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

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

Product Safety Standard Checklist Report

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

2. EN 60204-1 Checklist 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 data shall be provided in English version)

1. Machine Specification Sheet

2. Machine Overall Dimension Drawing

3. Illustration of Main Machine Components

4. Drawing of Operator Position and Operating Space

5. Electrical Circuit Diagram and Electrical Component List     

6. Pneumatic Circuit Diagram and Pneumatic Component List

7. Hydraulic Circuit Diagram and Hydraulic Component List

8. Warning Labels and Markings

9. Operation Manual

I. EC Declaration of Conformity

Core Definition: A procedure whereby the manufacturer or authorised representative within the European Union declares that the machinery complies with all essential health and safety requirements of the relevant directives; signing this document entitles the affixation of the CE marking.

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

Technical Construction File:

• Complete equipment drawings and control circuit diagrams

• Detailed drawings, calculation records and test results necessary for compliance verification

• List of essential requirements under this Directive, standards and technical specifications applied

• Description of hazard elimination methods, relevant technical reports or certificates as required

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

• Equipment operating instructions.

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

Document Retention Rules:

• Permanent paper archiving is not mandatory, provided all documents can be compiled for inspection upon request;

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

• Documents shall be retained for a minimum period of 10 years starting from the manufacturing date of an individual 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 drafted in one of the official EU languages (except operating instructions).

II. EC Type-Examination

Core Definition: A procedure whereby a Notified Body ascertains and certifies that a machinery prototype satisfies the provisions of the relevant directives.

Application Requirements: The manufacturer or EU-based authorised representative shall submit an application to a Notified Body together with the following materials:

• Applicant’s name, address and equipment manufacturing location;

• Technical file (identical to the Technical Construction File for EC Declaration of Conformity, including a copy of operating instructions);

• Documents outlining internal series production control measures;

• One prototype representative of mass-produced goods (or specification of inspection venue).