Are your interests as a United States stakeholder represented in ISO standards for Implants for Surgery?‎

U.S. Stakeholders are officially coordinated and represented in the ISO Technical ‎Committee (TC) 150 work through the ANSI/ASTM TAG ‎to ISO/TC 150 (hereinafter referred ‎to as the TAG). To fulfill this mission, the TAG is led by selected volunteers who ‎represent ‎the U.S. interests together with other members of ANSI, ‎AAMI and ASTM ‎International.‎ ‎ ISO/TC 150 annual meetings are held in different countries ‎every year. The US ‎participates through an official ‎delegation led by selected individuals from the TAG.‎ The main mission of the TAG is dissemination, consultation, comment collection, discussions, and final synthesis, preparation and submitting of the US position on all ISO TC 150 ballots and other work relating to ISO standards on surgical implants. This website was created by the leaders of the ANSI/ASTM TAG to ISO/TC 150‎ to help explain our mission to all stakeholders. The last item on the menu is a password protected link for the TAG leaders only to handle the online management and workflow of all items dealt with by the TAG.

Find out who our leaders are

Background

  • The US currently has a dominant global market share of medical devices.  It is vital for our companies to be at the table shaping ISO standards with a strong voice to represent US interests.
  • The International Organization for Standardization (ISO) develops medical device standards through the (TC) 150 Technical Committee.
  • ISO standards are more consistently recognized by regulatory bodies (e.g. the US FDA).  Many countries use only ISO standards so US exporters have to follow them.
  • The US is represented at ISO through its ANSI/ASTM Technical Advisory Group (TAG).  That ANSI/ASTM TAG to ISO/TC 150 is led by selected volunteers who represent the US interests together with other members of ANSI, AAMI and ASTM International.·  
  • ISO/TC 150 annual meetings are held in different countries every year. The US participates through an official delegation of US experts led by selected volunteers who are charged with casting the single US vote.
Our mission and accomplishments

Our mission and accomplishments

  • With support from US stakeholders like you, the TAG’s recent successes include:
    • Hosting a very successful US meeting in 2018 in San Diego. More than 100 US delegates participated for the benefit of their organizations
    • Reforming the TAG procedures to more widely disseminate information and consult stakeholders on ISO standards work
    • Starting a concerted effort to reduce duplication between ISO and ASTM standards and harmonize conflicting versions which are a burden to US stakeholders
    • Actively influenced ISO standards on behalf of US stakeholders.

ANSI/ASTM ISO TC/150 Technical Advisory Group (TAG)