11.040.01 : Medical equipment in general

ISO 14971:2019

ISO 14971:2019

Active Most Recent

ISO 14971:2019 Medical devices - Application of risk management to medical devices

€189.00

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ISO TR 24971:2020

ISO TR 24971:2020

Active Most Recent

ISO TR 24971:2020 Medical devices - Guidance on the application of ISO 14971

€237.00

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IEC 61847:1998

IEC 61847:1998

Superseded Historical

IEC 61847:1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics

€302.00

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IEC 60601-1-2:2007

IEC 60601-1-2:2007

Superseded Historical

IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

€499.00

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IEC TR 61258:2008

IEC TR 61258:2008

Active Most Recent

IEC TR 61258:2008 Guidelines for the development and use of medical electrical equipment educational materials

€93.00

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IEC TR 60930:2008

IEC TR 60930:2008

Active Most Recent

IEC TR 60930:2008 Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems

€244.00

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IEC TR 62296:2009

IEC TR 62296:2009

Active Most Recent

IEC TR 62296:2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements

€441.00

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IEC TR 80002-1:2009

IEC TR 80002-1:2009

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IEC TR 80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software

€441.00

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IEC TR 80001-2-3:2012

IEC TR 80001-2-3:2012

Withdrawn Most Recent

IEC TR 80001-2-3:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks

€342.00

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IEC TR 80001-2-2:2012

IEC TR 80001-2-2:2012

Superseded Historical

IEC TR 80001-2-2:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls

€389.00

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IEC TR 80001-2-1:2012

IEC TR 80001-2-1:2012

Withdrawn Most Recent

IEC TR 80001-2-1:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples

€441.00

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IEC TR 80001-2-4:2012

IEC TR 80001-2-4:2012

Withdrawn Most Recent

IEC TR 80001-2-4:2012 Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations

€186.00

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IEC TR 62348:2012

IEC TR 62348:2012

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IEC TR 62348:2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition

€470.00

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IEC TR 80002-3:2014

IEC TR 80002-3:2014

Withdrawn Most Recent

IEC TR 80002-3:2014 Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)

€244.00

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IEC TR 62354:2014

IEC TR 62354:2014

Active Most Recent

IEC TR 62354:2014 General testing procedures for medical electrical equipment

€551.00

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