Hälso- och sjukvård

ISO 11140-4:2007 specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads). An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration. This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.

This document specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field use and transport use.

This document provides specific requirements for the basic safety and essential performance for oro-tracheal and naso-tracheal tubes and tracheal tube connectors, tracheal tubes with walls reinforced with metal or plastic, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning, monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications.
Tracheobronchial (including endobronchial) tubes (see ISO 16628), tracheostomy tubes (see ISO 5366), and supralaryngeal airways (see ISO 11712) are excluded from the scope of this document.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers, or electrosurgical equipment are outside the scope of this document.
NOTE 1      There is guidance or rationale for this clause contained in Annex A.2.
NOTE 2      ISO 11990-1, ISO 11990-2, and ISO 14408 deal with laser surgery of the airway.

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• Hänvisas till standarden i svensk författningstext?
• Har Sverige beviljats en A-avvikelse (A-deviation) från denna standard, och i så fall, gäller den avvikelsen fortfarande? SIS/TK beslutar, genom konsensus, om vad SIS ska svara.

Vänligen bortse från texten i informationsrutan nedan.

This document specifies minimum requirements for the design and performance of stretchers and other patient handling equipment used in road ambulances for the handling and carrying of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.

ISO 5364:2016 specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal. ISO 5364:2016 is not applicable to metal oropharyngeal airways, nor to requirements concerning flammability of oropharyngeal airways. Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard. ISO 5364:2016 is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.

This document is intended for forensic reporting on human identification by dental evidence.

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies. This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring. This document applies to both preformed sterile barrier systems and sterile barrier systems. This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management. This document is intended to be used prior to process validation. NOTE ISO 11607-2 provides requirements for process specification and process validation.

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of human origin. The materials are non-viable or have been rendered non-viable. The document specifies, in junction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing human tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts; b) contamination by viruses; c) contamination by agents causing Transmissible Spongiform Encephalopathies (TSE); d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply. This document does not stipulate levels of acceptability, because they are determined by a multiplicity of factors. This document does not specify a quality management system for the control of all stages of production of medical devices.

This document specifies requirements and recommendations that can enable an organization to design, develop and provide products and services so that they can be accessed, understood and used by the widest range of users, including persons with disabilities. This document specifies requirements and recommendations that can enable an organization to widen their range of users by identifying diverse needs, characteristics, capabilities, and preferences, by directly or indirectly involving users, and by using knowledge about accessibility in its procedures and processes. This document specifies requirements that can enable an organization to meet applicable statutory and regulatory requirements as related to the accessibility of its products and services. The requirements and recommendations set out in this document are generic and are intended to be applicable to all relevant parts of all organisations, regardless of type, size or products and services provided. This document promotes accessibility following a Design for All approach in mainstream products and services and interoperability of these with assistive technologies.

This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

Detta dokument beskriver processen för mottagande, kontroll, rengöring och desinfektion, paketering, märkning samt sterilisering av låneinstrument innan de ska användas. Dokumentet beskriver även en säkrad returprocess till den som äger ansvaret för låneinstrumentet.

Denna standard anger termer och definitioner i anslutning till hjärtsäker zon. Standarden anger också krav på hjärtstartare samt krav och rekommendationer för utbildning, underhåll, tillgänglighet och ansvar i anslutning till användning av hjärtstartare i offentliga och andra miljöer utanför sjukvården.