Medizintechnik

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  • Process engineering - Turnaround management - Fundamentals

    Technical rule [CURRENT] 2021-11

    VDI 2775 Blatt 1:2021-11

    Process engineering - Turnaround management - Fundamentals

    The standard provides assistance for the successful implementation of a turnaround in the pharmaceutical, chemical, and petrochemical industry according to a project approach. It describes ...

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  • Process engineering - Turnaround management - Integration of project measures into a turnraround

    Technical rule [NEW] 2026-10

    VDI 2775 Blatt 2:2026-10

    Process engineering - Turnaround management - Integration of project measures into a turnraround

    A key factor in the success of turnarounds (TA) is the optimal integration of maintenance and capital projects. Precise planning and coordination are crucial for exploiting synergies, optimising ...

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  • Traditional Chinese medicine - Simplified accelerated stress simulation methods

    Standard [CURRENT] 2024-12

    ISO 8284:2024-12

    Traditional Chinese medicine - Simplified accelerated stress simulation methods

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  • BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples

    Draft standard 2022-08-03

    22/30447779 DC:2022-08-03 - Draft

    BS ISO 20658. Medical laboratories. Requirements for collection and transport of samples

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  • Medical devices. Information to be supplied by the manufacturer

    Standard [CURRENT] 2026-04-08

    BS EN ISO 20417:2026-04-08

    Medical devices. Information to be supplied by the manufacturer

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  • Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

    Standard [CURRENT] 2023

    ASTM E 2363:2023

    Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry

    1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms ...

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  • Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

    Standard [CURRENT] 2023

    ASTM E 2475:2023

    Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

    1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran, 1992; 2 ...

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  • Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

    Standard [CURRENT] 2026

    ASTM E 2891:2026

    Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications

    1.1 This guide covers the applications of multivariate data analysis (MVDA) to support pharmaceutical development and manufacturing activities. MVDA is one of the key enablers for process ...

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  • Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry

    Standard [CURRENT] 2023

    ASTM E 2968:2023

    Standard Guide for Application of Continuous Manufacturing (CM) in the Pharmaceutical Industry

    1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of CM technologies for the manufacture of pharmaceutical products. Athough ...

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  • Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

    Standard [CURRENT] 2022

    ASTM E 3263:2022

    Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

    1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of ...

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