T/JSAS 016-2021 Active Group standards

T/JSAS 016-2021 Enema lubricating jelly (the name varies from region to region)

Publish Date: 2021-09-25 Implement Date: 2021-09-25 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/JSAS 016-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical hygiene products

ICS Name: Medical materials

Publish Date: 2021-09-25

Implement Date: 2021-09-25

Scope

Scope: This document specifies the performance indicators, test methods, inspection rules, and marking, packaging, transportation, and storage of lubricating jelly for colonoscopy. This document applies to lubricating jelly for colonoscopy, which consists of lubricating jelly and plastic bottles (bags). The lubricating jelly is composed of glycerin, dimethyl silicone oil, carbomer, sodium carboxymethyl cellulose, nipagin ethyl ester, and purified water, supplemented with solubilizing agents (propylene glycol) and alkaline regulators (sodium hydroxide). Main technical contents: 4.1 The raw materials and plastic bottles meet the requirements of the "Chinese Pharmacopoeia", and the plastic bottles comply with the requirements for pharmaceutical packaging materials. 4.2 Appearance: The lubricating jelly is a colorless, transparent or slightly white gel-like liquid with uniform color and no visible impurities. 4.3 Specifications: The filling quantity of the lubricating jelly should be in accordance with the marked specifications, with an error of ±10%. 4.4 Chemical properties: The pH value should be 5.5–7.0. The relative density of the lubricating jelly is 1.00–1.10. The glycerin content in 1g of lubricating jelly for colonoscopy should not be less than 150mg. The iron salt should not exceed 0.15mg/g. The heavy metals, calculated as lead, should not exceed 0.03mg/g. The viscosity of the lubricating jelly for colonoscopy should not be less than 10,000mPa·s. 4.5 Sealing: According to the test method in 5.4.7, the bottle mouth and cap should fit properly and not slip. According to the test method in 5.4.7, the lubricating jelly for colonoscopy should not have water leakage or foaming. 4.6 Microbiological indicators: The total bacterial count of the lubricating jelly for colonoscopy should be ≤100 cfu/g, and the total fungal count should be ≤100 cfu/g. Escherichia coli, Pseudomonas aeruginosa, and Staphylococcus aureus should not be detected.