BS EN ISO 8871-1:2004
Elastomeric parts for parenterals and for devices for pharmaceutical use - Extractables in aqueous autoclavates
Название (английский):
BS EN ISO 8871-1:2004
Elastomeric parts for parenterals and for devices for pharmaceutical use - Extractables in aqueous autoclavates
- Статус документа:
- D
- Формат:
- Электронный (PDF)
- Дата публикации:
- 8 сентября 2004 г.
- ICS:
- 11.040.20
- Технический комитет:
- CEN
- SKU:
- BS EN ISO 8871-1:2004
Тип поставки:
Язык документа:
Срок поставки:1 рабочий день
Цена:50 €
Abstract
1 Scope
1.1 This part of [ISO 8871](/search?q=ISO%C2%A08871) defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates (see Clause 4) and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of [ISO 8871](/search?q=ISO%C2%A08871) are regarded as minimum requirements.
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