T/ZAMEI 9-2024 Active Group standards

T/ZAMEI 9-2024 High-definition rigid endoscope

Publish Date: 2024-12-30 Implement Date: 2024-12-31 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/ZAMEI 9-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical optical instruments and equipment, and endoscopes

ICS Name: Other medical equipment

Publish Date: 2024-12-30

Implement Date: 2024-12-31

Scope

Scope: This document specifies the terms and definitions, technical requirements, test methods, manufacturing, inspection rules, labels and accompanying materials, packaging, transportation and storage, and documentation for high-definition rigid endoscopes (hereinafter referred to as endoscopes). This document applies to optical high-definition rigid endoscopes with a diameter of less than 6mm. Main technical content: 4. Technical requirements 4.1 Optical performance 4.2 Mechanical performance 4.3 Interconnection conditions 4.4 Interface safety 5. Test methods 5.1 Optical performance 5.2 Mechanical performance 5.3 Interconnection conditions 5.4 Interface safety 6. Manufacturing 7. Inspection rules 7.1 Factory inspection 7.2 Type inspection 8. Labels and accompanying materials, packaging, transportation and storage 8.1 Labels and accompanying materials 8.2 Packaging 8.3 Transportation 8.4 Storage 9. Documentation