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.

 

BTS - Wild Horse Nine

IBC

Martin McDonagh writes specifically for places and characters that inspire him, and Easter Island could not simply be recreated elsewhere, DoP Ben Davis explains

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Isolated in the Pacific, 2,300 miles from the mainland, Rapa Nui provides an extraordinary setting for Martin McDonagh’s Wild Horse Nine. Its green hills, violent history and monumental moai statues establish a world that is both beautiful and unsettling, reflecting the film’s blend of political intrigue, dark comedy and emotional complexity.

The location itself was non-negotiable, explains cinematographer Ben Davis BSC.

“Martin wouldn't have made the film anywhere else. It was only ever going to be on Easter Island.”

Working with McDonagh for the fourth time after Seven Psychopaths; Three Billboards Outside Ebbing, Missouri; and The Banshees of Inisherin, Davis says the director typically develops a project privately before bringing collaborators into the process.

“I'm used to working on films where they’re still writing the script as you're making it but never with Martin. He has usually told me about the project that's in his head as a general outline but he’ll only send me the script once he's completely happy with it and that's exactly what we make.”

Wild Horse Nine is set in 1973, shortly before the CIA-backed coup which toppled Chilean president Salvador Allende. The story evolved considerably from an earlier version that was also set on Easter Island but featured different characters and a different historical period.

“This is far more political than anything he's made,” Davis suggests. “It was only after Martin went there and spent some time in Chile that he realised what he wanted to say. I guess there's a lot of anger in what we see in politics at the moment, so this story was a response to what's going on in the world since making Banshees.”

Davis himself had visited Easter Island for a week in 1999 giving him a head-start in imagining the script playing out.

“From the first outset I felt both Martin and I wanted it to have colour and contrast and we wanted you to feel this big juxtaposition between Santiago and Easter Island.”

To develop the look, he took several cameras on a location scout, including a stills camera loaded with Kodak Ektachrome, a Super 8 camera also loaded with Ektachrome, and a digital camera.

“It was the same process with Banshees [where Irish west coast island Inis Mór was a principal location for the fictional Inisherin]. When you go there, naturally there's a lot of weather and it can be very windswept with slate-grey seas and overcast.”

He says they wanted to contrast the island’s beauty with the melancholic mood of Chris, one of two bickering CIA protagonists (played by John Malkovich, the other by Sam Rockwell), holidaying among the moai.

“Chris is a man coming to the end of his life and trying to comes to terms with what he has done. There's a line of dialogue about a college student he has met on the island where he says ‘She's life and I’m leaving it’ which I think speaks to a part of all of us that becomes very aware of the beauty of the world that we’re leaving. So it was very important that the island felt like that, with big punches of colour.”

Another idea that Davis pitched to McDonagh was to evoke the 1970s strongly enough that audiences might imagine the film had been photographed in the period, “without making the imagery excessively nostalgic or reverential.”

To achieve this the production shot on a mix of film and digital. The principal camera was the ARRI Alexa 35, with select scenes captured on 16mm and Super 8mm film.

The opening sequence establishes this layered approach. Archival 16mm footage of crowds cheering Allende’s electoral victory in the Plaza de Armas de Santiago in 1970 bleed into the dramatised narrative shot at the same location on Super 8mm.

“It was very important we get that right. It’s always tricky to balance exteriors in bright sun to a darker interior, but here we also segue from grainy library footage into the Super 8 which is an integral element of the film.”

The Super 8 material is nominally shot by Chris as a home video accompanied by his narrated introspection. Davis also used a 16mm camera to capture dusk scenes and details of the island that he felt were important to the story (some of it tuned in post to resemble Super 8) while aerial photography is used to establish the island itself. Davis briefed a drone operator and pilot to film an “arsenal of shots” for coverage.

“If you shoot an island from land you could be anywhere but to show you’re on an island and how isolated it is, you kind of need to remove yourself photography from the ground.”

Although there were opportunities for elaborate camera movement, much of Wild Horse Nine unfolds through extended conversations, often between two characters in a car or sitting at a table.

“You could circle around them and do funky moves, but this isn't that sort of film. The cinematography has to serve the story. If you started to notice what the camera's doing, then I've failed in some way because you should really be listening to what they're saying.”

Davis and ‘A’ camera operator Des Whelan frequently worked with two cameras and shot multiple takes, allowing McDonagh and editor Mikkel E.G. Nielsen to explore different emotional registers in performance.

“The idea was to give editorial a wealth of coverage so that they had control over the rhythm of the film and options to cut these intense conversations with wider visual counterpoints.”

Davis chose vintage Super Baltar lenses for their distinctive rendering and gentle fall-off, favouring their imperfections over a more clinical image. He also carried Cooke lenses, switching to them particularly when characters were positioned towards the edges of the frame.

Achieving consistency across the acquisition formats required extensive preparation, not least because of the distance the production was from any post facility, let alone a lab.

He developed a LUT with Goldcrest colourist Adam Glasman, referencing the colour photography of William Eggleston, and in post worked on “isolating colours that you want to punch, like the red car, to sort of leap off the screen at you.

“Ektachrome really lends itself to colour so then we had to find a way of getting the digital to look like Ektachrome and it was a long process. It doesn't come naturally to get it that way.”

Davis elaborates, “I really do like shooting digitally but there are certain things that film does better. Particularly in the colours of day exterior where you're looking at these deep blues, these greens and this punchy red - film just does that right out the bat. You develop it, it comes back and you go ‘Wow! that looks great.’ To get the DI to look like that you have to work a little bit in post.”

Supported by Cinelab Film & Digital, dailies were sent to London where Glasman arranged remote grading sessions with the DP “just to tweak things. Generally we set up with a look we wanted and didn't do any messing around with it on set. The costumes and sets were all predetermined and tested.”

The Super 8 and 16mm rushes were only shipped to Cinelab at the end of ten weeks’ principal photography. “Fingers crossed, it was alright.”

Later Cinelab performed a Digital-Film-Digital (DFD) process, transferring the graded digital images onto 35mm film negative before scanning them back into the digital workflow. The transfer was made onto Kodak 50D stock.

Davis explains, “It just broke up the highlights in the digital footage and gave it more of the softer character we wanted. When you’re looking at hot sun on sea you get a lot of specular highlights which on film just works but on digital you can be left with hard hot lights, back lights or shiny faces. That’s a wonderful thing that film does that we had to try and emulate later.”

Much of the film’s budget went on the logistics of getting equipment to the island, including period cars. “We had to be very frugal with what we brought and that included a very small crew,” he says.

The production built two hotel rooms as an annex to an existing hotel on the island.  These accommodate substantial interior and exterior action, allowing the production to preserve the physical continuity and authenticity that Davis says McDonagh values.

“Everything with Martin has to be genuine. There could never be a combination of a plate shot on location with a set build. He writes specific to a location and to a specific cast.”

A national park representative and an archaeologist accompanied the crew, access to certain areas was restricted (some heads are also burial grounds), and camera equipment was kept away from protected sites.

Davis believes that, despite the irreverence of some characters’ dialogue, the film treats the island and its people with respect.

“The heads are sort of silent observers. They all share the same facial expression, like a slight grin, whatever they're looking at. We also have animals in Martin’s films – horses in thie case - which are innocent victims and also silent observers of characters that I don't think you're supposed to love.

“I think you're supposed to love and respect their friendship, which is really endearing, but they’ve both killed a lot of people. They've done some despicable things in their lives. So the whole island could be seen as silent character commenting on them in some way.”