11.120.01 : Pharmaceutics in general

DIN EN ISO 14971/A1:2003-10

DIN EN ISO 14971/A1:2003-10

Superseded Historical

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AMD 1:2003); German version EN ISO 14971:2001/A1:2003

€63.27

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ASTM E3263-22

ASTM E3263-22

Superseded Historical

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

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ASTM E3326-22

ASTM E3326-22

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Standard Guide for Application of Continuous Manufacturing (BioCM) in the Biopharmaceutical Industry

€72.00

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ASTM F640-23

ASTM F640-23

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Standard Test Methods for Determining Radiopacity for Medical Use

€65.00

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ASTM E2475-23

ASTM E2475-23

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Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

€65.00

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BS EN ISO 20417:2021

BS EN ISO 20417:2021

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Medical devices. Information to be supplied by the manufacturer

€404.00

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ASTM E1483-92(2000)

ASTM E1483-92(2000)

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Standard Test Method for Assessing Developmental Toxicity in Rats and Rabbits

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ASTM E2475-10(2016)

ASTM E2475-10(2016)

Superseded Historical

Standard Guide for Process Understanding Related to Pharmaceutical Manufacture and Control

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ASTM E2363-14

ASTM E2363-14

Superseded Historical

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

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ASTM E3263-22e1

ASTM E3263-22e1

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

€94.00

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ASTM E2968-23

ASTM E2968-23

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

€72.00

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ASTM E2363-23

ASTM E2363-23

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

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NBN EN 1041+A1:2013

NBN EN 1041+A1:2013

Superseded Historical

Information supplied by the manufacturer of medical devices

€50.00

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NBN EN 15986:2011

NBN EN 15986:2011

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Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

€89.00

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NBN EN 14375:2004

NBN EN 14375:2004

Superseded Historical

Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing

€50.00

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