands should disinfect their hands again at regular intervals. The type of bare hand disinfectant should be changed regularly.
Check the disinfectant preparation or receipt records, and check whether the types of bare hand disinfectants are regularly changed as required.
1.9.1 Staff health requirements should be established and staff health files established.
Check the documents of personnel health requirements, whether to stipulate the requirements of personnel health, and establish personnel health files.
1.9.2 Persons who come into direct contact with materials and products should undergo a physical examination at least once a year. Persons with infectious and infectious diseases shall not be employed in direct contact with the product.
Check the medical report or health certificate of the personnel in direct contact with the materials and products in the clean room, and check whether the medical examination is performed at the prescribed time. The personnel with infectious and infectious diseases are not engaged in direct contact with the product.
1.10.1 Personnel clothing requirements should be clarified, and management regulations for clean and sterile work clothes should be formulated. Work clothes and their quality should be compatible with the requirements of production operations and the cleanliness level of the operating area, and their style and wearing style should be able to meet the requirements of protecting products and personnel. Sterile work clothing should be able to cover all hair, beards, and feet, as well as to retain human body fallout.
Check the regulations for clean and sterile work clothes; observe on-site compliance with clothing and compliance with personnel wear.
1.10.2 Clean work clothes and sterile work clothes must not shed fibers and particulate matter.
Check whether the clean work clothes and aseptic work clothes are made of materials that are smooth in texture, not prone to static electricity, and do not fall off fibers and particulate matter. [1]
2.1.1 Plants and facilities shall meet production requirements.
* 2.2.1 The factory buildings and facilities should be reasonably designed, laid out and used according to the characteristics of the products produced, the process flow and the corresponding cleanliness requirements.
2.2.2 The production environment should be tidy and meet the requirements of product quality and related technical standards.
2.2.3 If the product has special requirements, it shall be ensured that the external environment of the plant cannot affect the product quality, and verification shall be carried out if necessary.
2.3.1 The factory building shall ensure that the quality of production and storage products and the performance of related equipment are not directly or indirectly affected.
2.3.2 The factory building should have appropriate lighting, temperature, humidity and ventilation control conditions.
2.4.1 The design and installation of plant and facilities shall take necessary measures according to product characteristics to effectively prevent insects or other animals from entering.
Check whether the relevant facilities are equipped on site.
2.4.2 The maintenance and repair of workshops and facilities should not affect product quality.
2.5.1 The production area should have sufficient space and be compatible with the scale and variety of product production.
2.6.1 The storage area should be able to meet the storage conditions and requirements of raw materials, packaging materials, intermediate products, and products.
2.6.2 The storage area shall store all kinds of materials and products in an orderly and partitioned manner according to pending inspection, qualified, unqualified, returned or recalled, etc., so as to facilitate inspection and monitoring.
Check whether relevant areas have been set and marked on the spot, and whether all kinds of materials are stored in the prescribed area should have a record of storage of various items.
* 2.7.1 Inspection sites and facilities shall be provided in accordance with the production scale, variety and inspection requirements of the products.
Verify that the company has the relevant testing conditions against the requirements of the production process, product inspection requirements and inspection methods.
2.8.1 There should be a clean production environment. The ground, road surface environment and transportation of the factory area should not cause pollution to the production of sterile medical devices. The factory area should be far away from areas with pollution sources such as polluted air and water.
The production environment should be inspected on site, and it should be tidy and free of standing water and weeds. The ground, road environment and transportation of the factory area should not cause pollution to the production of products. Check the ground, road leveling, measures to reduce dew and dust, the greening of the plant area, and the storage of garbage and idle items.
2.8.2 The overall layout of administrative, living and auxiliary areas shall be reasonable and shall not adversely affect production areas.
* 2.9.1 The production process in the clean room (area) of the corresponding level should be determined according to the quality requirements of the sterile medical devices produced to avoid pollution during production.
Check the relevant documents to see if the cleanliness level of the production process is clear; check whether to carry out production in the clean room (area) of the corresponding level on site and whether to avoid pollution during production.
2.9.2 The static pressure difference between clean rooms (areas) with different air cleanliness levels should be greater than 5 Pa, and the static pressure difference between the clean room (area) and the outdoor atmosphere should be greater than 10 Pa, and there should be a device indicating the pressure difference.
Check on site whether it is equipped with a device that indicates the pressure difference, whether the static pressure difference between clean rooms (areas) with different air cleanliness levels, and between the clean room (areas) and the outdoor atmosphere meets the requirements.
2.9.3 When necessary, proper pressure gradients should also be maintained between different functional areas (operating rooms) of the same cleanliness level.
View different functional areas (operating rooms) of the same cleanliness level on site, and areas with high pollution levels should maintain proper pressure gradients with their adjacent areas.
2.10.1 Sterile medical devices implanted and intervened into blood vessels and sterile medical devices or single packages that require subsequent processing (such as filling and sealing) in a local Class 100 clean room (area) under Class 10,000 The production area of spare parts for final cleaning, assembly, initial packaging, sealing, and the processing and production areas of components that have not been cleaned shall not be less than Class 10,000 cleanliness.
2.11.1 Sterile medical devices or single-package factory-made accessories that come into direct or indirect contact with blood, bone marrow cavity, or unnatural cavities, have final cleaning treatment, assembly, primary packaging, sealed production areas, and The processing and production area of parts and components shall not be less than 100,000 cleanliness.
2.12.1 The production area of sterile medical devices or single-packed parts that come into contact with the surface of human injury and mucous membranes in the final cleaning process, assembly, primary packaging, sealing, and processing and production of parts that have not been cleaned shall be No less than 300,000 cleanliness level.
2.13.1 For primary packaging materials that are in direct contact with the surface of the sterile medical device and are used without cleaning, the setting of the cleanliness level of the production environment should follow the same principles as the cleanliness level of the product production environment, so that the primary packaging The quality of the material meets the requirements of the packaged sterile medical device; if the primary packaging material does not directly contact the surface of the sterile medical device, it should be produced in a clean room (area) of not less than 300,000.
2.14.1 Aseptic medical devices (including medical materials) that are required or processed using aseptic technique should be produced in a local Class 100 clean room (area) under Class 10,000.
2.15.1 The level of air cleanliness in the area for the final cleaning and disinfection of cleaning and drying rooms, sanitary ware rooms, and special station appliances may be lower than one level in the production area, but not lower than 300,000. The storage and storage of sterile work clothes should be in a Class 10,000 clean room (area).
2.16.1 The clean room (area) should be reasonably arranged in accordance with the production process of sterile medical equipment and the required air cleanliness level, and the flow of people and logistics should be reasonable. Production operations in the same clean room (area) or between adjacent clean rooms (areas) must not cross contaminate each other.
Check on site whether the flow of people and logistics in the clean room (area) is reasonable and whether cross-contamination can be avoided.
There should be buffer facilities between the clean room (area) and the non-clean room (area).
2.17.1 The cleanliness level indicators of clean rooms (areas) shall meet the requirements of relevant medical device industry standards.
Check the environmental test report to see if it meets the requirements of the selected standard (YY0033).
2.18.1 The temperature and relative humidity of the clean room (area) shall be compatible with the requirements of the production process. When there is no special requirement, the temperature should be controlled at 18 28 , and the relative humidity should be controlled at 45% 65%.
Check the temperature and humidity devices and records on site to see if they meet the requirements.
2.19.1 The layout of the pipes and air inlets and outlets entering the clean room (area) shall be reasonable, and the interface between the water, electricity and gas transmission lines and the wall shall be reliably sealed, and the lighting fixtures shall not be suspended.
2.20.1 The operating table in the clean room (area) should be smooth, flat, and free from dust particles and fibers, not easy to accumulate dust, and easy to clean and disinfect.
2.21.1 The production plant shall be provided with facilities to prevent dust and insects from entering.
2.21.2 The doors, windows and safety doors of clean rooms (areas) should be closed, the doors of clean rooms (areas) should be opened in a direction of high cleanliness, and the inner surfaces of clean rooms (areas) should be easy to clean, free from cleaning and disinfection. Impact.
2.21.3 Floor drains shall not be installed in Class 100 clean rooms (areas).
2.21.4 In other clean rooms (zones), the pool or floor drain should be properly designed and maintained, and devices that are easy to clean and have an air blocking function should be installed to prevent backfilling. The connection to the external drainage system should be able to prevent Invasion of microorganisms.
2.22.1 Compressed air and other process gases used in clean rooms (areas) should be purified.
Check the process gas purification equipment and pipeline settings on site to see if the process gas has been purified.
2.22.2 The degree of influence of the gas in direct contact with the surface of the product on the product shall be verified and controlled to meet the requirements of the product produced.
Check the records of the evaluation and verification of the impact of the gas in direct contact with the product's use surface on the product, and whether control measures are specified and implemented based on the results of the evaluation and verification.
2.23.1 The number of persons in the clean room (area) shall be appropriate to the area of the clean room (area).
Check the verification records to verify whether the upper limit of the number of on-site staff can be verified to meet the requirements of clean control. Check the number of field staff and check related records, and it should not exceed the maximum number of field staff confirmed during verification. [1]
* 3.1.1 It should be equipped with production equipment and technological equipment that match the products and scale produced, and should ensure effective operation.
Check the equipment list against the production process flow chart to see if the listed equipment meets the production needs; check whether the on-site equipment is consistent with the relevant content of the equipment list; equipment management system should be formulated.
3.2.1 The design, selection, installation, repair and maintenance of production equipment shall meet the intended use and be easy to operate, clean and maintain.
Check the production equipment verification records to confirm whether they meet the predetermined requirements. Check on-site whether the production equipment is easy to operate, clean and maintain.
3.2.2 Production equipment should have obvious status signs to prevent unintended use.
View production equipment identification on site.
3.2.3 Operational procedures for the use, cleaning, maintenance and repair of production equipment shall be established, and corresponding equipment operation records shall be kept.
* 3.3.1 It shall be equipped with inspection instruments and equipment suitable for product inspection requirements. The main inspection instruments and equipment shall have clear operating procedures.
Based on the product inspection requirements and inspection methods, verify that the company has relevant inspection equipment. The main test equipment is whether the operating procedures have been established.
3.4.1 A record of the use of inspection instruments and equipment should be established, and the record should include information on use, calibration, maintenance, and repair.
3.5.1 Appropriate measuring instruments shall be provided. The measuring range and accuracy of the measuring instruments shall meet the requirements for use. The measuring instruments shall indicate the validity period of their calibration and keep corresponding records.
Check the calibration records of measuring instruments to determine whether they are used within the validity period.
3.6.1 Production equipment, process equipment and work station appliances shall meet the requirements of clean environment control and process documents.
3.7.1 The clean room (area) air purification system shall be confirmed and maintained in continuous operation, maintaining the corresponding cleanliness level, and reconfirmed after a certain period.
Check the cleanroom (area) air purification system confirmation and reconfirmation records.
3.7.2 If the air purification system is turned on again after shutdown, the necessary tests or verifications shall be carried out to confirm that the required cleanliness level can still be met.
If the clean room (area) air purification system is not used continuously, the requirements for reactivation of the clean room (area) air purification system shall be clarified through verification, and the operation records before each time the air purification system is activated shall be checked to meet the control requirements.
If the verification is not performed, the environmental parameters of the clean room (area) should be tested before restarting production after shutdown to confirm that it meets the relevant standards.
* 3.8.1 The required process water should be determined. When process water is used in the production process, it should be equipped with corresponding water-making equipment, and there are measures to prevent pollution. When the amount is large, it should be piped to the water point in the clean room (area). Process water shall meet the requirements of product quality.
For sterile medical devices that are in direct or indirect contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid or medicinal fluid, if water is a component of the final product, water for injection that meets the requirements of the Chinese Pharmacopoeia should be used; For cleaning, use water for injection that meets the requirements of the Chinese Pharmacopoeia, or water for injection produced by other methods such as ultrafiltration. For sterile medical devices that come in contact with human tissue, bone cavity, or natural cavity, purified water that meets the requirements of the Chinese Pharmacopoeia should be used for final cleaning.
3.9.1 Management documents for process water shall be formulated. Storage tanks and pipelines for process water shall meet product requirements and shall be regularly cleaned and disinfected.
Storage tanks and pipelines for process water inspection on site shall be made of stainless steel or other non-toxic materials, and shall be regularly cleaned, disinfected and recorded.
3.10.1 The surface of equipment, process equipment and pipelines in direct contact with materials or products shall be smooth, flat, free of particulate matter, non-toxic and corrosion-resistant, and shall not cause chemical reactions and adhesion with materials or products. Sterilize. [1]
* 4.1.1 The quality management system documents should be established, including quality policy and quality objectives, quality manuals, procedural documents, technical documents and records, and other documents required by regulations.
The quality policy should be communicated and understood within the enterprise; it should be reviewed for continued suitability. The quality objectives should be consistent with the quality policy; they should be broken down at relevant functions and levels according to the overall quality objectives, and the quality objectives of each function and level should be established; they should include the content needed to meet product requirements; they should be measurable and assessable ; There should be specific methods and procedures to guarantee.
4.1.2 The quality manual shall specify the quality management system.
Viewing an enterprise's quality manual should include the enterprise's quality goals, organization and responsibilities, and the scope and requirements of the quality system.
4.1.3 Procedural documents shall be formulated in accordance with various working procedures that need to be established in the process of product production and quality management, including various procedural documents specified in this specification.
* 4.1.4 Technical documents shall include product technical requirements and related standards, production process regulations, work instructions, inspection and test operating procedures, installation and service operating procedures, and other related documents.
4.2.1 Document control procedures should be established to systematically design, formulate, review, approve and issue quality management system documents.
4.2.2 Drafting, revising, reviewing, approving, replacing, or revoking, duplicating, keeping, and destroying documents shall be managed in accordance with control procedures, and there shall be corresponding records of document distribution, revocation, duplication and destruction.
4.2.3 When updating or revising a document, it shall be reviewed and approved in accordance with regulations, and the change and revision status of the document shall be identified.
Check the relevant records to confirm whether the update or revision of the document has been reviewed and approved; whether its change and revision status can be identified.
4.2.4 The documents to be distributed and used shall be appropriate texts, and the revoked or obsolete documents shall be identified to prevent misuse.
Go to the work site to spot check the documents used on the site to confirm whether it is a valid version. Whether obsolete documents are clearly identified.
4.3.1 The retention period of obsolete technical documents and other necessary quality management system documents shall be determined to meet the needs of product maintenance and traceability of product quality responsibilities.
The storage period shall be not less than the life span of the medical device specified by the enterprise.
4.4.1 Record control procedures should be established, including the identification, storage, retrieval, retention period and disposal requirements of records.
4.4.2 Records shall ensure traceability of product production, quality control and other activities.
4.4.3 Records shall be clear and complete, easy to identify and retrieve, and prevent damage and loss.
4.4.4 Records shall not be altered or destroyed at will. Changes to records shall be endorsed with the name and date, and the original information shall still be legible. If necessary, the reasons for the changes shall be explained.
4.4.5 The record retention period is at least equivalent to the life span of the medical device specified by the manufacturer, but it is not less than 2 years from the date of release of the product, or meets the requirements of relevant regulations and can be traced. [1]
5.1.1 Design control procedures should be established and documented to plan and control the design and development process of medical devices.
Viewing design control program files should be clear, operable, and capable of controlling the design development process, including at least the following:
1. Division of each stage of design and development;
2. Suitable for review, verification, validation and design conversion activities at each design and development stage;
3. Responsibilities, authorities and communication of personnel and departments at all stages of design and development;
4. Risk management requirements.
5.2.1 During the design and development planning, the design and development phases and the reviews, verifications, confirmations, and design conversion activities of each phase should be determined. The activities and interfaces for the design and development of each department should be identified and determined, and the responsibilities should be clear And division of labor.
When viewing the design and development planning data, the design and development activities shall be planned according to the characteristics of the product, and the planning results shall be documented. Include at least the following:
1.Describe the goals and meanings of the design and development projects, and analyze the technical indicators;
2.Identified the stages of design and development, as well as the review, verification, validation and design conversion activities suitable for each stage of design and development;
3 The activities and interfaces designed and developed by each department should be identified and determined, and the responsibilities of personnel or organization at each stage, the composition of reviewers, and the expected output of each stage should be identified;
4. The planning of main tasks and periodic tasks is consistent with the entire project;
5. Determine the measurement devices required for the formulation, verification, validation and production of product technical requirements;
6. Risk management activities.
The design and development should be implemented in accordance with the plan. When the plan needs to be modified when it deviates from the plan, the plan should be reviewed and approved again.
5.3.1 Design and development inputs shall include functional, performance and safety requirements, regulatory requirements, risk management controls and other requirements specified for the intended use.
5.3.2 Design and development inputs should be reviewed and approved, and relevant records maintained.
* 5.4.1 The design and development output shall meet the input requirements, including relevant information required for procurement, production and service, and product technical requirements.
View the design and development output data, at least meet the following requirements:
1. Purchasing information, such as technical requirements for raw materials, packaging materials, components and components;
2. Information required for production and service, such as product drawings (including parts drawings), process recipes, work instructions, environmental requirements, etc .;
3. Product technical requirements;
4. Product inspection procedures or instructions;
5. Specify the product characteristics necessary for the safety and normal use of the product, such as product instruction manuals, packaging and labeling requirements. Whether the product instruction manual is consistent with the registration declaration and approval;
6. Identification and traceability requirements;
7. Documents submitted to the registration approval department, such as research data, product technical requirements, registration inspection reports, clinical evaluation data (if any), and basic requirements for the safety and effectiveness of medical devices;
8. Prototype or sample;
9. Biological evaluation results and records, including the main performance requirements of the material.
5.4.2 Design and development outputs shall be approved and relevant records maintained.
5.5.1 Design and development to production conversion activities should be carried out during the design and development process so that the output of design and development can be verified before becoming the final product specification to ensure that the design and development output is suitable for production.
Review related documents to meet at least the following requirements:
1. Design conversion activities should be carried out during the design and development process to address manufacturability, availability of components and materials, required production equipment, training of operators, etc .;
2. Design conversion activities shall correctly translate each technical requirement of the product into specific processes or procedures related to the realization of the product;
3. Records of design conversion activities should indicate that design and development outputs are verified before becoming the final product specification, and retention verification records are maintained to ensure that design and development outputs are suitable for production;
4. The conversion of special processes should be confirmed to ensure that the results are applicable to production, and confirmation records should be maintained.
5.6.1 Reviews should be arranged at appropriate stages of design and development, and records of the results of the reviews and any necessary measures should be maintained.
Review related documents and records, at least meet the following requirements:
1. According to the results of design and development planning, design and development reviews should be conducted at appropriate stages;
2. Design and development review records should be maintained, including records of review results and necessary actions taken during the review.
5.7.1 The design and development shall be verified to ensure that the design and development output meets the requirements of the inputs, and records of the verification results and any necessary actions are maintained.
Review related documents and records, at least meet the following requirements:
1. The design and development verification should be carried out at the appropriate stage based on the results of the planning to ensure that the design development output meets the input requirements;
2. Records of design and development verification, verification results and any necessary measures shall be maintained;
3. If the design and development verification uses an alternative calculation method or a verified design comparison method, the suitability of the methods used should be reviewed to confirm whether the methods are scientific and effective.
5.8.1 The design and development shall be confirmed to ensure that the product meets the specified use requirements or requirements for the intended use, and records of the results of the confirmation and any necessary measures are maintained.
Review related documents and records, at least meet the following requirements:
1. Design and development confirmation should be conducted at an appropriate stage to ensure that the product meets the specified use requirements or the requirements of the intended use;
2. Design and development validation activities should be performed before product delivery and implementation;
3. Records of design and development validation, including records of clinical evaluations or clinical trials, records of validation results and any necessary measures shall be maintained.
5.9.1 Confirmation may use clinical evaluation or performance evaluation. The clinical trials shall meet the requirements of the clinical trials regulations for medical devices.
View clinical evaluation reports and supporting materials. If clinical trials are conducted, they shall meet the requirements of regulations and provide corresponding certification materials. For medical devices that require clinical evaluation or performance evaluation, evaluation reports and / or materials should be available.
5.10.1 Design and development changes shall be identified and recorded.
5.10.2 When necessary, design and development changes shall be reviewed, verified and confirmed, and approved before implementation.
View review records of design and development changes that meet at least the following requirements:
1. The impact of changes on product components and delivered products should be included;
2. The implementation of design and development changes shall comply with the relevant provisions of medical device product registration;
When the content and result of the design change involve changing the content stated in the medical device product registration certificate (recording certificate), the enterprise should conduct a risk analysis and apply for registration change (recording) in accordance with the relevant regulations to meet the requirements .
* 5.10.3 When changes in selected materials, parts or product functions may affect the safety and effectiveness of medical device products, the risks that may be caused by the changes should be evaluated, and measures should be taken to reduce the risks to acceptable levels if necessary. At the same time, it shall meet the requirements of relevant regulations.
5.11.1 During the entire process of product realization including design and development, requirements for risk management shall be formulated and documented, and relevant records shall be maintained.
Review risk management files and records that meet at least the following requirements:
1. Risk management should cover the entire process of product realization by the enterprise;
2. Documents for risk management of medical devices should be established and relevant records maintained to determine evidence of implementation;
3. The risk of medical device products should be controlled to an acceptable level.
5.12.1 For the sterilization of the manufacturing enterprise, the sterilization process (method and parameters) and sterility assurance level (SAL) should be specified, and a sterilization confirmation report should be provided.
5.13.1 If the method used for sterilization is prone to residues, the information on the residues and the treatment methods adopted should be clear. [1]
* 6.1.1 Procurement control procedures should be established.
The content of the procurement process includes at least: procurement process, selection of qualified suppliers, evaluation and re-evaluation regulations, requirements for inspection or verification of purchased items, and requirements for procurement records.
* 6.1.2 It shall be ensured that the purchased items comply with the specified requirements and are not lower than the relevant provisions of laws and regulations and the relevant requirements of national mandatory standards.
6.2.1 The method and degree of controlling the purchased items shall be determined according to the impact of the purchased items on the products.
Check the regulations on the control method and degree of the purchased items, and verify that the control method and degree can meet the product requirements.
6.3.1 A supplier audit system should be established to audit and evaluate suppliers. When necessary, an on-site audit should be conducted.
Whether it meets the requirements of the Supplier Audit Guidelines for Medical Device Manufacturers.
6.3.2 Records of the results of the supplier evaluation and the evaluation process shall be maintained.
* 6.4.1 A quality agreement should be signed with the main raw material supplier to clarify the quality responsibility assumed by both parties.
6.5.1 Purchasing information should be clearly stated when purchasing, and procurement requirements should be clearly stated, including the categories of purchased items, acceptance criteria, specifications, models, procedures, drawings, etc.
Check the purchase requirements of relevant purchase items from the purchase list to confirm whether they meet the requirements of this article.
6.5.2 Procurement records shall be established, including procurement contracts, raw material lists, supplier qualification documents, quality standards, inspection reports and acceptance standards.
* 6.5.3 Purchasing records should meet traceability requirements.
6.6.1 The purchased items shall be inspected or verified, and the materials that need to be biologically evaluated shall be the same as the biologically evaluated materials.
Check the inspection or verification records of purchased items, and whether the materials that need to be biologically evaluated meet the requirements.
6.7.1 Raw and auxiliary materials derived from animals shall meet product quality control requirements.
Check the source materials of raw and auxiliary materials from animals to check whether the virus is removed.
For virus control of animal-derived medical devices, refer to ISO22442 "Animal Tissues and Their Derivatives for Medical Device Production".
6.8.1 The primary packaging materials of sterile medical devices should be suitable for the sterilization process used or the packaging requirements for aseptic processing, and implement the relevant regulations and standards to ensure that the product will not be damaged during packaging, transportation, storage, and use. create pollution.
View the company's selection and / or confirmation of the primary packaging materials used;
For packaging requirements for final sterilized medical devices, see GB / T19633 "Packaging for final sterilized medical devices."
6.8.2 The acceptable levels of initial contaminated bacteria and particulate contamination of purchased primary packaging materials shall be determined and documented according to product quality requirements. The purchased primary packaging materials shall be inspected for incoming goods and relevant records maintained in accordance with the requirements of the documents.
Check the purchasing documents to determine the acceptable levels of initial contamination bacteria and particulate contamination of the purchased primary packaging materials; check the purchase inspection records to see if they meet the document requirements. [1]
* 7.1.1 Production should be carried out in accordance with the established quality management system to ensure that the products meet the compulsory standards and the technical requirements of registered or filed products.
* 7.2.1 Production process regulations, work instructions, etc. should be prepared to identify key procedures and special processes.
Check the relevant documents; whether the key processes and special processes are clear, and whether the important parameters of the key processes and special processes are verified or confirmed.
7.3.1 Where cleaning treatment of raw materials, intermediate products, etc. is required during the production process, the cleaning methods and requirements shall be clarified and the cleaning effect shall be verified.
7.4.1 The environment shall be monitored according to the characteristics of the production process, and records shall be kept.
7.5.1 The special process of production shall be confirmed, and records shall be kept, including the contents of the confirmation plan, the confirmation method, the operator, the result evaluation, and the reconfirmation.
7.5.2 If the computer software used in the production process has an impact on product quality, it shall be verified or confirmed.
* 7.6.1 Each batch (set) of products should have production records and meet traceability requirements.
7.6.2 Production records shall include: product name, specifications, raw material lot number, production lot number or product number, production date, quantity, main equipment, process parameters, operators, etc.
7.7.1 A product identification control program should be established to identify products by appropriate methods in order to identify and prevent misuse and misuse.
* 7.8.1 The product inspection status should be identified during the production process to prevent unqualified intermediate products from flowing to the next process.
Check whether the inspection status identification method is specified, and check whether the inspection status identification during the production process meets the document requirements.
* 7.9.1 Product traceability procedures shall be established, specifying the scope, extent, identification and necessary records of product traceability.
* 7.10.1 The manuals and labels of the products shall meet the requirements of relevant laws, regulations and standards.
7.11.1 Product protection procedures should be established to specify the protection requirements of the product and its components, including requirements for pollution protection, electrostatic protection, dust protection, corrosion protection, and transportation protection. Protection should include identification, handling, packaging, storage and protection.
Check whether the product protection program meets the requirements on the spot; check and check relevant records on site to confirm that the product protection meets the requirements.
7.12.1 Plants and equipment that produce harmful substances such as dust, smoke, poisonous substances, rays and ultraviolet rays during the production process shall be installed with corresponding protective devices, establish requirements for their working environmental conditions and document them for effective control.
7.13.1 Hygiene management documents for clean rooms (areas) shall be formulated, and clean rooms (areas) shall be cleaned and disinfected in accordance with regulations, and records shall be kept.
Check the clean room (area) process hygiene management documents and records. The process hygiene management document should contain the following: 1. Equipment cleaning regulations; 2. Tooling mold cleaning regulations; 3. Station equipment cleaning regulations; 4. Material cleaning regulations; 5 .Operation table, site, wall, ceiling cleaning regulations; 6.Cleaning and storage regulations for cleaning tools; 7.Air disinfection regulations for clean rooms (areas); 8.Administrative regulations for the selection and use of disinfectants.
Check on-site the cleaning and sanitary tools in the clean room (area), whether there are no falling off objects, easy to clean, easy to sterilize, and whether they are used according to the purpose.
7.13.2 The disinfectant or disinfection method used shall not cause pollution to the equipment, process equipment, materials and products.
Check the relevant documents to see if there are provisions on disinfectants or disinfection methods. They should include the types of disinfectants, use time, frequency, replacement cycle, etc., and relevant records should be kept.
The selected disinfection method and selected disinfectant should be evaluated or verified for effectiveness; the disinfectant or disinfection method used should not cause pollution to equipment, process equipment, materials and products.
Check on-site whether the disinfectant used meets the requirements of the document and whether it is replaced on schedule.
7.13.3 The variety of disinfectant should be changed regularly to prevent the generation of resistant strains.
7.14.1 Lubricants, coolants, cleaning agents used in production equipment, and release agents used for parts that do not need to be cleaned after being molded by a mold in a clean room (area) shall not cause pollution to the product.
Check the verification report, the lubricant, coolant, cleaning agent, etc. used will not cause pollution to the product, or there are corresponding measures to eliminate the impact of pollution.
7.15.1 The management documents of station appliances should be formulated. The selected station appliances should be able to prevent the product from being contaminated and damaged during storage and handling.
Check the management documents of the station appliances to see if they meet the requirements.
On-site inspection to see if the station equipment meets product protection requirements, whether the surface is smooth, flat, easy to clean and disinfect, and has no material falling off; whether the product can be prevented from being contaminated and damaged during storage and handling; whether the station equipment is stored by area Whether the station appliances are strictly distinguished and separated are clearly marked.
7.16.1
* 7.16.2 For the parts and components of sterile medical devices that need to be cleaned, the final cleaning process should be performed in a clean room (area) of the corresponding level, and the final cleaning processing medium should meet the product quality requirements.
Check on-site whether the final cleaning treatment is performed in a clean room (area) of the corresponding level and whether the processing medium used can meet the quality requirements of the product.
7.17.1 Clearance management regulations should be established to prevent cross-contamination of products and keep clear records.
Whether to formulate management regulations and records for site clearance according to the production process.
Check on site whether the disposal of the last production relics meets the regulations.
7.18.1 The batch number management regulations shall be established, the relationship between the production batch number and the sterilization batch number shall be clarified, and a record shall be established for each batch of products.
Check whether the batch number management file has been established, whether the batch number of raw material batch, production batch, sterilization batch, intermediate batch and other batch numbers are clearly defined, the production batch and sterilization batch group batch method are specified, and whether the production batch number and sterilization batch number are specified Whether the division of production batches meets the requirements of relevant documents of the enterprise. Is it clear what records should be formed for each batch.
7.19.1 Appropriate methods should be selected to sterilize products or adopt appropriate aseptic processing techniques to ensure product sterility, and implement the requirements of relevant regulations and standards.
Check the documents provided by the company for analysis and demonstration of the selected sterilization method or aseptic processing technology, and evaluate whether it is suitable for the sterile medical devices produced. The analysis can include searching from the literature, comparison of different methods of sterilization of the same product, sterilization methods of other similar product manufacturers, and specific regulations of the country (such as the provisions of national standard technical requirements), etc. Suitability for selected sterilization method.
7.20.1 Procedures for confirming the sterilization process of sterile medical devices should be established and documented.
Check the program files confirmed during the sterilization process to see if they meet the requirements.
* 7.20.2 The sterilization process should be confirmed before the initial implementation in accordance with the requirements of relevant standards, and then confirmed if necessary, and the sterilization process confirmation records should be maintained.
Before the product is sterilized for the first time, is the sterilization process confirmed? Whether to reconfirm the sterilization process when the product, sterilization equipment, process parameters, etc. change.
Confirm whether the sterilization process or aseptic processing meets the requirements of relevant standards, such as GB18278 GB18280 "Requirements for Confirmation and Routine Control of Sterilization of Medical Care Products", and whether records or reports have been reviewed and approved.
If aseptic processing technology is used to ensure the sterility of the product, is the process simulation test carried out in accordance with relevant standards, such as YY / T0567 "Aseptic Processing of Medical Products".
Is there a record of confirmation of the sterilization process?
Through sterilization confirmation, determine the acceptable level of initial contaminated bacteria and particulate contamination of the primary packaging and product.
7.21.1 Sterilization process control documents shall be established to maintain records of sterilization process parameters for each sterilization batch. The sterilization records shall be traceable to each production batch of the product.
View the sterilization process control documents. These documents should include: sterilization process documents; sterilization equipment operating procedures; sterilization equipment maintenance and maintenance regulations; where applicable, ethylene oxide purchase and storage control should be included; confirmation of sterilization process And reconfirm.
Check the process parameters and related records of the sterilization equipment on site, whether they conform to the confirmed sterilization process, whether the sterilization equipment has automatic monitoring and recording devices, and whether the sterilization process and parameter records are complete, complete and traceable.
* 7.22.1 Parts that come into direct or indirect contact with the cardiovascular system, lymphatic system, or cerebrospinal fluid or medicinal fluid should be traceable to at least the raw materials, sterilization equipment and production environment used in the production of the product.
View identification and production batch records.
7.23.1 The storage conditions of various sterile medical device products and materials should be specified according to the degree of impact on product quality. The storage location should have corresponding environmental monitoring facilities. The storage conditions should be controlled and recorded. The storage conditions should be on the label or instruction manual. Noted. [1]
8.1.1 Quality control procedures should be established to specify requirements for product inspection departments, personnel, and operations.
Check the quality control procedures, and determine whether the duties of the inspection department, personnel qualifications, inspection operation procedures, etc. of the product are stipulated.
8.1.2 Requirements for the use and calibration of inspection instruments and equipment, and procedures for product release should be specified.
Check the quality control procedures to see if there are provisions for the use and calibration of inspection instruments and equipment.
8.2.1 The inspection instruments and equipment shall be regularly calibrated or verified and marked.
Check whether the inspection instruments and equipment have been calibrated or verified as required, and whether they have been identified.
8.2.2 The protection requirements of inspection instruments and equipment during handling, maintenance and storage shall be specified to prevent the inspection results from being inaccurate.
8.2.3 When it is found that the inspection instruments and equipment do not meet the requirements, the past inspection results shall be evaluated and the verification records shall be kept.
Check the equipment use and maintenance records. When the inspection equipment does not meet the requirements, whether the results of previous tests have been evaluated and the relevant records are kept.
8.2.4 The computer software used for inspection shall be confirmed.
* 8.3.1 Product inspection procedures shall be formulated in accordance with compulsory standards and the technical requirements of registered or filed products, and a corresponding inspection report or certificate shall be issued.
Check whether the product inspection procedures cover the mandatory standards and the performance indicators of the technical requirements of registered or filed products; confirm whether the inspection records can confirm that the products meet the requirements; check whether the corresponding inspection reports or certificates are issued according to the inspection procedures and inspection results.
8.3.2 Incoming inspections, process inspections, and finished product inspection projects that require routine control may not be commissioned inspections in principle. For items with high inspection conditions and equipment requirements, and the inspections that do need to be entrusted, a qualified institution may be entrusted to carry out inspections to prove that the products meet the compulsory standards and registered or filed product technical requirements.
* 8.4.1 There should be batch inspection records for each batch (set) of products and meet the traceability requirements.
8.4.2 Inspection records shall include inspection records, inspection reports or certificates of incoming inspection, process inspection and finished product inspection.
* 8.5.1 Product release procedures, conditions and release approval requirements should be specified.
Check the product release procedures to see if the release conditions and release approval requirements are clear. Personnel authorized to release products and their duties and responsibilities should be specified, and records of approval should be maintained.
8.5.2 The released product shall be accompanied by a certificate of conformity.
8.6.1 Management regulations for retained samples shall be formulated according to product and process characteristics, and retained samples shall be maintained in accordance with regulations, and observation records of retained samples shall be maintained.
* 8.7.1 It should have the ability and conditions for detection of sterility, microbiological limits and positive controls.
Check whether there are detection conditions for sterility, microbial limit and positive control on site, and whether they are equipped with corresponding equipment and testing personnel (such as: ultra-clean bench, constant temperature incubator, biochemical incubator, pressure steam sterilizer, membrane filtration equipment , Biological safety cabinet, etc.).
8.8.1 Process water shall be monitored and regularly tested, and monitoring records and test reports shall be maintained.
Check whether there are process water management regulations, whether process water testing items and testing requirements meet the corresponding level of water quality requirements, and whether sampling points and frequency of testing are specified.
Check on-site whether the biochemical laboratory has relevant equipment, utensils, reagents and storage environment for process water inspection. If the reagents are prepared by themselves, whether the name of the reagent, the person who prepared it, the date of preparation, and the expiration date are available.
Check whether the process water monitoring records and test reports meet the requirements of the document.
8.9.1 Periodic inspection (supervision) shall be performed on dust particles, plankton or sediment bacteria, number of air changes or wind speed, static pressure difference, temperature and relative humidity in clean rooms (areas) in accordance with the requirements of relevant medical equipment industry standards Save inspection (monitoring) test records.
Check the monitoring records of the clean room (area) to check whether the items and testing cycles meet the requirements of YY0033 standards.
Check whether the culture medium used meets the requirements specified in GB / T16294-2010.
Check whether the equipment is equipped with dust particle counter, anemometer (or air volume hood), temperature and humidity meter, pressure difference meter, etc., whether it has been verified or calibrated, and whether it is within the validity period.
Check on site whether the pressure difference, temperature and humidity meet the requirements of the document.
8.10.1 The control level of the initial contaminated bacteria and particulate pollution of the product shall be determined and documented according to the product quality requirements, and the storage environment requirements and storage time of the intermediate product shall be clarified.
Check to see if there are any documentary regulations on the initial level of contaminated bacteria and particulate contamination of the product, and whether the storage environment requirements and storage time of the intermediate product are specified in the document.
8.10.2 Periodically inspect and maintain relevant records in accordance with document requirements.
Check the initial contaminated bacteria and particulate pollution test records to see if they meet the requirements of the document.
8.10.3 The inspection records shall be regularly summarized and trend analyzed.
8.11.1 The quantity and method of retaining samples (according to production batch or sterilization batch, etc.) should be determined according to the purpose of retaining samples, and management methods for retaining samples should be formulated.
Check whether there is a management method for retaining samples, and ensure that each production batch or sterilization batch should retain samples (whether the number of retention samples, retention methods, observation methods, observation frequency, etc. are specified in the document according to the purpose of retaining samples) ).
Check whether there is a sample room (or sample area), whether the environment of the sample room (or sample area) meets the requirements of product quality characteristics, whether it is equipped with environmental monitoring equipment that meets product quality requirements, and whether there is a record.
8.11.2 Records of observations or inspections of retained samples shall be made.
Check whether the sample keeping account, sample observation or inspection records meet the requirements of the document. [1]
* 9.1.1 Product sales records should be established and meet traceability requirements.
9.1.2 The sales record should at least include: medical device name, specifications, model, quantity, production batch number, expiration date, sales date, purchase unit name, address, contact information, etc.
9.2.1 The direct sale of self-produced products or the selection of a medical device operating company shall comply with the relevant laws and regulations of medical devices.
9.2.2 When a medical device operating enterprise is found to have engaged in illegal or illegal business operations, it shall promptly report it to the local food and drug supervision and administration department.
9.3.1 It is necessary to have after-sales service capabilities compatible with the products produced, and establish and improve after-sales service systems.
9.3.2 After-sales service requirements shall be specified and after-sales service records shall be established and traceability requirements shall be met.
9.4.1 For medical devices that need to be installed by the enterprise, the installation requirements and acceptance standards for installation verification shall be determined, and installation and acceptance records established.
9.4.2 If installation or maintenance is performed by the user or other enterprises, the installation requirements, standards and maintenance parts, materials, passwords, etc. shall be provided and provided with guidance.
9.5.1 Customer feedback processing procedures should be established to track and analyze customer feedback information.
Check whether the program file stipulates the implementation of the above activities, and track and analyze the customer feedback information. [1]
10.1.1 A non-conforming product control procedure shall be established to specify the duties and authority of the departments and personnel for non-conforming product control.
* 10.2.1 The non-conforming product shall be identified, recorded, isolated, and reviewed. According to the results of the review, corresponding measures shall be taken for the non-conforming product.
Check on site whether the identification and isolation of non-conforming products meet the requirements of the procedural documents, spot check the processing records of non-conforming products, and check whether they are reviewed in accordance with the provisions of the documents.
10.3.1 When the product is found to be unqualified after the product is sold, measures such as recall and destruction shall be taken in a timely manner. Check on-site the disposition measures when the product is found to be unqualified, and whether to recall and destroy it.
10.4.1 If non-conforming product can be reworked, the enterprise shall prepare rework control documents. Rework control documents shall include instructions for operations, re-inspection and re-verification.
Check the rework control file to see if there are provisions for non-conforming products that can be reworked; check the rework activity records to confirm whether they meet the requirements of the rework control file.
10.4.2 If it is impossible to rework, a relevant disposal system should be established. [1]
11.1.1 The relevant department should be designated to receive, investigate, evaluate and handle customer complaints, and maintain relevant records.
Review the documents regarding responsibilities and permissions to determine if the above activities are regulated.
* 11.2.1 An adverse event monitoring system for medical devices shall be established in accordance with the requirements of relevant laws and regulations, and adverse event monitoring and re-evaluation shall be carried out to maintain relevant records.
Check whether the monitoring system for adverse events established by the enterprise specifies the duties, reporting principles, reporting procedures, and reporting deadlines of the managers of suspicious adverse events, and has established procedures and documents for starting the implementation of re-evaluation of medical devices, and meets the requirements of regulations. View relevant records to confirm whether there are adverse events and implement them as required.
11.3.1 Data analysis procedures should be established to collect and analyze data related to product quality, adverse events, customer feedback and operation of the quality management system, verify product safety and effectiveness, and maintain relevant records.
Check the implementation records of data analysis, whether it is carried out in accordance with the procedures, whether statistical techniques have been applied, and records of data analysis results have been retained.
11.4.1 A corrective action procedure should be established to determine the cause of the problem and take effective measures to prevent related problems from recurring.
11.4.2 Preventive action procedures should be established to determine the cause of potential problems and take effective measures to prevent problems from occurring.
* 11.5.1 For medical devices with hidden safety hazards, measures such as recall should be taken in accordance with the requirements of relevant regulations and reported to the relevant departments in accordance with regulations.
11.6.1 A product information notification procedure shall be established to notify the user, related enterprise or consumer of supplementary information such as product changes and usage in a timely manner.
11.7.1 An internal audit procedure for the quality management system should be established, specifying the audit criteria, scope, frequency, participants, methods, record requirements, and assessment of the effectiveness of corrective and preventive measures to ensure that the quality management system meets the requirements of this specification.
See if the internal audit process includes the above. Check the internal audit data, whether the personnel conducting the internal audit have been trained, whether the internal audit records meet the requirements, whether corrective measures have been taken against the problems found in the internal audit, and whether they are effective.
* 11.8.1 Management review should be carried out regularly to evaluate and audit the quality management system to ensure its continued suitability, adequacy and effectiveness.
Viewing the management review documents and records shall include the management review plan, management review report and related improvement measures, and whether the management review report includes an assessment of regulatory compliance. Whether the management review has been carried out within the prescribed time, whether improvement measures have been proposed and specific responsibilities and requirements have been implemented, and whether they have been implemented as planned. [1]
annotation:
1. The numbering method of this Guiding Principle is: X1.X2.X3, where X1 is the sequence number of the chapter, such as the first place in 1.1.1, X1 represents the chapter of Organization and Personnel, and the first place in 2.1.1 X1 represents the chapter of Plant and Facilities; X2 is the sequence number of the clauses in the same chapter. For example, the second digit of 1.1.1 X2 represents the first requirement of the Organization and Personnel chapter, and the second X2 of 1.2.1 represents The second requirement of the chapter "Organizations and personnel"; X3 is the sequence number of the detailed inspection guidance in the same clause, such as the third digit of 1.1.1. The third checkpoint X1 in 1.1.2 indicates the second checkpoint of the first requirement detailed in the "Institutions and Personnel" chapter.
The other chapters have the same numbering rules.
2. The inspection guidelines for each chapter consist of two parts before and after. The first half of each chapter is an inspection guide formulated in accordance with the provisions of the Medical Device Production Quality Specification, and the second half of each chapter is in accordance with the Medical Device Production. Inspection guidelines formulated by the provisions of the Sterile Medical Device in the Appendix to the Quality Specification.

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