With RoHS 2 directive established, it is important to know what constitutes the documentation for the compliance.  It is impractical for manufacturers to do their own chemical testing at homogenous material level to identify the presence and concentration of restricted chemicals. Instead the most prevalent and advised methodology is to work with the suppliers of the parts to manage compliance and compile evidences by collecting a set of technical documentation.  This methodology is well accepted by industry and all enforcement authorities.

EN 50581:2012 Standard

European Union has published the 50581: 2012 standards to give clarity on the technical documentation required for the assessment of electrical and electronic products with respect to the restriction of hazardous substances.  This standard reconfirms that the methodology of collecting technical documentation from manufacturers of parts is an acceptable mode of handling the compliance process.

What constitutes a technical documentation?

As per the standard, the technical documentation should contain a minimum of the elements outlined below:

• A general description of the product

(This should also assess in which product category it falls under- This evaluation will determine the applicability of certain exemptions available)

• Documents for material, parts and assemblies/sub-assemblies
• Information showing the relationship between technical documents and corresponding material, part, assemblies/sub-assemblies
• List of harmonized standards used to establish technical documentation

What tasks should a manufacturer do?

A manufacturer should do the following task to be and stay in compliance

• He has to determine the information needed for compliance
• Collect the information needed to declare compliance
• Evaluate the information with regard to quality and trustworthiness to include in technical documentation
• Maintain the technical documentation up to date and valid

Implementing each of this step requires clear understanding of process required in each of this stage.  If you are in an industry which got included in RoHS recently,  and implementing this process for the first time in your company, then you should put in necessary  effort to understand applicability of the regulation for each of your product and then implement each of these steps to manage your effectively.

The post What Documentation is Required for your RoHS Compliance Program? appeared first on ¿Û¿Û´«Ã½.

‘Directive 2011/65/EU’ (RoHS2 recast) focuses on the restriction of the use of certain hazardous substances in electrical and electronic equipment, thereby requiring every manufacturer selling to the EU market to re-evaluate their inventory and ensure compliance with the recast RoHS and WEEE directives.

Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive. The implications of Non-Compliance to the RoHS2 directive are grave and will prevent the product from carrying a ‘CE’ mark and eventual removal of the product from the market.

In order to demonstrate compliance to the RoHS2 recast, Medical Device Manufacturers are required to

1. Define their product and identify the directives applicable to it
2. Source RoHS compliant material from suppliers & analyse and identify material changes needed to comply with the RoHS2 directive
3. Show proof of compliance to RoHS2 recast by drawing up required technical documentation surrounding their product including conformity risk assessment report, test reports for each part
4. Cite relevant harmonized standards applicable to the device
5. Maintain a register of non-conforming products
6. Provide explanations as to why certain parts do not include test reports
7. Analyze their internal production and implement an appropriate internal production control procedure in line with the recast
8. Draw up an EC declaration of Conformity and affix the ‘CE’ mark on the finished product
9. Be wary of new materials introduced to the medical equipment and ensure that the equipment is tested & re-certified
10. Include a complete evaluation of the product against the list of Restricted Substances by 2014

Medical Device Manufacturers now facing the daunting task of understanding the RoHS2 directive, identifying the rules and regulations impacting their products and providing relevant documentation to demonstrate full compliance. Medical Device Manufacturers have to get comfortable with requirements of RoHS2 directive as fast as they can in order to maintain their competence in EU market.

The post Impact of the ROHS2 directive on Medical Device Manufacturers appeared first on ¿Û¿Û´«Ã½.

The RoHS directive restricts the use of certain substances in the manufacture of Electrical and Electronic Equipment (EEEs). It is commonly known as the lead-free directive, but the use of certain other harmful substances is also prohibited under the RoHS Directive. These include mercury, cadmium, hexavalent chromium and the polybrominated flame retardants such as, polybrominated biphenyls (PBB) and polybrominated diphenyl ether (PBDE). These cause harm not only to the environment but also to the health conditions of the employees in the firm and users of the product.

The WEEE directive assigns the responsibility of managing the e-wastes to the manufacturing firm. It directs the manufacturers to collect the e-waste and make provisions for its reuse or recycle. The obsolete or used electrical and electronic goods also are termed as e-waste. WEEE directive applies to the small and large-scale household appliances, electrical and electronic tools, lighting equipments, etc. Some of the medical devices, monitoring and control instruments and IT and telecommunications equipment are, however, exempted from being WEEE compliant.

The post RoHS and WEEE – to Minimize E-Waste appeared first on ¿Û¿Û´«Ã½.