Rechercher

1.1 General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet...

This Standard covers construction, marking and test requirements for flat cable systems for indoor use, in non-hazardous locations, and intended for installation on branch circuits of not more than 600 V between conductors...

This Technical Report provides guidelines for the development and maintenance of the documentation necessary to ensure an effecti ve quality management system, tailored to the specific needs of the organization. The use of...

This part of IEC 60079 specifies the requirements for the design, construction, testing and marking of electrical apparatus with type of protection increased safety "e" intended for use in explosive gas atmospheres. This...

This part of IEC 60079 specifies the requirements for the construction and testing of oilimmersed electrical equipment, oil-immersed parts of electrical equipment and Ex components in the type of protection oil immersion "o"...

This Standard specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the...

This Standard specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized...

This Standard specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile...

This Standard specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility...

This Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. Flammability of oropharyngeal airways...

1.1 Equipment covered This part of IEC 60950 applies to information technology equipment intended to be installed in an OUTDOOR LOCATION. The requirements for OUTDOOR EQUIPMENT also apply, where relevant, to empty OUTDOOR...

Scope of proposed project: Requirements and recommendations for planning, testing, implementing, and maintaining wayfinding systems in hospitals and other health care facilities. Scope will include signs, but will also...