Artificial Heart-Lung Machine Bubble Oxygenator-Implentation rules for compulsory certification of medical device 

Ref. No.CNCA-08C-040:2001

Artificial Heart-Lung Machine Bubble Oxygenator

Implentation rules for compulsory certification of medical device

Announced on Dec 7£¬2001                                         Implemented on May 1£¬2002

Certification and Accreditation Administration Of People¡¯s Republic of China

1. Scope
This document applies to the artificial heart-lung machine¨C bubble oxygenator£¬which is used during open heart surgery instead of living lung in blood-gas exchange.
2. Certification Model
Type Testing + Initial Factory Inspection + Follow up Surveillance
3. General Requirements for Certification
3.1Application for certification
3.1.1 Defining application for certification 
Principally, same products of a same factory but different producing site shall be applied separately when making application for certification.
3.1.2 Application documents
Applicant shall submit formal application and related documents including:
1) Chart of the of the product functioning theory
2) Manual in Chinese
3) Test report of the safety test for the product
4) Description of the differences among applying products of the same unit 
5) Other documents.
If the application is made by an agency£¬certificate of authorization shall be provided.
3.2 Type testing
3.2.1 Sample delivery for type testing
3.2.1.1 The principles of supplying samples for type testing
The samples supplied for type testing shall be selected from representative samples.
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 quantity of samples shall be according to the requirements of appendix 1..
3.2.1.3 Handle of samples and relating documents after type testing
The samples tested and/or the relating documents should be handled in appropriate ways after type testing.
3.2.2 Standards, items and methods of the type testing
3.2.2.1 Test standards
GB 12261 Artificial heart-lung machine- bubble oxygenator
3.2.2.2 Test items
The type testing shall be carried out according to total items specified in GB 12261.
3.2.2.3 Test methods
The type testing for artificial heart-lung machine bubble oxygenator shall be carried out according to GB 12261.
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 inspector assigned by the certification body shall carry out the factory quality assurance capability assessment according to the Requirements for Factory¡¯s Quality Assurance Ability  (see appendix 3) and the additional inspection requirements stipulated by CNCA.
3.3.1.2 Check of consistency of the product
The inspection for consistency of the products applying for certification shall be implemented on the site
of production during the factory inspection .
If the certification referred to the varied type /model of products, each type shall be sampled 6. Key
items to be checked are as follows:
1)The nameplates and marks of products to be certified shall be identical with those indicated in the
type test reports.
2)The product(s) construction referred to safety function shall be identical to those of the samples for
the type test reports.
3)The safety critical parts shall be identical with those declared in type test and confirmed by
certification body.
The certified product shall be sampled for test by inspector, if there is a question in the inspection results. The sample shall be chosen from the qualified product.  The sample, determined by inspector according to the actual situation, would be 6. Samples shall be tested by the designated inspection body.  No inspection organization under the factory shall be entrusted to do the test.  The test items shall be determined by the certification body according to actual situation.
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 Time for initial factory inspection
Normally, the initial inspection should be implemented after the sample has passed the type testing. The type testing and 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. It will normally take about 4 to 6 man-day for each processing premises.
3.4 Evaluation of the certification results and approval of certification
3.4.1 Evaluation of the certification results
3.4.1.1 Evaluation of the type testing results
If there are some items unqualified but easy to correct, the corrective action are allowed. When all the test items conform to the standard, the result is ¡°pass¡±.
Certification shall be terminated if the safety test result is ¡°fail¡±.
3.4.1.2 Evaluation for the Initial factory inspection.
The results can be divided into 3 levels:
1) If no nonconformity is found during the inspection, certificate is recommended to award to the manufacturer by the certification body.
2) If slight nonconformity is found and the nonconformity has no adversely influence on the product to conform to the standard£¬the manufacturer should take corrective action within 3 months Only after being confirmed by the inspection group, certificate is recommended to issue to the manufacturer by the certification body.
3) If severe nonconformity is found or the manufacturer doesn¡¯t have the quality assurance ability to meet the certification requirements, inspection can be terminated.
3.4.2 Approval of the certification results
When the results of type testing and factory inspection for the products are qualified and proved by the certification body , certification can be issued.  The application of the certificates shall comply with the requirements of  Administration of Compulsory Products Certification.   
3.4.3 Time frame for certification
The time frame for certification is the working days occurring from the acceptance of complete application till issuing certificates, which includes the time of type testing£¬ factory inspection, evaluation of certification results and approval of certificates and preparing the certificates.
The time frame for type testing(including making test reports of appliance normally should take 45 working days .
The time frame for submitting the test report shall be within 5 working days.
The time frame for evaluating on certification results, approving and typing certificates should not exceed 5 working days.
3.5 Follow up surveillance
3.5.1 The frequency of the follow up surveillance
3.5.1.1 The follow up surveillance shall be implemented once at least every year after getting the certificates for 12 months.
3.5.1.2 The frequency of surveillance shall be increased if occurring any of the following case:  
1) The quality of the certified product has seriously problems, or receiving the appeal from the client
and checking concludes that the holder of the certificate shall be responsible for it.
2) The certification body queries the conformity of the certified product against the requirements of
safety standards with sufficient reasons.
3) There is sufficient information that the conformity or the consistency of the certified products
would be affected since the changes of organization system, production condition and the quality system of the manufacturers.
3.5.2 Contents of the follow up inspection
3.5.2.1 Model of the inspection
Routine factory inspection + consistency inspection  
3.5.2.2 Routine factory inspection for the quality assurance capability of the factory
The routine inspection for factory quality assurance capability shall be implemented within 4 years after attaining the certificate and the scope shall cover the document of  Requirements of Factory Quality Assurance Capability  . The time frame for the routine inspection should take 1 to 2 person/day for each on spot.
There shall be an overall inspection to the factory in the 5th year of attaining the certificate according to the document of Requirements of Factory Quality Assurance Capability. The scope and time shall be in consistent with the initial factory inspection.
The span for an overall inspection period shall be of 4 years.
3.5.2.3 Inspection for consistency of the products
The consistency inspection for the applying certified product shall be implemented on the site of
production within 4 years after getting the certificate.
The inspection or testing on the site shall be carried out as the following list besides the scope of 
inspection in this provision of 3.3.1.2 of The Implementation Rules.
Spot test to the production line according to the requirements of the document of  Safety Certification Product Test Design of Artificial Heart-lung Machine- Bubble Oxygenator (Appendix 2)shall also be implemented .
Samples shall be provided according to the unit in the 5th year of certification. Principally one unit shall be sampled 6 for test. and the test shall be implemented by appointed testing bodies according to the requirements of 3.2 in this document. If no change on the product£¬the certification body shall have sample test or information inspection according to specific situation.
3.5.3 Sampling test for follow up surveillance
sampling test shall be implemented to the certified products by the appointed testing bodies when necessary. Each certified product should be sampled 6 for test .Concrete test items can be carried out according to 3.2.2.1 of this document.
Critical testing items are as follows according to GB12261:
1) leakage
2)material toxicity
3)pyrogen
4) heavy metals
5) defoam
6) oxygenation performance
7) sterility¡¢E.O.Residue
8) marking and  packaging of the oxygenator
The certification body may carry out the tests by choosing test items according to specific situation.
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 three months. Otherwise, the certificates will be withdrawn, the certification marks will be stopped using, and the relevant results will be announced.
4. Maintenance and modification of the certificates
4.1Maintenance of the certificate
The Implementation Rules specifies the conformity certificates without covering the closing date of the certificates.  The term of validity of the certificates depends on the surveillance inspection by the certification body at regular intervals for maintenance of it.
4.2 Modification for covering product of certificate
4.2.1 Procedure for change
If holders of the certificates require changing the scale of the products which are of the same unite as the certified ones, they shall make application first. The certification body shall check the consistency of the newly applied products against the certified ones and confirm the validity of the original certification against the newly applied products and carry out supplementary tests or inspection for the differences .  After being confirmed that the extension qualified by the certification body, new certification or supplement of the certification can be issued to the holder. Or maintain the original certification or keep as technical information.
4.2.2 The requirements of sample product     
The holders of the certificates shall firstly submit the technical materials related to the extending products and, as necessary, supply 6 samples according to the requirements of provision 3.2 of The Implementation Rules for checking by the certification body.  The items for checking shall be specified by the certification body for the samples required testing . 
5. Use of compulsory certification mark
The certificate holder shall follow the Regulation for Compulsory Product Certification Mark.
5.1 Derivations of Certification mark
The products listed in the Rule shall not be allowed to use any derivation of certification.
5.2 Design of the mark that allowed to use 
When certification concerns with safety only£¬the mark shall be:
5.3 Application of the mark
Standard specification mark shall be used.
5.4 Location of the marks
The certification marks shall be used on the products near the nameplate.
6. Suspension, cancellation and withdrawal of the certificates
The certificates shall be suspended, cancelled and withdrawn in accordance with the requirements of the document  Administration of Compulsory Product Certification .
7. Charge
The certification shall be charged by the certification body according to the national statutory structural fee chart.

Appendix 1

Safety Certification Product Test Design of Artificial Heart-lung Machine- Bubble Oxygenator

Type of  Product	Product	Standard	International Standard	Test items (Article No. of Standard)	Frequency (at least)	Equipment	Methods	Routine Test	Selected Type Test
Artificial Heart-lung Machine Bubble Oxygenator	Artificial Heart-lung Machine Bubble Oxygenator	GB 12261		1.          Marking and instruction outlook 7.1 £¬7.2£¬ 4.2 ~4.4	once/half a year or once /block*1	visual inspection	Appendix		¡Ì
				2.          Leakage      4.5	once/half a year or once /block*1	Precise pressure gauge	Appendix		¡Ì
				3  biological   Characteristic    4.6~4,.7	once/ a year	. portable steam sterilizer£¬Sterile bench£¬incubator etc	Appendix		¡Ì
				3                       Heavy metals       4.8	once/half a year or once /block*1	incubator/oven	Appendix		¡Ì
				4                       defoam       4.9	once/half a year or once /block*1	Roller pump	Appendix		¡Ì
				5                       Oxygenating Performance 4.11~4.15	once/half a year or once /block*1	blood /gas analyzer£¬roller pump£¬ water cooling and heating system£¬glass rotor flowmeter£¬self-balance micro-centrifuge	Appendix		¡Ì
				7  E.O.  Residue      4.16	once/half a year or once /block*1	gas chromatograph	Appendix		¡Ì
				8                 Sterility       4.16	once/half a year or once /block*1	incubator£¬sterile bench£¬portable steam sterilizer	Appendix		¡Ì

Note: 1. Certificated equivalent and speedy method is permitted on the routine test. 2.Type test should be carried out according to the parameter and method in the standard and in specific environment simultaneously. 3. Some items have no corresponding clauses£¬no fulfillment is required on the Standard column and Corresponding International Standard column. 4.Take a ¡°¡Ì¡±on the corresponding column for applicable test items. *1  once/block should be no less than once/ half a year. APPENDIX 3
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 t
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.

Corporate Link