Consider Replacing ANSI/HIMA MD70.1 with ISO 594.

It is highly suggested that Luer fittings be manufactured and tested according to ISO 594, either ISO 594/1 or ISO 594/2 which ever your design requirements dictate.

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.

Work on ISO 594 was completed and it was ratified in 1986. ISO 594 has better definition of gages and reference 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 Technically ANSI/HIMA MD70.1 has expired and is no longer valid.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. All the individuals I have spoken with in the various organizations likely to take responsibility for ANSI/HIMA MD70.1 are suggesting movement of requirements from ANSI/HIMA MD70.1 toward ISO 594 for new designs, and the conversion of all old designs to ISO 594 when tooling changes and/or repairs are required.

The Luer connections manufactured under either ANSI/HIMA MD70.1 or ISO 594 are intended to be fully interchangeable. There are some minor differences in the gages and reference fittings, but the ISO 594 gages and reference fittings are preferred and desired to be universally used. The ISO 594 gages and references fittings, in most applications are expected to, and will accept, ANSI/HIMA MD70.1 product. Or stated a little stronger; if your ANSI/HIMA MD70.1 product fails tests performed with ISO 594 gages and reference fittings, sooner or later your product will have a failure in the field.

Implementation of ISO 594 into old designs should be done as quickly as feasible. Drawings and manufacturing specifications should be converted to allow either standard with a note that ANSI/HIMA MD70.1 is obsolete and has been replaced by ISO 594. As ANSI/HIMA MD70.1 gages wear out, replace them the with the appropriate corresponding ISO 594 gages, and at that time move your test procedures to be in compliance with ISO 594.

The ANSI/HIMA MD70.1 gages identified on the 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.

FYI:
ISO = International Standards Organization
ANSI = American National Standard Institute
HIMA = Health Industry Manufacturers Association

Comments about the above statement can be sent to: gageguy@gagecrib.com
Last revision: February 15, 2010