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Normas DIN – AENOR
DIN EN ISO 1135-3:2014-12

DIN EN ISO 1135-3:2014-12

Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO/DIS 1135-3:2014); German version prEN ISO 1135-3:2014 / Note: Date of issue 2014-11-07

Matériel de transfusion à usage médical - Partie 3: Appareils non réutilisables pour prélèvement de sang (ISO/DIS 1135-3:2014); Version allemande prEN ISO 1135-3:2014 / Attention: Date de parution 2014-11-07

Transfusionsgeräte zur medizinischen Verwendung - Teil 3: Blutentnahmegeräte zur einmaligen Verwendung (ISO/DIS 1135-3:2014); Deutsche Fassung prEN ISO 1135-3:2014 / Achtung: Erscheinungsdatum 2014-11-07

Fecha Anulación:
2017-05 /Withdrawn
Equivalencias internacionales:

ISO/DIS 1135-3 (2014-09)

prEN ISO 1135-3 (2014-09)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 1135-3:2017-05

Resumen:
This part of EN ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only. The materials and the components of the sets are validated by various test methods. The manufacturer shall select appropriate test methods to comply with the requirements laid down in this part of EN ISO 1135. Secondary aims of this part of EN ISO 1135 are to provide a) specifications relating to the quality and performance of materials used in transfusion equipment; b) a unified presentation of terms and designations for such equipment. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of EN ISO 1135.
Keywords:
Blood, Blood taking, Blood transfusion equipment, Blood-taking set, Cannulas, Disposable, Disposables, Equipment for single use, Haematology, Inspection, Marking, Materials, Medical equipment, Medical sciences, Packages, Specification (approval), Specifications, Sterile equipment, Sterility, Testing, Transfusions
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