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 2018-07-16

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Downloads

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Date

Closing

Date

CENELEC

Voting /

Comment

Of interest to

Committees

62D/1699/CD

ISO 80601-2-87 ED1: Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency critical care ventilators

2019-07-12 2019-09-06 N
62D/1661A/CC

Compilation of Comments on 62D/1630/CD - ISO 80601-2-13 ED2: Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

2019-07-05 N
62D/1680A/CC

Compilation of Comments on 62D/1660/CD - IEC 80601-2-87 ED1: Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency critical care ventilators

2019-07-05 N
62D/1698/DTR

IEC TR 62653 ED2: Guideline for safe operation of medical equipment used for haemodialysis treatments

2019-07-05 2019-08-30 N
62D/1696/CDV

ISO 80601-2-69 ED2: Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

2019-06-21 2019-09-13 N
62D/1697/DA

Draft agenda for the meeting to be held in Shanghai, China on 2019-10-23 (starting time: 14:00 to approximate finishing time: 17:00)

2019-06-21 N/A
62D/1694/CD

ISO 80601-2-85 ED1: Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS)

2019-06-14 2019-10-04 E
62D/1606A/CC

Compilation of Comments on 62D/1571/CD - ISO 80601-2-67 ED2: Medical electrical equipment -- Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

2019-06-07 N
62D/1607A/CC

Compilation of Comments on 62D/1570/CD - ISO 80601-2-69 ED2: Medical electrical equipment -- Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment

2019-06-07 N
62D/1657A/CC

Compilation of Comments on 62D/1633/CD - ISO 80601-2-85 ED1: Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS)

2019-06-07 E
62D/1692/CD

ISO 81060-3 ED1: Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous non-invasive automated measurement type

2019-06-07 2019-08-02 E
62D/1693/DTS

ISO TS 81060-5 ED1: Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing

2019-06-07 2019-08-30 N
62D/1691/RVD

Result of Voting on 62D/1683/FDIS - IEC 80601-2-60 ED2: Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

2019-05-31 Y
62D/1690/CDV

ISO 81060-2/AMD1 ED3: Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

2019-05-24 2019-08-16 N
62D/1556A/RVN

Result of Voting on 62D/1526/NP - PNW TS 62D-1526: Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing

2019-05-17 N
62D/1658A/CC

Compilation of Comments on 62D/1610/CD - ISO 81060-3 ED1: Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous non-invasive automated measurement type

2019-05-17 E
62D/1668A/RVC

Result of Voting on 62D/1576/CDV - IEC 60601-2-31 ED3: Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

2019-05-17 Y
62D/1688/RVD

Result of Voting on 62D/1676/FDIS - IEC 80601-2-78 ED1: Medical Electrical Equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

2019-05-17 Y
62D/1689/RVD

Result of Voting on 62D/1675/FDIS - IEC 80601-2-77 ED1: Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

2019-05-17 Y
62D/1687/RVD

Result of Voting on 62D/1682/FDIS - IEC 60601-2-83 ED1: Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

2019-05-10 Y
62D/1673A/CC

Compilation of Comments on 62D/1654/CD - IEC TR 62653 ED2: Guideline for safe operation of medical equipment used for haemodialysis treatments

2019-04-26 N
62D/1685/CC

Compilation of Comments on 62D/1672/CD - IEC 60601-2-41 ED3: Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

2019-04-26 Y
62D/1686/CC

Compilation of Comments on 62D/1677/CD - ISO 80601-2-70 ED2: Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

2019-04-26 N
62D/1684/RQ

Result of Questionnaire on 62D/1678/Q: Question regarding IEC/SC 62D – ISO/TC 173 proposed new work to develop a standard on medical beds for children

2019-04-19 N/A
62D/1683/FDIS

IEC 80601-2-60 ED2: Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

2019-03-29 2019-05-10 Y Voting Result
62D/1681/RVD

Result of Voting on 62D/1666/FDIS - IEC 80601-2-26 ED1: Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

2019-03-22 Y
62D/1682/FDIS

IEC 60601-2-83 ED1: Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

2019-03-22 2019-05-03 Y Voting Result
62D/1680/CC

Compilation of Comments on 62D/1660/CD - IEC 80601-2-87 ED1: Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency critical care ventilators

2019-03-15 N
62D/1679/RQ

Result of Questionnaire on 62D/1664/Q: Nomination of convenor of IEC/SC 62D/MT 23, Infusion pumps

2019-03-01 N/A
62D/1678/Q

uestion regarding IEC/SC 62D – ISO/TC 173 proposed new work to develop a standard on medical beds for children

2019-02-22 2019-04-05 N/A Report of Comments
62D/1675/FDIS

IEC 80601-2-77 ED1: Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

2019-02-15 2019-03-29 Y Voting Result
62D/1676/FDIS

IEC 80601-2-78 ED1: Medical Electrical Equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

2019-02-15 2019-03-29 Y Voting Result
62D/1677/CD

ISO 80601-2-70 ED2: Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

2019-02-15 2019-04-12 N Report of Comments
62D/1662A/RVDTR

Result of Voting on 62D/1652/DTR - IEC TR 61289 ED2: High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

2019-02-08 N
62D/1673/CC

Compilation of Comments on 62D/1654/CD - IEC TR 62653 ED2: Guideline for safe operation of medical equipment used for haemodialysis treatments

2019-02-08 N
62D/1674/RR

Review report of ISO 80601-2-70 ED1: Medical Electrical Equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment

2019-02-08 N
62D/1671/FDIS

Withdrawn

2019-02-01 N/A
62D/1672/CD

IEC 60601-2-41 ED3: Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

2019-02-01 2019-03-29 Y Report of Comments
62D/1622A/CC

Compilation of Comments on 62D/1568/CD - IEC 60601-2-41 ED3: Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

2019-01-25 Y
62D/1667/RVD

Result of Voting on 62D/1653/FDIS - ISO 80369-3/AMD1 ED1: Amendment 1 - Small-bore connectors for liquids and gases in healthcare applications -Part 3: Connectors for enteral applications

2019-01-25 E
62D/1668/RVC

Result of Voting on 62D/1576/CDV - IEC 60601-2-31 ED3: Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

2019-01-25 Y
62D/1669/RR

Review Report of ISO 81060-2 ED3: Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

2019-01-25 N
62D/1670/INF

ISO/TC 210 Draft Standard – Of Interest to IEC/SC 62D - ISO 20417: Medical devices – Requirements for general information to be provided by the manufacturer

2019-01-25 N/A
62D/1665/DC

Document for Comment for the National Committees of SC 62D: ISO/TC 215, Health informatic - DTS 22077-4: Medical waveform format – Part 4: Stress test electrocardiography

2019-01-18 2019-02-22 N/A Report of Comments
62D/1666/FDIS

IEC 80601-2-26 ED1: Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

2019-01-18 2019-03-01 Y Voting Result
62D/1656A/CC

Compilation of Comments on 62D/1627/CD - IEC 60601-2-23 ED4: Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

2019-01-11 Y
62D/1661/CC

Compilation of Comments on 62D/1630/CD - ISO 80601-2-13 ED2: Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

2019-01-11 N
62D/1662/RVDTR

Result of Voting on 62D/1652/DTR - IEC TR 61289 ED2: High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

2019-01-11 N
62D/1663/AC

MT 21: Paediatric equipment - Call for experts

2019-01-11 N/A
62D/1664/Q

Nomination of convenor of IEC/SC 62D/MT 23, Infusion pumps

2019-01-11 2019-02-22 N/A Report of Comments
62D/1641/CDV

IEC 60601-2-19 ED3: Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

2018-12-28 2019-03-22 Y Voting Result
62D/1642/CDV

IEC 60601-2-20 ED3: Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

2018-12-28 2019-03-22 Y Voting Result
62D/1643/CDV

IEC 60601-2-21 ED3: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

2018-12-28 2019-03-22 Y Voting Result
62D/1644/CDV

IEC 60601-2-50 ED3: Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

2018-12-28 2019-03-22 Y Voting Result
62D/1645/CDV

IEC 80601-2-35 ED3: 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

2018-12-28 2019-03-22 Y Voting Result
62D/1615A/RVN

Result of Voting on 62D/1534/NP - PNW 62D-1534: Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency critical care ventilators

2018-12-21 N
62D/1656/CC

Compilation of Comments on 62D/1627/CD - IEC 60601-2-23 ED4: Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

2018-12-21 Y
62D/1657/CC

Compilation of Comments on 62D/1633/CD - ISO 80601-2-85 ED1: Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS)

2018-12-21 E
62D/1658/CC

Compilation of Comments on 62D/1610/CD - ISO 81060-3 ED1: Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous non-invasive automated measurement type

2018-12-21 E
62D/1659/CC

Compilation of Comments on 62D/1628/CD - IEC 80601-2-86 ED1: Medical electrical equipment - Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires

2018-12-21 Y
62D/1660/CD

IEC 80601-2-87 ED1: Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency critical care ventilators

2018-12-21 2019-02-15 N Report of Comments
62D/1620A/RVC

Result of Voting on 62D/1587/CDV - IEC 60601-2-83 ED1: Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

2018-12-14 Y
62D/1608A/RVC

Result of Voting on 62D/1583/CDV - ISO 80601-2-56/AMD1 ED2: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

2018-12-07 E
62D/1653/FDIS

ISO 80369-3/AMD1 ED1: Amendment 1 - Small-bore connectors for liquids and gases in healthcare applications -Part 3: Connectors for enteral applications

2018-11-23 2019-01-04 E Voting Result
62D/1646/INF

Information regarding the revision of IEC 60601-2-19, Medical electrical equipment – Part 2–19: Particular requirements for the basic safety and essential performance of infant incubators

2018-11-09 N/A
62D/1647/INF

Information regarding the revision of IEC 60601-2-20, Medical electrical equipment – Part 2–20: Particular requirements for the basic safety and essential performance of infant transport incubators

2018-11-09 N/A
62D/1648/INF

Information regarding the revision of IEC 60601-2-21, Medical electrical equipment – Part 2–21: Particular requirements for the basic safety and essential performance of infant radiant warmers

2018-11-09 N/A
62D/1649/INF

Information regarding the revision of IEC 60601-2-50, Medical electrical equipment – Part 2–50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

2018-11-09 N/A
62D/1650/INF

Information regarding the revision of 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

2018-11-09 N/A
62D/1651/RR

Review report of IEC TR 62653 ED1: Guideline for safe operation of medical equipment used for haemodialysis treatments

2018-11-09 N
62D/1652/DTR

IEC TR 61289 ED2: High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

2018-11-09 2019-01-04 N Voting Result
62D/1654/CD

IEC TR 62653 ED2: Guideline for safe operation of medical equipment used for haemodialysis treatments

2018-11-09 2019-02-01 N Report of Comments
62D/1655/RVC

Result of Voting on 62D/1617/CDV - ISO 80601-2-12 ED2: Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators

2018-11-09 E
62D/1623A/CC

Compilation of Comments on 62D/1565/CD - IEC TR 61289 ED2: High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

2018-10-19 N
62D/1634/RR

Review report of IEC 60601-2-19:2009 ED2: Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

2018-10-19 Y
62D/1635/NP

PNW 62D-1635: Medical electrical equipment - Part 2-xx: Particular requirements for the basic safety and essential performance of medical beds for children

2018-10-19 2019-01-11 U Voting Result
62D/1636/RR

Review Report of IEC 60601-2-20 ED2: Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators

2018-10-19 Y
62D/1637/RR

Review report of IEC 60601-2-21 ED2: Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

2018-10-19 Y
62D/1638/RR

Review report of IEC 60601-2-50 ED2: Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

2018-10-19 Y
62D/1639/RR

Review report of IEC 80601-2-35 ED2: 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

2018-10-19 Y
62D/1640/RVD

Result of Voting on 62D/1619/FDIS - ISO 81060-2 ED3: Non-invasive sphygmomanometers: Part 2: Clinical investigation of intermittent automated measurement type

2018-10-19 E
62D/1435A/RVN

Result of Voting on 62D/1417/NP - Medical electrical equipment - Part 2-xx: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS)

2018-10-12 E
62D/1633/CD

ISO 80601-2-85 ED1: Medical electrical equipment - Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment (t-NIRS)

2018-10-12 2018-12-07 E Report of Comments
62D/1632/RVD

Result of Voting on 62D/1618/FDIS - ISO 80369-1 ED2: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

2018-10-05 E
62D/1631/RQ

Result of Questionnaire on 62D/1616/Q: Questionnaire on a Liaison A to be established with the International Medical Device Regulators Forum (IMDRF)

2018-09-28 N/A
62D/1580A/RVC

Result of Voting on 62D/1532/CDV - IEC 80601-2-77 ED1: Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

2018-09-21 Y
62D/1581A/RVC

Result of Voting on 62D/1531/CDV - IEC 80601-2-78 ED1: Medical Electrical Equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

2018-09-21 Y
62D/1533A/RVC

Result of Voting on 62D/1499/CDV - ISO 80369-3/AMD1 ED1: Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications

2018-09-14 E
62D/1629/RR

Review report of ISO 80601-2-13 ED1: Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

2018-09-14 N
62D/1630/CD

ISO 80601-2-13 ED2: Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

2018-09-14 2018-12-07 N Report of Comments
62D/1625/RVC

Result of Voting on 62D/1475/CDV - IEC 80601-2-60 ED2: Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

2018-08-31 Y
62D/1626/RR

Review report of IEC 60601-2-23 ED3: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

2018-08-31 Y
62D/1627/CD

IEC 60601-2-23 ED4: Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment

2018-08-31 2018-11-23 Y Report of Comments
62D/1628/CD

IEC 80601-2-86 ED1: Medical electrical equipment - Part 2-86: Particular requirements for the basic safety and essential performance of electrocardiographs, including diagnostic equipment, monitoring equipment, ambulatory equipment, electrodes, cables and leadwires

2018-08-31 2018-11-23 Y Report of Comments
62D/1540A/RVC

Result of Voting on 62D/1497/CDV - ISO 81060-2 ED3: Non-invasive sphygmomanometers: Part 2: Clinical investigation of intermittent automated measurement type

2018-08-24 E
62D/1619/FDIS

ISO 81060-2 ED3: Non-invasive sphygmomanometers: Part 2: Clinical investigation of intermittent automated measurement type

2018-08-24 2018-10-05 E Voting Result
62D/1620/RVC

Result of Voting on 62D/1587/CDV - IEC 60601-2-83 ED1: Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

2018-08-24 Y
62D/1621/CC

Compilation of Comments on 62D/1517/CD - IEC 60601-2-18 ED4: Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

2018-08-24 Y
62D/1622/CC

Compilation of Comments on 62D/1568/CD - IEC 60601-2-41 ED3: Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

2018-08-24 Y
62D/1623/CC

Compilation of Comments on 62D/1565/CD - IEC TR 61289 ED2: High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance

2018-08-24 N
62D/1624/RVN

Result of Voting on 62D/1538/NP - PNW 62D-1538: Non-invasive sphygmomanometers - Part 4: Requirements for devices intended for use during patient transport

2018-08-24 U
62D/1550A/RVD

Result of Voting on 62D/1537/FDIS - ISO 80369-1 ED2: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

2018-08-17 E
62D/1618/FDIS

ISO 80369-1 ED2: Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements

2018-08-17 2018-09-28 E Voting Result
62D/1617/CDV

ISO 80601-2-12 ED2: Medical electrical equipment - Part 2-12: Particular requirements for the basic safety and essential performance of critical care ventilators

2018-08-10 2018-11-02 E Voting Result
62D/1613/RVN

Result of Voting on 62D/1567/NP - PNW 62D-1567: Medical electrical equipment -- Part 2-xx: Particular requirements for the basic safety and essential performance of electro-acupuncture stimulator

2018-07-27 U
62D/1614/RVN

Result of Voting on 62D/1572/NP - PNW 62D-1572: Medical electrical equipment - Part 2-xx: Particular requirements for the basic safety and essential performance of ORTHOPEDIC FRACTURE REDUCTION EQUIPMENT

2018-07-27 U
62D/1615/RVN

Result of Voting on 62D/1534/NP - PNW 62D-1534: Medical electrical equipment - Part 2-87: Particular requirements for the basic safety and essential performance of high frequency critical care ventilators

2018-07-27 N
62D/1616/Q

Questionnaire on a Liaison A to be established with the International Medical Device Regulators Forum (IMDRF)

2018-07-27 2018-09-07 N/A Report of Comments