Medical devices registers product standard to write a standard

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Medical devices registers product standard to write a standard

1, limits

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This standard stipulated medical devices registers product standard to write a standard.

2, normative sex citation

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The clause in following file makes this normative provision through this normative adduction. The citation that always fixes date, its subsequently all modification sheet (the content that does not include correct errors in printing) or revised edition all does not apply to this standard, however, encourage each research that comes to an agreement according to this standard to whether can use the newest version of these files. The citation that always does not fix date, its latest edition applies to this standard originally.

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Medical devices monitors regulation

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Medical devices registers administrative measure

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Standard of medical devices runs way

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GB/T1.1-2000 standard chemical industry makes guideline the 1st part: Standard structure and write regulation

3
Requirement

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Register product standard to should include following and basic content commonly:

3.1
Register product standard name

..Register product standard name to answer with register product name to agree, should avoid to use trade name to register product name certainly.

3.2
Introductive

..Register product level due and introductive, basically give out following news:

The consistency degree of occupation standard or 3.2.1 specifications and corresponding national level, international standard;

3.2.2 specifications this standard and other standard or before the relation of edition standard (if have) ;

3.2.3 when necessary, show the nature of the appendix in this standard

3.3
Limits

..Each aspects that the object that states this standard standard clearly and place involve, the bounds with applicable demonstrate.

3.4
Normative sex citation

..Should include to guide language and compasses plasticity to cite the schedule of the file. The file cites in schedule arrange order to be: Standard of national level, occupation standard, international and normative sex file.

3.5
Classify and classify mark

..The product that asks to accord with a standard (series) build code of a classification, model, product or product number, can include norms, dimension, basic parameter to wait.

3.6
Security and effectiveness ask

..Security and the write requirement of Lv of take an examination rationality that effectiveness asks, effectiveness, security, applicability, guide get chime of gender, integrality to move a gender.

3.6.1
Safety performance requirement

..Should notice to choose applicable and following level:

..GB 9706 is medical and electric facilities is general and safe requirement series standard;

..Biology of GB/T 16886 medical devices evaluates series standard;

..Biology of material of YY/T oral cavity evaluates series standard;

..Reach other safety to ask.

3.6.2
Effective performance asks

..Should include main function and average performance target. Have the product of national level, occupation standard, its function should accord with the requirement of afore-mentioned standards. Without the product of national level, occupation standard, its function should be anticipated according to the product by product manufacturer applied circumstance is affirmatory, in carrying performance demand and manual bright shown technical index is coincident.

3.7
Try proved recipe way

..Try proved recipe law to answer with the requirement relatively. Experiment method should use the standard experiment method that already issued commonly. When if do not have active experiment,the method can be used, experiment method of the regulation should be had maneuverability and but repeatability. The test instrument that uses in the experiment, equipment, tool and standard sample general and due formulary accuracy class.

3.8
Test gauge criterion (if have)

3.9
Mark, label (if have)

..The requirement that should wait according to product characteristic, use requirement, relative standard and legal laws and regulations provides mark, ticket.

3.10
Pack, carry, store (if have)

..The packing requirement that should provide a product according to the characteristic of the product and relative standard, carry store requirement. Accompanying documents is the one part of the product, answer accompanying documents to make a provision.

3.11
Appendix (if have)

..Answer to list in standard appendix standard text is added