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I.S. 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)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2018

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
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

Defines 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.

DocumentType
Standard
Pages
24
PublisherName
National Standards Authority of Ireland
Status
Current

Standards Relationship
ISO 8536-14:2016 Identical
EN ISO 8536-14:2018 Identical

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

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