Standards represent expert opinions from industry, regulators, and users.
ISO defines standards as "a formula that describes the best way of doing something."
Standards ensure device safety and performance throughout the lifecycle.
WTO's Code of Conduct includes transparency, balance, openness, due process, and consensus.
Consensus is crucial, ensuring all objections are considered fairly; it means general agreement, not unanimity.
The use of standards is voluntary unless mandated by regulatory authorities (RAs) for conformity assessment.
Manufacturers can use alternative solutions but must prove they meet the requirements outlined in standards.
FDA recognizes voluntary consensus standards with varying levels of recognition.
Use of consensus standards is voluntary unless incorporated by reference in regulations (e.g., IEC 601-1:1998 in 21 CFR Part 898, ISO 13485:2016 and ISO 9000:2015 in 21 CFR Part 820).
Using consensus standards in premarket submissions increases predictability and streamlines review.
In the EU, harmonized standards are in the Official Journal of the European Union (OJEU).
Conformity with harmonized standards allows presumption of conformity with EU MDR and EU IVDR.
The International Medical Device Regulators Forum (IMDRF) maintains a list of recognized international standards.
Standards are published by standard development organizations (SDOs).
Standards development is formal and follows stringent protocols.
Published standards are available for sale globally.
SDOs are categorized into international, regional, and national levels.
The chapter provides an overview of each type of SDO, its history, standards development process, and relevant technical committees.
It also discusses collaboration between SDOs and RAs for standards development.
International SDOS
Standardization emerged during the 19th-century industrialization.
The International Telegraph Union (ITU), established in 1865, standardized cross-border communication via telegraphy.
ITU evolved to encompass radio, telephone, television, space, satellites, and the internet.
The first SDO was the International Electrotechnical Commission (IEC), created in 1906.
IEC aimed to overcome hindrances in electrical science due to lack of common terminology, measurements and ratings.
The International Standards Association (ISA) was created in 1930, and replaced by ISO in 1947 after WWII.
ISO and IEC play a crucial role in developing and publishing international standards for medical devices.
ISO
History and Mission:
ISO was created in 1947 and grew rapidly in the 1960s to facilitate international trade.
Initially focused on harmonizing national standards, it shifted to direct development of international standards.
In 1971, ISO changed its terminology from "recommendation" to "international standard".
ISO's first standard, the Standard Reference Temperature for Industrial Length Measurements, was published in 1951.
ISO is headquartered in Geneva, with a mission to "bring people together to agree on International Standards that respond to global challenges."
Members:
As of 2024, ISO has published over 25,000 standards.
Standards cover agriculture, construction, manufacturing, distribution, transport, healthcare, IT, energy, safety, security, quality management, and medical devices.
ISO membership is limited to one NSB per country; private companies and individuals cannot directly participate.
Participation must be through the NSB as a stakeholder or expert.
As of 2024, ISO has 170 members in three categories: full, correspondent, and subscriber.
Members can be governmental agencies or private sector organizations (approximately 80% are governmental).
Each member represents their country's view within ISO.
Governance Structure:
Includes organs such as the General Assembly, Council, Council Standing Committees, President's Committee, Policy Development Committee, and Technical Management Board.
Technical committees (TCs) consist of working groups (WGs).
If the scope is large, TCs may be divided into sub-committees (SCs) with WGs.
TCs/SCs make strategic decisions and oversee standards development.
WGs draft the technical content.
As of December 2023, ISO has 268 TCs, 498 SCs, and 2506 WGs.
Deliverables and Standards Development:
Main deliverables are international standards, but ISO also drafts Technical Specifications, Publicly Available Specifications (PAS), Guides, and Technical Reports (TRs).
Guides offer advice to standards writers or NSBs.
Example: ISO/IEC Guide 63 on developing and including safety aspects in medical device standards.
TRs contain technical research or survey data, providing informative guidance on applying an ISO standard.
Example: ISO/TR 24971:2020, which provides guidance for manufacturers to meet risk management requirements defined in ISO 14971.
The standards development process begins with consensus among experts and at the national level.
Development follows the ISO/IEC Directives (Part 1) in six stages.
International standards are assigned a development track determining the project timeframe (e.g., 18, 24, or 36 months).
Standards are reviewed every 5 years to confirm, revise, or withdraw.
The lifecycle and current stage are available on the ISO website.
IEC
History and Mission:
Founded in 1906 by a dozen countries, IEC established advisory committees focusing on nomenclature and electrical machinery ratings.
IEC's first standard was the International Electrotechnical Vocabulary (IEV), now Electropedia, published in 1938.
IEC is headquartered in Geneva, with a mission to "achieve worldwide use of IEC International Standards and Conformity Assessment Systems to ensure the safety, efficiency, reliability and interoperability of electrical, electronic and information technologies, to enhance international trade, facilitate broad electricity access and enable a more sustainable world."
IEC operates four Conformity Assessment (CA) Systems to ensure electrical equipment complies with IEC standards.
Members:
As of 2024, IEC has published over 7,400 international standards in electrotechnology.
Membership is limited to national members, termed National Committees.
Individuals or companies cannot become members.
As of 2024, IEC has 90 members across two levels: full and associate.
The IEC offers an Affiliate Country Programme to help industrializing or newly developing countries participate in standardization and conformity assessment without financial burden. As of 2024, 75 countries participate.
Governance Structure:
Includes organs such as the General Assembly, IEC Board, Business Advisory Committee, President's Committee, Advisory Groups, Market Strategy Board, Standardization Management Board (SMB), and Conformity Assessment Board.
WGs within TCs (reporting to the SMB) undertake standardization work.
TCs may contain SCs depending on their scope.
As of 2024, IEC consists of 114 TCs, 102 SCs, and 772 WGs.
Deliverables and Standards Development:
In addition to international standards, IEC publishes TRs, Technical Specifications, PAS, Guides, Technical Corrigenda, and Interpretation Sheets.
Guides and TRs serve the same purpose as their ISO counterparts.
Example: IEC/TR 80002-1 on software used in device design, testing, component acceptance, and quality systems.
Standards development follows an identical six-stage process as outlined in the ISO/IEC Directives, Part 1.
IEC assigns stability dates to some publications, indicating the period (usually 3 to 12 years) during which the contents will remain unchanged.
At the review date, the publication will be reconfirmed, revised, amended, or withdrawn. The TC may advance the review date if needed.
Collaboration Between ISO and IEC
ISO, IEC, and ITU cooperate to promote worldwide visibility of international standardization through World Standards Cooperation.
ISO and IEC work closely to ensure standards are coherent and avoid duplication.
Coordination occurs at the management level (General Secretaries collaborate) and between TCs.
Formal liaisons between TCs/SCs facilitate the exchange of documents, including new work item proposals and working drafts.
Liaison representatives can participate in meetings and submit written comments but do not have voting rights.
As of 2024, 490 liaisons between IEC and ISO have been established.
Examples of standards published under liaisons include ISO 14971 and IEC 62304, liaisons between ISO TC 210 and IEC 62/SC 62A.
Regional SDOS
Regional SDOs focus on standardization activities within countries in their region.
The first regional SDOs were established in the 1960s and are intermediate bodies between international SDOs and NSBs.
Examples of regional SDOs for major global regions:
Africa: African Organization for Standardization (ARSO)
Americas: Pan American Standards Commission (COPA)
Asia: ASEAN Consultative Committee for Standards and Quality (ACCSQ)
Europe: European Committee for Standardization (CEN), European Electrotechnical Committee for Standardization (CENELEC)
Middle East: Arab Industrial Development and Mining Organization (AIDMO)
In Europe, CEN, CENELEC, and the European Telecommunications Standards Institute (ETSI) are recognized by the EU and EFTA.
They develop voluntary standards at the European level.
Europe and Harmonized Standards
European standards (ENs) provide safety and performance requirements for products in the European market, based on Article 2(1)(c) of Regulation (EU) No 1025/2012.
Each NSB within the SDO must adopt each EN as a national standard and withdraw conflicting national standards.
ENs are voluntary, but become harmonized when published by CEN and CENELEC in response to a European Commission (EC) mandate.
European and harmonized standards are denoted with “EN” and published in the OJEU.
Harmonization involves adopting international ISO or IEC standards and establishing a relationship between EU legislation requirements and the standard's clauses, described in informative