International Standard
ISO 8871-1:2003
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates
Reference number
ISO 8871-1:2003
Edition 1
2003-10
International Standard
Read sample
ISO 8871-1:2003
33770
Published (Edition 1, 2003)
This standard was last reviewed and confirmed in 2019. Therefore this version remains current.

ISO 8871-1:2003

ISO 8871-1:2003
33770
Language
Format
CHF 129
Convert Swiss francs (CHF) to your currency

Abstract

ISO 8871-1:2003 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 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 are regarded as minimum requirements.

Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time.

Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.

General information

  •  : Published
     : 2003-10
    : International Standard confirmed [90.93]
  •  : 1
     : 19
  • ISO/TC 76
    11.040.20 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)