Overview

1. Overview of Mechanical Structure and Functions

2. Comparative Description of Machine Series Models

3. Description of Quality Assurance System

4. Declaration of Conformity

5. Description of Applicable Directives and Standards

Basic Conformity Assessment

1. Conformity Report on Essential Health and Safety Requirements of the Machinery Directive

2. Product Risk Assessment and Countermeasure Report (EN 1050)

Product Safety Standard Check Report

1. EN ISO 12100-1 / EN ISO 12100-2 Check Report (Machinery Directive)

2. EN 60204-1 Check Report (Low Voltage Directive)   

3. EN 60204-1 Test Report (Low Voltage Directive)

4. Noise Test Report

5. Other Applicable Standards

Compilation of Technical Data (All documents shall be provided in English version)

1. Machine Specification Sheet

2. Machine Outline Dimension Drawing

3. Schematic Diagram of Main Machine Components

4. Drawing of Operator Position and Operating Space

5. Circuit Diagram and Electrical Component List     

6. Pneumatic Diagram and Pneumatic Component List

7. Hydraulic Diagram and Hydraulic Component List

8. Warning Labels

9. Operation Manual

I. EC Declaration of Conformity

Core Definition: A procedure whereby the manufacturer or authorised representative established within the EU declares that the machinery complies with all essential health and safety requirements of the relevant directives. Once signed, the CE marking may be affixed.

Pre-document Requirements: Prior to compilation, two categories of documents shall be available on-site for inspection:

Technical Construction File:

• Complete drawings of the equipment and control circuit diagrams

• Detailed drawings / calculation records / test results required for compliance verification

• List of essential requirements of the directive, standards and technical specifications applied

• Description of hazard elimination methods, necessary technical reports or certificates

• Test reports demonstrating compliance with harmonised standards (tests may be conducted in-house or entrusted to third-party bodies)

• Instructions for use of the equipment.

Series Production Control Documents: Internal measures to ensure continuous compliance of mass-produced products. The manufacturer shall carry out necessary research and testing on components, accessories or complete machinery to verify safety during assembly and operation. Failure to satisfy documentary requirements imposed by competent authorities may invalidate the presumption of conformity.

Document Retention Rules:

• Permanent paper storage is not mandatory, but documents shall be compiled and available for inspection;

• Detailed component plans are not required unless indispensable for compliance verification;

• Retention period of at least 10 years (starting from the date of manufacture of a single unit or the production date of the last unit of a batch),

• and shall be accessible to national competent authorities at any time;

• Documents shall be drawn up in one of the official EU languages (except for instructions for use).

II. EC Type-Examination

Core Definition: A procedure by which a notified body ascertains and attests that a prototype of machinery satisfies the provisions of the directives.

Application Requirements: The manufacturer or authorised representative established within the EU shall submit an application to a notified body together with:

• Name and address of the applicant and the place of machinery manufacture;

• Technical documentation (the same Technical Construction File required for the EC Declaration of Conformity, including a copy of the instructions for use);

• Documentation on internal series production measures;

• One prototype representative of mass production (or specification of the inspection location).