Search results
Results From The WOW.Com Content Network
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 ...
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.
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]
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
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 61557 Electrical safety in low voltage distribution systems up to 1 000 V a.c. and 1 500 V d.c. – Equipment for testing, measuring or monitoring of protective measures IEC 61558 Safety of power transformers, power supplies, reactors and similar products
CISPR is the acronym of Comité International Spécial des Perturbations Radio, [1] or the International Special Committee for Radio Protection of IEC. CISPR Standards aim to the protection of radio reception in the range 9 kHz to 400 GHz from interference caused by operation of electrical or electronic appliances and systems in the electromagnetic environment.
The safety life cycle has 16 phases which roughly can be divided into three groups as follows: Phases 1–5 address analysis; Phases 6–13 address realisation; Phases 14–16 address operation. All phases are concerned with the safety function of the system. The standard has seven parts: Parts 1–3 contain the requirements of the standard ...