Medical devices registers a product " standard name " the work out explains

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Medical devices registers a product " standard name " the work out explains

One, product introduction

Main content incorporates principle of structure, job, anticipate the purpose is mixed already approved domestic and internationally appear on the market the circumstance of same product.

2, whether is the material that contacts with human body already clinical on had applied, whether does its security, dependability get a proof:

1)
Already applied at clinical -- everybody is accepted (infusion implement, heart valve) ;

2)
Just began to apply, did not gain ground -- (offer a proof material, publish on professional, industry, journal, clinical unit applies its security, dependability to get a proof) ;

3)
New material -- must have biologic evaluation and test.

3, the relative standard that cite or consults and data:

Cite of the file arrange order: Standard of GB, YY, ISO, IEC, press suitable serial number of the standard to arrange.

4, the basis with administrative firm category:

1)
Medical devices classifies catalog;

2)
Medical devices classifies regulation;

3)
Concerned medical devices classifies limitted announcement.

5, the basis with main technique firm index:

1)
Chemical performance side (include material to analyse (burn residual, microelement, monomer) or appliance dissolve gives content to analyse (reductive material, acid-base value, heavy metal, not volatile, ultraviolet set limit to of absorbance, hangover, microelement) , in controlling finished product harmful composition, processing aid, sterilization agent remain) ;

2)
Physical performance side (should provide a product each clinical use requirement) ;

3)
The environment experiments (stability test)

4)
Electric safety (or biology consistence) respect

5)
Other

6, the product measures a report oneself

For report of product routine inspection test

7, the issue that other needs to explain

1)
Technical index and relevant travel mark, GB is in differently;

2)
Products plan decides the concerned document of index explains;

3)
Other

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Unit name

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