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17/30325386 DC : 0

NA

NA

Status of Standard is Unknown

BS ISO 18250-1- CONNECTORS FOR RESERVOIR DELIVERY SYSTEMS - PART 1: GENERAL REQUIREMENTS AND COMMON TEST METHODS

Available format(s)

Hardcopy , PDF

Language(s)

English

€23.37
Excluding VAT

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Materials used for RESERVOIR CONNECTORS
5 Requirements for RESERVOIR CONNECTORS
  for specific APPLICATIONS
6 Alternative RESERVOIR CONNECTORS for
  APPLICATIONS not already covered in this series
  of Standards
7 Common TEST METHODS for RESERVOIR CONNECTORS
8 PROCEDURE to assess a proposed new design of
  RESERVOIR CONNECTOR for inclusion in this series of
  Standards
Annex A (informative) - Rationale
Annex B (normative) - TEST METHODS for
        demostrating NON-INTERCONNECTABLE
        characteristics
Annex C (normative) - Positive pressure liquid leakage
        TEST METHOD
Annex D (normative) - Subatmospheric-pressure air leakage
        TEST METHOD
Annex E (normative) - Stress cracking TEST METHOD
Annex F (normative) - Resistance to separation from axial load
        TEST METHOD
Annex G (normative) - Resistance to separation from
        unscrewing TEST METHOD
Annex H (normative) - Resistance to overriding
        TEST METHOD
Annex I (normative) - Disconnection by unscrewing
        TEST METHOD for floating or rotating screw thread
        locking CONNECTORS and locking CONNECTORS
        with fixed threads
Annex J (informative) - Modification of the TEST METHODS
        to generate variable data for statistical Analysis
Annex K (informative) - Common CONNECTOR geometries
        and functioning
Annex L (informative) - Examples of MEDICAL DEVICES
        on which RESERVOIR CONNECTORS may be used
        for each APPLICATION category
Annex M (informative) - Reference to the Essential
        Principles
Annex N (informative) - Alternative mechanical TEST METHODS
Annex O (informative) - Terminology - Alphabetized index
        of defined terms
Bibliography

BS ISO 18250-1.

Committee
CH/210/5
DocumentType
Draft
Pages
76
PublisherName
British Standards Institution
Status
NA

ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 527-2:2012 Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics
CR 13825:2000 Luer connectors - A report to CEN chef from the CEN forum task group "Luer fittings"
ISO 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
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
ISO 5479:1997 Statistical interpretation of data — Tests for departure from the normal distribution
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 178:2010 Plastics Determination of flexural properties
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
ISO 527-1:2012 Plastics Determination of tensile properties Part 1: General principles

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