Mechanical engineers advocate
market-driven world standards
The International Organization of Standardization (ISO) often produces standards that are not truly global. So complains ASME International, a worldwide engineering organization stemming from the American Society of Mechanical Engineers. "ISO standards acquire the title of 'international standards' solely by virtue of the membership composition of ISO," states ASME in an issue paper. That, it adds, does not guarantee the technical quality or commercial merit of the resulting standards. "The true test of an international standard is fair and open access to the standards-development process," ASME contends. The society urges the U.S. government to support market-driven, de facto international standards as a means of satisfying the Agreement on Technical Barriers to Trade adopted during negotiations under the General Agreement on Tariffs and Trade. The paper cites difficulties in developing standards for such a diversity of products throughout the globe. "It may not be possible to harmonize different existing design standards with each other," it says, "but it may be possible to develop a single performance-based standard which would be compatible with each of the different design standards."
Makers of medical devices have until next June to comply
Manufacturers of medical devices must get set to meet complex new standards if they want to sell in Europe. The European Union's Medical Devices Directive (MDD) becomes mandatory on June 14, 1998. It will apply to all makers of medical devices doing business in 18 European countries. Technology International, a firm specializing in European regulatory approvals, says MDD is "probably one of the most stringent and cumbersome directives to meet, as it includes many of the requirements of other directives, such as EMC and Product Safety." Complying with MDD can take a manufacturer anywhere from one and a half to two years, company officials add. MDD includes design and construction requirements relating to performance, health, and safety. It covers issues such as chemical, physical, and biological properties; infection and microbial contamination; EMC; radiation; mechanical; and thermal and electrical risks. MDD applies to all devices that are intended mainly for diagnosis, prevention, monitoring, treatment, or alleviation of disease, injury, or replacement or modification of the anatomy. Excluded are active implantable devices and in-vitro diagnostic devices. They already have their own directives. Until next June's deadline, manufacturers can comply either with individual national regulations or meet MDD requirements.
Environmental, safety aspects urged for product standards
Developers of international standards for products will be giving more consideration to environmental and safety impacts. That, at least, is the hope of two key standards-drafting groups. One working group, TC 207/WG1, has produced Draft ISO Guide 64.2, "Guide for the inclusion of environmental aspects in product standards." The document is ISO's first official attempt to raise awareness that provisions in product standards can affect the environment in both negative and positive ways, says Klaus Lehmann, convenor of WG1. "I would like to see this Guide being used by as many technical groups and working groups of ISO as possible," he adds, "as well as those of our sister organization, the IEC." Meanwhile, the joint ISO/IEC Technical Advisory Group has revised its Guide 51. The new document focuses on the risk-based approach to solving safety problems.
Aerospace groups to harmonize launch systems for satellites
European organizations are working together to draft what they hope will become international standards for launches of commercial satellites. The European Committee for Standardization has signed a joint agreement with two European aerospace groups. They will draft documents for design, project management, product assurance, and safety for space programs and engineering. Results are expected to conform mostly to the system currently used for the Ariane launcher, a project of the European Space Agency.
Modem innovations outpace approval of guidelines
Standards-writing organizations are attempting to streamline their operations to keep up with rapid advances in technology. Often a product or process is obsolete by the time a guideline for it reaches the approval state. An example is the effort to set standards for computer modems. Winn L. Rosch gives details in his new book Hardware Bible from Sams Publishing of Indianapolis, IN. Manufacturers, he writes, are too competitive to wait for action by the Telecommunications Standards Sector of the International Telecommunications Union. Some have released products, such as V.Fast and V.32ter modems, before the formal adoption of standards for them. Most modern modems, Rosch points out, use digital signal processors that can be easily reprogrammed. One manufacturer even labeled its products "V.anything," alleging they could be updated through software to fit any change in standards.