Normative references
The provisions of the following documents become the provisions of this specification by reference. All subsequent change orders (excluding errata) or revisions of dated references do not apply to this Code, however, parties to agreements under this Code are encouraged to investigate the possibility of using the most recent versions of these documents. Where a document is cited without date, the latest version applies to this
Specification.
Medical Device Supervision and Administration Regulations
Methods for the Administration of Medical Device Registration
Methods for the Administration of Medical Device Standards
GB/T 1.1-2000 Standardized Work Guidelines Part 1: Standard Structure and Preparation Rules
Requirements
Registration of product standards should generally include the following basic content:
3.1 Registered Product Standards
Registered product standards should include the following basic content.
3.1 Registered product standard name
Registered product standard name should be consistent with the name of the registered product, and should avoid the use of trade names to determine the name of the registered product.
3.2 Preamble
Registered product standards should have a preamble, mainly to give the following information:
3.2.1 Description of the degree of consistency with the corresponding national standards, industry standards or international standards;
3.2.2 Description of the relationship between this standard and other standards or the previous version of the standard (if any);
3.2.3 If necessary. Explain the nature of the appendices in this standard
3.3 Scope
Clearly state the object of this standard specification and all aspects involved, indicating the boundaries of application.
3.4 Normative references
Should include introductory remarks and a list of normatively referenced documents. The order of cited documents in the list is as follows: national standards, industrial standards, international standards and normative documents.
3.5 Classification and classification mark
To meet the standard requirements of the product (series) to establish a classification, model, product code or product marking, which can include specifications,
size, basic parameters and so on.
3.6 Safety and validity requirements
Safety and validity requirements should be prepared taking into account the reasonableness, validity, safety, applicability, comprehensiveness, completeness
and coordination of the requirements.
3.6.1 Safety Performance Requirements
Attention should be paid to the selection of the following standards apply:
GB 9706 General Safety Requirements for Medical Electrical Equipment series of standards;
GB/T 16886 Biological Evaluation of Medical Devices series of standards;
YYY/T Biological Evaluation of Dental Materials series of standards;
and other safety requirements.
3.6.2 Effective performance requirements
Should include important performance and general performance indicators. There are national standards, industry standards of the product, its performance should be in line with the above standards
Requirements. There are no national standards, industry standards of the product, its performance should be determined by the product manufacturer in accordance with the expected application of the product, and
Keep the performance requirements and specifications expressed in the specification is consistent.
3.7 Test methods
The test methods shall correspond to the requirements. The test method should generally adopt the standard test methods that have been promulgated. If there is no existing test
The test method can be used, the specified test method should be operable and reproducible. Test instruments, equipment,
tools and standard samples used in the test should generally have the required level of accuracy.
3.8 Inspection rules (if any)
3.9 Signs, labels (if any)
Signs and labels shall be specified according to the product characteristics, use requirements, relevant standards and laws and regulations.
3.10 Packaging, transportation, storage (if any)
Should be based on the characteristics of the product and the relevant standards for the product packaging requirements, transportation and storage requirements. Randomized documents are a part of the product
Specifications should be made for randomized documents.
3.11 Appendix (if any)
Should be listed in the standard appendix to the standard body attached.