Optima® Conception
Generate your machine instruction manual in minutes.
Enhance your functional and risk analyses. Our AI automatically generates an instruction manual structured in accordance with ISO 20607 and compliant with Regulation (EU) 2023/1230.
In accordance with ISO 20607
Regulation 2023/1230
Sovereign AI hosted in France
Immediate result
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Proprietary standard base
ISO 20607, ISO 12100, EN 62061, EU Regulation 2023/1230, our AI is trained on official normative texts, not on summaries.
Sovereign AI hosted in France
Your industrial data remains in France. No transfers outside the EU. Native GDPR compliance.
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Why trust Optima AI®?
From 2 weeks to 2 days
Our clients are reducing the generation time for an instruction manual from 3 weeks to a few hours.
Automatic update
Regulation 2023/1230 is evolving. OPTIMA Conception automatically integrates regulatory updates into your existing documents.
Machine instruction notice: what the regulations say
The machine instruction manual is one of the most critical documents in the EC technical file, and one of the most frequently poorly written. EU Regulation 2023/1230, which replaces Directive 2006/42/EC from 20 January 2027, strengthens the requirements for this document and formalises the digital format as the default.
«The instruction handbook shall be drawn up in the official language or one of the official languages of the Member State in which the machinery is to be placed on the market or put into service.
ISO 20607 specifies general requirements for technical documentation that are applicable to all product types. It aims to ensure that technical documentation is clear, complete, and easy to use.
The ISO 20607 standard, titled «Machinery safety, Instruction handbook, General drafting principles», defines the structural framework and mandatory minimum content for a compliant instruction handbook. It applies in conjunction with the essential health and safety requirements of the EC Machinery Directive.
Specifically, ISO 20607 states that the instructions must cover the entire life cycle of the machine: transport, installation, commissioning, use in all intended configurations, preventive and corrective maintenance, through to decommissioning and disposal.
The mandatory sections of an ISO 20607 machine instruction manual
- Machine identification: designation, model, serial number, manufacturer's contact details
- General description: intended use, use limitations, description of main components
- Safety information: general instructions, PPE required, danger zones, warning signals
- Transport and storage: lifting conditions, storage constraints, packaging
- Installation and commissioning: installation conditions, connections, start-up
- Usage: operating procedures for all intended operating modes
- Maintenance: preventive interventions, access to maintenance areas, spare parts
- Troubleshooting: diagnosing frequent faults, recommissioning procedures
- Decommissioning and disposal: decontamination procedures, material sorting
Specifically, ISO 20607 states that the instructions must cover the entire life cycle of the machine: transport, installation, commissioning, use in all intended configurations, preventive and corrective maintenance, through to decommissioning and disposal.
Instruction notice and risk analysis: a mandatory relationship
The instruction manual cannot be written independently of the risk assessment. According to ISO 12100, the reference standard for machine safety, residual risks that cannot be eliminated by design or physical safeguards must be communicated in the instruction manual.
This interdependence is at the heart of OPTIMA Design: the tool takes your functional analysis and risk analysis as input to generate the safety sections of the manual in a structured way, with no risk of omission.
What is the cost of a non-compliant instruction manual?
An incomplete or non-compliant instruction leaflet exposes the manufacturer to several risks:
- Criminal penalties: fines of up to €100,000 for repeat offences under the Labour Code
- Public liability: in the event of an accident, the absence of clear instructions may incur the manufacturer's liability for the full extent of the damage.
- Market withdrawal: Market surveillance authorities can demand the withdrawal of machinery with non-compliant documentation
- Insurability loss: some industrial insurers make their coverage conditional on the documentary compliance of machinery.
What changes with Regulation 2023/1230 for instruction manuals
The transition from Directive 2006/42/EC to Regulation EU 2023/1230 introduces several significant changes for instruction manuals that manufacturers must anticipate before 20 January 2027:
- Default digital format: the notice is now provided in digital format, with the paper version only sent upon explicit request
- Sustainable accessibility: the notice must remain accessible for the entire lifespan of the machine, including via an online portal or a QR code
- Cybersecurity: for connected machines, cybersecurity guidelines must be integrated into the manual
- Collaborative robots: cobots require specific sections on adaptive human-machine interface
FAQ
Frequently asked questions about the machine instruction manual
Is a machine instruction manual compulsory?
Yes, without exception. The instruction manual is an essential health and safety requirement under EU Regulation 2023/1230 (applicable from 20 January 2027) and its predecessor Directive 2006/42/EC. Any machinery placed on the European market must be accompanied by a manual in the language of the country of sale. The absence of a compliant manual exposes the manufacturer to criminal and civil penalties, and may result in its withdrawal from the market.
What is the difference between ISO 20607 and ISO 12100 for the instruction manual?
ISO 12100 is the general machine safety standard that defines the methodology for risk analysis and reduction. ISO 20607 is the standard specific to instructions for use, defining its content, structure, and drafting principles. These two standards are complementary: the risk assessment carried out according to ISO 12100 serves as a direct source for drafting the safety sections of the instructions for use according to ISO 20607.
How long does it take to write machine instructions?
Manually, it takes an experienced engineer between 2 and 4 weeks to draft a complete set of operating instructions (excluding revisions and approvals). With OPTIMA Conception, the initial generation takes just a few hours, based on the existing functional and risk analyses. Teams then switch to review mode rather than drafting mode, which reduces the total time by 60 to 80%.
Can the instruction manual be in English for the French market?
No. EU Regulation 2023/1230 requires that the instruction manual be drawn up in the official language of the country where the machine is placed on the market or put into service. For France, the manual must be in French. An original manual in another language may be included, but the French version is mandatory. OPTIMA Conception generates the manuals directly in French.
Does an AI-generated instruction manual have the same legal standing?
The legal value of an instruction manual depends on its content and compliance with regulatory requirements, not on the method by which it was generated. A manual generated by AI and validated by a competent engineer has exactly the same legal value as a manually drafted manual, provided it complies with the requirements of ISO 20607 and Regulation 2023/1230. OPTIMA Conception incorporates these standards into its normative database and produces a structured manual that the technical team validates before signing.
What is the difference between the instructions for use and the EC technical file?
The instruction manual is a component of the EC technical file, but it is not the entirety of it. The EC technical file also includes: a general description of the machine, overall and detailed drawings, a complete risk assessment (ISO 12100), the harmonised standards applied, test reports, and the EU declaration of conformity. OPTIMA Conception covers all of these documents in its full version.
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