NF EN ISO 8871-1

NF EN ISO 8871-1

April 2005
Standard Current

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1 : Extractables in aqueous autoclavates

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.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2005

Number of pages

29 p.

Reference

NF EN ISO 8871-1

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-102-1

Print number

1 - 24/03/2005

International kinship

ISO 8871-1:2003

European kinship

EN ISO 8871-1:2004
Sumary
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1 : Extractables in aqueous autoclavates

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.

Replaced standards (2)
NF EN ISO 8871
December 1997
Standard Cancelled
Elastomeric parts for aqueous parenteral preparations.

NF EN ISO 8871/A1
December 1999
Standard Cancelled
Elastomeric parts for aqueous parenteral preparations

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Classification
    2
  • 4 Exigences
    2
  • 5 Échantillonnage
    2
  • 6 Appareillage et réactifs
    3
  • 7 Préparation des solutions pour essai
    3
  • Annexe A (normative) Aspect de la solution
    5
  • Annexe B (normative) Acidité ou alcalinité
    9
  • Annexe C (normative) Absorbance
    10
  • Annexe D (normative) Substances réductrices
    11
  • Annexe E (normative) Métaux lourds extractibles
    12
  • Annexe F (normative) Zinc extractible
    14
  • Annexe G (normative) Ammoniaque extractible
    15
  • Annexe H (normative) Résidus d'évaporation
    16
  • Annexe I (normative) Sulfures volatils
    17
  • Annexe J (informative) Détermination de la conductivité
    18
  • Bibliographie
    19
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