New Specification Number
ISO 594 was replaced with ISO 80369-7 in 2016. This was essentially a clerical change so that the Needle and Syringe Luer Connectors could be included under the Small-Bore Connector collection of specifications: ISO 80369-x. ISO 80369 is where you find the patient side connectors for various disciplines/families of connections.
Non-Interconnectivity Begins
The big news of 2016 was that California legislated non-interconnectable couplings for patient side connections. This was done a few years ago with implementation slated for 2016. The medical industry, agreeing with California that it was a good idea, set about designing patient side connectors which are non-interconnectable. Their effort resulted in a body of specifications under the umbrella of ISO 80369. In 2016, specification ISO 80369-7 was published. The ISO 80369-7 specification canceled and replaced the ISO 594/1 and ISO 594/2 specifications. By the intent of the authors of ISO 80369-7; ISO 80369-7 is basically ISO 594/1 and ISO 594/2, consolidated and technically revised. The ISO 594 connector sizes and general requirements were kept in tact so that ISO 594 is fully forward compatible with ISO 80369-7. It is expected that all existing ISO 594 connectors will be understood to meet the requirements of ISO 80369-7, and that when testing or validation occurs; it is made using the requirements of ISO 80369-7. In essence; this is mostly just a clerical change of the specification number. This expectation is clearly stated in the ISO 80369-7 Forward.
ISO 80369-7 Foreword: 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.
Obsolete Specifications:
There are two obsolete specifications related to Luer connectors:
1. ANSI/HIMA MD 70.1 (discussion on ANSI/HIMA MD 70.1)
2. ISO 594. This page focuses on ISO 594.
Old Specifications Never Go Away.
Sometimes the problem gets worse as the replacement specification becomes older.
a. The old specification number is called-out on drawings which stay in production for many years past when the specification was replaced; the drawing is not revised because of cost and other possible ramifications.
b. The old specification number is copied to new products by ignorant people developing the new designs. Ignorance is fixable with a little education. The person making this type of mistake just does not take the time to learn the correct information. He assumes that if it was correct on the previous product; then it must be still accurate for this new product. I have seen this many times; and have even been guilty of the practice on occasion.
c. Even when all in the company know that the old specification has been replaced, and the drawings are not changing because a Global Engineering Directive is used to cover the change; ignorant 3rd-party inspectors who know nothing about the product, but only what is listed on a drawing insist on having inspection tools identified-by/certified-to the old obsolete specification number.
d. People get persistent because: "The drawing is always right!" These people do not realize that the specification overrides the drawing; so the drawing is not always correct.
How do we make our life easier when specification numbers change?
The best move is to get militant about making the change; anytime the old specification number is referenced, change it. Unfortunately this is impractical. This does not remove the fact that implementation of ISO 80369-7 should be done immediately. Things which must be done include changing advertising documents/catalogs 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.
Directive:
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.
Engineering Justification:
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. In 2016 both ISO 594/1 and ISO 594/2 have been superseded by ISO 80369-7 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.
Testing Procedures
Immediately begin using test procedures according to those specified in ISO 80369-7.
Gages and Reference Connectors
As ISO 594 gages and reference connectors wear out, replace them the with the appropriate corresponding ISO 80369-7 Gages and ISO 80369-7 Reference Connectors. ISO 594 gages and reference connectors are identical to ISO 80369-7 gages and reference connectors with a couple of exceptions.
1. ISO 80369-7 did not carry forward any of the ISO 594/1 Fig 3 gages. This does not mean that gages are forbidden, or not useful, this just means that ISO 80369-7 does not define a gage. You have two choices:
a). You can continue to use the gages defined in ISO 594/1.
b). You can use gages specially designed for ISO 80369-7.
2. ISO 594/1 Fig 4 Reference Connector has been replaced with ISO 80369-7 Fig C.5. The new Reference Connector has a longer minimum length than the previous reference connector. This longer length is only used to test non-interconnectivity; which is a test rarely conducted, so functionally (not officially) you can still use the ISO 594/1 Fig 4 Reference Connector when conducting ISO 80369-7 tests; until it wears-out.
3. ISO 594/1 Fig 5 Reference Connector has been replaced with ISO 80369-7 Fig C.2. The new Reference Connector has a longer minimum length than the previous reference connector. This longer length is only used to test non-interconnectivity; which is a test rarely conducted, so functionally (not officially) you can still use the ISO 594/1 Fig 4 Reference Connector when conducting ISO 80369-7 tests; until it wears-out.
DUO-Marking and DUO-Certification
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.
FYI:
ISO = International Standards Organization
ANSI = American National Standard Institute
HIMA = Health Industry Manufacturers Association
Disclaimer:
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.
Comments:
Original Posting: 12/16/2016
Last Revision: 6/12/2018
Error corrections in, or comments about, the above data can be sent to: office@gagecrib.com
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