MD(machine) certification system
Outline for Europe MD(machine) certification system
Machine is whole that is assembled with at least one component such as appropriate actuator, controller, electric circuit, etc. that are used for specific use. Manufacturer who tries to sale or distribute within Europe, must attach CE mark after showing that its product is following EU Directive through conformity evaluation method such as declaration or product test from Notified Body, factory inspection, etc.
Guide for machine defines general requirement and detail hygiene and safety requirement about risk in order to assure it meets standard on essential safety and requirement on health.
Requirement includes all fields in technology for machine and protection for human, animal, and property. If there is no standard in Europe, national standard is applicable. Application of standard is not enforced, but must ensure certain level of safety is maintained.
Each country in Europe is announcing standard and national standard, all machines used in Europe must possess guideline on machine and other applicable guideline proving obedience. Relevant document (Technical Construction File) must be kept by manufacturer or Authorized Representative in Europe.
Item subject for certification
As machine and device it needs to have “motor” and if that could cause harm, it is subject for guideline for machine. Not only for industry use, but machine for household and business are included.
| Item | Type |
|---|---|
| Machine for industry | Semiconductor equipment, accessories for excavator , CNC shelf, Compressor for industry use, hoist for industry use, Printer for industry use,etc. |
| Machine with risk | Circular saw similar machine, press, plastic, rubber injector, Mine and product for underground, Lift for operation car, Lift for passenger, For safety relay |
Certification procedure
For general machine, technical document are written about risk assessment and conformity declaration by manufacturer (DoC). For machine that is included in ANNEX Ⅳ, EC Type Examination could be required from official product certification agency ( Circular saw and similar machine, press, plastic, rubber injector, mine, etc product for underground work, Car lift for operation, Lift for passenger, Safety relay). For dangerous machine included in ANNEX Ⅳ which meets requirement of standard, manufacturing company for machine equipment can be chosen from below.
- → To get EC approval, inspect and apply requirement for products at official EU product certification agency.
- → Including information on risk assessment and technical document must be submitted to official certification agency and certification agency must issue conformity certificate and manufacturers of machine equipment follow conformity.
- → If manufacturer for machine equipment meets requirement for conformity, sign on declaration of conformity following guidelineand attach CE mark on the products.
1. Selection of guidelines
Appropriate safety requirement that shows oligation to guidelines should be applied. For machine, Machinery Directive as basic guidelines including LVD Directive, EMC Directive,PED Directive, etc. should be inspected as the same time. Type C must be applied first and if there is no appropriate product requirement, typeA, B are applicable
2. Risk Assessment
Risk Assessment and analysis are conducted based on EN 1050 Standard.
- - Seriousness of possible injury (Consequence of the risk)
- - Duration and frequency of exposure to risk in the danger zone.
- - Probability of an injury or death
3. Design Document
For product conformity evaluation, technical document must be written following regulation.
- - General description of machine
- - Floor plan to understand machine operation, control circuit diagram, parts, etc. floor plan and diagram
- - User guide such as operation and installment of product
- - Essential condition for EU guideline
- - Standard list for proving conformity
- - Product test report
- - Guide to eliminate risk
- - Catalogue
- - Manufacturer conformity declaration
4. Writing declaration of self-appropriateness for manufacturer
Declaration of self-appropriateness is document that proves safety and hygine required by guideline. It needs signature of person in charge on CE Mark. This declaration must be written after getting approval from organization. Also except for manufacturer in EU nation are required to nominate "legal representative" within Europe. Legal representative should be nominated by legal representative and should exist within Europe and will be responsible for contract.
- - Name and address for manufacturer
- - Name of product, model, serial nubmer
- - Standard for evaluation of machine, Harmonized standard
- - Certificate number of EC Type-examination
- - Identificaiton number and name of NB which carried out Full Quailty Assurance
- - Date declared conformity
- - Signature of person in charge within manufcaturer
Point of contact
| Name | Position | Task | Tel | |
|---|---|---|---|---|
| Park Jinjae | Manager | KC, CB, CCC, CE etc Global Certificate | +82-2-2164-1479 | jjpark@ktr.or.kr |
