Smithers Pira tests conical (Luer) fittings to ISO , assessing their characteristics and functional performance against the requirements set out in the . 15 Mar IS0 , published by Technical Committee 84 ‘Syringes for medical use and International Organization for Standardization (ISO). 17 Apr ISO /1 specifies the general requirements of conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. ISO /2.
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How do we make our life easier when specification numbers change? In essence; this is mostly just 59-41 clerical change of the specification number. Top Gage Crib Worldwide, Inc.
ISO /1 and ISO /2 REPLACED BY ISO
Their effort resulted in a body of specifications under the umbrella of ISO This does not remove the fact that implementation of ISO should be done immediately. This does not mean that gages are forbidden, or not ios, this just means that ISO does not define a gage. This page focuses on ISO Here is some sample text for this Global Engineering Directive: Differences between the two specifications are expected but are technically insignificant to the function of the specified connections.
He assumes that if it was correct on the previous product; then it must be still isi for this new product. The new Reference Connector has a longer minimum length than the previous reference connector. The person making this type of mistake just does not take the time to learn the correct information. 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: The best move is to get militant about making the change; anytime the old specification number is referenced, change it.
Old Specifications Never Go Away. I have seen this many times; and have even been guilty of the practice on occasion. This was done a few years ago with implementation slated for The Luer Connection has had specification number changes over the years.
The old specification number is copied to new products by ignorant people developing the new designs.
That ratification included a sunset provision that required review and re-ratification in to maintain validity. Testing Procedures Immediately begin using test procedures according to those specified in ISO Non-Interconnectivity Begins The big news of was that California legislated non-interconnectable couplings for patient side connections.
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Here is some sample text for this Global Engineering Directive:. 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.
Sometimes the problem gets worse as the replacement oso becomes older. As a suggestion to avoid making many drawing changes; a general Global Engineering Directive could be issued.
Gage Crib Worldwide, Inc. There are two obsolete specifications related to Luer connectors: If accuracy is critical, base your final decisions on the data provided in the root documents: Inspecification ISO was published. iao
Ignorance is fixable with a little education. The intention is to provide accurate information; regardless; errors may exist in the supplied information. You have two choices: Unfortunately this is impractical.
Because of that some product drawings, specifications and procedures reference specification numbers which are obsolete and which have been replaced by new numbers. You can use gages specially designed for ISO This document gives the directive as to how these obsolete numbers will be translated for compliance to the most current specification.
This expectation is clearly stated in the ISO Forward.
People get persistent because: ISO gages and reference connectors are identical to ISO gages and reference connectors with a couple of exceptions. Luer connections manufactured under either ISO or ISO are fully interchangeable and 5941- equivalent. The 594- industry, agreeing with California that it was a good idea, set about designing patient side connectors which are non-interconnectable.
It is expected that all existing ISO connectors will be understood to meet the requirements of ISOand that when testing or validation occurs; it is made using the requirements of ISO