ISO 8871-5:2016
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 10
- Дата публикации:
- 13 октября 2016 г.
- Издание:
- ISO IS 8871 edition 2 version 1
- ICS:
- 11.040.20
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
Abstract
Overview
ISO 8871-5:2016 - "Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing" defines functional requirements and test methods for elastomeric closures (rubber stoppers) used with vials that are pierced by metal injection needles. The standard specifies measurable criteria and normative test procedures (Annexes A–D) to assess penetrability, fragmentation, self‑sealing and aqueous solution tightness, and supports container closure integrity evaluation for multidose and single‑dose pharmaceutical products.
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