ISO DIS 18250-1

Description / Abstract: This part of ISO 18250 specifies general requirements for RESERVOIR CONNECTORS, which convey fluids in healthcare APPLICATIONS. These RESERVOIR CONNECTORS are used in MEDICAL DEVICES or ACCESSORIES intended for use with a PATIENT.

This International Standard also specifies the healthcare fields in which these RESERVOIR CONNECTORS are intended to be used.

These healthcare fields of use include, but are not limited to, APPLICATIONS for:

─ respiratory,

─ enteral,

─ neural,

─ intravascular,

─ citrate-based anticoagulant solution, and

─ irrigation.

RESERVOIR CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with:

─ any of the RESERVOIR CONNECTOR of every other APPLICATION specified in the ISO 18250 series of Standards;

─ the defined surfaces of the temperature sensor port made in compliance with Annex DD of ISO/IEC 80601-2-74;

─ the defined surfaces of nipples of ISO 17256:2017;

unless otherwise specified in this series of International Standards.

APPLICATION parts of ISO 18250 may specify additional CONNECTORS with which RESERVOIR CONNECTORS (as specified in those APPLICATION parts) are to be NON-INTERCONNECTABLE.

This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics of RESERVOIR CONNECTORS based on their inherent design and dimensions in order to reduce the RISK of MISCONNECTIONS between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS.

This International Standard does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these RESERVOIR CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.

NOTE 1 New designs of RESERVOIR CONNECTORS can be included in this series of standards after they have been assessed according to the PROCEDURE given in Clause 8.

NOTE 2 MANUFACTURERS are encouraged to incorporate the RESERVOIR CONNECTORS specified in this series of Standards into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for RESERVOIR CONNECTORS as specified in the series of Standards will be included.

NOTE 3 MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the RESERVOIR CONNECTORS specified in this series of standards to the Secretariat of ISO/TC 210 to consider this feedback during the revision of the relevant part of this series of Standards.

NOTE 4 The ISO 18250 series of Standards does not apply to screw and crown cork caps and necks as they are not CONNECTORS specific for MEDICAL DEVICES. Examples of screw caps and necks are defined in DIN 55525:1988, ASTM D2911-94 (reapproved 2001), DIN 6063-1:2004, DIN 6063-2:2004, DIN 168-1:1998. Examples of crown cork caps and necks are defined in DIN 6094:1982, EN 14634:2010, EN 14635:2010.

This part of ISO 18250 also specifies common TEST METHODS to verify the functional requirements for RESERVOIR CONNECTORS.

This part of ISO 18250 does not specify the functional requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.