Machinery MD Certification

In June 2006, the EU issued the new Machinery Directive 2006/42/EC, which has been fully enforced since December 30, 2009, replacing the old Directive 98/37/EC. It sets new requirements on product coverage, boundary definition with other directives, market supervision, conformity assessment procedures and essential health & safety rules. All machinery exported to the EU shall complete safety assessment per 2006/42/EC and affix the CE marking.

Scope of Machinery Directive

01Machinery
02Interchangeable equipment
03Safety components
04Lifting accessories
05Chains, ropes and webbing
06Removable mechanical transmission devices
07Partly completed machinery
08Others

Safety Principles for Machinery

1. Eliminate or minimize risks as much as possible in machinery design and manufacturing;

2. Adopt protective measures for unavoidable risks;

3. Mark residual risks caused by limited protection, and specify requirements on special operation training and personal protective equipment.

Main Harmonized Standards

01 Machinery safety assessment mainly covers mechanical and electrical parts:

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

EN ISO 12100 Safety of machinery - General design principles - Risk assessment and reduction

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

EN 60204-1 Safety of machinery - Electrical equipment - Part 1: General specifications
02 Machinery with dedicated standards shall be assessed in accordance with relevant specifications, for example:

- Air compressor EN 1012-1:2010 Compressors and vacuum pumps - Safety requirements - Part 1: Air compressors

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

Machinery Certification Modes

Machinery is divided into general machinery and dangerous machinery. 17 categories of dangerous machinery are specified in Annex IV, with stricter safety assessment requirements by regulations.

Certification Mode for General Machinery:

- Internal production control (Annex VIII)

Certification Mode for Dangerous Machinery:

1. Manufactured in line with harmonized standards
- Internal production control (Annex VIII)
- EC type examination (Annex IX) + Internal production control (Annex VIII)
- Full quality assurance (Annex X)

2. Manufactured without harmonized standards
- EC type examination (Annex IX) + Internal production control (Annex VIII)
- Full quality assurance (Annex X)