CAN CSA-C22 2 NO 601 2 3 AMD 1-2001 Modification 1 Appareils Electromedicaux - Deuxieme Partie Regles Particulieres De Securite Pour Appareils De Therapie A Ondes Courtes.pdf

1、 Amendment 1:2001 to National Standard of Canada CAN/CSA-C22.2 No. 601.2.3-92 Amendment 1:1998 to International Standard IEC 601-2-3:1991 has been adopted without modification as Amendment 1:2001 to CAN/CSA-C22.2 No. 601.2.3-92. This Amendment was reviewed by the CSA Technical Committee on Consumer

2、and Commercial Products under the jurisdiction of the Strategic Resource Group and was formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the Technical Committee on Applications of Electricity in Health Care under the jurisdiction of th

3、e Strategic Steering Committee on Health Care Technology. February 2001 Modification 1 :2001 a la Norme nationale du Canada CAN/CSA-C22.2 no 601.2-3-92 LAmendement no 1:1998 i la norme internationale CEI 601-2-3:1991 a ete adopt6 sans modification et constitue la Modification no 1:2001 a la norme CA

4、N/CSA-C22.2 no 601.2.3-92. Cette modification a 6te revisee par le Comite technique CSA sur les produits commerciaux et grand public, sous lautorite du Groupe sur les ressources strategiques et a ete adoptee par le Comite technique. En raison du contenu medical de cette norme, la modification a auss

5、i et6 approuvee par le Comite technique sur lutilisation de 16lectricit6 dans les Ctablissements de soins de sante, sous lautorite du Comite directeur strategique sur la technologie des soins de sante. FWer 2001 CSA INTERNATIONAL / - Amendment 1 Medical electrical equipment - Part 2: Particular requ

6、irements for the safety of short-wave therapy equipment 0 IEC 1998- Copyright - all rights resewed International Electrotechnical Commission Telefax: 41 22 919 0300 3, rue de Varembe Geneva, Switzerland IEC web site http: /lwww.iec.ch e-mail: inmailiec.ch PRICECODE c Commission Electrotechnique Inte

7、rnationale International Electrotechnical Commission Memnvnaponnar KTPOIOXMYBCMR HOMHCCHR 0 For price. see currant catalogue -2- 60601-2-3 Amend.1 0 IEC:1998(E) FOREWORD This amendment has been prepared by subcommittee 62D: Electromedical equipment, of- IEC technical committee 62: Electrical equipme

8、nt in medical practice. The text of this amendment is based on the following documents: I FDlS I Report on voting 1 I 62D12921FDIS I 62D/298/RVD I Full information on the voting for the approval of this amendment can be found in the report on voting indicated in the above table. INTRODUCTION This am

9、endment contains a series of revisions to IEC 60601-2-3 (second edition, 1991) taking into account amendments 1 and 2 of the General Standard, which include reference to the collateral standards. The technical content remaining essentially unchanged. NOTE -The page numbers referenced in this amendme

10、nt are those in IEC 60601-2-31991. Page 3 CONTENTS Delete clauses 13 and 18 from the Contents. Page 5 Replace “FIGURES 101 a 104“ by “FIGURES 101 to 104“ Page 9 INTRODUCTION Replace in the last sentence “.an * after .“ by “.an asterisk (*) before.“. Page 11 1 Scope and object Add, after the introduc

11、tory sentence of this clause, the following subclause heading: 1.1 Scope Replace, in the existing text of the first paragraph of the Addition, “Sub-clause 2.1“ by “subclause 2.1.101 “. 60601-2-3 Amend.1 0 IEC:1998(E) -3- Replace the second paragraph of the Addition by the following: “LOW POWER EQUIP

12、MENT as defined in subclause 2.2.101 is exempted from certain requirements of this standard“. Add the following subclause to the Particular Standard: 1.5 Collateral Standards Addition: The following Collateral Standards apply: IEC 60601 -1 -1 :1992, Medical electrical equipment - Part 1: General req

13、uirements for safety - 1. Collateral Standard: Safety requirements for medical electrical systems IEC 60601 -1-2:1993, Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests IEC 60601 -1 -4:1996, Medical

14、 electrical equipment - Part 1: General requirements for safety - 4. Collateral Standard: Programmable electrical medical systems 2 Terminology and definitions Add, after 2.1.103, the following new definition: 2.2.1 01 LOW POWER EQUIPMENT EQUIPMENT having a RATED OUTPUT POWER not exceeding 10 w. Pag

15、e 13 4.1 1 Sequence In the Amendment replace “temperature-rise test of Sub-clause 42.4“ by “compliance test which follows subclause 42.3“. *5.2 Amendment: Replace “EQUIPMENT“ by “APPLIED PART“. Page 15 6.1 Marking on the outside of EQUIPMENT p) output In the text of the first dash of the Replacement

16、, replace “power in watts“ by “POWER in watts“. - 4. - 60601-2-3 Amend.1 0 IEC:1998(E) 6.8.2 instructions for use Page 17 Replace the introductory sentence before item aa) 2. c) by the following: For all EQUIPMENT except LOW POWER EQUIPMENT: Replace the text of item aa) 2. d) by the following: Short

17、-wave therapy should not be applied to PATIENTS through clothing. Additionally, it should not be applied to PATIENTS wearing metallic objects like jewellery or clothing containing metallic material (for example metallic buttons, clips or thread). In the text of item aa) 2. h) replace “or conductive“

18、 by “or with conductive“. 6.8.3 Technical description In the parenthetical text of Additional item aa), rc?place “Sub-clause 50.2“ by “clause 50“. 7 Power input In the second line replace “hem a) of the compliance test“ by “Compliance test, first dash, first sentence“. In the third line replace “Ame

19、ndment:“ by “Replacement:“. Page 19 14.6 Replacement: Replace the existing text by the following: APPLIED PARTS of SHORT-WAVE THERAPY EQUIPMEIUT shall be TYPE BF or CF. 17 Separation In the first line of item aa) replace “LIVE PARTS“ by “LIVE parts“ and, at the beginning of the second sentence, repl

20、ace “protectively earthed“ by “PROTECTIVELY EARTHED“. Page 21 19.2 Item b) In the Addition, replace “between the APPLIED PART“ by “between APPLIED PARTS“ 60601-2-3 Arnend.1 0 IEC:1998(E) -5- Page 23 SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION Replace the title “INT

21、RODUCTION“ by “General“. Delete the first paragraph of the Addition. 36 Electromagnetic compatibility Replace the title “Replacement:“ by “36.201.1 Radiofrequency (RF) EMISSIONS, Addition:“ Delete the first paragraph. In the compliance text delete “Sub-clause 5.3.1.1 of“. Page 25 42 Excessive temper

22、atures Replace the title “Tests, addition:“ by “42.3 compliance test, additional item 6):“ In the fourth line of the text replace “Sub-clause 50.2“ by “clause 50“. In the fifth line of the text replace “Sub-clause 42.4“ by “the compliance test which follows subclause 42.3 “. 50 Accuracy of operating

23、 data In the third paragraph of the Replacement, replace “EQUIPMENT having a RATED OUTPUT POWER not exceeding 10 W“ by “LOW POWER EQUIPMENT“. Replace, on page 27, in the second paragraph of the second note of the Replacement fhe test circuit consisted“ by The test circuit consists “. Page 27 W.2 Rep

24、lacement: At the end of the first paragraph replace “Sub-clause 50.2“ by “clause 50“ Page 29 After the title “Additional sub-clauses:“ delete the introductory sentence. 51.101 In the text, replace “The EQUIPMENT“ by “EQUIPMENT other than LOW POWER EQUIPMENT“. 51.1 02 In the text, replace “The EQUIPM

25、ENT“ by “EQUIPMENT other than LOW POWER EQUIPMENT“ -6- 60601-2-3 Amend.1 0 IEC:1998(E) W.103 In the text, replace “EQUIPMENT“ by “EQUIPMENT other than LOW POWER EQUIPMENT“ Page 39 AA50 Accuracy of operating data In the first line of the last paragraph, replace “EQUIPMENT with a RATED OUTPUT POWER no

26、t exceeding 10 W“ by “LOW POWER EQUIPMENT“. AA51.2 In the first sentence, replace “Safety hazards“ by “SAFETY HAZARDS“. ICS 11.040.60 CSA INTERNATIONAL / A not-for-profit private sector organization Organisme sans but lucratif du secteur prive 178 Rexdale Boulevard 01 78, boulevard Rexdale Toronto, Ontario, Canada M9W 1 R3 1 800 463.6727 + 1 416 747.4044 www.csa-international.org