标准编号：ISO 11040-4:2015
中文名称：预灌封注射器 第4部分：注射剂和消毒未装配填补用注射器
英文名称：Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
发布日期：2015-04
标准范围
This part of ISO 11040 applies to— tubing-glass barrels (single-chamber design) for injection preparations, and— sterilized subassembled syringes ready for filling.It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.This part of ISO 11040 also specifies those components that are part of the sterilized subassembledsyringe ready for filling.Glass barrels and sterilized subassembled syringes ready for filling in accordance with this part ofISO 11040 are intended for single use only.Components to complete the subassembled syringe, such as plunger and rod, are not specified in thispart of ISO 11040.NOTE Attention is drawn to applicable national or regional regulations such as Ph. Eur., USP, or JP. Whererelevant, specific references to Ph. Eur., USP, and JP have been given in specific clauses or subclauses of this partof ISO 11040.
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