UNSC/IEC TAGs General Procedures
1.1. These procedures for AAMI-Administered USNC/IEC Technical Advisory Groups (USNC/IEC TAGs) meet the requirements for due process and coordination in the development of U.S. positions for IEC activities as given in ANSI “Criteria for the Development and Coordination of U.S. Positions in the International Standardization Activities of the ISO and IEC.” (ANNEX B) AAMI administered USNC/IEC TAGs consists of a Technical Advisor (TA) and Secretary, the TAG members, and two cochairs (normally representing different stakeholder interest categories—See section 7). A Deputy TAG Advisor (DTA) may also be appointed to assist the TA for each TAG. A particular TAG is related to a particular IEC Technical Committee or Subcommittee (e.g. “USNC/IEC TAG to IEC/TC xx.”).
The UNSC/IEC TAGs administered by AAMI are those for the following:
- IEC/TC 62, Electrical equipment in medical practice;
- IEC/SC 62A, Common aspects of electrical equipment used in medical practice; and
- IEC/SC 62D, Electromedical equipment.
1.2 The creation of new TAGs is addressed in Section D of the USNC’s Rules of Procedure2 for TAG operation) Under these Rules of Procedure, a TAG can be created for Technical Committees (TCs) or Subcommittees (SCs), depending on the levels of interest of materially affected U.S. parties.
Subgroups of USNC/IEC TAGs or separate USNC/IEC TAGs may be formed to relate to Subcommittees of an IEC Technical Committee. Where the USNC/IEC TAG to an IEC Subcommittee is not independently recognized, the degree of independent authority to take actions shall be defined in writing (as part of the TAG procedures, or as a policy or agreement) and shall be approved by the parent USNC/IEC TAG, and a copy provided to the USNC TMC. In certain circumstances, the USNC TMC may authorize the establishment of TAGs for Working Groups (WGs), Maintenance Teams (MTs), or Project Teams (PTs). In these cases, the relationship between these TAGs and the parent TC or SC TAG must be clearly documented.
There are several responsibilities that may be shared among the TA, the DTA, and the TAG Secretary. They shall have an agreement on who has the primary responsibility for each. Examples of shared responsibilities are indicated in clauses 2.2c and 7.4.
1.3 The official language of AAMI-administered USNC TAGs is English
1.4 From time to time, U.S.-domiciled Standards Developing Organizations (SDOs) may enter into various types of agreements with IEC, such as Category D Liaisons and Dual Logo or Joint Development Agreements. In such cases, the SDO is encouraged to advise the related USNC TAG in advance of its intent to submit a standard for consideration as an IEC Standard. In such instances, it is expected that the USNC TAG will raise any concerns related to the proposed IEC standard during its development cycle so that, if the standard is subsequently balloted for approval at the IEC level, the U.S. position will be to support its approval. For this reason, it is also strongly encouraged that the U.S.-based participants in the SDO actively participate as voting members of the related TAG.
2Statutes and Rules of Procedures of the USNC/IEC Approved by USNC 29 July 2005 and by ANSI Board of Directors, 8 December 2005.
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