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Medical X-ray Diagnostic Equipment-Implementation rules for compulsory certification of medical
Ref . No. CNCA-08C-037:2001
Medical X-ray Diagnostic Equipment
Implementation rules for compulsory certification of medical
Announced on Dec.7, 2001 Implemented on May 1, 2002
Certification and Accreditation Administration of the People’s Republic of China
1 Scope
This document applies to those X-ray equipment, which is use the principle of X-ray imaging for clinical diagnosis or/and with the aid of X-ray imaging to realize operation or treatment.
It includes:
Radiographic X-ray system
Fluoroscopic X-ray system
Gastrointestinal X-ray system
Mammography X-ray system
Dental X-ray system
Surgical Imaging X-ray system
Intervention Treatment X-ray system
Angiographic X-ray system
X-ray Bone Densitometer
X-ray Equipment For Computed tomography
This document is unsuitable to those X-ray equipment that used the X-ray biological effect for radiation therapy.
2 Certification Model
Type Testing + Initial Inspection of the Factory + Follow up Inspection
3 General Requirements for Certification
3.1 Application for certification
3.11 Defining application unit for certification
3.111 Principles of unit definition
A model/type sample of medical X-ray diagnostic equipment shall be defined in one application unit. The definition of same series product shall be defined by reviewing (checking) the technical documents. For typical product, type testing shall be carried out instead of similar product.
Application unit shall be defined according to different product of structure and applying range. It should take into consideration of the main parts that difference in characteristics, capacities, structures, and its combination mode, technical specifications and main functions.
Basic principles of unit definition are as follows:
a.The equipment of different use and different type shall be (defined) in different application unit.
b.The equipment having great difference in the combination of the main parts shall be defined in different application unit.
c.The equipment of important parts such as high-voltage generator, imaging system and X-ray tube that having different structures and characteristics shall be defined in different application unit.
d.The same series equipment distinguished largely in its functions of the safety and the power supply shall be defined in different application unit.
e.The products of the same model/type, the same manufacturer but from different manufacturers shall be defined in different application unit.
f.The same series equipment distinguished largely in its technical characteristics shall be defined in different application unit.
For the same or similar safety structure, ordinarily the more complicated one shall replace the simple one and the larger capacity shall replace the smaller one. Tests shall be carried out just for the different parts.
3.1.1.2 Handling principle of changed product
a.If the product applying for certification is the changed type that already got the certificate and it is affirmed to match the original application unit condition by reviewing the documents, it shall be regarded as the same type testing unit without any type testing.
b.If the newly applying for safety critical parts of the changed product are consistency with that used for the original certificate product, the safety critical parts shall not be claimed to provide any more.
c.If the applying for modified product has the partial difference with the original certificate equipment affirmed by (checking) reviewing the documents, supplement test shall be carried out only for the different part from the original equipment.
3.1.2 Application documents
The formal application shall be submitted with the following documents.
a.Instructions for use, technical description and service manual.
b.Product assembly chart, working (electrical) principle diagram, circuit diagram and parts diagram.
c.Product instructions for installation and adjustment.
d.Product inspection/testing report (including data, procedure and method).
e.List of critical parts (including name, model, specifications, manufacturer, executive standard and safety certification).
(When applying for changed product, the applicant shall submit the description of the difference between the original certificate product).
3.2 Type testing
3.2.1 Sample delivery for type testing
3.2.1.1 The principles of sample delivery for type testing
The representative samples from the application unit for certification shall be selected and supplied for type testing.
3.2.1.2 Samples quantity
The applicants shall take responsibility of sample delivery for type testing in accordance with the requirements of the certification body and be responsible for them.
The appliance sample shall be supplied 1 set and those for safety parts tested accompanying the appliances shall be according to the requirements of appendix 1.
3.2.1.3 Disposal of samples and related documents after type testing
The samples tested and/or the related documents should be disposed of in appropriate ways after type testing.
3.2.1.4 Testing site
In principle, type testing should be carried out in the appoint laboratory.
The sample shall be installed on site or tested expeditiously because of hard transportation, site testing shall be implemented after the approval of certification body.
3.2. 2 Test standards, items and methods for type testing
3.2.2.1 Test standards
GB9706.1 (idt. IEC60601-1)
Medical electrical equipment - Part 1: General requirements for safety
GB9706.3 (idt. IEC60601-2-7)
Medical electrical equipment - Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
GB9706.11 (idt. IEC 60601-2-28)
Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
GB9706.12 (idt. IEC 60601-1-3)
Medical electrical equipment - Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
GB9706.14 (idt. IEC 60601-2-32)
Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X- ray equipment
GB9706.15 (idt. IEC 60601-1-1)
Medical electrical equipment - Part 1: General requirements for safety
1. Collateral standard: safety requirements for medical electrical systems
GB9706.18 (idt. IEC 60601-2-44)
Medical electrical equipment — Part 2: Particular requirements for the safety of X-ray equipment for computed tomography.
3.2.2.2 Test items
The test items for safety shall include all appropriate items specified in
standards of 3.2.2.1.
3.2.2.3 Test methods
The type testing shall be carried out according to the methods specified
and/or referred to the standards in the provision of 3.2.2.1.
3.3 Initial inspection of the factory
3.3.1 Contents of the inspection
3.3.1.1 Assessment of factory quality assurance ability
The “Requirements for Factory Quality Assurance Ability”(see appendix 2) is the basic requirements for the factory quality assurance ability assessment covered by the product of Implementation rules.
3.3.1.2 Check of consistency of the product
The consistency of the product applying for certification shall be checked on the site of production during the factory inspection.
If the certification referred to the varied type /model of products, one sample shall be taken from each type to check. The following major points shall be checked:
1)The nameplates and marks of products to be certified shall be identical with those indicated in the type testing reports.
2)The construction of certified products referred to safety function shall be identical to those of the samples for the type testing reports.
3)The safety critical parts shall be identical with those declared in type testing and confirmed by certification body.
The inspector assigned by the certification body shall carry out the sampling testing for certified product if it doubt about the above verification results.
The samples for testing shall be randomly sampled from the conformity products of the factory by the inspector who shall make sure of the quantities for the product set, main components and /or doubtful critical parts under the concrete conditions.
One set (case) product or component shall be sampled, and the quantity of critical parts shall be sampled according to the appendix 1.
The sampling samples shall be tested by the appointed testing body, which shall not be entrusted to the testing body of the manufacturers. The sampling testing items shall confirm by certification body under the concrete conditions.
3.3.2 Inspection scope
All the products to be certified and processing premises shall be covered for inspection of factory quality assurance ability and of consistency of the products.
3.3.3 Timing of initial factory inspection
Normally, the initial factory inspection should be implemented after the sample has passed the type testing. The type testing and initial factory inspection can be implemented at the same time in special cases.
The duration of factory inspection shall be determined by the amounts of application units of products to be certified and with the consideration of the scale of the factory production. It will normally take about 4 to 6 man-day for each processing premises.
3.4 Evaluation of certification results and approval of certification
3.4.1 Evaluation of certification results
3.4.1.1 Evaluation of type testing results
If the testing items have non-conformity individually, corrective actions shall be taken in compliance with modification.
When all the testing items complied with the standards, the result shall be regarded as “Pass”.
Certification shall be terminated if the safety testing result judged as“Fail”.
3.4.1.2 Evaluation of the initial factory inspection.
Evaluation result shall be defined as three levels:
a. If there is no any non-conformity found during whole inspection, the certification shall be recommended to award by certification body.
b. If there are slight non-conformities found which do not adversely affect the safety standard for certificate product, the manufacturer shall take corrective actions within 3 months. if the actions are regarded as effective by inspection team, the certification shall be recommended to award by certification body.
c. If there are serious non-conformities found and/or the factory does not have the ability to produce the products, which conform to relevant standards, the inspection shall then be terminated.
3.4.2 Approval of the certification results
After the results of type testing and factory inspection are evaluated to conform to the requirements, the certification body shall issue certificate(s).
The application of the certificates shall comply with the requirements for Regulations for Compulsory Product Certification.
3.4.3 Time frame
The time frame for certification means the working days from the acceptance of complete application till the issuance of the certificates, which includes the time of type testing, factory inspection, evaluation of certification result and approval of certification and preparing the certificate(s).
The time for type testing should take 60 working days (including the time for a safety type testing report).
The factory inspection reports should be submitted within 5 working days.
Evaluating certification results, approving the certification and preparing the certificates should normally be completed within 5 working days.
3.5 Follow up inspection
3.5.1 The frequency of the follow up inspection
3.5.1.1 The follow up inspection shall be implemented at least once per year normally after getting the certificate for 12 months.
3.5.1.2 The frequency of inspection should be increased in any of the following cases when:
1)the certified product has serious quality problem, or is complained by clients, which has been verified to be the responsibility of the certificate holder.
2)the certification body doubts the conformity of the certified product against the requirements of safety standards with sufficient reasons.
3)sufficient information indicates that the conformity or the consistency of the certified products would be affected due to the changes in organization system, production condition and the quality system of the factories/ manufacturers.
3.5.2 Contents of the follow up inspection
3.5.2.1 Model of the inspection
The model of the follow up inspection:
Re-assessment of factory quality assurance ability + check of consistency of certified product
3.5.2.2 Re-assessment of factory quality assurance ability
The Re-assessment for factory quality assurance ability shall be carried out within 4 years after certificates granted. It shall be inspected according to the Requirement of Factory Quality Assurance ability. The time for the Re-assessment should take 1 to 2 man-day for each processing premise.
In the fifth year, the overall Re-assessment for factory shall be carried out according to Requirement of Factory Quality Assurance Ability. The contents and time frame of the Re-assessment is the same as the initial factory inspection.
The span for overall re-assessment shall be 4 years.
3.5.2.3 Check of consistency of the products
The consistency inspection for the certified products shall be carried out on the site of production within 4 years after the certificate(s) granted.
The check shall be carried out on the spot as follows, otherwise specified in article of 3.3.1.2:
1. The items in question relating to the construction consistency inspection.
2.The items relating to critical parts which are not in consistency with those submitted for the initial type testing.
3. Safety items difficult to judge without testing, or major safety items, or safety items likely to change, such as:
a）Marking on the outside (according to 6.1, GB 9706.1 and GB 9706.3).
b）Protective earthing impedance ( measuring the specified position between impedance according to 18,GB 9706.1 ).
c）Leakage current (including earthing leakage current and enclosure leakage current according to 19,GB 9706.1 ).
d）Dielectric strength ( according to 20,GB9706.1 and GB 9706.3).
3.5.2.4 After getting the certificate for the fifth year, the testing of supplying samples shall be compliance with the application unit.
In principle, every application unit shall be supplied one sample set to test by appointed testing body. The concrete testing requirements shall be carried out according to the provision of 3.2 of the Implementation rules.
If the follow up product hasn’t got any change, certification body shall choose supplying samples or inspection documents under the concrete condition.
3.5.3 Sampling testing for follow up inspection
One set for every kind of certificate model product and critical parts (sampling according to appendix 1 ) shall be sampled if it need to sample testing for follow up products. The samples shall be randomly sampled from the conformity products of the factory (including production lines and product storehouse ).
The sampling samples shall test by the appointed testing body. The standards specified to the applicable item in the provision of 3.2.2.1 shall be suitable for surveillance testing item.
The important testing items are as follows:
1)Identification, marking and documents
2)Limitation of voltage and /or energy
3)Enclosures and protective covers
4)Protective earthing impedances
5)Continuous leakage currents and patient auxiliary currents (Both at operating temperature and following the humidity preconditioning treatment)
6)Dielectric strength
(Both at operating temperature and following the humidity preconditioning treatment)
7)Mechanical strength
8)Surfaces, corners and edges
9)Human errors
10)Accuracy of operating data
11)Protection against hazardous output
12)Protective earthing – terminals and connections
Certification body shall define testing items under the concrete condition also.
3.5.4 Evaluation of follow up inspection results
The certificates can be retained and the certification marks can be continuously used upon favorable inspection results. If there is any non-conformities found in the follow up inspection, the corrective actions shall be taken within 3 months. Otherwise, the certificates will be withdrawn, the use of certification marks will be stopped, and the relevant results will be announced.
4 Maintenance and change of the certificates
4.1 Maintenance of the certificate
The certificate of the products covering by the Rules itself does not indicate specific expiry date. The validity of the certificates depends on the follow up inspection.
4.2 Change of the covering certificate product
4.2.1 Procedure for change
If holders require change for the scale of products on the same application unit, the holders of the certificates shall make application for change of the certificates.
The certification body shall check the consistency of the change products against the certified products, and confirm the effective of the original certified results against the modified products and carry out the supplement tests or inspection based on the differences with the original product.
After the confirming to fit for the change requirements by the certification body, the certificate shall be issued, or on the concrete condition, it shall be either supplied again or put on the technical record to maintain the original certificate for holders of the certificates.
4.2.2 The requirements of sample product
The holders of the certificates shall supply one sample according to the requirements of 3.2 provision of the Implementation rules for checking by the certification body. The items for checking shall be specified by the certification body.
5 Use of compulsory product certification mark
The certificate holder shall follow the Regulations for Compulsory Product Certification Mark.
5.1 Derivations of Certification mark
The products listed in the Rules shall not be allowed to use any derivation of certification mark.
5.2 Design of the mark allowed to use
5.3 Application of the mark
The standard specification mark shall be applied.
5.4 Location of the mark
The standard certification marks shall be applied on the product close to the nameplate.
6 Suspension, cancellation and withdrawal of the certificates
The suspension, cancellation and withdrawal of the certificates shall follow the Regulations for Compulsory Product Certification.
7 Charge
The certification shall be charged by the certification body according to the national statutory structural fee chart.
Appendix 1:
List of critical parts, testing standard and sampling quantity
|
No. |
Name |
National standard |
Corresponding to IEC standard |
Sampling quantity |
|
1 |
Hand-held switch |
GB9706.1 |
IEC 60601-1 |
3 |
|
2 |
Foot switch |
GB9706.1 |
IEC 60601-1 |
3 |
|
3 |
Power switch |
GB9706.1 |
IEC 60601-1 |
3 |
|
4 |
Power supply cord(with plug and socket) |
GB9706.1 |
IEC 60601-1 |
3 |
|
5 |
Table control switch
(containing emergency switch) |
GB9706.1 |
IEC 60601-1 |
Each for 3 |
|
6 |
Connector |
GB9706.1 |
IEC 60601-1 |
Each for 3 |
|
7 |
Fuse(applied to primary mains supply) |
GB9706.1 |
IEC 60601-1 |
Each for 3 |
|
8 |
Fuse socket (use with fuse) |
GB9706.1 |
IEC 60601-1 |
Each for 3 |
|
9 |
Power transformer |
GB9706.1 |
IEC 60601-1 |
2 (one is unsealed) |
|
10 |
Relay (applied to primary mains supply) |
GB9706.1 |
IEC 60601-1 |
3 |
Appendix 2:
Compulsory Product Certification Requirements for Factory’s Quality Assurance Ability
Manufacturer shall meet the requirements for factory’s quality assurance ability specified in this document, in order to ensure that all certified products are identical with the sample(s) against which the type test was approved.
1. Responsibilities and Resources
1.1 Responsibility
Manufacturer shall define the responsibilities and inter-relations of all the personnel involved in quality activities. And manufacture should appoint a management representative for quality, who, irrespective of other responsibilities, shall be responsible to:
a)ensuring that quality system, which meets the requirements of this document, is established, implemented and maintained.
b)ensuring that the products with the compulsory certification mark are produced in conformity with the standards to which they were certified.
c)establishing documented procedures to ensure that compulsory certification marks are kept and used appropriately.
d)establishing documented procedure to ensure that the compulsory certification mark is not affixed on any non-conforming product or changed product that was not notified to certification body.
The management representative for quality shall be competent to perform the work.
1.2 Resources
Factory shall be equipped with necessary production facility and testing equipment in order to consistently manufacture the products in conformity with relevant standards. In addition, and factory shall provide relevant human resources, to ensure that personnel performing work affecting product quality is competent, and shall establish and maintain necessary environment suitable for manufacturing, testing and inspection, storage etc.
2. Documents and Records
2.1 Manufacturer shall establish and maintain documented quality plan or relevant documents for certified products, and the documents need to ensure that related processes to product quality are operated and controlled effectively. Quality plan shall define the objective of product design, realization process, test and related resource, as well as the requirements for changes (i.e. specification, processing, critical components etc.) to certified products, use and management of marks.
Standard or specification which the design is based on, as one essential part of quality plan, shall be more strict than the requirements specified in this Rules.
2.2 Manufacturer shall establish and maintain documented procedure to control the documents required in this document, to ensure that
a) all documents issued and changed shall be approved by authorized personnel prior to issue and change.
b) changes and current revision status of documents are identified to prevent unintended use of obsolete documents.
c) relevant valid versions of applicable documents are available at points of use.
2.3 Manufacturer shall establish and maintain documented procedures to define the controls for the identification, storage, protection and disposition of records. Records shall be legible, integral to provide evidence of product conformity to requirements.
Records shall be retained for an appropriate period.
3. Purchasing and receiving Inspection
3.1 Control of Supplier
Manufacturer shall establish the procedures that define the criteria for selection, evaluation and routine supervision of supplier, which provide critical components and material, to ensure the supplier has ability to provide the critical components and material in accordance with requirements.
Records of the evaluations and routine supervision shall be maintained.
3.2 Inspection/Verification for Critical Components and Material
Factory shall establish and maintain procedures of inspection or verification for purchased critical components and material, and procedure of periodic verification inspection, to ensure that critical components and material meet specified certification requirements.
Inspection for purchased critical components and material may be carried out at the factory or supplier’s premises. Where inspection is performed at supplier’s premise, Manufacturer shall specify the intended inspection requirements to supplier.
Manufacturer shall maintain records of inspection or verification of critical components, verification inspection records, evidence of conformity and relevant inspection data, etc.
4. Process Control and Inspection
4.1 Manufacturer shall identify critical production processes and arrange operators with appropriate qualification at the processes. Where product quality can not be guaranteed when no operating document, appropriate operating instructions shall be prepared to make production processes under control.
4.2 Where environment condition is required, factory shall meet the requirements.
4.3 Manufacturer shall monitor and control appropriate process parameters and product characteristics, as applicable.
4.4 Manufacturer shall establish and maintain maintenance procedure for the manufacturing equipment.
4.5 Production shall be inspected at appropriate stages of manufacture to ensure that products, components and parts are in accordance with the certification approved sample.
5. Routine Tests and Verification Tests
Factory shall establish and maintain documented routine tests and verification tests procedures to verify and demonstrate that products are in compliance with relevant requirements. The procedures shall include test items, contents, method, acceptance criteria etc. Test records shall be maintained. Routine tests and verification tests shall meet the requirements specified in relevant product certification implementation rule.
Routine tests are performed on 100% of production and are normally carried out at the final stage of production. Normally no further operations, except for labeling and packing, may be carried out after these tests.
Verification tests are tests on samples taken randomly in order to verify and demonstrate that products consistently meet standard requirements.
6. Inspection and Test Equipment
The equipment used for inspection and test must be regularly calibrated and checked for correct operation, and meet inspection and test capacity requirements.
Manufacture should stipulate the operation rules of the inspection and test equipment. Testing personnel should follow the rules and use the equipment correctly.
6.1 Calibration
Inspection and test equipment used for determining the conformity of the products being manufactured shall be calibrated on a regular basis. All calibrations undertaken on such equipment must be traceable to national or international standards. For in-house calibration, the method, acceptance criteria, calibration interval etc. shall be documented. Calibration status of the equipment shall be easily identified by operator and personnel in-charge.
Calibration records shall be maintained appropriately.
6.2 Functional Check
The Functional check to the equipment used for routine tests and verification tests shall be undertaken on a daily basis. When functional check is found to be not satisfied with specified requirements, arrangements shall allow previous product to be traced, retrieved and re-tested if necessary. Operator shall be instructed on what action is to be taken if a functional test is found to be unsatisfactory.
The results of functional check and all subsequent corrective action taken must be recorded.
7. Control of Non-conforming Product
Manufacturer shall establish procedure of control of non-conforming product, which shall includes identification method, segregation, disposal, corrective action and preventive action. Repaired and reworked product shall be re-tested. Records of repairing for critical components and parts and disposal of non-conforming product shall be maintained.
8. Internal Audit
Internal audit procedures shall be established and documented to ensure that quality system is implemented effectively and certified products are complied with specific requirements. The results of internal audit shall be maintained.
Factory shall keep records of all complaints, especially to a product’s non-compliance with requirements of relevant standard, and make these complaints as one of input of internal audit.
Corrective and preventive action shall be taken to non-conformities and records shall be maintained.
9. Changes to Certified Product
Any constructional Changes from original sample for Type Testing should be controlled so as to make certified products consistently be in conformity with relevant standard.
Manufacturer shall establish procedures to monitor changes of the critical component, material, construction and factors that may affect compliance with relevant standard. The changes on certified products must be notified to the certification body for authorization, prior to their implementation.
10. Packing, Handling and Storage
Finished products shall be packaged, stored and handled in such a way as to ensure that they will continue to comply with the applicable standards.
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