T/CVDA 1-2019 Active Group standards

T/CVDA 1-2019 Animal pre-filled plastic mammary injection device

Publish Date: 2019-12-18 Implement Date: 2020-05-01 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/CVDA 1-2019

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Laboratory medicine

Publish Date: 2019-12-18

Implement Date: 2020-05-01

Scope

Scope: This standard specifies the terms and definitions, product classification, technical requirements, characteristic indicators, test methods, inspection rules, marking, packaging, transportation, and storage of pre-filled plastic breast injectors for veterinary use. This standard applies to the packaging of uterine injections and breast injections for veterinary use. This standard applies to plastic pre-filled injectors manufactured by injection molding using polyethylene (PE) and polypropylene (PP) as the main raw materials. Main technical content: 5. Technical requirements 5.1 Raw materials: The main raw materials of each component are polypropylene (PP) or polyethylene (PE). 5.2 Appearance quality: The appearance quality requirements shall comply with Table 1. Table 1 - Appearance quality requirements Item Name Requirements The needle head should be flat, without flying edges, bending, cracks, or nozzle defects. The inner wall of the tube should be smooth and free of color differences. The tube cap should be fully molded with uniform color and without cracks or deformation. The push rod should be fully molded with uniform color and without deformation. The piston should be fully molded without flying edges or obvious shrinkage. 5.3 Characteristic indicators: The characteristic indicators shall comply with Table 2. Table 2 - Characteristic indicators Item Name Requirements Tightness: There should be no leakage at the tube cap seal and piston seal. Lubricity: The push rod and piston should move smoothly without sudden stops. Residue on ignition *: Not more than 0.1% (the residue left in the bottle with light-shielding agent shall not exceed 3.0%). Dissolved substances *: The PH change value: The difference between the two should not exceed 1.0. Heavy metals: Not more than one hundredth of a percent. Oxidizable substances: Not more than 1.5ml. Non-volatile substances: Not more than 12.0mg. Discoloration test *: Not darker than the blank sol