||Attestation of CE
|Medical Devices-general (MDD)
The product wants to pass the attestation of CE smoothly, needing to work well three works of the aspects.It a, the collections have relation with attestation product the EU technique laws and the EU( EN) standard, pass the digest and absorb, bring into the business enterprise product standard.It two, the business enterprise produces according to the standard organization of above product strictly, is also a request that chases the above-mentioned technique laws and EN standard, carry through the design development of the business enterprise product and produce the whole process of the manufacturing.The third, the business enterprise must press ISO9000+ the standard of ISO13485 sets up and supports the quantity system, and obtain the ISO9000+ attestation of ISO13485.
The EU technique laws and standard of ENs that the gamma knife CE attestation should follow
For currently 18 industries product instruction that EU release already, see from the structure of these instructions, they can is divided into the perpendicular instruction and level instructions.The perpendicular instruction is to take concrete product as the object, such as the medical treatment apparatus instruction;The level instruction is applicable to various product line, such as the electromagnetism and permit sex instruction, it is applicable to zero parts products of all electric appliances and electronicses.
For the gamma knife, the instruction that apply has Clause 14, Clause 1 and Clause 5s, namely:The 93/42/ EEC medical treatment apparatus instruction,73/23/ EEC low electric voltage( LVD) instruction 89/336/ EEC electromagnetism and permit sex( EMC) instruction.EU standard that supports these instructions is:(1)The EN60601-1 cures to use the electricity equipments the first part:Safe and in general use request;(2)The EN60601-1-1 cures to use the electricity equipments the first part:The safe and in general use request passes the No.1 correction;(3)The EN60601-2-11 cures to use the electricity equipments the second part:The γ shoots to tie to cure the safe appropriation request of equipments;(4)The EN60601-1-2 cures to use the electricity equipments the first part:The safety is in general use to request the 1.2 sections to proceed together the standard electromagnetism and permit sex- request and test.Among them(1),(2),(3) a standard is the gamma knife basis of the low electric voltage( LVD) test:(4) a standard is the gamma knife electromagnetism and permit sex( EMC) test of basis.
Gamma knife CE attestation procedure, contents
The EU is divided into four of the medical treatment apparatus products, namely:Ⅰ , Ⅱ A, Ⅱ b, Ⅲ .The Ⅰ product wants to add to stick the marking of CE, the way that can adopt to by oneself announce.Then the factory draws up the technique document file of the product, by oneself pressing relevant standard of EN to carry on the test or entrust the capable laboratory to the product to carry on the test at the same time qualified.Ⅱ A, Ⅱ b, the Ⅲ product wants to add to stick the marking of CE, then must the verification organization verification specify by EU.The EU still rules, this several product acquire the attestation of CE precondition is a manufactory to need it can lead the ISO9000+ the ISO13485 quantity system attestation, obtain the ISO9000+ the ISO13485 quantity system attestation certificate, and the certificate distribute the attestation organization that the unit should approve for the EU.ISO9000+ the ISO13485 quantity system attestation and attestation of CEs can carry on at the same time, but the certificate of CE must need the ISO9000+ after the ISO13485 quantity system attestation pass, the square can distribute.
Belong to to the classification gamma knife of the product according to the EU the Ⅱ b, its CE
attestation procedure and contents is as follows:
1) the business enterprise puts forward the attestation application toward the attestation
organization, and fill in the attestation inquiry list to hand over the attestation organization;
2) the attestation organization to application the attestation business enterprise puts forward the
quotation, business enterprise the signing confirm namely complete the contract;
3) the business enterprise hands over the ISO9000 toward the attestation organization+ the
ISO13485 quantity system document namely the quantity manual and the procedure document,
confess the certificate organization to carry on the system document's examine;The quantity
system is before examine, the business enterprise should have at least three quantity systems of
month to circulate the record, and complete 1-2 times the internal quantity system examine.
4) the attestation organization sends out the laboratory that the attestation product test notification approves for the attestation organization, the laboratory will carry on the low electric voltage( LVD) test and electromagnetisms and permit sex( EMC) test to the product of the application attestation.In the test if appear unqualified, change from the business enterprise the empress re- tests, until the test is qualified.Test be over, the laboratory has to experiment the report.
5) the business enterprise plait writes the technique document file of apply for the attestation product.( brief name the TCF document)Above-mentioned experiment the report to also be one of the TCF document contentses.The document of TCF is a manufactory that applies for the attestation of CE toward an important document that the CE attestation organization hand over, it is the attestation organization examine to deliver the certificate of importance according to.Draw up the document of TCF must use English all.The document of TCF includes seven contentses:Brief introduction of ① : the specification of the product of ② describe;Main file contents of the ③ design;The ④ risk analysis and valuation;The ⑤ test report and the clinic examine a patient the data;The control of the ⑥ document design;The avowal declaration of the ⑦ product application.
6) the attestation organization to the ISO9000 of the business enterprise+ the ISO13485 quantity system and document of TCFs carry on the first trial.The attestation organization will point out the quantity system and document of TCFs after the first trial in the existent problem, business enterprise should on these grounds perfect quantity system and document of TCF.
7) the attestation organization to the ISO9000 of the business enterprise+ the ISO13485 quantity system and document of TCFs carry on formality's examine.
8) examine to pass formally after, the attestation organization will sign the frame agreement with business enterprise, the everyone should follow the scope that the principle and products uses the marking of CE after obtaining the certificate of CE definitely, and with the processing way that the hurl tell.Then distribute the ISO9000+ the ISO13485 quantity system attestation certificate and CEs symbolize the certificate.
Generally speaking, apply for attestation to the attestation organization to distribute the certificate to need the from half a year to a year about from the business enterprise.
The usefulness of the CE marking
The product obtained the attestation of CE, can symbolize with a CE, but be limited by to apply for the attestation only the TCF that hand over in the product describe, stick to mean that that product can enter the EU market and request the product to obtain the nation and the region that the attestation of CE then can enter that region up the CE marking.The term of validity of the product CE attestation is five years.The certificate of CE that we acquire this time is the data of the generation head gamma knife because of the document of TCF hand over, so the CE marking can add to stick only in generation head gamma knife.Have the graveness to change such as the head gamma knife, the document data that must hand over to change toward the CE attestation organization afresh attestation, otherwise can't add to stick the marking of CE.
The general outline and the classification of the medical treatment apparatus
Actively the transplant type medical and surgical equipment( AIMD 90/385/ EEC)
Any through surgical operation or the medical treatment method, all or the part transplant the human body, or insert the apposition to stay in the natural teaching of Confucius of human body its active type medical and surgical equipment.
Medical and surgical equipment( MDD 93/42/ EEC)
Manufactory design usage in any human body alone or combination the instrument, equipments of the usage, equip, material or other products, contain necessity of software, want to reach following various circumstance:
The · examines a patient, prevent°from, track, cures to ease the disease
The · examines a patient, track, cures or fixs the whole wound or disabled parts
The · dissect or the physiology process in its inquisition, displacement or fix whole
The · birth control
And these devices shouldn't have the pharmacology, immunity or metabolism, but can have the adjutant function.
The body examines a patient the medical and surgical equipment outside( IVDD 98/79/ EC)
Manufactory any design alone or the combination use of try, try a product, correct the machine, control the material, a set, instrument, equipments, equip, or system, its purpose only or mainly provide to check the body, include the blood and organize, the derivatives of the human body, test data outside the body such as:
- Physiology or pathologic appearance
- Inborn abnormality- be safety by the body with patient with and permit sex
- Track the measure of the treatment
Check the container of the body, regardless whether is the vacuum form, be to accept to pack the check body of come from the human body especially, the one who want to carry on the body outside diagnostic test purpose, see as for the body to examine a patient the medical and surgical equipment outside.
The medical treatment product rule in the instruction of MDD, specify the organization to need to participate to match the sex valuation procedure.Specify the organization needs to match the appendix of MDD 11 of need.
The German because of F pass by approbation, match the appendix of MDD 11 of need and for EU of qualified specify the organization.
The medical and surgical equipment classification
The appendix of the medical and surgical equipment instruction 9 categorize medical and surgical equipment 18 rule. The manufactory needs to see the product use to do the product classification:
The rule 1 to 4 invade the type medical and surgical equipment not
The rule 5 tos 8 invade the type medical and surgical equipment
12 further programmings of the active medical and surgical equipments of the rule 9 tos
18 special rules of the rule 13 tos
According to the above provision, the medical and surgical equipment risk of the patient or user and match sex valuation procedure and can therefore take in to judge. The risk is more high, match sex valuation procedure and also would be more strict.