It is highly suggested that Luer connectors (fittings) be manufactured and tested
according to ISO 80369-7.
If you are specifying: ANSI/HIMA MD70.1 you should know the following:
Work on ANSI/HIMA MD70.1 began in 1978, but the standard was not
ratified until 1983. Part of the ratification required that the
standard be reviewed and again ratified in 1989 to maintain validity.
ISO 594 was ratified in 1986. ISO
594 had better definition of gages and reference connectors (fittings); better
designed test procedures and clearer test parameters.
Because the ISO 594 was a superior standard, no committee was ever
convened to review and re-ratify ANSI/HIMA MD70.1. Technically ANSI/HIMA
MD70.1 has expired and is no longer valid; thus, ANSI/HIMA MD70.1 has not been backed by any organization
since the 1988. There is no interest by any standardization organization
in maintaining the standard in any form; reviewing the standard,
or ratifying it.
ISO 80369-7 was completed in 2016 as part of the industry wide drive to have non-interchangeability between small bore connectors. The ISO 80369-7 Foreword specifically states: ISO 80369-7 cancels and replaces the first edition ISO 594-1:1986 and the second edition of ISO 594-2:1998, clauses, subclauses, tables, figures, and annexes of which have been consolidated and technically revised.
The Luer connections manufactured under either ANSI/HIMA MD70.1
or ISO 594 or ISO 80369-7 are intended to be fully interchangeable. There are some
minor differences in the gages and reference connectors (fittings), but the ISO
80369-7 gages and reference connectors are preferred and desired to be
universally used. The ISO 80369-7 gages and references connectors, in
most applications are expected to, and will accept, ANSI/HIMA MD70.1
product and are in most cases identical to ISO 80369-7 gages and references connectors (fittings). Or stated a little stronger; if your ANSI/HIMA MD70.1 product
fails tests performed with ISO 80369-7 gages and reference connectors,
sooner or later your product will have a failure in the field.
Implementation of ISO 80369-7 should be done immediately by changing advertising documents and including the new specification number on new drawings. As a suggestion to avoid making many drawing changes; a general Global Engineering Directive could be issued. Here is some sample text for this Global Engineering Directive:
Global Engineering Directive
Statement of Objective:
The Luer Connection has had specification number changes over the years. Because of that some product drawings, specifications and procedures reference specification numbers which are obsolete and which have been replaced by new numbers. This document gives the directive as to how these obsolete numbers will be translated for compliance to the most current specification.
Any reference to ANSI/HIMA MD 70.1 is replaced with ISO 80369-7.
Any reference to ISO 594/1 is replaced with ISO 80369-7.
Any reference to ISO 594/2 is replaced with ISO 80369-7.
ANSI/HIMA MD 70.1
ANSI/HIMA MD70.1 by HIMA was ratified in 1983. That ratification included a sunset provision that required review and re-ratification in 1989 to maintain validity. In 1986 ISO 594 was ratified as the replacement for ANSI/HIMA MD 70.1. Because the ISO 594 was the subsequent and superior standard, no committee was ever convened to review and re-ratify ANSI/HIMA MD70.1. Technically ANSI/HIMA MD70.1 has expired and is no longer valid. Luer connections manufactured under either ANSI/HIMA MD70.1 or ISO 594 are fully interchangeable. Differences between the two specifications are expected but are technically insignificant to the function of the specified connections. In a dispute the newer ISO 594 is to be given precedence over the older ANSI/HIMA MD 70.1.
ISO 594/1 and ISO 594/2
ISO 594 was ratified in 1986. Both ISO 594/1 and ISO 594/2 have been superseded by ISO 80369-7 in 2016 as part of the industry wide drive to have non-interchangeability between small bore connectors. Luer connections manufactured under either ISO 594 or ISO 80369-7 are fully interchangeable and technically equivalent. Differences between the two specifications are expected but are technically insignificant to the function of the specified connections. In a dispute the newer ISO 80369-7 is to be given precedence over the older ISO 594.
Gages and Reference Connectors
As ANSI/HIMA MD70.1
and ISO 594 gages wear out, replace them the with the appropriate corresponding ISO 80369-7 Gages and ISO 80369-7 Reference Connectors, and at the same time move your test procedures to be
in compliance with ISO 80369-7.
ANSI/HIMA MD70.1 gages identified on the ANSI/HIMA MD70.1 catalog
page, may not be available for sale. The gage makers have discontinued
new production of these gages and once existing inventory has been
depleted they intend to make no more of them. My estimate is that
they may be available as a special, but the cost may double.
ISO 594 gages and reference connectors are identical to ISO 80369-7 gages and reference connectors with one exception. ISO 594/1 Fig 3a has not been carried forward into ISO 80369-7. To assist in your conversion from ISO 594 to ISO 80369-7 we offer a DUO-Marking/DUO-Certification Service for your existing gages. For new gage and reference connector purchases we supply them DUO-Marked/DUO-Certified to both ISO 594 and ISO 80369-7.
ISO = International Standards Organization
ANSI = American National Standard Institute
HIMA = Health Industry Manufacturers Association
This data is provided for general information only. The intention is to provide accurate information; regardless; errors may exist in the supplied information. If accuracy is critical, base your final decisions on the data provided in the root documents: ISO594/1:1986; ISO 594/2:1998; ISO80369-7:2016; and ISO80369-20:2015; which are copyrighted documents.
To purchase copies visit an Authorized Reseller.
Original Posting: 1/15/2009
Last Revision: 10/3/2017
Error corrections in, or comments about, the above data can be sent to: firstname.lastname@example.org