Is there a standard for exoskeletons?

The answer in detail

There is indeed a French standard: NF X35-800, titled "Ergonomics – Method of integrating exoskeleton-type physical assistance devices and robots". Published on 2 August 2023, it covers needs statement, selection, design, evaluation and deployment.

It is aimed at user organizations, designers, manufacturers and integrators, in all sectors. However, it concerns only work situations: medical, rehabilitation, gaming, sports and leisure applications are excluded, which includes most of the consumer devices in our catalog. This is not medical advice or legal advice: for a company project, have the applicable framework confirmed by a lawyer or your prevention service.

What the sources say

• AFNOR: standard NF X35-800, status published, publication date 2 August 2023, integration method for work situations.
• INRS: no dedicated standard applies to exoskeletons as personal protective equipment, and no manufacturer claims that status.
• Machinery: only robotized exoskeletons fall under Machinery Directive 2006/42/EC, not mechanical models.
• Medical devices: an exoskeleton for medical use falls under the European medical devices regulation, with classes I to III (ANSM).

The standard is an integration method, not a product certification: it does not say a model is compliant or effective.

Step-by-step instructions

1. Identify your use: work, medical, sport or leisure.
2. For work, read the approach based on NF X35-800 and apply its four phases.
3. For medical use, look for the device's medical device status and CE marking.
4. For sport or leisure, there is no specific standard of this family: check the manufacturer's documentation.
5. Always ask for the manufacturer's declaration of conformity, whatever the use.

Common mistakes

The standard is often wrongly cited as a product label.

• Believing an exoskeleton "compliant with NF X35-800" is certified: the standard describes a method, not a product.
• Applying it to a sports or leisure exoskeleton, when it is limited to work.
• Confusing CE marking with compliance to this standard.
• Ignoring that INRS recognizes no exoskeleton as personal protective equipment, and that no manufacturer claims that status.

Key takeaways

Standard NF X35-800, published on 2 August 2023, describes a method for integrating exoskeletons in work situations, excluding medical, sports and leisure. It certifies no product, and the applicable texts vary with the use. To check a device, ask for the declaration of conformity, as explained in our question on compliance and CE marking. Also read our article on regulation at work.

Sources

• AFNOR: standard NF X35-800 (Norminfo page, in French)
• INRS: exoskeletons, frequently asked questions (in French)
• ANSM: key points of the European medical devices regulation (in French)