14/30277509 DC : 0
NA
Status of Standard is Unknown
BS ISO 18250-3 - CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 2: ENTERNAL APPLICATIONS
Hardcopy , PDF
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 |
Please Login or Create an Account so you can add users to your Multi user PDF Later.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
Users cannot be edited or removed once added to your Multi user PDF.