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The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
The electrical safety develops with the technical progress. In 1989 OSHA [1] promulgated a much-needed regulation in the General Industry Regulations. Several standards are defined for control of hazardous energy, or lockout/tagout. In 1995 OSHA was successful in promulgation of regulations for utility. [2]
The RoHS 2 directive (2011/65/EU) contains allowance to add new materials and 4 materials are highlighted for this attention in the original version, the amendment 2015/863 adds four additional substances to Annex II of 2011/65/EU (3/4 of the new restrictions are recommended for investigation in the original directive, ref Para 10 of preamble).
IEC 61508 is an international standard published by the International Electrotechnical Commission (IEC) consisting of methods on how to apply, design, deploy and maintain automatic protection systems called safety-related systems.
Electrical safety standard set forward by standards organizations across the globe such as the American National Standards Institute (ANSI), [5] Canadian Standards Association, [6] and European Commission in IEC60601-1. MOPP safety standards aim to set basic safety requirements for medical electrical equipment.
IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
IEC TR 60513 Fundamental aspects of safety standards for medical electrical equipment; IEC 60515 Nuclear power plants – Instrumentation important to safety – Radiation detectors – Characteristics and test methods; IEC 60519 Safety in installations for electroheating and electromagnetic processing
The IEC 62304 standard calls out certain cautions on using software, particularly SOUP (software of unknown pedigree or provenance).The standard spells out a risk-based decision model on when the use of SOUP is acceptable, and defines testing requirements for SOUP to support a rationale on why such software should be used.