IEC_60601-2-38-1996_amd1-1999.pdf

INTERNATIONALSTANDARDIEC60601-2-381996AMENDMENT 11999-12Amendment 1Medical electrical equipment Part 2-38:Particular requirements for the safetyof electrically operated hospital bedsAmendement 1Appareils lectromdicaux Partie 2-38:Rgles particulires de scuritdes lits dhpital lectriquesPRICE CODE IEC 1999 Copyright-all rights reservedInternational Electrotechnical Commission3,rue de Varemb Geneva,SwitzerlandTelefax:+41 22 919 0300e-mail:inmailiec.ch IEC web site http:/www.iec.chPFor price,see current catalogue Commission Electrotechnique Internationale International Electrotechnical CommissionLICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.2 60601-2-38 Amend.1 IEC:1999(E)FOREWORDThis amendment has been prepared by subcommittee 62D:Electromedical equipment,of IECtechnical committee 62:Electrical equipment in medical practice.The text of this standard is based on the following documents:FDISReport on voting62D/336/FDIS62D/346/RVDFull information on the voting for the approval of this amendment can be found in the report onvoting indicated in the above table._Page 3CONTENTSAdd the title of clause 23,as follows:23 Surface,corners and edgesAdd,on page 5,the titles of the new figures:Figure 113 Application of forces for test of SIDE RAILSFigure 114 Examples(only)of BEDS with segmented SIDE RAILS and single-piece SIDE RAILSFigure 115 Test conePage 132.1.109 SQUEEZING and SHEARING POINTSModify the title of the defined term to read:SQUEEZING and SHEARING POINTS(FOR FINGERS)Add,after 2.1.109,the following new definition:*2.1.110 PATIENT ENTRAPMENTThe ability for a PATIENT to insert his/her head,neck or chest cavity into a permanent openingin the BED and/or its ACCESSORIES or into a temporary opening created during NORMAL USE,from which the PATIENT cannot remove that portion of his/her anatomy.*2.2.101ELECTRICALLY OPERATED HOSPITAL BED(hereinafter referred to as BED)Replace the text of the definition by the following text and note:BED and its accessories intended for use in the diagnosis,treatment or monitoring of an adultPATIENT whilst under medical supervision.NOTE For an explanation of the basis for the definition of“adult”,see Rationale in annex AA.LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.60601-2-38 Amend.1 IEC:1999(E)3 Add,after 2.2.101,the following new definition:*2.2.102LIFTING POLEDevice suspended above the BED and intended to allow the PATIENT to change position bygripping it.3 General requirements3.101Add,on page 15,the following new text at the end of this subclause:Compliance with this requirement is checked by the following test:If alternative means of construction have been employed or if a requirement of this ParticularStandard has not been met,in order to provide benefit to the PATIENT,a risk assessment shallbe performed(in accordance with ISO 14971-1)to demonstrate that the overall level of safetyhas not been compromised.Page 156.1 Marking on the outside of EQUIPMENT or EQUIPMENT PARTS*u)Mechanical stabilityReplace the text of this item by the following:The BED and its ACCESSORIES(intended to support and/or immobilise masses)shall be markedwith their own SAFE WORKING LOAD.(See figure 108.)Page 176.8.2 Instructions for usea)General informationReplace the second dashed item by the following:The instructions for use shall indicate the SAFE WORKING LOAD of the BED and its ACCESSORIESintended to support masses and which can be removed during NORMAL USE.Add the following new dashed items:The instructions for use for the BED shall include a list of all ACCESSORIES which may beattached to or used with the BED.The instructions for use shall indicate any restriction with regard to the characteristics of thePATIENT(such as clinical condition,weight or size,etc.)necessary to insure safe operationof the BED.The instructions for use shall provide a warning that the BED should be left in its lowestposition when unattended in order to reduce the risk of injury due to falls whilst getting intoor out of the BED,or whilst lying on the BED.LICENSED TO MECON Limited.-RANCHI/BANGALOREFOR INTERNAL USE AT THIS LOCATION ONLY,SUPPLIED BY BOOK SUPPLY BUREAU.4 60601-2-38 Amend.1 IEC:1999(E)When the requirements of dimensions D and/or E of figure 114 of this Particular Standardare met only when the MATTRESS SUPPORT PLATFORM is in the flat position,the instructionsfor use shall include a warning that,when a PATIENTs condition(such as disorientation dueto medication or clinical condition)could lead to PATIENT ENTRAPMENT,the MATTRESSSUPPORT PLATFORM should be left in the flat position whilst unattended(except whenrequired otherwise by medical staff for special or particular circumstances).The instructions for use for ACCESSORIES shall list the BED type or model with which theACCESSORIES may be used(except when required otherwise by medical staff for special orparticular circumstances).Page 1918 Prot