IMPLEMENTATION RULES-Artificial Heart-Lung Machine Silicon rubber pump tube

Ref. No.CNCA-08C-039:2001

IMPLEMENTATION RULES FOR COMPULSORY CERTIFICATION OF MEDICAL DEVICE
Artificial Heart-Lung Machine
Silicon rubber pump tube
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 Artificial Heart-Lung Machine Silicon rubber pump tube, which is installed on the pump of artificial heart-lung machine for blood transport during extracorporeal blood circulation.
2. Certification model
Type testing + Initial factory inspection + Follow up inspection
3. General requirements for certification
3.1 Application for certification(http://china-ccc-certification.com/171.html)
3.1.1 Defining application unit for certification
Principally, products of one specification shall be defined as one application unit, products of a same factory but different producing sites shall be applied separately when making application for certification, details see appendix 1.
3.1.2 Application documents
The applicant shall submit related documents when applying formal certification, at least including:
1) Connecting of the product's structure;
2) Product manual in Chinese;
3) Test report of safety test for product (if have);
4) Description of the difference between the different specification of products in the same application unit.
3.2 Type testing
3.2.1 Sample delivery for type testing
3.2.1.1 The principles of sample delivery
The samples delivery for type testing shall be selected from representative samples.
3.2.1.2 Samples delivery
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 quantities and requirements of samples see 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
YY91048 Artificial Heart-Lung Machine Silicon rubber pump tube
3.2.2.2 Test items
The test items for safety shall include all appropriate items specified in YY91048.
3.2.2.3 Test methods
The type testing shall be carried out according to the requirements of YY91048 and standards and/or test methods referred in the standards.
3.3 Initial inspection of the factory
3.3.1 Contents of the inspection
3.3.1.1 Assessment of factory quality assurance ability
Compulsory Product Certification Requirements for Factory's Quality Assurance Ability (appendix 3) is the basic requirements covered by this rules for the initial inspection of the factory.
3.3.1.2 Check of conformity of the product
The inspection for conformity 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 specification of products, each specification product shall be sampled 12 pieces. 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 construction of the products to be certified shall be identical to those of the samples for the type testing;
3)The products to be certified shall be identical with those declared in type test and confirmed by the certification body.
The certified products shall be sampled for test by inspector, if there is a question in the inspection results. The samples shall be chosen from the qualified product produced in the factory. The quantity of the samples is 12 pieces, which shall be tested by the designated inspection body. No inspection body 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 conformity 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 appropriate 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 qualified.
Certification shall be terminated if the safety test result is unqualified.
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 factory 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 specified periods. Only after being confirmed by the inspection group, certificate is recommended to issue to the factory by the certification body;
3) If severe nonconformity is found or the factory 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, the certificates will be issued. The use 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 making the certificates.
The time frame for type testing(including making safety type testing reports) should take 45 working days.
The time frame for submitting the factory inspection report shall be within 5 working days.
The time frame for evaluating on certification results, approving and making certificates should not exceed 5 working days.
3.5 Follow-up inspection
3.5.1 The frequency of the follow-up inspection for certification
3.5.1.1 The follow-up inspection shall be implemented once at least every year after getting the certificates for 12 months.
3.5.1.2 The frequency of inspection shall be increased if occurring any of the following cases:
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 with sufficient reasons;
3) Sufficient information indicates that the conformity or the consistency of certified products might be affected due to the changes in organization structure, production condition and the quality management system of the factories.
3.5.2 Contents of the follow-up inspection
3.5.2.1 Model of the follow-up inspection
Re-assessment of factory + Certified products conformity check
3.5.2.2 Re-assessment of factory quality assurance ability
The Re-assessment for factory quality assurance ability shall be implemented within 4 years after attaining the certificate and the scope shall cover all contents of Requirements for factory quality assurance ability. The time frame for the re-assessment should take 1 to 2 man-day for each processing premises.
There shall be an overall inspection to the factory in the 5th year of attaining the certificate according to Requirements for factory quality assurance ability. The scope and time shall be same as the initial factory inspection.
The span for an overall inspection period shall be of 4 years.
3.5.2.3 Check of conformity of the products
In spite of implementing as 3.3.1.2 of this rules, spot test to the production line test items specified in Test program for compulsory certification product (appendix 2) shall also be implemented.
Sampling test shall be carried out by application unit in the 5th year of attaining the certificate. In principle, 12 pieces of samples shall be chosen from each unit shall be and delivered to the designated inspection body for test. Specific sampling and test requirements shall be implemented as 3.2 of this rules. If the certified products have not been changed before, the certification body may adopt sampling test or document inspection by real conditions.
3.5.3 Sampling & testing for follow-up inspection
If need to implement sampling test for the certified products, take 12 pieces by specification for each category of certified products and test. The sampling test shall be carried out by designated inspection body. Test items specified in standard of 3.2.2.1 of this rules shall be test items for follow-up inspection.
Key test items:
According to following in YY91048:
(1) Physical and mechanical property
(2) Pyrogen
(3) Abnormal toxicity
(4) Hemolysis
(5) Trace element and heavy metal
(6) Chemical property
(7) Marking and packing of pump tube
The certification body may implement sample test on different safy structures on different products, parts which have serious effects on safety performance of the products and suspect parts of the safety design of the products. Other items specified by the standard may be adopted too.
3.5.4 Evaluation of follow-up inspection results
The certificates can be retained and the certification marks can be continuously used upon qualified 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 change of the certificates
4.1 Maintenance of the certificate
The certificate of the products covered by this Rules itself doesn't indicate specific expiry date. The validity of the certificate depends on the follow-up inspection.
4.2 Change of the products covered by the certificates(http://china-ccc-certification.com/225.html)
4.2.1 Procedure for change
The certification holder shall first apply for change of products covered in the same unit of certified products and the certification body will review the conformity of the extension product with original certified product and then verify the effectiveness of previous certification results on the extension product, to decide the need for additional tests or inspection based on the differences. After confirming the extension has met the requirements, either a separate certificate can be issued or maintain the original certificate for recording according to real conditions.
4.2.2 The requirements of sample product
The holders of the certificates shall choose 12 samples in 3.2 of this Rules for checking by the certification body if need to test samples. The items for checking shall be specified by the certification body.
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 derivations of certification mark.
5.2 Design of the mark that allowed to use
5.3 Application of the mark
Standard specification mark(http://china-ccc-certification.com/148.html) shall be used.
5.4 Location of the marks
The certification marks shall be used on the packing box of the products.
6. Suspension, cancellation and withdrawal of the certificates
The suspension, cancellation and withdrawal of the certificates shall follow Regulations for Compulsory Product Certification.
7. Charge
The certification fee shall be charged by the certification body according to related regulations of China.