Documents we would need to provide to customers

[beniroquai]

• Leistungserklärung (DoP – Declaration of Performance) zu dem Produkt
• CE-Kennzeichnung mit allen zugehörigen Angaben zu dem Produkt
• Gebrauchsanleitung und Sicherheitsinformationen
• REACH-Informationen (siehe Kapitel 2.3.4) from https://ec.europa.eu/docsroom/documents/12305/attachments/1/translations/de/renditions/native:~:text=SCHRITTWEISE%20ANLEITUNG%20ZUR,%E2%80%BA%20renditions%20%E2%80%BA%20native

[beniroquai]

I found this very helpful:

e.g Maschinenrichtlinie https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32006L0042

All the directives and harmonized standards that a printer needs to comply with. In my opinion: We are very very similar.

Here is a summary of all the relevant Compontns of the EC/EU declaration of conformity @ranranking @christiankuttke @OrganaLeia

Here are the relevant standards and directives extracted from the document, along with their corresponding titles and a brief summary of their purposes:

Directives:

1. Directive 2006/42/EC

   • Title: Machinery Directive
   • Summary: This directive provides guidelines to ensure the safety of machinery placed on the market or put into service within the EU.

2. Directive 2014/30/EU

   • Title: Electromagnetic Compatibility (EMC) Directive
   • Summary: This directive ensures that electrical and electronic equipment does not generate, or is not affected by, electromagnetic disturbance.

3. Directive 2014/35/EU

   • Title: Low Voltage Directive (LVD)
   • Summary: The directive ensures that electrical equipment within certain voltage limits provides a high level of protection for EU consumers.

4. Directive 2011/65/EU

   • Title: Restriction of Hazardous Substances (RoHS) Directive
   • Summary: This directive restricts the use of certain hazardous substances in electrical and electronic equipment.

Harmonized Standards and Technical Specifications:

1. EN ISO 12100:2010

   • Title: Safety of machinery – General principles for design – Risk assessment and risk reduction
   • Summary: Provides a framework for designing safe machinery, including risk assessment and risk reduction strategies.

2. EN 894-1:1997 + A1:2008

   • Title: Safety of machinery – Ergonomics requirements for the design of displays and control actuators
   • Summary: Specifies ergonomic requirements for the design of machinery interfaces to enhance operator safety and performance.

3. EN 894-2:1997 + A1:2008

   • Title: Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 2: Displays
   • Summary: Focuses on the design of display interfaces on machinery for safe and effective use.

4. EN 894-3:2000 + A1:2008

   • Title: Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 3: Control actuators
   • Summary: Specifies ergonomic requirements for the design of control actuators (e.g., buttons, switches) on machinery.

5. EN 894-4:2010

   • Title: Safety of machinery – Ergonomics requirements for the design of displays and control actuators – Part 4: Layout and arrangement
   • Summary: Covers the layout and arrangement of displays and control actuators for optimal ergonomics and safety.

6. EN 1005-3:2002 + A1:2008

   • Title: Safety of machinery – Human physical performance
   • Summary: Addresses the safety implications of human physical performance in machinery operation.

7. EN ISO 13732-1:2008

   • Title: Ergonomics of the thermal environment – Methods for the assessment of human responses to contact with surfaces – Part 1: Hot surfaces
   • Summary: Provides methods for assessing human responses to hot surfaces on machinery to prevent burns.

8. EN ISO 13854:2019

   • Title: Safety of machinery – Minimum gaps to avoid crushing of parts of the human body
   • Summary: Establishes minimum gap requirements to avoid crushing injuries on machinery.

9. EN ISO 13857:2019

   • Title: Safety of machinery – Safety distances to prevent hazard zones being reached by upper and lower limbs
   • Summary: Specifies safety distances to prevent access to hazardous zones on machinery.

10. EN ISO 14118:2018

    • Title: Safety of machinery – Prevention of unexpected start-up
    • Summary: Provides measures to prevent unintended machinery start-ups that could lead to accidents.

11. EN ISO 14120:2015

    • Title: Safety of machinery – Guards – General requirements for the design and construction of fixed and movable guards
    • Summary: Specifies general requirements for the design and construction of guards on machinery.

12. EN ISO 20607:2019

    • Title: Safety of machinery – Instruction handbook – General drafting principles
    • Summary: Establishes principles for drafting instruction manuals for machinery to ensure user safety.

13. EN 55032:2015 + A11:2020 + A1:2020

    • Title: Electromagnetic compatibility of multimedia equipment – Emission requirements
    • Summary: Specifies emission requirements for multimedia equipment to ensure electromagnetic compatibility.

14. EN 55035:2017 + A11:2020

    • Title: Electromagnetic compatibility of multimedia equipment – Immunity requirements
    • Summary: Sets immunity requirements for multimedia equipment to withstand electromagnetic disturbances.

15. EN IEC 62368-1:2020 + A11:2020

    • Title: Audio/video, information, and communication technology equipment – Part 1: Safety requirements
    • Summary: Provides safety requirements for audio, video, information, and communication technology equipment.

16. EN IEC 63000:2018

    • Title: Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
    • Summary: Outlines documentation requirements for assessing compliance with RoHS directives.

[beniroquai]

Applided to our docs

1. Directive 2006/42/EC (Machinery Directive)

• Risk Assessment and Risk Reduction:
  • Include a section in the documentation that performs a risk assessment following the guidelines of EN ISO 12100:2010. This should identify potential hazards associated with the microscope, assess the risks, and outline measures taken to mitigate these risks (e.g., safe design, guarding, and operational procedures).
  • Provide detailed safety instructions and warnings for assembly, operation, and maintenance of the microscope to ensure user safety.
• Emergency Stop and Safeguarding:
  • Incorporate emergency stop features and other safeguarding measures as per EN ISO 14118:2018 and EN ISO 14120:2015. The documentation should include clear instructions on how to use these safety features.

2. Directive 2014/30/EU (Electromagnetic Compatibility - EMC)

• EMC Testing and Compliance:
  • Document the steps taken to ensure compliance with EN 55032:2015 + A11:2020 + A1:2020 (emission requirements) and EN 55035:2017 + A11:2020 (immunity requirements).
  • Include a summary of EMC testing results and any design considerations made to minimize electromagnetic interference.
• Technical Documentation:
  • Ensure the documentation includes information about how the microscope avoids creating electromagnetic disturbances and how it is protected against external disturbances, particularly when operating in environments with significant electronic noise (e.g., on a boat).

3. Directive 2014/35/EU (Low Voltage Directive - LVD)

• Electrical Safety Compliance:
  • Include a detailed section on compliance with EN IEC 62368-1:2020 + A11:2020. This should cover the design considerations for safe operation at low voltage, particularly with respect to the 12V power supply and any internal power conversions.
  • Ensure that the documentation specifies safe handling instructions, including protection against electrical shock and proper use of the IP66-rated case.

4. Directive 2011/65/EU (RoHS Directive)

• Restriction of Hazardous Substances:
  • The documentation should include a statement of compliance with the RoHS directive, referencing EN IEC 63000:2018.
  • Provide a list of materials and components used in the microscope, confirming that none of the restricted hazardous substances exceed the permissible levels.
  • Include instructions for proper disposal and recycling of the microscope in accordance with RoHS guidelines.

5. EN ISO 12100:2010 (Safety of Machinery – Risk Assessment and Risk Reduction)

• Risk Mitigation Strategy:
  • Include a section that outlines how risks identified in the initial design phase were mitigated. This could involve mechanical design choices, software safeguards, and operational protocols.
  • Detail any residual risks and the precautions users must take to avoid them.

6. EN 894 Series (Ergonomics Requirements for Design of Displays and Control Actuators)

• Ergonomic Design:
  • Ensure the documentation covers how the microscope’s interface (e.g., the 7-inch touchscreen and control buttons) meets ergonomic standards as per EN 894-1:1997 + A1:2008, EN 894-2:1997 + A1:2008, EN 894-3:2000 + A1:2008, and EN 894-4:2010.
  • Include ergonomic assessments in the user manual, providing guidance on the optimal setup for prolonged use and minimizing operator fatigue.

7. EN ISO 13732-1:2008 (Ergonomics of the Thermal Environment)

• Thermal Safety:
  • If the microscope or its components (like the LED light or peristaltic pump) have surfaces that could become hot during operation, the documentation should include a thermal assessment.
  • Provide guidance on safe handling and use of these components to avoid burns, in line with EN ISO 13732-1:2008.

8. EN ISO 13854:2019 and EN ISO 13857:2019 (Safety Distances and Minimum Gaps)

• Physical Safety:
  • Include specifications on the minimum gaps in the microscope’s design to avoid pinch points or crushing hazards, particularly in the motorized focus mechanism.
  • Document the safety distances maintained to prevent access to hazardous zones, ensuring compliance with EN ISO 13854:2019 and EN ISO 13857:2019.

9. EN ISO 20607:2019 (Instruction Handbook Drafting Principles)

• Instruction Manual:
  • The documentation should adhere to the general drafting principles set out in EN ISO 20607:2019. This includes clear, concise language, logical structure, and easy-to-follow instructions, with safety warnings and precautions highlighted where necessary.
  • Ensure that all technical terms are clearly defined and that instructions are supported by diagrams, images, and step-by-step guides.

10. Maintenance and Safety (Regular Updates and Safety Checks)

• Ongoing Compliance:
  • Include a section on regular maintenance, ensuring that the microscope continues to meet the required standards over time. This should include routine safety checks and software updates, particularly for maintaining EMC compliance and safe operation.