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CCC attestation - national attestation approves supervisory management committee
From;  Author:Stand originally
The country is mandatory attestation product is medical the level of new edition state that X ray diagnostic equipment involves " medical and electric equipment the 2nd part: Safety of equipment of photography of layer of airframe of X ray computation is special requirement " (GB9706.18-2006) already released on October 17, 2006, carried out formally on July 1, 2007. To assure mandatory of product certification system carry out effectively, according to " when editing about the standard mandatory the announcement of product certification concerned problem " (the country adopts division couplet [2005]18 date) medium relevant provision, now will medical equipment of body layer photography carries out the X ray computer in X ray diagnostic equipment the item that new edition standard concerns and requirement announcement are as follows, carry out about unit comply with each please.

One, medical the X ray computer in X ray diagnostic equipment equipment of body layer photography detects the basis is " medical and electric equipment the first part: Safe and current requirement " (GB9706.1-1995) wait for 6 states level, this standard change involves GB 9706.18 only, other level was not changed;

2, rise from July 1, 2007, attestation, detect the job must be carried out according to new edition standard;

3, the standard is changed edition transfer period for on July 1, 2007 on June 30, 2008, hold a witness to should be in afore-mentioned transition period introversion appoints attestation to the orgnaization submits application and complete standard transition. For convenience enterprise, if hold,the witness is changed to what attestation orgnaization offers corresponding product or cycle answer is evaluated (should product answer evaluates cycle to be 4 years) , attestation orgnaization can affirm what the project plans new edition standard to difference detects when the product is changed or cycle answer is evaluated hair attestation certificate is traded after detecting.

In view of X ray computer equipment of body layer photography is in production, installation, carry, the characteristic that debugs a respect, changing edition transfer period inside, if hold a witness,was not changed to what attestation orgnaization offers corresponding product or cycle answer evaluation, hold a witness to be able to refer those who accord with new edition standard to detect report, by appoint detect the orgnaization undertakes checking, issue confirm a report, attestation orgnaization will trade hair attestation certificate accordingly, detect arrangement the orgnaization is in hold a witness to put forward new standard of the basis when the product is changed or cycle answer is evaluated to undertake detecting.

If hold a witness to transfer in certificate changeover period inside cannot offer those who accord with new edition standard to detect report, appoint attestation orgnaization to will be in transfer period its attestation letter is cancelled when the end.

This the standard is changed edition be opposite only overall undertake detecting, to safety component need not send appearance to detect alone. When product change detects, should undertake difference experiments, when cycle answer is evaluated, should undertake whole project detects.
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