CAN CSA-C22 2 NO 60601-2-31 AMD 1-2014 Amendment 1 Medical electrical equipment - Part 2-31 Particular requirements for the basic safety and essential performance of external cardi.pdf

1、 IEC 2011. CSA Group 2014. All rights reserved. Unauthorized reproduction is strictly prohibited. CEI 2011. Groupe CSA 2014. Tous droits rservs. Toute reproduction sans autorisation est strictement interdite.Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-2-31-09(IEC 60601231:2008, IDT)National St

2、andard of CanadaNorme nationale du CanadaModification 1:2014 (IDT) la CAN/CSA-C22.2 No. 60601-2-31-09Appareils lectromdicaux Partie 2-31-Exigences particulires pour lascurit de base et les performances essentielles des stimulateurs cardiaquesexternes source dnergie interne(IEC 60601231:2008, IDT)Ame

3、ndment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-2-31-09Medical electrical equipment Part 2-31-Particular requirements for thebasic safety and essential performance of external cardiac pacemakers withinternal power source(IEC 60601231:2008, IDT)Standards Update ServiceAmendment 1:2014 (IDT) to CAN/CSA

4、-C22.2No. 60601-2-31-09December 2014Title: Medical electrical equipment Part 2-31-Particular requirements for the basic safetyand essential performance of external cardiac pacemakers with internal power sourceTo register for e-mail notification about any updates to this publication go to shop.csa.ca

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6、ormation.Service de mise jour des normesModification 1:2014 (IDT) la CAN/CSA-C22.2No. 60601-2-31-09Dcembre 2014Titre : Appareils lectromdicaux Partie 2-31-Exigences particulires pour la scurit debase et les performances essentielles des stimulateurs cardiaques externes source dnergieinterneVous deve

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9、ONAL STANDARD NORME INTERNATIONALE Medical electrical equipment Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Appareils lectromdicaux Partie 2-31: Exigences particulires pour la scurit de base et les perfor

10、mances essentielles des stimulateurs cardiaques externes source dnergie interne IEC60601-2-31:2008/A1:2011AMENDMENT 1 AMENDEMENT 1 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2011 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be repro

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25、l electrical equipment Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source Appareils lectromdicaux Partie 2-31: Exigences particulires pour la scurit de base et les performances essentielles des stimulateurs card

26、iaques externes source dnergie interne INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE ICS 11.040.01 AMENDMENT 1 AMENDEMENT 1 Registered trademark of the International Electrotechnical Commission Marque dpose de la Commission Electrotechnique Internationale 2 606

27、01-2-31 Amend. 1 IEC:2011 FOREWORD This amendment has been prepared by subcommittee 62D: Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical practice. The text of this amendment is based on the following documents: FDIS Report on voting 62D/918/FDIS 62D/931/RVD F

28、ull information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. The committee has decided that the contents of this publication will remain unchanged until the stability date indicated on the IEC web site under “http:/webstore.iec.c

29、h“ in the data related to the specific publication. At this date, the publication will be reconfirmed, withdrawn, replaced by a revised edition, or amended. _ INTRODUCTION The purpose of this amendment is to address comments received during the process of harmonizing the standard in Europe, update s

30、everal references to defined terms that were not printed in SMALL CAPS, and improve terminology usage. INTRODUCTION Replace the term “IMPLANTABLE“ in the first and third lines of the third paragraph with the same term in normal case Replace the defined terms “pacemaker“ and “patient“ in the fourth l

31、ine of the fifth paragraph with the same terms in SMALL CAPS. 201.1.1 Scope Replace the second paragraph with: This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS as defined in 201.3.106. Delete the third paragraph. Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No.

32、 60601-2-31-0960601-2-31 Amend. 1 IEC:2011 3 In the fifth paragraph, replace the defined term “active implantable medical devices“ with the same term in SMALL CAPS. 201.1.2 Object Replace “AS DEFINED IN“ in the second line with the same words in normal case. Replace definition 201.3.105 with: 201.3.

33、105 EXTERNAL PACEMAKER CARDIAC PACEMAKER consisting of a NON-IMPLANTABLE PULSE GENERATOR and PATIENT CABLE(S) (if used) 201.3.106 Replace the defined term “patients“ in the second line with the same term in SMALL CAPS. Replace definition 201.3.107 with: 201.3. 107 MAXIMUM TRACKING RATE maximum PULSE

34、 RATE at which the NON-IMPLANTABLE PULSE GENERATOR will respond on a 1:1 basis to a triggering signal ISO 14708-2:2005, definition 3.3.18 modified 201.3.108 Replace the defined term “pulse“ in the second line of the definition with the same term in small caps. 201.4.3.101 Replace “PERFORMACNE” with

35、“PERFORMANCE”. 201.4.10.2 Supply mains for ME EQUIPMENT and ME SYSTEMS Replace the defined term “Supply mains“ in the title with the same term in SMALL CAPS. 201.7.9.2.2 * Warning and SAFETY notices Replace the term “pulse generator“ with “NON-IMPLANTABLE PULSE GENERATOR“ in three places in item 201

36、.7.9.2.2 aa). Replace the term “external pulse generator“ with “NON-IMPLANTABLE PULSE GENERATOR“ in item 201.7.9.2.2 ff). Replace the defined terms “patient“, “lead“, “leakage current“, “manufacturer“, “ non-implantable pulse generator“, “patient cable“ and “supply mains“ with same terms formatted i

37、n SMALL CAPS in items 201.7.9.2.2 bb), cc), dd), ee), ff) and gg). Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-2-31-09 4 60601-2-31 Amend. 1 IEC:2011 201.7. 9.2.4 * Electrical power source Replace the defined term “primary battery“ in the second paragraph with the same term in SMALL CAPS. 201.

38、7.9.2.13 Maintenance Replace the term “EQUIPMENT“ in the final dashed item with “ME EQUIPMENT“. 201.8.5.5 Defibrillation-proof applied parts Replace the subclause title with: 201.8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS 201.8.5.5.1 Add Note: NOTE ANSI/AAMI PC69:2007 is being adopted as ISO 14117. 20

39、1.8.7.3 * Allowable values In the requirement, replace “for both d.c. and a.c.“ with “for d.c.“. Add note: NOTE Where the a.c. component of the current is intended to produce a physiological effect, it is therefore outside the definition of PATIENT AUXILIARY CURRENT. 201.8.7.4.8 Measurement of the P

40、ATIENT AUXILIARY CURRENT Replace test method with the following text: For measurement of the PATIENT AUXILIARY CURRENT, the ME EQUIPMENT is connected as shown in Figure 201.101. Each PATIENT CONNECTION is connected to a common bus through a 500 1% load resistor (RL). Using a measuring device (MD) co

41、nsisting of a DC voltmeter, resolution better than 2 V, fed through a low pass filter with a time constant of at least 10 s, measure the average direct voltage across each low resistor. Steady state condition shall be reached before the measurement is made. The NON-IMPLANTABLE PULSE GENERATOR shall

42、be set to the nominal settings recommended by the manufacturer (i.e., the factory recommended settings) but with the PULSE AMPLITUDE and PULSE DURATION programmed to the highest available settings. NOTE The low pass filter can be implemented by a four-element RC filter with elements built from 1 M r

43、esistors and 10 F metalized polypropylene capacitors. The input resistance of the dc voltmeter should be 400 M. Figure Replace the existing Figure 201.101 with the following: Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-2-31-0960601-2-31 Amend. 1 IEC:2011 5 + 7 4 4 RLRLMD 1 IEC 1373/11 Legend M

44、E EQUIPMENT ENCLOSURE PATIENT CONNECTIONS INTERNAL ELECTRICAL POWER SOURCE RL Load resistor MD Measuring device (see 201.8.7.4.8) 201.11.6.5 * Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS Replace the requirement with: The ME EQUIPMENT shall be so constructed that the ingre

45、ss of liquids (accidental wetting), shall not result in an unacceptable RISK. 201.12.1.101 * ME EQUIPMENT PARAMETERS Replace the defined term “pulse“ in two places in the fifth paragraph with the same term in SMALL CAPS. 201.12.4.1 * Intentional exceeding of safety limits In the requirement, replace

46、 the reference to “12.4.103“ by “201.12.4.103“.: 201.12.4.102 * Protection against a low battery condition Replace the term “EQUIPMENT“ in the first line of the first paragraph with ME EQUIPMENT. 4 1 7 Amendment 1:2014 (IDT) to CAN/CSA-C22.2 No. 60601-2-31-09 6 60601-2-31 Amend. 1 IEC:2011 202.6.2.2

47、 Electrostatic discharge (ESD) 202.6.2.2.1 * Requirements Replace the defined term “operator“ in the fourth dashed item with the same term in SMALL CAPS. Annex AA Particular guidance and rationale Table AA.1 EXTERNAL PACEMAKER HAZARD inventory In column 2, row 18, change tampering to maladjustment a

48、s follows: High rate Fault Rate limit (runaway protection) 201.12.4.103 Maladjustment Protective means 201.12.4.101 Temporary high rate Protective means 201.12.4.1 Atrial tachyarrhythmia MAXIMUM TRACKING RATE 201.12.4.105 Replace “leakage current“ and “patient auxiliary current“ in Table AA.1 with s

49、ame terms in SMALL CAPS. AA.2 Rationale for particular clauses and subclauses Subclause 201.1.1 Scope Delete the third bullet. Replace the defined term “pulse generator“ in the second line of the paragraph following the bulleted list with “NON-IMPLANTABLE PULSE GENERATOR“. Clause 201.3 Terms and definitions Delete the last sentence