SIST EN ISO 9187-2:2011 PDF
Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)
Injection equipment for medical use - Part 2: One-point-cut (OPC) ampoules (ISO 9187-2:2010)
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 11
- Дата публикации:
- 14 декабря 2010 г.
- ICS:
- 11.040.20
- Технический комитет:
- VAZ - Healthcare
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
SIST EN ISO 9187-2:2011 is an international standard specifying the requirements for one-point-cut (OPC) ampoules used in medical injection equipment. Developed by ISO/TC 76 and adopted by CEN, this standard focuses on the materials, dimensions, and performance criteria for OPC ampoules-specifically forms B, C, and D-designed for injectables. These ampoules are intended for , ensuring safety and sterility for pharmaceutical applications. The standard aligns with , which covers ampoules for injectables in general.
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