LEGALITIES OF UNIT CONVERSION

The land of the free hides an unexpected reminder of the old colony. I am not talking of much, it just a matter of units. The US shares with Malaysia the doubtful merit of sticking to Imperial units, the same units which shaped Queen Victoria’s vision of the world.

The length of some forgotten king’s arm and foot, and the long lost love for fractions are still dominating the American scene. The British had plenty of reasons for maintaining their own system. Commercially, it was useful to better control their markets, and politically, it distanced their nation from another disgusting revolution.

With UK investors as the largest alien economic presence on American soil, it made perfectly good sense for early Congress to follow British standards.

Today, the American predicament is just an obstacle to commerce.

The Imperial system hinders US businesses with several hidden burdens. It raises the start up costs associated with foreign markets; it marginally increases the cost of training foreign-born workers producing goods both in the States and abroad; and substantially complicates multinational tooling and production of goods as well as inventory management.

Conversely, it does not offer much protectionist advantage anymore. As it did for their British counterparts before, American corporations did benefit from the permanence of the Imperial system well after the European-Japanese reconstruction, spelling out to every potential competitor the difficulties of entering the US market, with the same finality of the DOD or ANSI standards.

Nowadays, the adoption of a base 4 system does not seem to really deter determined competitors, as proven by current and past foreign trade balances. Almost everybody owns a set of wrenches in fractions of inches made in metric PanAsia, and Armani has lost little sleep in order to come up with suits in American sizes.

This tempest in a teapot effects technical translators in subtle ways, forcing us to dedicate extra time and energy to educate our clients while paying close attention to the maddening complexities of national and, in the case of Europe, Community laws and regulations.

I have encountered two scenarios.

Sometimes, clients had to be convinced to avoid "overconversions". It might be nice to give surface equivalents of leather skins expressed in square centimeter, but in Stra and Vigevano (two major centers of shoe production Made in Italy) everybody in the trade can visualize square feet with the greatest ease.

Instead, to define outside diameters of American high pressure pipes in metric units can be outright dangerous. Metric wall schedules are different and flow miscalculations can have dire consequences, whereas every engineer from Russia to Argentina is quite familiar with the fractional measurements of pipes, following a tradition more than two centuries old.

Most of the time, the opposite holds true. The client wants the "proper" measures first, followed by their metric equivalent in parenthesis, as if the target audience could find a yard stick or a measuring cup in fluid ounces in a 10 kilometer radius.

As long as we talk of cloth or ingredients, the issue is minor. There, to drop the imperial attitude is a matter of good form, a concrete way to respect the intended readers (and consumers). The implications are much different when we deal with medical devices.

In Europe, nothing should be simpler. Two European Community directives and mountains of national regulations specify the issue in the clearest terms. The DMD 93/42 issued on June 14 1993 (and last amended on January 10, 2002) states in section 10.3: "The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC", later amended by Directives 85/1 and 89/617."

Directive 80/181, issued on December 20, 1979, defines the units of measurement in clear terms on the basis of the General Conference of Weights and Measures (CGPM) set up by the Metre Convention signed in Paris on 20 May 1875, and the International System of Units (SI) then established.

Referring to Directive 76/770/EEC and ISO standard 2955 of March 1st, 1974, Directive 80/181 indicates in Chapter 1 of its Annex the units allowed, and their approved abbreviations (for instance, gram must be abbreviated with a lower case g, contrary to the often seen American G or gm).

Directive 85/1 authorizes the use of mm Hg and barns.

Directive 89/617 is dedicated instead to the exceptions to the rule, as found in marine navigation; beer, cider, waters, lemonades and fruit juices in returnable containers; dispense of draught beer and cider; milk in returnable containers; spirit drinks; goods sold loose in bulk; gas supply; road traffic signs, distance and speed measurement; land registration, and transactions in precious metals.

All terms are defined, together with their exceptions (1) and Imperial equivalents. The mandatory value of such terms for Class IIb and III devices is confirmed by the margin of freedom allowed. DMD Art.1 indicates: "The legal units of measurement within the meaning of this Directive which must be used for expressing quantities shall be …those listed in Chapter I of the Annex", whereas Art. 4.3 states: "At trade fairs, exhibitions, demonstrations, etc. Member States shall not create any obstacle to the showing of devices which do not conform to this Directive, provided that a visible sign clearly indicates that such devices cannot be marketed or put into service until they have been made to comply".

Be as it may, all of the above does not appear to suffice. Some US producers seem strangely reluctant to swim in the metric sea and offer several excuses in order to continue waddling in their Imperial pond.

The most common one refers to FDA requirements. True enough, FDA expects that medical devices marketed and sold in the US express their measuring unit and values according to standard American usage. Nevertheless, products sold abroad fall under the jurisdiction of local agencies and regulatory framework, making FDA wishes irrelevant.

No losses will be suffered in humoring FDA requirements and mentioning in every manual translated for the international market an insignificant US regulation indicating those who are authorized to sell medical devices, but American firms should not defy the laws of other countries and deny the authority of local institutions while hiding behind the FDA, its total lack of jurisdiction notwithstanding.

The solution often chosen is believed to be smart, while it is just contemptuous: give them the units they want but keep our measurements in parenthesis, so we understand what we are talking about. The legal reasoning I have been offered is that the double units are not expressively forbidden, therefore they are allowed.

Directive 93/42 does not seem to justify this interpretation. Art. 4 defines the only cases in which " The use of units of measurement which are not or are no longer legal shall be authorized for: - products and equipment already on the market and/or in service on the date on which this Directive is adopted [1993], - components and parts of products and of equipment necessary to supplement or replace components or parts of the above products and equipment." Even then, "However, the use of legal units of measurement may be required for the indicators of measuring instruments."

All products bearing the ̀ Î mark and marketed after 1993 must conform to the relevant directives. As DMD Art. 8.3 points out: "Where a non-complying device bears the ̀ Î marking, the competent Member State shall take appropriate action against whomsoever has affixed the mark and shall inform the Commission and the other Member States thereof."

In Italy, several laws and decrees enact the European legislation. The two most important are Presidential Decree 802, August 12, 1982, (Attuazione della direttiva 80/101/CEE relativa alle unitá di misura) and Law 473, October 28, 1988, (Attuazione della direttiva n° 85/1/CEE che modifica la direttiva 80/181/CEE sulle unitá di misura giá attuata con decreto del Presidente della Repubblica 12 agosto 1982, n° 802).

Presidential Decree 802/82 by itself did clarify once and for all the situation. Art. 1 states: "Le unità di misura legali da utilizzare per esprimere grandezze sono quelle riportate nel capitolo I dell'allegato al presente decreto. … Per indicare le unità di misura di cui ai commi precedenti si devono usare esclusivamente le denominazioni, le definizioni e i simboli previsti nell'allegato."(2) The quoted Annex offer the official translation of the relevant Annex to Directive 80/181/CEE.

To further clarify the issue, Art. 3 is even more explicit: "… Gli strumenti di misura devono recare le indicazioni di grandezza in un'unica unità di misura legale."(3)

The terms used (exclusively, unique) are crystal clear, and perfectly in line with the spirit of DMD 93/42/CEE.

Still, in at least one instance, no coaching was sufficient to modify my client’s position. Knowing that my translation was illegal, that it would have exposed my client to a fine of US$ 250-1,000 (see PDR 802/82, Art. 4) and the possible revocation of the Ministry of Health authorization to marketing, I had to refuse to certify the sections of the manual which contain the double units. Clearly, a much stronger and more generalized effort is needed to educate the public on this matter.

NOTES

1. DMD 83/42, Art.1, Sect.5 states: This Directive does not apply to:
   1. in vitro diagnostic devices;
   2. active implantable devices covered by Directive 90/385/EEC;
   3. medicinal products covered by Directive 65/65/EEC;
   4. cosmetic products covered by Directive 76/768/EEC (18);
   5. human blood, human blood products, human plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells;
   6. transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin;
   7. transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue
2. My underlying, The text reads: "The legal units of measurement used to express quantities are those indicated in Chapter 1 of the Annex to this decree. … In order to indicate the units of measurement mentioned above it is mandatory to exclusively use the denominations, definitions and symbols stated in the Annex.
3. "Measuring instruments shall indicate quantities with only one legal unit of measurement".

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