ISO 9187-2:2010
Injection equipment for medical use — Part 2: One-point-cut (OPC) ampoules
Injection equipment for medical use — Part 2: One-point-cut (OPC) ampoules
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 4
- Дата публикации:
- 30 сентября 2010 г.
- Издание:
- ISO IS 9187 edition 2 version 1
- ICS:
- 11.040.20
ISO 9187-2:2010 specifies materials, dimensions and requirements for forms of one-point-cut (OPC) ampoules (forms B, C and D) for injectables. Ampoules complying with ISO 9187-2:2010 are intended for single use only.
Abstract
Overview
ISO 9187-2:2010 is an international standard established by the International Organization for Standardization (ISO) that specifies requirements for one-point-cut (OPC) ampoules used as injection equipment for medical use. This standard focuses on forms B, C, and D of OPC ampoules designed specifically for the storage and administration of injectable pharmaceutical products. ISO 9187-2:2010 outlines detailed specifications regarding materials, dimensional criteria, breaking force, and quality parameters to ensure patient safety and optimal product performance.
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