BS ISO 11197:2016 pdf download – Medical supply units
201.1.3.2 Particular standards
IEC 60601-1:2005+A1:2012,1.4 applies with the following additions:
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 60601-1:2005+A1:2012 with the prefix“201″(e.g. 201.1 in this standard addresses the content of IEC 60601-1:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix “20x”” where x is the final digit(s) ofthe collateral standard document number [(e.g.202.4 in this particular standard addresses the content of Clause 4of the IEC 60601-1-2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of theIEC 60601-1-3 collateral standard, etc.). The changes to the text of IEC 60601-1:2005+A1:2012 are specified bythe use of the following words:
-“Replacement”means that the clause or subclause of IEC 60601-1:2005+A1:2012 or applicablecollateral standard is replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements ofIEC 60601-1:2005+A1:2012 or applicable collateral standard.
“Amendment”means that the clause or subclause of IEC 60601-1:2005+A1:2012 or applicablecollateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of IEC 60601-1:2005+A1:2012 are numbered starting from201.101.Additional Annexes are lettered AA,BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x,where “x” is the number of the collateral standard, e.g.202 for IEC 60601-1-2,203 for IEC 60601-1-3,etc.
The term “this standard” is used to make reference to IEC60601-1:2005+A1:2012, any applicable collateralstandards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause orsubclause of IEC 60601-1:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applieswithout modification; where it is intended that any part of IEC 60601-1:2005+A1:2012 or applicable collateralstandard, although possibly relevant, is not to be applied, a statement to that effect is given in this particularstandard.
201.2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensablefor its application.For dated references, only the edition cited applies.For undated references, the latest edition ofthe referenced document (including any amendments) applies.
NOTE Informative references are listed in the Bibliography on page 25.
IEC 60601-1:2005+A1:2012,Clause 2 applies and IEC 60601-1-2:2014,Clause 2 applies, with the following additions:IEC 60364-5-54:2011,Electrical installations of buildings — Part 5-54:Selection and erection of electricalequipment; Earthing arrangements, protective conductors and protective bonding conductors
IEC 60364-7-710:2002,Electrical installations of buildings — Part 7-710: Requirements for specialinstallations or locations; Medical locations
IEC 60529:1989+AMD1:1999 +AMD2:2013 CSV/COR2:2015，Degrees of protection provided byenclosures (IP Code)
IEC 60598-1:2014, Luminaires — Part 1: General requirements and tests
IEC 60601-1:2005+A1:2012,Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment —Part 1-2:General requirements for basic safety andessential performance -Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-3:2008,Medical electrical equipment — Part 1: General requirements for safety 3.CollateralStandard:General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
IEC 60601-1-6:2010,Medical electrical equipment — Part 1-6: General requirements for basic safety andessential performance – Collateral standard: Usability
IEC 60601-1-8:2006+A1:2012,Medical electrical equipment — Part 1-8:General requirements for basicsafety and essential performance — Collateral Standard:General requirements, test and guidance foralarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-9:2007,Medical electrical equipment — Part 1-9: General requirements for basic safety andessential performance —Collateral Standard: Requirements for environmentally conscious design
IEC 60601-1-10:2007,Medical electrical equipment — Part 1-10:General requirements for basic safetyand essential performance — Collateral Standard: Requirements for the development of physiologicclosed-loop controllers
IEC 61386-1:2008,Conduit systems for cable management — Part 1: General requirements
IEC 61950:2007,Cable management systems — Specifications for conduit fittings and accessories forcable installations for extra-heavy duty electrical steel conduit
ISo 3744:2010,Acoustics —Determination of sound power levels and sound energy levels of noise sourcesusing sound pressure — Engineering methods for an essentially free field over a reflecting plane
IS0 5359:2014,Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use withmedical gases
IS0 7396-1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gasesand vacuum.BS ISO 11197 pdf download.