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The guidelines for the technical review of the registration of ECG products are applicable to the second type of ECG machines in the Medical Device Classification Catalogue. The class code is now 6821.

Guiding principles for the technical review of ECG product registration

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The guidelines for the technical review of the registration of ECG products are applicable to the second type of ECG machines in the Medical Device Classification Catalogue. The class code is now 6821.

This guideline is applicable to the second type of electrocardiograph in the "Category of Medical Devices". The class code is now 6821.

Guiding Principles for Technical Review of ECG Product Registration I. Purposes and Basis of Guiding Principles

This guideline is mainly used to guide and regulate the technical review of registered products by medical device registration reviewers. The aim is to allow registered reviewers who are new to this type of products to have a basic understanding of the product's principles, structure, main performance, intended use, etc., and to allow technical reviewers to unify basic standards during product review technical reviews to ensure that Marketed products are safe and effective.

The basis for the preparation of these guidelines is: "Regulations for the Supervision and Administration of Medical Devices", "Administrative Measures for the Registration of Medical Devices" (Administrative Decree No. 16), "Provisions for Medical Device Clinical Trials" (Decree No. 5), , Regulations on the Management of Labels and Packaging Marks (Administrative Decree No. 10), "Administrative Measures for Medical Device Standards" (Administrative Decree No. 31), and other regulatory documents issued by the State Food and Drug Administration.

This guideline implements GB / T 191-2000 "Packaging, Storage and Transportation Graphical Signs", GB 9706.1-1995 "Medical Electrical Equipment Part 1: General Safety Standards", GB 10793-2000 "Medical Electrical Equipment Part 2 ECG Machine Safety" Specific requirements ", GB / T 14710-1993" Environmental requirements and test methods for medical electrical equipment ", GB / T16886.1-2001" Biological evaluation of medical devices Part 1: Evaluation and test ", GB / T 16886.5-2005" Biological evaluation of medical devices Part 5: In vitro cytotoxicity test ", GB / T 16886.10-2005" Biological evaluation of medical devices Part 10: Stimulation and delayed hypersensitivity test ", YY / T 0196-2005" One time Sexual use of ECG electrodes ", YY 0505-2005" Medical Electrical Equipment Part 1-2: General Safety Standards Collateral Standard: Electromagnetic Compatibility Requirements and Tests ", YY1139-2000" Single and Multi-channel ECG Machines ".

Guiding Principles for Technical Review of ECG Product Registration II. Explanation of Part of the Guiding Principles

The historical records of adverse events of such products are mainly searched from the National Food and Drug Administration's adverse event database. Clinical experts in related fields have also been consulted. No adverse events have been found for the time being.

Due to the continuous development and change of scientific and technological and clinical needs, the parameter composition of single-channel and multi-channel electrocardiographs is also constantly changing. This guideline explains the details of various parameters as much as possible in accordance with the current technical level and existing products. The most basic requirements. The main technical performance indicators are based on national standards and industry standards. All parties using this guideline should analyze and confirm the technical requirements of the product from the perspective of the specific situation of the product and the risk management of the medical device to ensure that the product is safe and effective.

Guiding Principles for Technical Review of ECG Product Registration III. Guiding Principle Writers

This Guiding Principle is drafted and prepared by the Shanghai Food and Drug Administration Certification and Evaluation Center in accordance with the work deployment of the Department of Medical Devices of the National Bureau in 2005. The preparation of this guiding principle has received strong support and assistance from the Shanghai Food and Drug Administration Medical Device Registry, experts from related parties, and relevant manufacturing enterprises. In the process of writing, make full use of all aspects of information and resources, comprehensively consider the current status and development trends of the guiding principles of medical devices, especially the factors of regulations, and try to make the guiding principles correct, comprehensive and practical.