What do regulators want from standards?

IEC E-tech

How do legislators use IEC Standards and conformity assessment? Ahead of the IEC General Meeting (GM) in Hamburg, we ask regulators around the world for their feedback.

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A key question which will be addressed at the IEC GM in Hamburg is how independent standardization and regulators can work effectively together. The relationship between regulation and standards is becoming increasingly important as technologies such as artificial intelligence (AI) connected products, software-defined systems and digital infrastructure evolve faster than traditional rulemaking processes.

Regulators need standards bodies to provide expert, up-to-date technical solutions. Standards organizations, on the other hand,  rely on regulatory feedback to identify emerging risks, safety issues and market needs. Stronger collaboration helps maintain consumer trust and supports innovation. It also reduces barriers to international trade and ensures global interoperability. It protects against fragmented national requirements and duplicated testing and regulatory uncertainty. This cross fertilization between regulation and standards allows products to reach markets more efficiently while meeting consistent safety, performance and public-interest objectives.

“Standards turn complexity into practical action,” says Pouline Terpager, Director of International Policy at Danish Standards. “They support compliance, safety, innovation and efficiency by providing recognized methods and a common language. But we also need standards that are faster to develop, less ambiguous and easier to use across sectors.”

Terpager along with senior executives at the US Food and Drug Administration (FDA) and Singapore’s Competition and Consumer Commission (CCS) share their views on how regulation and standardization complement each other and shape trust.

Eric Franca, Director for the Conformity Assessment Program (CAP) and Assistant Director at the Division of Standards and Conformity Assessment (DSCA) at the US FDA.

How do IEC Standards help the FDA in its work?

Consensus standards play an important role in supporting medical device premarket submissions. The FDA leverages these national and international standards through our recognition process to help streamline our premarket review and thus speed patient access to safe and effective medical devices. From the IEC 60601‑1 series of standards and more, the FDA is committed to helping develop regulatory-ready standards that we can recognize. We need manufacturers to  declare conformity to them in order to support FDA pre-market submissions and bring safe and effective medical devices to patients.

The Center for Devices and Radiological Health (CDRH) also modelled the Accreditation Scheme for Conformity Assessment (ASCA) Programme off international and national conformity assessment (CA) programmes, including the IEC CB Scheme operated by IECEE (the IEC System of Conformity Assessment Scheme for Electrotechnical Equipment and Components). Schemes like these help us to increase our confidence in the CA activities and can help streamline what we need to look at before a device can access the US market.

What would you like to see in future standards development?

FDA and CDRH support prioritizing the development of regulatory-ready standards, meaning that standards should strive to have clearly defined methodology that is easily reproducible across competent CA bodies. This includes clearly defined acceptance or pass/fail criteria and uniform expectations for reporting results from the testing. Ideally, that is a goal that can be achieved across standards development organizations and with relative speed in relation to the technology it is standardizing.

Having regulatory-ready standards may not only improve how standards use is conveyed to regulatory authorities, but it may also improve how CA bodies demonstrate their competencies in testing to standards covering these highly complex technologies. One of the strengths of the IEC is having the IECEE testing report form (TRF) working groups operate with the standards development process. This critical element helps ensure that the standards translate well to CA activities.

Do standards accelerate or put the brake on innovation? 

There are instances where the standards community has responded very quickly to a global need, such as the COVID pandemic which saw a speedy publication of standards to address global needs like ASTM F3502 Standard Specification for Barrier Face Coverings, first published in early 2021 or ISO 80601‑2‑90  for high flow nasal cannula which was published within about a year of the approval of the new work item proposal. However, there are cases where innovation moves quite rapidly and the development of standards, in particular regulatory-ready standards, takes a bit more time - which I would characterize as placing a controlled mechanism in place to measure for safety and provide harmonized approaches to market entry.

Look no further than AI. This is an area where the development and use of the technology is moving extremely quickly and standards development is moving at a more deliberate pace. This is understandable. It’s more important to take time to get the testing or methods in the standards to a point where consensus can be achieved than it is to publish something quickly that doesn’t serve the use of the technology.

At the same time, regulators are also interested in seeing how testing new, emerging technologies under competent pathways, in which we have confidence, can provide assurance for improving and protecting public health. Ultimately, having regulatory ready standards that have the necessary testing or methods built in, while keeping pace with evolving technology as quickly as possible, would be beneficial.

Pouline Terpager, Director of International Policy at Danish Standards

What would you like to see in future standards?

We need standards that are faster to develop, less ambiguous and easier to use across sectors. Online development tools and SMART, machine-readable standards can help companies integrate requirements directly into compliance systems and wider business frameworks. Digital tools, however, must preserve consensus and quality. Also, a deep cooperation between IEC and ISO is needed to address the challenges brought up by many new technologies such as Quantum, AI, etc.

How can the synergy between standards and regulation be achieved consistently and globally going forward?

Consistency requires a clear allocation of roles. Regulators should define public-interest objectives; standards organizations should develop voluntary technical solutions through transparent and inclusive processes that might support legislation. These roles should not be confused. The EU’s New Legislative Framework is based on this approach and has been a tremendous success and a model for regulators in other parts of the world. International standards used in this way lead to a pathway for easy trade across the globe, without unnecessary red tape.

The EU is about to revise the New Legislative Framework and the way it works with standards in support of legislation. I hope that the revision will continue its approach based on the use of  international standards, whenever relevant for public objectives to continue to support a well-integrated and safe European and global market.

What role can international standards play in supporting innovation while ensuring trust, safety and market access?

Innovation creates value when it can scale. International standards provide common terminology, interfaces, test methods and safety principles. They also play a role in lowering entry costs and opening markets. A Danish analysis found that companies buying standards subsequently achieved stronger growth than companies which didn’t: on average, they had 12% higher exports after one year and 8% higher revenue after four years.

Standards also build trust. In a Danish survey on ISO/IEC 27001, 84% said it helped with legal and compliance requirements, 87% gained a shared overview of risks and 71% reported more trusted relationships with external stakeholders.

IEC 60364 on low-voltage electrical installations is a concrete example of this. Its European adoption, HD 60364, is referenced in Danish rules, showing how an international foundation can support regional and national regulation.

Beatrice Wong, Director for the Product Safety, Weights and Measures Division, at the Competition and Consumer Commission (CCS) of Singapore   

How do you view the relationship between standards and regulatory objectives?

Laws and standards play different but complementary roles. Legislation establishes safety obligations, regulatory authority and consequences for non-compliance. Standards provide the technical benchmarks and test methods that support consistent implementation so that enterprises have greater certainty in their business practices and costs.

Legislative references to standards should be clear and kept up-to-date as regulatory and technical issues evolve. This can be achieved if regulators have a meaningful voice in standards development. They can contribute timely evidence from incidents and market surveillance. They can also raise implementation issues and emerging risks with the relevant technical committees. Standards developers, in turn, should give regulators access to appropriate technical expertise, helping standards to remain globally relevant and forward-looking.

Global consistency should mean common safety objectives and technical foundations, with justified, transparent and proportionate national adaptations where necessary. Standards should also remain responsive to technological change and real-world product experience, particularly as products increasingly combine electrical functions with software, connectivity and AI. Safety is assessed at the whole-product level and against a reasonably foreseeable use.

Do standards accelerate innovation or slow it down?

Well-designed standards can accelerate innovation by establishing clear safety principles and test methods. This gives innovators a clear understanding of the outcomes their products need to achieve, reducing uncertainty for product designers. It also builds consumer and regulatory confidence in emerging technologies and facilitates access to multiple markets.

However, standards can constrain innovation when they prescribe established designs too narrowly or are not updated quickly enough. Emerging products may combine functions or use operating principles that are not fully anticipated by existing standards. From a competition perspective, standards should also avoid unnecessarily favouring particular technologies or approaches. Where standards are sufficiently open and objective, businesses remain free to compete on how best to meet the required outcomes, which can in turn support innovation and the development of alternative solutions.

To remain enabling rather than restrictive, safety standards should focus on hazards, safety outcomes and reasonably foreseeable use. The standards development system should also provide practical routes for addressing genuinely novel products. IEC Publicly Available Specifications (PAS) can provide a faster route for addressing rapidly evolving technologies because they may be approved through a simpler process than a full international standard. A continuing challenge is securing timely participation from suitably qualified technical experts to keep standards responsive without compromising technical rigour.

How important is national flexibility for global standards?

A global standard delivers the greatest value when its core safety objectives and technical requirements are applied consistently across jurisdictions. Unnecessary national deviations can increase compliance costs, duplicate testing and reduce the benefits of international standardization.

At the same time, some national flexibility is necessary due to differences in local operating conditions, infrastructure and regulatory experience. These may include the voltage and frequency of the standard electricity supply, climate, national plug and socket systems, installation practices or risks identified from local incident and market surveillance experience.

Singapore therefore uses international standards as the technical foundation, supplemented where necessary by clearly stated local requirements. For example, Controlled Goods in Singapore may need to be assessed for operation at 230 alternating current volts (VAC) and 50 Hertz, to meet applicable tropical-condition testing. And they will also use appropriate plugs or fixed wiring arrangements in compliance with local requirements.

National adaptations should be risk-based, transparent and technically justified as well as limited to what is necessary. From a competition perspective, national adaptations should also avoid creating unnecessary barriers to market entry or disadvantaging particular suppliers or technologies without objective justification. This helps preserve the benefits of international standardization while ensuring that legitimate local regulatory needs are addressed.

Where a local issue is also relevant to other jurisdictions, there should be a mechanism to feed the evidence back into the international standards process so the global standard can evolve accordingly.

How do you and your team work with IEC Standards?

IEC Standards form an important part of Singapore’s consumer product safety framework. Under the Consumer Protection (Safety Requirements) Regulations, specified categories of household electrical and gas appliances and accessories are regulated as controlled goods. Before controlled goods can be supplied to consumers in Singapore, they must be tested to the specified safety standards, registered with the CCS Consumer Product Safety Office and carry a safety mark. Many are based on IEC standards, including IEC 60335‑2‑24 for refrigerators or IEC 60335‑2‑35 for instantaneous water heaters.

We adopt a risk-based CA approach. Depending on the product’s risk level, registration may require type testing supported by either a supplier’s declaration or independent certification. Singapore recognizes test reports issued under internationally recognized accreditation arrangements, including the IECEE CB Scheme, helping to streamline CA and reduce unnecessary repeat testing.  This approach reflects our view that international standards applied in the appropriate national context support both consumer safety and efficient market access.