IMPLEMENTATION RULES-Electrocardiographs

Ref. No. CNCA-08C-032:2001

IMPLEMENTATION RULES FOR COMPULSORY CERTIFICATION OF MEDICAL DEVICES
Electrocardiographs
Announced on Dec.7, 2001 Implemented on May 1, 2002
Certification and Accreditation Administration of People's Republic of China

1. Scope
Electrocardiographs in this document involved is intended for the production of detachable electrocardiographs for diagnostic purposes, including vector-cardiographs and equipment for stress testing.
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.
3.1.2 Application documents
The formal application shall be submitted with the following documents:
1) Instructions for use, technical description and maintenance manual.
2) Assembly drawing, principle diagram, circuit diagram and layout of components of the product.
3) Product inspection/testing report (including basis and method of testing).
4) History of the factory and its ability of manufacturing the product.
5) 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 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 of samples shall be one set and those for components tested accompanying the appliances shall be according to the requirements of appendix 1.
3.2.2 Test standards, items and methods for type testing
3.2.2.1 Test standards
1) GB 9706.1-1995 (idt. IEC 60601-1:1988, + A1:1991)
Medical electrical equipment – Part1: General requirement for safety
2) GB10793-1999 (idt.IEC 60601-2-25:1993)
Particular requirements for the safety of electrocardiographs
3.2.2.2 Test items
The test items for safety shall include all appropriate items specified in the standards of GB 9706.1 and GB10793.
3.2.2.3 Test methods
The type testing shall be carried out according to the methods specified and/or referred in these two standards.
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.
3.3.1.1Assessment 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 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 safety critical parts shall be identical with those declared in type testing and confirmed by certification body.
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 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 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 tale corrective actions compliance with modification, and the time should not exceed 3 months. 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 for certification
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 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 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 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:
a. The items in question relating to the construction consistency inspection.
b. The items relating to critical parts, which are not in consistency with those submitted for the initial type testing.
c. Safety items difficult to judge without testing, or major safety items, or safety items likely to change, such as:
1) Marking on the outside (to be carried out according to clause 6.1 in GB 9706.1-1995).
2) Protective earthing resistance (resistance to be calibrated between regulated parts, to be implemented according to clause18 in GB 9706.1-1995, if applicable).
3) Continues leakage current (including earthing leakage current, enclosure leakage current and patient leakage current, to be implemented according to clause19 in GB 9706.1-1995).
4) Dielectric strength (to be carried out according to clause6.1 in GB 9706.1-1995).
If the consistency and safety of products were doubted during the inspection, the inspector has the rights to have sampling test for the certified product.
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 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 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 store house)
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 testing items are the following:
Following items are according to GB 9706.1-1995 and GB10793-2000:
1) Identification, marking and documents
2) Limitation of voltage and/or energy
3) Enclosures and protective covers
4) Protective earthling resistance
5) Continuous leakage currents and patient auxiliary current (under operation temperature and after humidity preconditioning treatment)
6) Dielectric strength (under operation temperature and after 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) Protection earthing – terminal and connections
The certificate body 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 modification of the certificates
4.1 Maintenance of the certificates
The Implementation rules specify 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 certificate 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 scope of the Special Rules shall not be allowed to use the deformed certification marks of any shape.
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.