Norm

NEN-ISO 8871-1:2003 en

Onderdelen van elastomeer voor parenteralia en voor hulpmiddelen voor farmaceutisch gebruik - Deel 1: Extraheerbare bestanddelen in waterige extracten na autoclaveren

  • Deze norm is ingetrokken sinds 31-03-2005

98,05

Over deze norm

Status Ingetrokken
Aantal pagina's 19
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-10-2003
Taal Engels
This part of ISO 8871 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 are regarded as minimum requirements. 1.2 This part of ISO 8871 is applicable for the categories of elastomeric parts given in Clause 3; specific requirements, however, are laid down in the relevant International Standards dealing with the items or devices listed in Clause 3. 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.

Details

ICS-code 11.040.20
Nederlandse titel Onderdelen van elastomeer voor parenteralia en voor hulpmiddelen voor farmaceutisch gebruik - Deel 1: Extraheerbare bestanddelen in waterige extracten na autoclaveren
Engelse titel lastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
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