ISO 11607-1:2019
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ISO 11607-1:2019
70799
No disponible en español

Estado : Publicado (En proceso de revisión)

es
Formato Idioma
std 1 173 PDF + ePub
std 2 173 Papel
  • CHF173
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Resumen

This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.

It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

It does not describe a quality assurance system for control of all stages of manufacture.

It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

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Informaciones generales

  •  : Publicado
     : 2019-02
    : Norma Internacional en proceso de revisión sistemática [90.20]
  •  : 2
     : 44
  • ISO/TC 198
    11.080.30 
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