IMPLEMENTATION RULES-Implantable Cardiac Pacemakers

Ref. No. CNCA-08C-036:2001

IMPLEMENTATION RULES FOR COMPULSORY CERTIFICATION OF MEDICAL DEVICE
Implantable Cardiac Pacemakers
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 all types of wholly implantable cardiac pacemakers, but not cover pacemaker powered by isotope cells (nuclear-powered pacemakers).
2. Certification Model
Type testing + Initial inspection of the factory + 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
In principle, one type/model sample should be defined as one application unit. The products, of same manufacturer, but from different manufacturing premises, shall be in different application units. The products, of same manufacturer, but from different model/type, shall be tested the difference of the test items.
3.1.2 Application documents
The formal application shall be submitted for application certification and relational documents. At least it needs including the following documents:
1) Instructions for use and technical description of product.
2) Assembly drawing, principle diagram, circuit diagram and layout of components of the product.
3) Technical requirements of product.
4) Product inspection/testing report (including basis and method of testing).
5) The history of the factory and its ability of manufacturing the product.
6) List of the critical parts for the safety (including name, type/model, and specification, manufacturer, and executive standard and safety certification).
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 units of application for certification shall be selected and supplied for type testing. According to requirements, samples of other products covered by the application unit should be supplied for additional testing on differences.
3.2.1.2 Samples quantity/amount requirements
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 sample for one unit is one set.
3.2.2 Test standards, items and methods for type testing
3.2.2.1 Test standards
GB16174.1-1996 (idt. ISO5841-1:1989)
Cardiac pacemakers – Part1: Implantable pacemakers
3.2.2.2 Test items
The testing items for product is according to the standard of GB16174.1 -1996 (idt. ISO5841-1:1989) for all applicable items.
3.2.2.3 Test methods
The type testing shall be carried out according to the methods specified and/or referred in the standard of GB16174.1-1996
3.3 Initial inspection of the factory
3.3.1 Contents of the inspection
The contents of factory inspection shall include the factory quality assurance ability assessment and the products consistency check.
3.3.1.1 Assessment of factory quality assurance ability.
The Requirements for Factory Quality Assurance Ability is the basic requirements for the initial inspection of the factory (see appendix 1). If necessary, it may be according to the related stipulation carried out by the certification body
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. If more than one model are involved in the certification, at least one type/model sample shall be taken from each unit for the product consistency 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 constructions of products to be certified (mainly constructions in terms of safety) shall be identical with those of the samples for type testing.
3) The manufacturers of batteries and chips, which used in certification products, model and materials of batteries should be consisted with those declared in type testing and confirmed by certification bodies.
4) According to the requirements of GB16174.1-1996, manufacturers must mark the use life of batteries in normal setting in “clinical doctor manual” (including100%pacing, 50%pacing, 100%inhibition) and consisted with manufacturer's inspection report.
If the above contents were doubted during the inspection, the inspector has the rights to have sampling test for the certification product. The sample should be randomly sampled among the qualified products of factory. The quantity for sampling is one set concerned by the inspector according to the concrete condition. The samples should be tested by the testing bodies, which entrusted by certificate body and specified by state. The certification bodies may carry out sampling testing items according to the concrete condition.
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 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 certification results and approval of certification
3.4.1 Evaluation of the certification results
3.4.1.1 Evaluation of type testing results
If the testing items have non-conformity individually, but easily to modified, it is allowed to take corrective actions compliance with modification or re-sample delivery for testing. If there has anyone non-conformity item in re-sample delivery testing, the testing result judged as “Fail”. When all the testing items complied with the standards, the result shall be adjudicated 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
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, reports submission after inspection, evaluation of certification results and approval of certificates, etc.
The time for type testing should take 60 working days (including the time for preparing type testing report).
The factory inspection reports should be submitted within 5 working days.
Evaluating certification results and approving the certificates shall normally be completed within 5 working days.
3.5 Follow-up inspection
3.5.1 The frequency of follow-up inspection
3.5.1.1 The follow-up inspection shall normally be implemented at least once per year. The first follow-up inspection shall normally be implemented 12 months after the certificate being granted.
3.5.1.2 The frequency of inspection should be increased in 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 and EMC standards 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 system of the manufacturer and/or factories.
3.5.2 Contents of the follow-up inspection
3.5.2.1 mode of the inspection:
The model of follow-up inspection: re-assessment of factory quality assurance ability + check of consistency of products certified
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 person/day for each processing premises.
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) Pulse amplitude
2) Pulse duration
3) Pulse interval or pulse rate
4) Sensitivity
5) Pacing refractory period
6) Storage packages, marking and accompanying documents
7) Sterilized packages, marking and accompanying documents
After getting the certificate for the fifth year, the testing of supplying samples shall be compliance with the application unit.
In principle, every certification 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 3.2.2 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 test for follow up inspection
One set for every kind of certificate model product and battery 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.
Important test items are the following:
Following items are according to GB16174.1-1996:
1) Pulse amplitude
2) Pulse duration
3) Pulse rate or pulse interval
4) Sensitivity
5) Escape interval
6) Characteristics of programmable pacemakers
7) Storage packages, marking and accompanying documents
8) Sterilized packages, marking and accompanying documents
9) Temperature cycle test
10) Test of protection against defibrillation
The certification bodies may carry out the inspection items according to the concrete condition.
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 change of the certificates
4.1 Maintenance of the certificates
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 Change for covering product of certificate(http://china-ccc-certification.com/225.html)
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 modification 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 of extending 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 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 marking(http://china-ccc-certification.com/148.html) should be applied.
5.4 Location of the mark
The standard certification marks should be applied on product close to the nameplate.
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 the national statutory structural fee chart.