Organizations focused on developing, publishing, or disseminating technical standards using a consensus-based standards development process.
ASME is a non-profit organization that promotes collaboration, knowledge sharing, career enrichment, and skills development across all engineering disciplines. ASME has published nearly 600 consensus standards covering a wide range of mechanical engineering topics—including biomedical devices and bioprocessing equipment—that are used in more than 100 countries around the world. ASME also provides certification/accreditation programs assessing the ability of companies to meet the requirements of ASME standards.
ASTM International is a globally recognized leader in the development and delivery of voluntary consensus standards. Today, more than 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.
ASTM Committee F04 on Medical and Surgical Materials and Devices develops standards relevant to regenerative medicine in the areas of:
Classification and Terminology for Tissue Engineered Medical Products (TEMPs)—F04.41
Biomaterials and Biomolecules for TEMPs—F04.42
Cells and Tissue Engineered Constructs for TEMPs—F04.43
Assessment for TEMPs—F04.44
Adventitious Agents Safety—F04.45
ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products develops standards relevant to regenerative medicine in the areas of:
Lyophilization – E55.05
Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products – E55.06
Terminology – E55.91
ATCC develops stakeholder-proposed national consensus standards for biomaterials and related processes, along with certified reference materials, including reference materials for adeno-associated viruses (AAVs). ATCC was the first biological resource organization to become an ANSI-accredited SDO.
CLSI is a U.S.-based nonprofit organization—with a membership of more than 1,400 organizations and 400 individuals from more than 60 countries—that develops and publishes consensus standards for the healthcare industry. CLSI is active in ISO (International Organization for Standardization) and serves as the secretariat of ISO/TC 212, the technical committee for clinical laboratory testing and in vitro diagnostic test systems.
IEEE is a technical professional organization—with more than 430,000 members in more than 160 countries—that is dedicated to advancing technology in a broad range of sectors, including biomedical engineering, aerospace systems, computers and telecommunications, electric power, and consumer electronics. IEEE has an active portfolio of more than 1,300 consensus standards and projects under development and is a leading developer of industry standards in numerous technological areas.
ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market-relevant international standards that support innovation and provide solutions to global challenges.
The ISO Technical Committee 276 on Biotechnology (ISO/TC 276) develops standards relevant to regenerative medicine in the areas of terms and definitions, analytical methods, data processing, biobanks and bioresources, bioprocessing, and metrology.
Additionally, ISO/TC 150/SC7 on Tissue-Engineered Medical Products develops standards specifically focused on the area of tissue-engineered medical products. Select standards efforts from other ISO technical committees—including ISO/TC 194 on Biological and Clinical Evaluation of Medical Devices—are also relevant to regenerative medicine but are not all exclusive to the field.
PDA was recently accredited by the American National Standards Institute (ANSI) and is dedicated to the advancement of pharmaceutical and biopharmaceutical manufacturing science and regulations. Prior to receiving ANSI accreditation, PDA produced technical reports offering peer-reviewed expert guidance and opinions on various scientific and regulatory topics. Forthcoming standards will build on these technical reports using a consensus-based development approach.
Organizations focused on areas of academic or industrial interest, including organizations dedicated to developing non-consensus standards and aligning their field under common best practices.
BSI is the recognized National Standards Body for the United Kingdom. BSI produces more than 2,700 standards annually, using a collaborative approach with input from industry experts, government bodies, trade associations, businesses, and consumers.
ICCBBA is a non-profit organization responsible for the management and development of ISBT 128, the global standard for terminology, identification, coding, and labeling of medical products of human origin (including blood, cells, tissue, milk, and organ products). ISBT 128 is used in more than 87 countries, spanning six continents and a wide variety of health systems, to support the transfer, traceability, and transfusion/transplantation of blood, cells, tissues, and organs.
ICH – International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICH’s mission is to promote harmonized global efforts to ensure the resource-efficient development and registration of safe, effective, and high-quality medicines. ICH produces standards in the form of ICH guideline documents, many of which have been adopted by regulatory agencies, including the U.S. Food and Drug Administration (FDA), Health Canada, European Commission (EC), and other national bodies.
ISAC is a non-profit organization formed to promote research, development, and applications in analytical cytometry. ISAC develops standard file formats for reading and writing flow cytometry data and has published a documentary standard providing guidance for tests using the flow cytometry standard (FCS) format.
ISCT is a global society of clinicians, regulators, technologists, and industry partners with a shared vision to translate cellular therapy into safe and effective treatments for the benefit of patients worldwide. ISCT is the global leader focused on pre-clinical and translational aspects of developing cell-based therapeutics, thereby advancing scientific research into innovative treatments for patients.
ISSCR is an independent, nonprofit organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, encourage the general field of research involving stem cells, and promote professional and public education in all areas of stem cell research and application.
NIBSC is the United Kingdom’s Official Medicines Control Laboratory (OMCL) and is dedicated to assuring the quality of biological medicines. NIBSC is a global leader in the production and distribution of biological reference materials and standards, including World Health Organization (WHO) international standards, influenza reagents, in vitro diagnostic standards, quality control reagents, and clinical virology standards.
The ONE Study Consortium is an international association of eight academic institutions and five representatives from industry dedicated to advancing the field of organ and tissue transplantation through immunoregulatory cell therapy research. Through this work, the ONE Study Consortium has published guidelines for monitoring patients in clinical trials involving transplants to facilitate meaningful comparisons between trials.
Organizations that offer third-party certification (also called accreditation) programs to confirm that facilities fully meet the process or system requirements of a standard they have chosen to adopt.
AABB is a global leader in standards development, accreditation, and implementation of quality systems in transfusion medicine and cellular therapies. AABB standards combine internationally accepted quality management system requirements with relevant technical requirements, allowing AABB standards to serve as the basis for accreditation anywhere in the world.
FACT is a non-profit corporation co-founded by the International Society for Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT). FACT establishes standards for high-quality medical and laboratory practice for the purposes of voluntary inspection and accreditation in the field of cellular therapy.
Non-consensus standards-developing bodies that have been designated by regulators as a source for consistent drug manufacturing methods within their country or region. They publish compendial standards—also known as pharmacopeia—which are collected volumes of standards that are often given the force of law by national regulation.
The European Pharmacopoeia (Ph. Eur.) publishes standards from the European Directorate for the Quality of Medicines and Healthcare (EDQM) [see EDQM entry for additional information].
USP is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide. USP’s drug standards are enforceable in the United States by the U.S. Food and Drug Administration, and these standards are used in more than 140 countries.
Organizations established by either a national government or a state government that create their own standards. Government regulations and guidance can incorporate consensus-based non-government standards, making a voluntary standard mandatory.
EDQM – European Directorate for the Quality of Medicines and Healthcare/Ph. Eur - European Pharmacopoeia
EDQM is a developer of compendial standards in the European Union that publishes standards through the European Pharmacopoeia (Ph. Eur.), which is legally binding for member states and is accepted as a scientific benchmark worldwide. EDQM has a mission of protecting public health by enabling the development, supporting the implementation, and monitoring the application of standards for safe medicines. EDQM develops globally recognized standards on blood transfusion; organ, cell, and tissue transplantation; and consumer health issues.
The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
NIST, part of the U.S. Department of Commerce, is one of the nation's oldest physical science laboratories and is a publisher of standard reference materials and reference data. NIST measurements support the smallest of technologies to the largest and most complex of human-made creations—from nanoscale devices so tiny that tens of thousands can fit on the end of a single human hair up to earthquake-resistant skyscrapers and global communication networks.
PMDA is a Japanese government organization responsible for ensuring the safety of pharmaceutical products. PMDA conducts review and safety testing of new drugs and medical devices, monitors existing drugs for potential safety risks, and publishes standards related to the manufacturing and use of medical products and devices.