In June 2006, the European Union issued the Machinery Directive 2006/42/EC, which will be mandatory from December 30, 2009, replacing the old directive 98/37/EC. The new directive introduces new requirements in areas such as the scope of products, demarcation with other directives, market surveillance, conformity assessment procedures, and fundamental health and safety requirements. Mechanical products exported to the EU must undergo a safety assessment in accordance with the new directive 2006/42/EC and affix the CE marking.

Scope of Mechanical Instructions

1. Machinery

2. Interchangeable Equipment

3. Zero-component Security

4. Elevator Components

5. Chains, ropes, and silk ribbon straps

6. Detachable mechanical transmission equipment

7. Semi-finished Machinery

Comprehensive Safety Principles for Machinery

Eliminate and minimize risks as much as possible from the perspectives of mechanical design and manufacturing.

2. Implement necessary protective measures for risks that cannot be eliminated.

3. Inform users of risks caused by deficiencies in protective measures through labels and other means, and clarify whether special training is required for operating equipment and the type of personal protective equipment needed.

Primary Coordination Standards

Safety assessments for machinery primarily involve two main components: mechanical and electrical.

EN ISO 12100:2010 Safety of machinery - General principles for design - Risk assessment and risk reduction

EN ISO 12100: Mechanical Safety - General Principles of Design - Risk Assessment and Risk Reduction

EN 60204-1:2006/AC:2010 Safety of machinery - Electrical equipment of machines - Part 1: General requirements

EN 60204-1 Mechanical Safety - Electrical Equipment of Machines - Part 1: General Technical Requirements

For mechanical products with specific standards, evaluations will be conducted according to the respective specialized standards, such as:

Air Compressors EN 1012-1:2010 - Compressors and Vacuum Pumps - Safety Requirements - Part 1: Air Compressors

Earth-moving Machinery - Safety - Part 1: General Requirements EN 474-1:2006+A4:2013/AC:2014

Mechanical Certification Model

In the directive, machinery is divided into two main categories: ordinary machinery and dangerous machinery. The detailed provisions for the 17 types of dangerous machinery are outlined in Annex IV of the directive. For dangerous machinery, there are also higher safety assessment requirements under the regulations.

Standard Mechanical Certification Model:

- Internal Production Controls of Annex VIII

Hazardous Machinery Certification Model:

Manufacturers produce according to coordinated standards.

- Internal Production Controls of Annex VIII

Annex IX EC Type Test + Annex VIII Internal Production Control

Quality Assurance for Annex X

2. The manufacturer failed to produce in accordance with the coordinated standards.

- EC Type Test of Annex IX + Internal Production Control of Annex VIII

- Quality Assurance for Annex X