Customer Support: +353 (0)1 857 6730

Corporate Website About Us
  • Shopping Cart
    There are no items in your cart
Please enter a keyword to search
Advanced search
Home
CEN
EN ISO 8536-13:2016

EN ISO 8536-13:2016

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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

Withdrawn date

30-04-2017

Published date

19-10-2016

Publisher

Comite Europeen de Normalisation

Sorry this product is not available in your region.

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Design
5 Materials
6 Physical requirements
7 Chemical requirements
8 Biological requirements
Annex A (normative) - Physical tests
Bibliography
Annex ZA (informative) - Relationship between
         this European Standard and the Essential
         Requirements of Directive 93/42/EEC [OJ L 169]
         aimed to be covered

ISO 8536-13:2016 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 ISO 8536-13:2016.

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

ISO 80000-4:2006 Quantities and units Part 4: Mechanics
ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
EN ISO 80000-4:2013 Quantities and units - Part 4: Mechanics (ISO 80000-4:2006)

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Get in touch with us