International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62D

Electromedical equipment

 
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SC 62D Working Documents since 2014-05-28

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62D/1225A/CC

Revised compilation of comments on 62D/1176/CD - ISO 80369-1: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
2015-05-22yes
62D/1253A/CD

IEC 60601-2-49: Medical Electrical Equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
2015-05-222015-08-14?
62D/1257/RR

Review report of IEC 80601-2-58 Ed.2.0: Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2015-05-15?
62D/1259/AC

JWG 6: Respiratory gas monitors - Call for experts
2015-05-15
62D/1260/AC

JWG 22: Electromedical diagnostic and patient monitoring equipment - Call for experts
2015-05-15
62D/1251/INF

Report of comments and comments on 62D/1142/DC: Proposed amendment/revision to remove dated references and make additional changes (60601-2-49)
2015-05-08
62D/1252/RR

Review report of IEC 60601-2-49 Ed.2.0: Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
2015-05-08?
62D/1253/CD

Cancelled and replaced by 62D/1253A/CD
2015-05-08?
62D/1254/RVN

Result of voting on 62D/1277/RVN - IEC 80601-2-77: Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of medical robots for surgery
2015-05-08?
62D/1255/RVN

Result of voting on 62D/1228/NP: IEC 80601-2-78: Medical Electrical Equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability
2015-05-08?
62D/1256/RR

Review report of ISO 80601-2-55 Ed.1.0: Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
2015-05-08?
62D/1241A/RVN

Revised result of voting on 62D/1177/NP - IEC 60601-2-75: Medical Electrical Equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
2015-04-17?
62D/1242A/RVN

Revised result of voting on 62D/1183/NP - IEC 60601-2-76: Medical Electrical Equipment - Part 2-76: Particular requirements for the basic safety and essential performance of ionized gas coagulation equipment
2015-04-17?
62D/1249/RVD

Report of Voting on 62D/1229/FDIS - ISO 80601-2-72: Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
2015-04-17no
62D/1250/Q

Proposal to participate in ISO/TC 249's work that may fall under the scope of SC 62D
2015-04-172015-05-29
62D/1248/CDV

ISO 80601-2-74: Medical Electrical Equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
2015-04-102015-07-10no
62D/1241/RVN

Cancelled and replaced by 62D/1241A/RVN
2015-03-27?
62D/1242/RVN

Cancelled and replaced by 62D/1242A/RVN
2015-03-27?
62D/1243/RR

Review report on IEC 60601-2-16 Ed.4: Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
2015-03-27yes
62D/1244/RR

Review report on IEC 60601-2-39 Ed.2: Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
2015-03-27yes
62D/1245/INF

Result of 62D/1125/DC, Proposed amendment/revision to remove dated references and make additional changes (60601-2-16 and 60601-2-39 only)
2015-03-27
62D/1246/CD

IEC 60601-2-16 Ed.5: Medical Electrical Equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
2015-03-272015-05-29yes
62D/1247/CD

IEC 60601-2-39 Ed.3: Medical Electrical Equipment - Part 2-39: Particular requirements for the basic safety and essential performance of peritoneal dialysis equipment
2015-03-272015-05-29yes
62D/1209/CDV

IEC 60601-2-19: Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators - Proposed Horizontal Standards
2015-03-202015-06-26yes
62D/1210/CDV

IEC 60601-2-20: Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators - Proposed Horizontal Standard
2015-03-202015-06-26yes
62D/1211/CDV

IEC 60601-2-21: Medical Electrical Equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers - Proposed Horizontal Standard
2015-03-202015-06-26yes
62D/1212/CDV

IEC 80601-2-35: Medical Electrical Equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use - Proposed Horizontal Standard
2015-03-202015-06-26yes
62D/1213/CDV

IEC 60601-2-50: Medical Electrical Equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment - Proposed Horizontal Standard
2015-03-202015-06-26yes
62D/1220/CDV

IEC 60601-2-3: Medical Electrical Equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment - Proposed Horizontal Standard
2015-03-202015-06-26yes
62D/1221/CDV

IEC 60601-2-6: Medical Electrical Equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment - Proposed Horizontal Standard
2015-03-202015-06-26yes
62D/1222/CDV

IEC 60601-2-10: Medical Electrical Equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - Proposed Horizontal Standard
2015-03-202015-06-26yes
62D/1238/FDIS

IEC 80601-2-71: Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment
2015-03-202015-05-22yesVoting Result
62D/1239/CC

Compilation of comments on 62D/1078/CD - IEC 60601-2-40: Medical electrical equipment - Part 2-40: Particular requirements for basic safety and essential performance of electromyographs and evoked response equipment
2015-03-20yes
62D/1236/NP

ISO 80601-2-xx: Medical Electrical Equipment - Part 2-xx: Particular requirements for basic safety and essential performance of home healthcare environment ventilatory support equipment for respiratory impairment
2015-03-132015-06-19?
62D/1237/NP

ISO 80601-2-xx: Medical Electrical Equipment - Part 2-xx: Particular requirements for basic safety and essential performance of home healthcare environment ventilatory support equipment for respiratory insufficiency
2015-03-132015-06-19?
62D/1198A/INF

Revised result of comments on the Document for Comment (62D/1179/DC) on the revision of ISO 80601-2-56
2015-03-06
62D/1233A/RM

Unconfirmed minutes of the meeting held in New Orleans, Louisiana, USA on 24 November 2014
2015-02-27
62D/1235/INF

Report of comments and comments on 62D/1223/DC: Health Software Ad hoc Group Draft Report - September 2014 / Health Software and Health IT Safety Standards / FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report
2015-02-27
62D/1232/RVD

Report of Voting on 62D/1186/FDIS - Amendment 1 to IEC 60601-2-52: Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
2015-02-20yes
62D/1233/RM

Wirhdrawn and replaced by 62D/1233A/RM
2015-02-20
62D/1234/INF

Documents for Comment being circulated in IEC/SC 62A that is of interest to SC 62D
2015-02-20
62D/1230/RVD

Report of Voting on 62D/1185/FDIS - ISO 80369-20: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
2015-02-13no
62D/1231/RVC

Result of voting on 62D/1163A/CDV - ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
2015-02-13no
62D/1229/FDIS

ISO 80601-2-72: Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
2015-02-062015-04-10noVoting Result
62D/1227/NP

IEC 80601-2-xx: Part 2-XX: Particular requirements for the basic safety and essential performance of medical robots for surgery
2015-01-232015-04-24?Voting Result
62D/1228/NP

IEC 80601-2-XX: Part 2-XX: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, compensation or alleviation of disease, injury or disability
2015-01-232015-04-24?Voting Result
62D/1159A/RVC

Revised result of voting on 62D/1115/CDV - IEC 80601-2-71: Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional oximeter equipment
2015-01-16yes
62D/1225/CC

Compilation of comments on 62D/1176/CD - ISO 80369-1: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
2015-01-16yes
62D/1226/RQ

Result of on 62D/1165/Q: Proposal to limit the membership of IEC/SC 62D/MT 22, Electromedical diagnostic and patient monitoring equipment
2015-01-16
62D/1152A/CC

Revised compilation of comments on 62D/1123/CD - ISO 80601-2-74: Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
2015-01-09no
62D/1198/INF

Result of the Document for Comment (62D/1179/DC) on the revision of ISO 80601-2-56
2015-01-09
62D/1199/INF

Result of Document for Comment: IEC 62D/1130/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-19)
2015-01-09
62D/1200/INF

Result of Document for Comment: IEC 62D/1131/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-20)
2015-01-09
62D/1201/INF

Result of Document for Comment: IEC 62D/1132/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-21)
2015-01-09
62D/1202/INF

Result of Document for Comment: IEC 62D/1139/DC - Proposed amendment/revision to remove dated references and make additional changes (80601-2-35)
2015-01-09
62D/1203/INF

Result of Document for Comment: IEC 62D/1143/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-50)
2015-01-09
62D/1204/RR

Review report of IEC 60601-2-19 Ed.2.0: Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
2015-01-09yes
62D/1205/RR

Review report of IEC 60601-2-20 Ed.2.0: Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
2015-01-09yes
62D/1206/RR

Review report of IEC 60601-2-21 Ed.2.0: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
2015-01-09yes
62D/1207/RR

Review report of IEC 60601-2-50 Ed.2.0: Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
2015-01-09yes
62D/1208/RR

Review report of IEC 80601-2-35 Ed.2.0: Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
2015-01-09yes
62D/1214/INF

Result of Document for Comment: IEC 62D/1126/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-3)
2015-01-09
62D/1215/INF

Result of Document for Comment: IEC 62D/1128/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-6)
2015-01-09
62D/1216/INF

Result of Document for Comment: IEC 62D/1129/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-10)
2015-01-09
62D/1217/RR

Review report of IEC 60601-2-3 Ed.3.0: Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
2015-01-09yes
62D/1218/RR

Review report of IEC 60601-2-6 Ed.2.0: Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
2015-01-09yes
62D/1219/RR

Review report of IEC 60601-2-10 Ed.2.0: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
2015-01-09yes
62D/1223/DC

Document for Comment: Health Software Ad hoc Group Draft Report - September 2014 - Health Software and Health IT Safety Standards - FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report
2015-01-092015-02-20Report of Comments
62D/1224/CC

Compilation of comments on 62D/1182/CD - ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
2015-01-09no
62D/1187/INF

Information regarding IEC/SC 62D - ISO/TC 210/JWG 10 on Small bore connectors for liquids and gases in healthcare applications - ISO/TC 210/JWG4 N282: Note about potential misconnection between E1 female and Luer slip female
2014-12-19
62D/1188/INF

Information regarding IEC/SC 62D - ISO/TC 210/JWG 10 on Small bore connectors for liquids and gases in healthcare applications - ISO/TC 210/JWG4 N283: ISO 80369-6 misconnection risk analysis and testing
2014-12-19
62D/1189/INF

Information regarding IEC/SC 62D - ISO/TC 210/JWG 10 on Small bore connectors for liquids and gases in healthcare applications - ISO/TC 210/JWG4 N285: Final report on usability study on 80369-6 connectors
2014-12-19
62D/1190/INF

Information regarding IEC/SC 62D - ISO/TC 210/JWG 10 on Small bore connectors for liquids and gases in healthcare applications - ISO/TC 210/JWG4 N279: WFSA Position Statement against ISO/DIS 80369-3.2
2014-12-19
62D/1191/INF

Information regarding IEC/SC 62D - ISO/TC 210/JWG 10 on Small bore connectors for liquids and gases in healthcare applications - ISO/TC 210/JWG4 N280: ISO 80369 series CAD validation report
2014-12-19
62D/1192/INF

Information regarding IEC/SC 62D - ISO/TC 210/JWG 10 on Small bore connectors for liquids and gases in healthcare applications - ISO/TC 210/JWG4 N281: Response to WFSA position statement against ISO/DIS 80369-3.2
2014-12-19
62D/1193/INF

Report of comments and comments on 62D/1140/DC - Result of Document for Comment: IEC 62D/1140/DC - Proposed amendment/revision to remove dated references and make additional changes (60601-2-46)
2014-12-19
62D/1194/RR

Review report of IEC 60601-2-46 Ed.2.0: Medical electrical equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating table
2014-12-19yes
62D/1195/CD

IEC 60601-2-46: Medical Electrical Equipment - Part 2-46: Particular requirements for basic safety and essential performance of operating tables
2014-12-192015-03-20yesReport of Comments
62D/1196/RR

Review report of IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
2014-12-19yes
62D/1197/CD

IEC 60601-2-2: Medical Electrical Equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories - Proposed Horizontal Standard
2014-12-192015-03-20yesReport of Comments
62D/1186/FDIS

Amendment 1 to IEC 60601-2-52: Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
2014-12-122015-02-13yesVoting Result
62D/1185/FDIS

ISO 80369-20: Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
2014-12-052015-02-06noVoting Result
62D/1183/NP

IEC 60601-2-XX: Medical electrical equipment - Part 2-xx:Particular requirements for the basic safety and essential performance of ionized gas coagulation equipment
2014-11-212015-02-27?Voting Result
62D/1184/AC

Chair of SC 62D: Electromedical equipment
2014-11-212015-02-27Report of Comments
62D/1107A/CC

Revised compilation of comments on 62D/1083/CD - ISO 80369-1: Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
2014-10-24yes
62D/1160A/DA

Revised draft agenda for the meeting to be held in New Orleans, Louisiana, USA on 24 November 2014 (starting time: 14:00) to (approximate finishing time: 17:00)
2014-10-24
62D/1174A/INF

Revised reports from the liaisons of other committees and Organizations for the November 2104 Subcommittee Meeting in New Orleans, Louisiana, USA (Agenda item 8.1)
2014-10-24
62D/1176/CD

ISO 80369-1: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
2014-10-242015-01-02yesReport of Comments
62D/1177/NP

IEC 60601-2-xx: Medical Electrical Equipment - Part 2-xx: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment
2014-10-242015-01-30?Voting Result
62D/1178/PW

Programme of work of the subcommittee as recorded by IEC Central Office in its database
2014-10-24
62D/1179/DC

ISO 80601-2-56 on clinical thermometers - Working draft is available for comments and vote to skip the CD stage and go to CDV/DIS stage is open until 12-05-2014
2014-10-242014-12-05Report of Comments
62D/1180/INF

ISO Compilation of comments on the Working Draft of ISO 80601-2-56 on clinical thermometers
2014-10-24
62D/1181/RR

Review report of ISO 80601-2-61 Ed.1.0: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
2014-10-24no
62D/1182/CD

ISO 80601-2-61: Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
2014-10-242015-01-02noReport of Comments
62D/1168A/INF

Revised report of the Secretary IEC/SC 62D (Agenda item 5.1)
2014-10-17
62D/1171/INF

Confirmation of working group conveners (Agenda Item 5.2)
2014-10-17
62D/1172/INF

Reports from the Maintenance Teams and Joint Working Groups of IEC/SC 62D for the November 2014 Subcommittee Meeting in New Orleans, Louisiana, USA (Agenda item 7.1)
2014-10-17
62D/1173/INF

Maintenance Schedule (Agenda Item 7.2.1)
2014-10-17
62D/1174/INF

Reports from the liaisons of other committees and Organizations for the November 2104 Subcommittee Meeting in New Orleans, Louisiana, USA (Agenda item 8.1)
2014-10-17
62D/1175/INF

Liaisons (Agenda item 8.4)
2014-10-17
62D/1170/RVC

Result of voting on 62D/1100/CDV - Amendment 1 to ISO 80601-2-13: Medical electrical equipment - Part 2-13: Particular requirements for the basic safety and essential performance of an anaesthetic workstation
2014-10-03no
62D/1168/INF

Report of the Secretary IEC/SC 62D (Agenda item 5)
2014-09-26
62D/1169/INF

Information regarding new IEC/SC 62D - ISO/TC 121/SC 3/JWG 22 on Electromedical diagnostic and patient monitoring equipment
2014-09-26
62D/1166/RQ

Result on 62D/1156/Q: Proposal to withdraw IEC 60601-2-40, Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
2014-09-19
62D/1167/INF

Information regarding ISO 80369-3, Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
2014-09-19
62D/1163A/CDV

ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
2014-09-122015-02-06noVoting Result
62D/1164/RVD

Result of voting on 62D/1153/FDIS - ISO 80601-2-70: Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
2014-09-12no
62D/1165/Q

Proposal to limit the membership of IEC/SC 62D/MT 22, Electromedical diagnostic and patient monitoring equipment
2014-09-122014-10-24Report of Comments
62D/1162/CDV

ISO 80369-3: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
2014-09-052014-12-05noVoting Result
62D/1163/CDV

Withdrawn and replaced by 62D/1163A/CDV
2014-09-05no
62D/1161/RVD

Report of Voting on 62D/1151/FDIS - IEC 80601-2-58: Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2014-08-08yes
62D/1159/RVC

Result of voting on 62D/1115/CDV - IEC 80601-2-71: Medical electrical equipment - Part 2-71: Particular requirements for the basic safety and essential performance of functional oximeter equipment
2014-07-25yes
62D/1160/DA

Draft agenda for the meeting to be held in New Orleans, Louisiana, USA on 24 November 2014 (starting time: 14:00) to (approximate finishing time: 17:00)
2014-07-25
62D/1024A/CC

Revised compilation of comments on 62D/999/CD - ISO 80369-6: Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
2014-07-04no
62D/1154/INF

62A/944/Q: Proposal to modify the scope of IEC/SC 62A - ISO/TC 215 Joint Working Group (JWG) 7, Application of risk management to information technology (IT) networks incorporating medical devices
2014-07-04
62D/1155/INF

Action taken by ISO/TC 210 - IEC/SC 62D/JWG 4 on Small Bore Connectors regarding IEC 80369-05
2014-07-04
62D/1156/Q

Proposal to withdraw IEC 60601-2-40, Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
2014-07-042014-09-05Report of Comments
62D/1157/INF

IHE Patient Care Device Committee's Technical Framework on Pulse Oximetry
2014-07-04
62D/1158/INF

Supplemental Information to IEC 62D/1024A/CC - ISO 80369-6: Significant changes made to the DIS/CDV draft from the CD draft
2014-07-04
62D/1153/FDIS

ISO 80601-2-70: Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment
2014-06-272014-09-05noVoting Result
62D/1152/CC

Compilation of comments on 62D/1123/CD - ISO 80601-2-74: Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
2014-06-06no
62D/1149/RVD

Report of Voting on 62D/1121/FDIS - ISO 80601-2-69: Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment
2014-05-30no
62D/1151/FDIS

IEC 80601-2-58: Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
2014-05-302014-08-01yesVoting Result