Representation / Stakeholders
Membership in the ATCC® SDO Consensus Standards Partnership (CSP) is open to all stakeholders of the biomaterials community. Stakeholders include, but are not limited to personnel involved in the production, application and regulation of biomaterials such as contractors, scientists, researchers and administrators from industry, academic, government, military and regulatory sectors.
- Industry- This category includes ommercial entities such as manufacturers and marketers.
- Government/Regulatory- This category includes entities of national, state or local governments, and entities that exercise a regulatory role, such as the US Food and Drug
Administration (FDA), and the Environmental Protection Agency ( EPA). This also includes similar agencies from other countries.
- Academia -This category includes entities that are or are a part of an educational institution.
- Other (General Interest) - General Interest members include those not classified as Industry, Government, Academia or Regulatory. Examples include, but are not limited to journals
and other publications or any individual or organization that is affected by or interested in the need for and application of biomaterials and related processes
Voting membership on the CSP is governed according to the ANSI Essential Requirements: Due process requirements for American National Standards and does not require affiliation with ATCC.
CSP members may be primary members or alternates. Primary members represent their stakeholder organization or group and are each allotted one vote. Each primary member may designate two alternate members. Primary members are each allotted one vote. Alternate members must be designated by primary members and may attend all CSP meetings and functions. Alternate members have no vote but may vote instead for their primary member when so authorized by the primary member.
The ATCC® SDO Steering Committee is selected from CSP membership and oversees the work of the CSP and its workgroups, recommending final actions for standards development to the ATCC SDO Office of the Director. Actions include circulation of draft standards for public review, acceptance of public reviews and publication of final standards. Steering Committee recommendations for action require concurrence of the ATCC SDO Director prior to publication.
Standards Development Workgroups
The ATCC® SDO develops standards for biomaterials and related processes through its Standards Development Workgroups. Workgroup membership is open to all stakeholders in the biomaterials community. Workgroup voting, however, is limited to workgroup members who are also members in good standing of the ATCC SDO CSP, which serves as the consensus body responsible for development of all ATCC SDO consensus standards.
As with balloting by the CSP, each CSP member serving on an ATCC SDO workgroup has one vote. Workgroup alternate members may only vote on behalf of the individual workgroup member they represent. A non-voting (non-CSP) workgroup member may elect to change their status at any time by applying for membership on the CSP.