11.040.01 : Medical equipment in general

PD ISO/TR 80001-2-6:2014

PD ISO/TR 80001-2-6:2014

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Application of risk management for IT-networks incorporating medical device guidance. Guidance responsibility agreements

€281.00

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DD ISO/TS 19218-1:2011+A1:2013

DD ISO/TS 19218-1:2011+A1:2013

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Medical devices. Hierarchical coding structure for adverse events Event-type codes

€281.00

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PD ISO/TR 80001-2-7:2015

PD ISO/TR 80001-2-7:2015

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Application of risk management for IT-networks incorporating medical devices. guidance Guidance Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

€421.00

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PD ISO/TR 19244:2014

PD ISO/TR 19244:2014

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Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters

€172.00

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BS EN ISO 15378:2015

BS EN ISO 15378:2015

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Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)

€421.00

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BS EN 62304:2006+A1:2015

BS EN 62304:2006+A1:2015

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Medical device software. Software life-cycle processes

€421.00

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BS ISO 16142-1:2016

BS ISO 16142-1:2016

Withdrawn Most Recent

Medical devices. Recognized essential principles of safety and performance medical devices General additional specific for all non-IVD guidance on the selection standards

€390.00

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PD IEC/TR 60601-4-1:2017

PD IEC/TR 60601-4-1:2017

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Medical electrical equipment Guidance and interpretation. medical systems employing a degree of autonomy

€421.00

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PD IEC/TR 62366-2:2016

PD IEC/TR 62366-2:2016

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Medical devices Guidance on the application of usability engineering to medical

€421.00

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PD IEC/TR 80002-3:2014

PD IEC/TR 80002-3:2014

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Medical device software Process reference model of medical life cycle processes (IEC 62304)

€281.00

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PD IEC/TR 80001-2-5:2014

PD IEC/TR 80001-2-5:2014

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Application of risk management for IT-networks incorporating medical devices guidance. Guidance on distributed alarm systems

€329.00

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PD IEC/TR 80001-2-8:2016

PD IEC/TR 80001-2-8:2016

Superseded Historical

Application of risk management for IT-networks incorporating medical devices guidance. Guidance on standards establishing the security capabilities identified in IEC TR 80001-2-2

€390.00

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PD IEC/TR 62354:2014

PD IEC/TR 62354:2014

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General testing procedures for medical electrical equipment

€421.00

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ASTM F988-86

ASTM F988-86

Withdrawn Most Recent

Guide for Specifying Carbon-Fiber Randomly Reinforced Ultra-High-Molecular-Weight Polyethylene for Medical Devices (Withdrawn 1992)

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ASTM F1839-01

ASTM F1839-01

Superseded Historical

Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

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