IEC 60601-1-11:2010 pdf free download

IEC 60601-1-11:2010 pdf free download 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
1 scope, object and related standards
1.1 * Scope
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofMEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS,hereafter referred to asME EQUIPMENT and ME sYSTEMS，which are intended by their MANUFACTURER for use in theHOME HEALTHCARE ENVIRONMENT, as defined in 3.2, regardless of whether the ME EQUIPMENT orME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.
NOTE1 HOME HEALTHCARE ENVIRONMENT MEEQUIPMENT and ME SYSTEMs can also be intended for use in otherenvironments, for example, in a professional healthcare facility.
This International Standard does not apply to ME EQUIPMENT and ME sYSTEMs intended solelyfor use by emergency medical services or solely for use in professional healthcare facilities.
NOTE 2 HOME HEALTHCARE ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can frequently be used in locations withunreliable electrical sources and poor electrical grounding.
1.2object
The object of this collateral standard is to specify general requirements that are in addition tothose of the general standard and to serve as the basis for particular standards.
1.3Related standards
1.3.1 IEC 60601-1
For ME EQUIPMENT and ME sYSTEMS, this collateral standard complements lEC 60601-1.
When referring to lEC 60601-1 or to this collateral standard，either individually or incombination, the following conventions are used:
“the general standard” designates lEC 60601-1 alone;
“this collateral standard” designates lEC 60601-1-11 alone;
“this standard” designates the combination of the general standard and this collateralstandard.
1.3.2Particular standards
A requirement in a particular standard takes priority over the corresponding requirement inthis collateral standard.
2Normative references
The following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies.For undated references, the latest editionof the referenced document (including any amendments) applies.
NOTE1The way in which these referenced documents are cited in normative requirements determines the extent(in whole or in part) to which they apply.
NOTE 2Informative references are listed in the bibliography on page 54.
IEC 60068-2-27:2008,Environmental testing – Part 2-27:Tests – Ea and guidance:Shock
IEC 60068-2-31:2008，Environmental testing – Part 2-31:Tests – Test Ec: Rough handlingshocks,primarily for equipment-type specimens
IEC 60068-2-64:2008,Environmental testing – Part 2-64: Tests – Test Fh: Vibration,broadband random and guidance
IEC 60529:1989,Degrees of protection provided by enclosures (IP Code)Amendment 1 (1999) 1)
IEC 60601-1:2005，Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-2:2007，Medical electrical equipment – Part 1-2: General requirements for basicsafety and essential performance – Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC 60601-1-6:2010,Medical electrical equipment – Part 1-6: General requirements for basicsafety and essential performance – Collateral Standard: Usability
IEC 60601-1-8:2006,Medical electrical equipment – Part 1-8: General requirements for basicsafety and essential performance – Collateral standard: General requirements，tests andguidance for alarm systems in medical electrical equipment and medical electrical systems
CISPR 11:2009,Industrial,scientific and medical equipment – Radio-frequency disturbancecharacteristics -Limits and methods of measurement