Standards

During the design and development of a medical device, numerous U.S. and international standards must be met to validate the device's performance, material used, and safety.

Device standards are either "process" or "product" standards, and cover all aspects of both the device itself and the way it is manufactured, labeled, and packaged. The set of standards identified as applicable to a given device become part of the specification for that device. The device is designed to conform to these standards.

Identifying the particular standards that pertain to a device is a challenge. The manufacturer of the device must determine which standards are appropriate. Standards are sometimes updated or replaced by a completely new standard, which supercedes any earlier versions, and numerous U.S. and international organizations issue standards, which may be relevant to various components of a medical device.

Organizations that issue standards include the American National Standards Institute (ANSI), International Organization for Standardization (ISO), and the American Society for Testing and Materials (ASTM). These organizations provide access to their standards on their Web sites.

International Classification of Standards (ICS) codes are used by most standards-issuing bodies. The classes relevant to medical devices are somewhat broad—for example, ICS field 11.040 is "medical equipment'' and 11.140 is "hospital equipment,'' while fields 25 and 29 cover various aspects of manufacturing engineering and electrical engineering, respectively. Nonetheless, use of these codes generally retrieves the most relevant search results. It is often effective to combine a broad code with a keyword search. The ICS codes are listed in the standards databases as well as on the ISO Web site.

Standards-Issuing Bodies and Government Institutes

Association for the Advancement of Medical Instrumentation (AAMI). 1110 North Glebe Road, Suite 220, Arlington, VA 22201-4795, U.S.A. Phone: +1 703-525-4890, Fax: +1 703276-0793. E-mail: [email protected]. URL: http:// www.aami.org. Founded in 1967, AAMI is an alliance of over 6000 members, whose goal is increasing the understanding and use of medical instrumentation. It is a primary industry resource for national and international standards. AAMI standards may be purchased online; some are available on CD.

Also offered are standards collections, including Sterilization, Dialysis, and Biological Evaluation of Medical Devices, and a list of all published standards. The site lists new and upcoming standards, events, and news. AAMI Standards Monitor Online, an updating service, is available to members.

American National Standards Institute (ANSI). 1819 L Street, NW, Suite 600, Washington DC 20036, U.S.A. Phone: +1 202293-8020. E-mail: [email protected], URL: http://www.ansi.org. ANSI is a private, non-profit organization which administers and co-ordinates the U.S. voluntary standardization and conformity assessment. It is the official U.S. representative to the International Accreditation Forum (IAF), the International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC). ANSI itself does not develop the standards, but rather it provides a forum for over 270 ANSI-accredited standards developers representing approximately 200 distinct organizations in the private and public sectors. These groups work co-operatively to develop voluntary national consensus standards and American National Standards (ANS). eStandards Store provides access to the catalogs of ANSI, ISO, and IEC standards.

ASTM International. 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, U.S.A. Phone: +1 610-8329585, Fax: +1 610-832-9555. E-mail: [email protected]m.org. URL: http://www.astm.org. Formerly known as the American Society for Testing and Materials, ASTM was formed over a century ago. It is one of the largest voluntary standards development organizations in the world, known for technical standards for materials, products, systems, and services. ASTM standards cover a diverse range of industries, and are developed by over 30,000 ASTM members who are technical experts in their fields. Standards, technical publications, journals, and other publications are available at the site.

International Electrotechnical Commission (IEC). 3. rue de Varembe, P.O. Box 131, CH-1211 Geneva 20, Switzerland. Phone: +41-22-919-0211, Fax: +41-22-919-0300. E-mail: [email protected] iec.ch. URL: http://www.iec.ch/. IEC is a global organization that prepares and publishes international standards for all electrical, electronic, and related technologies. These serve as a basis for national standardization and as references when drafting international tenders and contracts. IEC's multilateral conformity assessment and product certification schemes, based on its international standards, are intended to reduce trade barriers caused by different certification criteria in various countries and help industry to open up new markets. The IEC Web site gives extensive details about its technical work, conformity assessment, and various activities. You can search for and buy standards from their Web store.

Institute of Electrical and Electronics Engineers Inc. (IEEE). 3 Park Avenue, 17th Floor, New York, NY 10016-5997, U.S.A. Phone: +1 212-419-7900, Fax: +1 212-752-4929. E-mail: [email protected]. URL: http://www.ieee.org. IEEE is a non-profit, technical professional association of more than 360,000 individual members in approximately 175 countries. The IEEE Industry Standards and Technology Organization is a separate corporation closely affiliated with the IEEE. IEEE standards and publications are in technical areas ranging from biomedical technology and computer engineering to electric power, aerospace, and consumer electronics. They have almost 900 active standards with 700 under development. IEEE standards can be searched and purchased on their Web site. The site also links to portals for IEEE standards activities in Asia, Europe, and the Americas.

ISO International Organization for Standardization (ISO). 1. rue de Varembe, Case postale 56 CH-1211 Geneva 20, Switzerland. Phone: +41-22-749-0111, Fax: +41-22-733-3430. E-mail: [email protected]. URL: http://www.iso.org/. ISO is a network of national standards institutes from 148 countries working in partnership with international organizations, governments, industry, business, and consumer representatives. It is the world's largest developer of standards, primarily technical standards. ISO standards are technical agreements that provide the framework for compatible technology worldwide. They are formed by consensus, via some 2850 technical groups with over 30,000 experts participating annually in ISO

standards development. ISO standards are voluntary. However, many have been adopted by countries as part of their regulatory framework, particularly standards dealing with health, safety, and the environment. ISO 9000 has become an international reference for quality management requirements in business-to-business dealings. The ISO Web site provides detailed information about the organization and standards development. Electronic copies of international standards can be purchased on the ISO site, as well as Standards Handbooks, reference materials, and more.

National Institute of Standards and Technology (NIST). 100 Bureau Drive, Stop 3460, Gaithersburg, MD 20899-3460, U.S.A. Phone: +1 301-975-NIST (6478). E-mail: [email protected] gov. URL: http://www.nist.gov. Founded 1901. NIST is a non-regulatory federal agency within the U.S. Commerce Department's Technology Administration. NIST's mission is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life. NIST does not issue standards, but rather it provides technical support contributing to the development of domestic and international standards. NIST's National Center for Standards and Certification Information supplies information on U.S., foreign, and international voluntary standards; government regulations; and rules of conformity assessment for nonagricultural products. NIST has a number of specialized research laboratories, each providing measurement methods, tools, data, and reference standards. These include the Chemical Science and Technology lab, under which biotechnology falls; the Manufacturing Engineering lab, which includes precision engineering and intelligent systems; the Materials Science and Engineering lab; and the Physics lab, including optical technology and ionizing radiation.

Standards Databases

ILI. UK: ILI. URL: http://www.ili.co.uk/. ILI is a bibliographic standards database covering some 600,000 worldwide standards from over 250 major standards issuing authorities, including U.S. military (Milspec) and emerging markets standards. Search by Number, Title, Keyword, Publisher, Country, International Class, Equivalency or a combination of these. Information displayed includes the number, title, version, summary and table of contents, international equivalents, pending developments to the standard, approving authorities, and standards referenced. Standards referenced include the relevant EU "New Approach'' Directives listing the standards required to attain the CE Mark. Standards can be purchased from the ILI site. Some are available in PDF, others in hard copy for next-day delivery. Available online.

IHS. Englewood, Colorado: IHS Group. URL: http://www.ihs. com/. Information Handling Services (IHS) is an international provider of technical content and information solutions for standards, regulations, parts data, design guides, and other technical information. The IHS Standards library is now called IHS Specs and Standards. A searchable database provides bibliographic access to more than 568,000 documents in PDF format from more than 450 standards developing organizations and military operations. Includes more than 350,000 military specifications. Available online.

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