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Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
ANSI
IEC 60601-1-11 Ed. 2.0 en:2015(Redline version) - Start year: 2015 Redline Version
Location: Americas - US

Description:

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11:2015 RLV contains the International Standard and its Redline version. The Redline version is available in English only. The Redline version provides you with a quick and easy way to compare all the changes between this standard and its previous edition. The Redline version is not an official IEC Standard, only the current version of the standard is to be considered the official document.

IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:

- the dwelling place in which a patient lives;

- other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.

This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:

- correction of test method for relative humidity control at temperatures above 35 °C;

- redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and

- harmonizing with the changes to the amendments to the general standard and other collateral standards.

Notes:
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Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
British Standards Institution
BS EN 60601-1-11:2015 - Start year: 2015
Location: Europe - United Kingdom

Description:

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 

People are increasingly using medical equipment in their own homes, for monitoring, treatment and diagnosis - which raises the question, will the equipment work properly and safely when used by untrained operators in the uncontrolled home environment? This standard gives guidance on how to address these issues.

BS EN 60601-1-11 gives requirements and recommendations for the safety and performance of medical electrical equipment and medical electrical systems for home healthcare. Developed with contributions from clinicians, engineers and regulators, and originally published in 2010, it has now been revised to align with the current version of the general standard in this series, BS EN 60601-1:2006+-A12:2014. 

The standard applies to use by both lay operators and trained healthcare personnel. Among many other aspects of safety and performance, its scope includes:

 

  • Transport and storage 
  • Requirements for testing 
  • Operating instructions 
  • Marking and labelling
  • Usability of documents
  • Maintenance 

 

BS EN 60601-1-11:2015 will benefit manufacturers of medical electrical equipment and systems. Compliance with this standard can provide a presumption of conformity with EC Directive 93/42/EEC.

 

Notes:
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Agency (an Agency can be National, International, or a Non-Government Organization or NGO):
International Electrotechnical Commission
IEC 60601-1-11:2015 - Start year: 2019
Location: Global - Global

Description:

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 60601-1-11:2015 is available as IEC 60601-1-11:2015 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.

IEC 60601-1-11:2015 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the home healthcare environment. It applies regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. The home healthcare environment includes:
- the dwelling place in which a patient lives;
- other places where patients are present both indoors and outdoors, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.
This second edition cancels and replaces the first edition of IEC 60601-1-11, published in 2010, and constitutes a technical revision. The most significant changes with respect to the previous edition include the following modifications:
- correction of test method for relative humidity control at temperatures above 35 °C;
- redrafting of subclauses that altered instead of adding to the general standard or other collateral standards; and
- harmonizing with the changes to the amendments to the general standard and other collateral standards.

Notes:
  Sort by Start year / Status
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