{"id":415,"date":"2021-06-15T13:05:12","date_gmt":"2021-06-15T13:05:12","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?page_id=415"},"modified":"2021-06-15T13:24:07","modified_gmt":"2021-06-15T13:24:07","slug":"astm-international","status":"publish","type":"page","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/policy\/international-standardization\/standards-development-organizations-committees-and-standards-for-medical-technology\/astm-international\/","title":{"rendered":"ASTM International"},"content":{"rendered":"\n
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ASTM International is a not-for-profit organization that provides a forum for the development and publication of international voluntary consensus standards for materials, products, systems and services. The volunteer members represent producers, users, consumers, government, and academia from more than 140 countries.\u00a0<\/p>\n\n\n\n

The ASTM Committee F04 on Medical and Surgical Devices was organized in 1962 and includes over 950 members from 31 countries This committee is composed of 24 subcommittees that address specific segments organized into 4 divisions:<\/p>\n<\/div><\/div>\n<\/div><\/section>\n\n\n\n

Division I \u2013 Resources
Division II \u2013 Orthopedic Devices
Division III \u2013 Medical \/Surgical Devices
Division IV \u2013 Tissue Engineered Medical Products<\/p>\n\n\n\n

The ASTM Committee F42\u00a0on Additive Manufacturing Technologies<\/a>\u00a0was organized in 2009 and includes over 600 members from 28 countries. This committee is composed of 6 subcommittees. There are\u00a023 active standards and 15 draft proposed new standards that indirectly support the medical device community for additive manufacturing.<\/p>\n\n\n\n

Memorandum of Understanding – ASTM<\/h2>\n\n\n\n

MOUs are designed to encourage the participation of technical experts from around the world in the ASTM standards development process and broaden the global acceptance and use of ASTM International standards.<\/p>\n\n\n\n

As a benefit of the MOU program, technical experts from any country with an ASTM MOU can participate at no charge as full voting members in the ASTM standards development process. Access to ASTM standards is provided to the national standards body.<\/p>\n\n\n\n

ASTM MOUs<\/h2>\n\n\n\n

ASTM International has signed Memoranda of Understanding (MOU) with Latin American & Caribbean countries.\u00a0\u00a0A list of MOU signatories from these countries can be accessed\u00a0here<\/a>.<\/a><\/p>\n\n\n\n

More information:<\/p>\n\n\n\n

https:\/\/www.astm.org\/<\/a>
ASTM Medical Device Standards Committees<\/a>
ASTM Presentation<\/a>
ASTM MOU Program<\/a><\/p>\n\n\n\n

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REGULATORY COALITION PRINCIPAL MEMBERS<\/h3>\n\n\n