Who Develops Standards

AAMI standards are developed by more than 3,000 participants in 170 committees and working groups that represent the full life cycle and supply chain medical devices and health technology. In addition to representatives from the medical device industry, regulators (e.g., the U.S. Food and Drug Administration), clinicians, academicians, and others take an active role in standards development.

International (ISO/IEC) Technical Committees and Subcommittees

Among the 170+ AAMI Committees, working groups and TAGs, AAMI also has responsibility for the oversight (known as the Secretariat) for numerous ISO and IEC Technical Committees and Subcommittees that cover the most significant standards in the medical device, health technology and sterilization space including ISO 13485, ISO 14971 and IEC 60601, to name a few. The following are the ISO/IEC technical committees and subcommittees for which AAMI holds the Secretariat:

• ISO/TC 121 – Anesthesia and respiratory equipment
• ISO/TC 121/SC 2 – Tracheal tubes and other equipment
• ISO/TC 121/SC 3 – Lung ventilators and related equipment
• ISO/TC 121/SC 4 – Anesthesia terminology
• ISO/TC 121/SC 6 – Medical gas systems
• ISO/TC 150 SC 2 – Cardiovascular implants
• ISO/TC 150 SC 6 – Active implants
• ISO/TC 198 – Sterilization of health care products
• ISO/TC 210 – Quality management and corresponding general aspects for medical devices
• IEC/SC 62A – Common aspects of electrical equipment used in medical practice
• IEC/SC 62D - Electromedical equipment

International (ISO/IEC) Technical Committees and Subcommittees

Many of AAMI’s committees also serve as U.S. Technical Advisory Groups (U.S. TAGs), which provide input (review, comments) through our national member body (ANSI), to the international standards community (ISO and IEC). Standards development organizations (SDOs) like AAMI are accredited by ANSI to administer U.S. TAGs and must follow ANSI procedures, including the Model Operating Procedures for U.S. Technical Advisory Groups to ANSI for ISO and IEC activities. AAMI administers the U.S. TAGs for the following 18 ISO and IEC Technical Committees and Subcommittees:

• IEC SC 62A - Common aspects of electrical equipment used in medical practice
• IEC SC 62D - Electromedical equipment
• IEC TC 62 - Electrical equipment in medical practice
• TC 121 - Anesthetic and respiratory equipment
• TC 121/SC 1 - Breathing attachments and anaesthetic machines
• TC 121/SC 2 - Tracheal tubes and other equipment
• TC 121/SC 3 - Lung ventilators and related equipment
• TC 121/SC 4 - Anesthesia terminology
• TC 121/SC 6 - Medical gas systems
• TC 121/SC 8 - Suction devices for hospital and emergency care use
• TC 150/SC 2 - Cardiovascular implants
• TC 150/SC 6 - Active implants
• TC 194 - Biological evaluation of medical devices
• TC 194/SC 1 - Tissue product safety
• TC 198 - Sterilization of health care products
• TC 210 - Quality management and corresponding general aspects for medical devices
• TC 76 - Transfusion, infusion and injection equipment for medical for Pharmaceutical Use
• TC 84 - Devices for administration of medicinal products and intravascular catheters

U.S. TAGs, in addition to providing input into international standardization, appoint experts from the TAG, to attend as U.S. delegates and participate in activities and meetings of the appropriate ISO and IEC technical committee. Participation in a TAG is an opportunity for U.S. stakeholders to help shape international standards that will influence how they do business globally. Participants have devoted many years to becoming experts in their fields and have a tremendous responsibility to protect their countries' trade and commercial interests.