11.020.01 – Quality and environmental management in health care – PDF Standards Store ?u= Wed, 06 Nov 2024 00:58:31 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.1 ?u=/wp-content/uploads/2024/11/cropped-icon-150x150.png 11.020.01 – Quality and environmental management in health care – PDF Standards Store ?u= 32 32 ISO/IEC Guide 63:2012 ?u=/product/publishers/iso/iso-iec-guide-632012/ Wed, 06 Nov 2024 00:58:31 +0000 Guide to the development and inclusion of safety aspects in International Standards for medical devices
Published By Publication Date Number of Pages
ISO 2012-01 28
]]> ISO/IEC Guide 63:2012 provides guidance to standards writers on how to include safety aspects in the development of medical device safety standards intended to be used within the risk management framework established in ISO 14971. It expands on the concepts developed in ISO/IEC Guide 51 to include safety-related performance and usability.

ISO/IEC Guide 63:2012 is intended to be read in conjunction with ISO/IEC Guide 51 and ISO 14971.

]]> ISO 5258:2022 ?u=/product/publishers/iso/iso-52582022/ Tue, 05 Nov 2024 23:28:23 +0000 Healthcare organization management - Pandemic response (respiratory) - Drive-through screening station
Published By Publication Date Number of Pages
ISO 2022-02 20
]]> This document specifies the operation of a drive-through screening station (DTSS) for mass testing as part of pandemic response management.

NOTE       COVID-19 is an exemplary disease for which such a station is developed.

]]> ISO 22956:2021 ?u=/product/publishers/iso/iso-229562021/ Tue, 05 Nov 2024 22:39:39 +0000 Healthcare organization management — Requirements for patient-centred staffing
Published By Publication Date Number of Pages
ISO 2021-06 18
]]> This document provides requirements for patient-centred staffing in healthcare settings. It is generic and applicable to any healthcare organization.

]]> ISO 22886:2020 ?u=/product/publishers/iso/iso-228862020/ Tue, 05 Nov 2024 22:38:53 +0000 Healthcare organization management — Vocabulary
Published By Publication Date Number of Pages
ISO 2020-08 18
]]> This document defines terms used in healthcare organization management.

]]> VDI 5703 Blatt 1:2021 Edition ?u=/product/publishers/din/vdi-5703-blatt-1/ Tue, 05 Nov 2024 18:06:23 +0000 Systematische Entwicklung modellbasierter Prüfungen für Medizinprodukte - Grundlagen
Published By Publication Date Number of Pages
DIN 2021-12 34
]]> Einige Prüfverfahren für Medizinprodukte sind als internationaler Standard festgelegt. Für zahlreiche Medizinprodukte gestaltet sich jedoch die Auswahl und Festlegung notwendiger und geeigneter Prüfverfahren als schwierig. Dies gilt beispielsweise, wenn neuartige Medizinprodukte entwickelt werden, für die zunächst keine Prüfstandards oder andere Publikationen über geeignete Prüfverfahren existieren. Für andere Medizinprodukte existieren Normen, die eine Verantwortung des Herstellers zur Durchführung von Prüfungen beschreiben, jedoch keine konkreten Vorgaben zur Durchführung enthalten. Die Richtlinie systematisiert die relevanten Begriffe und beschreibt eine methodische Herangehensweise für die Auswahl, Festlegung und die gegebenenfalls notwendige Entwicklung von Prüfstrategien für Medizinprodukte. Dabei werden, ausgehend vom Zweck der Prüfung und unter Einbindung bereits existierender Prüfstandards, Maßnahmen zur Risikoreduktion aus einem grundlegenden Risikomanagementprozess abgeleitet.*www.vdi.de/5703

]]> VDI 5703 Part 1:2021 Edition ?u=/product/publishers/din/vdi-5703-part-1/ Tue, 05 Nov 2024 18:06:23 +0000 Systematical development for a model-based testing of medical devices - Fundamentals
Published By Publication Date Number of Pages
DIN 2021-12 34
]]> Some test methods for medical devices are defined by international standards. However, the selection and determination of necessary and appropriate test procedures for many medical devices results to be difficult. This applies, for example, to new medical devices being developed, for which there are no test standards or other publications on appropriate test methods. For other medical devices, existing standards define the responsibility to carry out testing for the manufacturer, but do not contain specific guidelines for implementation. The standard systematises the relevant terms and describes a methodical approach for the selection, establishment and any necessary development of testing strategies for medical devices. In the process, measures are derived for risk reduction from a basic risk management process, starting with the purpose of the test and accounting existing test standards.

]]> VDI 4075 Part 5:2014 Edition ?u=/product/publishers/din/vdi-4075-part-5/ Tue, 05 Nov 2024 18:02:03 +0000 Cleaner Production (PIUS) - Health care
Published By Publication Date Number of Pages
DIN 2014-01 22
]]> The standard gives a summary about the economic and ecological optimisation measures for a Cleaner Production (Production-Integrated Environmental Protection – PIUS) in the health service. It is intended for practitioners from companies and institutions of the health service who are familiar with the optimisation of design production processes and facilities and, thus, simultaneously intend to protect environment, optimise quality and reduce costs. All measures implemented in hospitals show special difficulties due to the large number of active members. A uniform environmental management starting with acquisition up to disposal as well as regular information of all active members on Cleaner Production measures and their advantages is a prerequisite for a successful realisation of the Cleaner Production potentials.

]]> VDI 4075 Blatt 5:2014 Edition ?u=/product/publishers/din/vdi-4075-blatt-5/ Tue, 05 Nov 2024 18:01:56 +0000 Produktionsintegrierter Umweltschutz (PIUS) - Gesundheitswesen
Published By Publication Date Number of Pages
DIN 2014-01 22
]]> Die Richtlinie gibt einen Überblick über die ökonomischen und ökologischen Optimierungsmaßnahmen zum Produktionsintegrierten Umweltschutz (PIUS) im Gesundheitswesen. Sie spricht Praktiker aus Unternehmen und Einrichtungen des Gesundheitswesens an, die mit der Optimierung von Arbeitsabläufen und Anlagen vertraut sind und somit gleichzeitig die Umwelt schützen, die Qualität optimieren und die Kosten senken wollen. Bei allen Maßnahmen in Krankenhäusern besteht eine besondere Problematik wegen der großen Zahl von Akteuren. Ein einheitliches Umweltmanagement von der Beschaffung bis zur Entsorgung sowie regelmäßige Information aller Akteure über PIUS-Maßnahmen sowie deren Vorteile sind Voraussetzung für eine erfolgreiche Realisierung der PIUS-Potenziale.*www.vdi.de/4075

]]> DIN EN 16224:2015 Edition ?u=/product/publishers/din/din-en-16224/ Tue, 05 Nov 2024 15:59:07 +0000 Healthcare provision by chiropractors
Published By Publication Date Number of Pages
DIN 2015-03 37
]]> This European Standard specifies requirements and recommendations for healthcare services provided by chiropractors.

]]> DIN EN 15224:2017 Edition ?u=/product/publishers/din/din-en-15224/ Tue, 05 Nov 2024 15:50:46 +0000 Quality management systems - EN ISO 9001:2015 for healthcare
Published By Publication Date Number of Pages
DIN 2017-05 87
]]> This is a sector specific quality management system standard for healthcare. This standard incorporates EN ISO 9001:2015 and replaces EN 15224:2012 Health services – Quality management systems – Requirements based on EN ISO 9001:2008. This is a standalone standard and can be used for certification of healthcare organizations. The requirements in this standard comprehensively incorporate those from EN ISO 9001:2015 with additional requirements, specifications and interpretations for healthcare. Requirements have been added when considered relevant and existing clarified according to the specific healthcare context. This standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes. This standard includes requirements for quality management but does not specify requirements for specific healthcare services. The quality management system requirements specified in this standard are complementary to requirements for healthcare products and services.

]]>