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14/30277509 DC : 0

NA
NA

Status of Standard is Unknown

BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS
Available format(s)

Hardcopy , PDF

Language(s)

English

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

BS ISO 18250-3.

Committee
CH/210/5
DocumentType
Draft
Pages
47
PublisherName
British Standards Institution
Status
NA

EN 1618 : 1997 CATHETERS OTHER THAN INTRAVASCULAR CATHETERS - TEST METHODS FOR COMMON PROPERTIES
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 10241-2:2012 Terminological entries in standards — Part 2: Adoption of standardized terminological entries
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
EN 1615 : 2000 ENTERAL FEEDING CATHETERS AND ENTERAL GIVING SETS FOR SINGLE USE AND THEIR CONNECTORS - DESIGN AND TESTING
ISO 10241-1:2011 Terminological entries in standards — Part 1: General requirements and examples of presentation
ISO 14971:2007 Medical devices Application of risk management to medical devices
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics

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