Improved conformity assessment needed, ISO says

Lack of global conformity to technical standards in the development of electronic and other products is a barrier to international trade and two organizations have banded together to improve the situation.

The International Organization for Standardization (ISO) and the United Nations Industrial Development Organization (UNIDO) have together published a guide to improving conformity assessment in the development of goods and services.

The handbook, Building trust – The Conformity Assessment Toolbox, provides the means for testing the compliance of such products and services in accordance with relevant standards, regulations and other specifications.

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Demystifying IEC 60601: A Practical Guide For Understanding The Standards

This whitepaper demystifies the IEC 60601 family of medical electrical safety standards, explaining general, collateral, and particular requirements and how they impact global market access. It offers practical guidance on integrating compliance, risk management, and testing strategies early to streamline regulatory approval and accelerate time to market.

Reviews of the World Trade Organization’s Agreement on Technical Barriers to Trade have noted that improved conformity assessment practices of the ISO as well as the International Electrotechnical Commission (IEC) have helped lower trade barriers.

The report is available as a free downloadable PDF file at the Web site of either ISO (www.iso.org) or UNIDO (www.unido.org).

 

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