T/SAMD 0010-2024 Active Group standards

T/SAMD 0010-2024 Guidelines for inspection and testing of production processes for medical electronic instruments, application of basic functions and performance tests of an electrocardiograph machine

Publish Date: 2024-11-14 Implement Date: 2024-11-14 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SAMD 0010-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: X-ray imaging equipment

Publish Date: 2024-11-14

Implement Date: 2024-11-14

Scope

Scope: This document is applicable to the process inspection of electrocardiograph manufacturers. The inspection items, requirements, and methods set forth in this document are for manufacturers' reference. This document includes basic functions such as electrocardiograph display, printing, and storage, as well as basic performance requirements such as input impedance, common-mode rejection, and gain requirements. Manufacturers can determine the test items based on their actual situation. Main technical content: This document is applicable to the process inspection of electrocardiograph manufacturers. The inspection items, requirements, and methods set forth in this document are for manufacturers' reference. This document includes basic functions such as electrocardiograph display, printing, and storage, as well as basic performance requirements such as input impedance, common-mode rejection, and gain requirements. Manufacturers can determine the test items based on their actual situation.

Development Information

Related Standards

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GB 5665-1985 Abolished

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GB 10151-1988 Abolished

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GB/T 10149-1988 Terminology and symbol for medical X-ray equipment

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GB 11239-1989 Replaced

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