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The Annex ZC harmonized ISO 14971:2012 with the In-vitro Diagnostic Medical Device Directive 98/79/EC of 1998. [10] The 2021 addendum to ISO 14971 (ISO 14971:2019+A11:2021) was published to harmonize ISO 14971 and two European Regulations associated with medical devices through the two 'Zed' Annexes (ZA & ZB).
As low as reasonably practicable (ALARP), or as low as reasonably achievable (ALARA), is a principle in the regulation and management of safety-critical and safety-involved systems. [1]
ISO 15784-1:2008 Part 1: General principles and documentation framework of application profiles; ISO 15784-2:2015 Part 2: Centre to field device communications using SNMP; ISO 15784-3:2008 Part 3: Application profile-data exchange (AP-DATEX) ISO 15785:2002 Technical drawings – Symbolic presentation and indication of adhesive, fold and pressed ...
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IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability. It does not address clinical decision-making related to use of the device. The standard will replace ISO/IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability.
Many of the parts of this series have been harmonized by CENELEC CLC/SR 66 "Safety of measuring, control, and laboratory equipment" [1] as EN standards, and almost all of them eventually get published in the Official Journal and receive Presumption of Conformity for the EU Low Voltage Directive, as seen in the lists of harmonised standards (PDF Version).
ISO 374-2:2019 Part 2: Determination of resistance to penetration; ISO 374-4:2019 Part 4: Determination of resistance to degradation by chemicals; ISO 374-5:2016 Part 5: Terminology and performance requirements for micro-organisms risks; ISO 375:1974 Steel — Tensile testing of tubes [Withdrawn: replaced with ISO 6892-1]
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).
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