• There are no items in your cart

EN ISO 8536-14:2018

Current
Current

The latest, up-to-date edition.

Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)
Published date

02-07-2018

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

ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.

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

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

View more information
Sorry this product is not available in your region.

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.