NA 176

DIN Standards Committee Health Technologies

Standards [CURRENT]

DIN EN ISO 8536-13
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO 8536-13:2016); German version EN ISO 8536-13:2016

Title (German)

Infusionsgeräte zur medizinischen Verwendung - Teil 13: Graduierte Durchflussregler zur einmaligen Verwendung mit Flüssigkeitskontakt (ISO 8536-13:2016); Deutsche Fassung EN ISO 8536-13:2016

Overview

This part of ISO 8536 specifies requirements for non-sterile, single-use graduated flow regulators used as subcomponents in sterilized infusion sets for single use to control the flow of intravenous infusion solutions with fluid contact under gravity feed conditions. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536. This document has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany) with the participation of German experts. The responsible national standardization committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und geräte aus Kunststoffen und Einmalprobengefäße für die In-vitro-Diagnostik" ("Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics") at DIN Standards Committee Medicine (NAMed).

Document: references other documents

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment  

Edition 2017-01
Original language German
Price from 70.50 €
Table of contents

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