IEC TR 60930:2008 pdf download – Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
1 Scope
This technical report is intended to lessen the RIsK to PATIENTS，OPERATORs，and theirsurroundings by providing a code of safe application.This reduction of RISK is in addition tothat brought about by the RISK CONTRoL measures incorporated in the MEDICAL ELECTRICALEQuUIPMENT, the MEDIcALELECTRICAL SYSTEM, and the electrical installation in medical locations,hereafter referred to as ME EQUIPMENT,ME SYSTEM and installation respectively.
Not all existing ME EQUIPMENT，ME SYSTEMs or installations meet the requirements of therelevant lEC standards. From time to time，oPERATORs and RESPONSIBLE ORGANIZATIONS willencounter ME EQUIPMENT and ME SYSTEMs complying with older safety standards.However,the guidelines for safe application given in this technical report should nevertheless befollowed in so far as this is possible.
The guidelines in this technical report can be used with ME EQUIPMENT or ME SYSTEMs for thehome healthcare environment provided the MANUFACTURER has included home use in theINTENDED uSE or the cLINIcAL’ENGINEERING DEPARTMENT has checked that the electricalinstallation and the physical environment will not result in any unacceptable RISKs. Theseguidelines can also be applied to equipment used for compensation or alleviation of disease,injury or disability.
lf the ME EQUIPMENT,an ME SYSTEM or the installation does not comply with the relevant lECstandards，the RESPONSIBLE ORGANIZATION should consult with the cLINIcAL ENGINEERINGDEPARTMENT or the MANUFACTURER for instructions on how to achieve an adequate level ofsafety.
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.
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 60601-1-8:2006,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
IEC 62353:2007,Medical electrical equipment – Recurrent test and test after repair of medicalelectrical equipment
3Terms and definitions
For the purposes of this document，the terms and definitions in lEC 60601-1:2005,IEC 60601-1-2:2007，IEC 60601-1-8:2006 and IEC 62353:2007 and the following term anddefinition apply.
NOTE1 The term “electrical equipment” is used to mean ME EQUIPMENT or other electrical equipment. Thistechnical report also uses the term“equipment”to mean ME EQUIPMENT or other electrical or non-electricalequipment in the context of an ME SYSTEM.
NOTE 2 An index of defined terms used in this technical report is found beginning on page 27.3.1
CLINICAL ENGINEERING DEPARTMENT
entity accountable on behalf of the RESPONSIBLE ORGANIZATION for the safe and effectivemanagement of technology and the application of medical and biomedical engineering withinthe clinical environment.
NOTE Clinical engineering services can be provided by the health care facility or they can be obtained fromoutside.
4Nature of HAZARDS
ME EQUIPMENT or ME SYSTEMs can introduce a number of HAZARDs for PATIENTS，OPERATORS orthe surroundings (e.g. poisonous gases，overpressure，explosion，electrical shock). Thesecan be caused by misapplication, faults in the equipment that might not be obvious, improperfunctioning, installation or environmental conditions.
PATIENTs can be exceptionally sensitive to HAZARDs because they are either unaware of them,unable to react normally (for example, if they are unconscious), or because the nature of theirtreatment makes them more susceptible.
Proper construction of the ME EQUIPMENT，ME SYSTEM or the installation alone do not alwaysachieve the desired safety; the mode of use (application),environment，MAINTENANCE andtraining also need to be considered.
5BASIC SAFETY provisions of and symbols on ME EQUIPMENT
5.1General
This clause contains a description of those BASIC SAFETY provisions of ME EQUIPMENT thatneed to be available to the oPERATOR in order to operate the ME EQUIPMENT properly.TheOPERATOR should also know the meaning of all symbols marked on the ME EQUIPMENT.For theBASIC SAFETY provisions for ME SYSTEMs, see Clause 9.
5.2AcGOMPANYING DOGUMENTS
ME EQUIPMENT is provided with ACCOMPANYING DOCUMENTS，which are considered to be anessential part of the ME EQUIPMENT.
The ACCOMPANYING DOCUMENTS consist partly of instructions for use intended for theOPERATOR and partly of a technical description for the CLINICALENGINEERING DEPARTMENT. Thetwo parts can be provided in separate volumes.
