Medical Device & Diagnostic Industry
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An MD&DI May 1999 Column

Devices that have intentional radiators must adhere to complex telecom requirements in order to be marketed in Europe.

In general, all products sold on the European market must comply with directives for safety, electromagnetic compatibility (EMC), and telecom requirements. Medical devices that include an intentional radiator (or transmitter) or that use public telecom lines must meet certain power and transmission requirements in order to be marketed in the European Union. This article explains what intentional radiators are and explores the complex requirements for marketing such products.

EMC requirements are covered under the horizontal EMC Directive (89/336/EEC). This directive specifically addresses intentional radiators in section 10.5, which describes the EMC requirements for transmitter and transceiver products. According to this section, intentional radiators must undergo a so-called EC type examination, based on the test report of a European accredited test lab, by a European notified body. Section 10.1 of the directive describes a self-declaration route for products, such as modems, that use public telecom lines. The applicable standards are published by the European Telecommunications Standards Institute (ETSI).

TELECOM REQUIREMENTS

Determining telecom requirements for medical systems is the most complicated part of the approval process. Many device manufacturers are not sure what defines an intentional radiator and whether there are any limitations regarding transmission power. An intentional radiator is a transmitter, receiver, or transceiver. Examples of devices that contain intentional radiators include telemetry products, programmable pacemakers, and wireless hearing aids. Such products have a communication link through the air, enabling information and data to be transferred from one point to another without a wire. European standards set no minimum or maximum power limit for such products. This means that even a product that has a transmitter power of less than 1 µW and a distance of less than 1 cm is considered an intentional radiator and is subject to the telecom products requirements described in the Telecom Terminal Equipment Directive (TTED) 91/263/EC, which was amended by TTED 98/13/EC.

To fulfill the telecom requirements, manufacturers must first determine whether the product falls under a common technical regulation (CTR). Each CTR standard is based on a technical basic regulation (TBR), which outlines the tests and limits required for marketing approval of telecom products. CTRs—such as the Global Systems for Mobile Communications (GSM), Integrated Services Digital Network (ISDN), and Enhanced Radio Message System (ERMES) standards—are published for a variety of products. A detailed list of all CTRs is available from the ETSI at http://www.etsi.com.

ACHIEVING APPROVAL

Assuming that a CTR has been published for the telecom product type, then the TTED allows the manufacturer to follow one of four routes—Annex I, II, III, or IV—to achieve a CE mark.

Annex I. A European notified body issues an EC type examination certificate based on the test report of a European accredited test house.

Annex II. Based on an EC type examination, a declaration of conformity to type, and a contract for product checks, the notified body issues an administrative approval, which allows the manufacturer to put the CE mark on the product (Figure 1). The contract for product checks is between the manufacturer and an accredited test house. This contract regulates the mass-production check by testing a random product sample. Requirements for the Medical Devices Directives (MDD) must also be fulfilled. The CE mark on the product is followed by the number of the notified body.

Figure 1. A CE mark. The number indicates that the administrative approval was issued by TÜV Product Service.

Annex III. If the manufacturer already has an ISO 9001– or ISO 9002–certified system, a contract for product checks is not required. It is important to note that any quality management system must be certified under the TTED. For example, an ISO 9000 system certified under the MDD is not sufficient, because this directive does not cover the telecom requirements. Under Annex III, the notified body issues the administrative approval based on an EC type examination certificate, a ISO 9000–certified system, and a declaration of conformity to type. The CE mark, including the number of the notified body, is applied to the product.

Annex IV. The fourth route can be used only if the manufacturer has an ISO 9000 system that has been certified under the TTED. The system must include: an independent person designated as responsible for telecom requirements, an accredited test lab, and standard operating procedures that describe relevant telecom tests and procedures.

With this quality management system in place, the manufacturer can issue a declaration of conformity to type and can place the CE mark directly on the product. In this case, the number of the notified body that certified the quality management system must follow the CE mark. The notified body must also be sent a copy of the declaration of conformity to type.

If no published CTR is available for a given product type, then national requirements must be fulfilled for each nation in which the product will be marketed. In the worst case, this means a manufacturer must perform an approval test in each country and apply for each national approval.

Figure 2. A national approval mark for Germany issued by TÜV Product Service GmbH.

Because only a few frequency ranges are harmonized in Europe (ISM bands), a manufacturer could conceivably have to produce transmitters and receivers operating at specific national frequencies. Most manufacturers, therefore, use an ISM band so that a single test in an accredited test lab is sufficient for approval. Even with the uniform test, however, the product must still be certified in each country. The approval method is the same for products that have access to a public network. Certification time for different notified bodies ranges from 1 week to 6 or 7 months. Following approval, the required marking is a national approval mark (Figure 2).

Figure 3. Approval procedure according to TTED 91/263/EWG.

Some nations, such as Germany, have integrated the European TTED into national law, so that a manufacturer, after undergoing the national examination, must also follow the same route as described above for Annex II or III (Figure 3).

CONCLUSION

Most device manufacturers already have a good understanding of European safety and EMC requirements for medical products. The complex telecom requirements, however, still cause a lot of problems and costly delays in bringing products into the European market.

A new directive, the Radio and Telecom Terminal Equipment Directive (R&TTED), is scheduled to be published soon. This directive is intended to enable manufacturers to bring products with intentional radiators or analog phone system access to the European market faster and easier.

Dieter Fröhlich is telecom manager for MIKES Product Service GmbH (Strasskirchen, Germany) and QMS auditor for Annex III and IV according to the TTED. Harald Buchwald is manager for medical products at MIKES Product Service GmbH and a member of IEC TC 62A Working Group 13.