M00022864
New product
MEDICAL DEVICES - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS FOR HEALTHCARE APPLICATIONS - PART 3: ENTERAL APPLICATIONS
International Organization for Standardization
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Availability date: 11/05/2021
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirement
5 Dimensional requirements for ENTERAL
feed reservoir CONNECTORS
6 Performance requirements
Annex A (informative) - Rationale and guidance
Annex B (normative) - RESERVIOR CONNECTORS for access port
on ENTERAL feeding sets and PATIENT interfaces
Annex C (informative) - Reference CONNECTORS
Annex D (informative) - Assessment of MEDICAL DEVICES and their
attributes with CONNECTIONS within this application
ANNEX E (informative) - Summary of the usability requirements for
RESERVIOR CONNECTORS for ENTERAL APPLICATIONS
ANNEX F (informative) - Summary of RESERVIOR CONNECTOR criteria
and requirements for ENTERAL APPLICATIONS
Annex G (informative) - Summary of assessment of the design of
the CONNECTORS for ENTERAL APPLICATIONS
Annex H (informative) - Reference to the Essential Principles
Bibliography
Terminology - Alphabetized index of defined terms
Annex ZA (informative) - Relationship between the document
and the Essential Requirements of EU Directive 93/42/EEC
Defines dimensions and requirements for the design and functional performance of CONNECTORS intended to be used on ENTERAL feed reservoirs.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 210 |