Rechercher

Scope 1.1 This Standard specifies the requirements for cord sets and power-supply cords employing molded-on or assembled-on fittings, rated 600 V maximum, and intended for use in non-hazardous locations in accordance with the Canadian Electrical Code, Part I, CSA C22.1-12 and General Requirements-Canadian Electrical Code, Part II, CSA C22.2 No. 0-10. 1.2 This Standard also specifies the…

1 Scope and normative references This clause of part 1 is applicable except as follows: 1.1 Replacement: This part of IEC 60730 applies to automatic electrical burner control systems for the automatic control of burners for oil, gas, coal or other combustibles for household and similar use including heating, air conditioning and similar use. This part 2-5 is applicable to a complete…

Scope 1.1 * Purpose This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES. 1.2 * Field of application This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE. This standard applies to the…

1 * Scope This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e. NORMAL USE. It can be used to identify but does not assess or mitigate…

Scope This International Standard provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or monitoring or delivery of drugs or other gases, and the many other types of…

1 Scope and object This clause of Part 1 is applicable, except as follows. 1.1.1 Equipment included in scope Replacement: This part of IEC 61010 specifies safety requirements and related verification tests for control equipment of the following types: – Programmable controllers (PLC and PAC); – the components of Distributed Control Systems (DCS); – the components of remote I/O – systems; –…

Scope and normative references This clause of Part 1 is replaced as follows: 1.1 This part of IEC 60730 applies to automatic electrical air flow, water flow and water level sensing controls for use in, or in association with, boilers with a maximum pressure rating of 2 000 kPA (20 bar) and equipment for general household and similar use including controls for heating, air- conditioning and…

ISO 21549-2:2014 establishes a common framework for the content and the structure of common objects used to construct data held on patient healthcare data cards. It is also applicable to common objects referenced by other data objects. ISO 21549-2:2014 is applicable to situations in which such data is recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1…

ISO 21549-3:2014 is applicable to situations in which limited clinical data are recorded on or transported by patient healthcards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. ISO 21549-3:2014 describes and defines the limited clinical data objects used in or referenced by patient healthcards using UML, plain text and abstract syntax notation (ASN.1). ISO 21549-3:…

ISO 21549-4:2014 is applicable to situations in which clinical data additional to the limited clinical data defined in ISO 21549‑3 is recorded on or transported by patient healthcare data cards compliant with the physical dimensions of ID-1 cards defined by ISO/IEC 7810. ISO 21549-4:2014 specifies the basic structure of the data contained within the data object extended clinical data, but does…