For medical devices, it is possible to provide instructions for use in electronic form. However, this was previously limited to certain products by Regulation (EU) 207/2012. New regulations under Regulation (EU) 2017/745 With the current Medical Devices Regulation (EU) 2017/745, this option has been retained in Annex I, Chapter III. More precise regulation was provided by the Implementing Regulation (EU) [...]
Date of issue: June 2022 DIN ISO 24495-1: Plain language - Part 1: Principles and guidelines DIN ISO 24495-1 has recently been published as a draft. The standard contains principles and guidelines for creating documents in plain language. Four principles are defined for this purpose: Relevance, Findability, Comprehensibility, Applicability. These are intended to make it easier for the creator of a document [...]
Date of issue: February 2022 DIN EN ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements A new version of Part 1 of DIN EN ISO 15223 has been published this month. It specifies requirements for symbols to be used on medical devices. This part of the [...]
Issue date: October 2019 DIN EN ISO 3166: Codes for the names of countries and their subdivisions - Part 1: Codes for country names A new draft of DIN EN ISO 3166 has been published this month. The standard deals with country codes, which are also used, for example, to identify language versions of documents and other [...]
Date of issue: May 2017 DIN EN ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements Part 1 of DIN EN ISO 15223 specifies requirements for symbols to be used with medical devices. This part of the standard is applicable to a wide range of medical devices [...]
Ausgabedatum: Juni 2016 DIN EN ISO 17664: Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten Diesen Monat ist ein Norm-Entwurf zur DIN EN ISO 17664 erschienen. Die Norm gilt für Hersteller von Medizinprodukten, welche zur gebrauchsfertigen Aufbereitung durch den Anwender oder Dritte vorgesehen sind. Die Norm legt [...]
