Hälso- och sjukvård

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.

• Är standarden bra som den är och kan den därmed tillstyrkas (och gälla i ytterligare fem år)?
• Eller behöver den revideras, eller kanske till och med upphävas?
• Är någon av kommittédeltagarna beredd att delta i arbetet om beslut fattas om revidering?
• 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.

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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.

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.  

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.