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ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.
The sub-clause 7.3.10 of ISO 13485:2016 requires a manufacturer of a medical device to maintain (and control) a design and development file for a medical device to document the design history of a medical device. This file shall also contain records for changes in design and development (per device type or family).
Institutions, which want to reprocess single-use medical devices, must adopt and implement a quality management system according to DIN EN ISO 13485:2007. Compliance with the quality management requirements is monitored annually by "Notified Bodies" that have been accredited by the Central Authority of the Länder for Health Protection with ...
ISO 13485:2016 is the medical industry's equivalent of ISO 9001. ISO 13485:2016 is a stand-alone standard. Because ISO 13485 is relevant to medical device manufacturers (unlike ISO 9001, which is applicable to any industry), and because of the differences between the two standards relating to continual improvement, compliance with ISO 13485 ...
The general standard IEC 60601-1 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance – gives general requirements of the series of standards. 60601 is a widely accepted benchmark for medical electrical equipment and compliance with IEC60601-1 has become a requirement for the commercialisation of electrical medical equipment in many ...
Quality assurance considerations such as those defined in ISO 13485. Quality control considerations: what testing can be performed on each manufactured unit prior to release for sale to demonstrate its usage suitability. [16] [17] [123] Traceability issues, can a single stent be traced from the manufacturer to the patient it was implanted in.
This part of the standard is aimed at operators of automation solutions and defines requirements for how security during the operation of plants is to be considered (see ISO/IEC 27001). IEC 62443-2-3 Patch management in the IACS environment Technical Report, Edition 1.0, June 2015 [5] IEC 62443-2-4 Requirements for IACS service providers
ISO/IEEE 11073 Personal Health Device (PHD) standards are a group of standards addressing the interoperability of personal health devices (PHDs) such as weighing scales, blood pressure monitors, blood glucose monitors and the like. The standards draw upon earlier IEEE11073 standards work, but differ from this earlier work due to an emphasis on ...