European Standardisation Organisation Reference and title of the standard (and reference document) Reference of the superseded standard Date of cessation of presumption of conformity of the superseded standard Note 1

CEN/CENELEC EN 46003:1999 Quality systems — Medical devices — Particular requirements for the application of EN ISO 9003 None —

CENELEC EN 60118-13:1997 Hearing aids — Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:1997) None —

CENELEC EN 60522:1999 Determination of the permanent filtration of X-ray tube assemblies (IEC 60522:1999) None —

CENELEC EN 60580:2000 Medical electrical equipment — Dose area product meters (IEC 60580:2000) None —

CENELEC EN 60601-1:1990 Medical electrical equipment — Part 1: General requirements for safety (IEC 60601-1:1988) None —

Amendment A1:1993 to EN 60601-1:1990 (IEC 60601-1:1988/A1:1991) Note 3 —

Amendment A2:1995 to EN 60601-1:1990 (IEC 60601-1:1988/A2:1995) Note 3 —

Amendment A13:1996 to EN 60601-1:1990 Note 3 Date expired (1.7.1996)

CENELEC EN 60601-1-1:2001 Medical electrical equipment — Part 1-1: General requirements for safety — Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000) EN 60601-1-1:1993 +A1:1996 Note 2.1 Date expired (1.12.2003)

CENELEC EN 60601-1-2:2001 Medical electrical equipment — Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests (IEC 60601-1-2:2001) EN 60601-1-2:1993 Note 2.1 Date expired (1.11.2004)

CENELEC EN 60601-1-3:1994 Medical electrical equipment — Part 1: General requirements for safety — 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:1994) None —

CENELEC EN 60601-1-4:1996 Medical electrical equipment — Part 1-4: General requirements for safety — Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996) None —

Amendment A1:1999 to EN 60601-1-4:1996 (IEC 60601-1-4:1996/A1:1999) Note 3 Date expired (1.12.2002)

CENELEC EN 60601-2-1:1998 Medical electrical equipment — Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to 50 MeV (IEC 60601-2-1:1998) None —

Amendment A1:2002 to EN 60601-2-1:1998 (IEC 60601-2-1:1998/A1:2002) Note 3 1.6.2005

CENELEC EN 60601-2-2:2000 Medical electrical equipment — Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2:1998) EN 60601-2-2:1993 Note 2.1 Date expired (1.8.2003)

CENELEC EN 60601-2-3:1993 Medical electrical equipment — Part 2: Particular requirements for the safety of short-wave therapy equipment (IEC 60601-2-3:1991) None —

Amendment A1:1998 to EN 60601-2-3:1993 (IEC 60601-2-3:1991/A1:1998) Note 3 Date expired (1.7.2001)

CENELEC EN 60601-2-4:2003 Medical electrical equipment — Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002) None —

CENELEC EN 60601-2-5:2000 Medical electrical equipment — Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment (IEC 60601-2-5:2000) None —

CENELEC EN 60601-2-7:1998 Medical electrical equipment — Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators (IEC 60601-2-7:1998) None —

CENELEC EN 60601-2-8:1997 Medical electrical equipment — Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:1987) None —

Amendment A1:1997 to EN 60601-2-8:1997 (IEC 60601-2-8:1987/A1:1997) Note 3 Date expired (1.6.1998)

CENELEC EN 60601-2-9:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors (IEC 60601-2-9:1996) None —

CENELEC EN 60601-2-10:2000 Medical electrical equipment — Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987) None —

Amendment A1:2001 to EN 60601-2-10:2000 (IEC 60601-2-10:1987/A1:2001) Note 3 Date expired (1.11.2004)

CENELEC EN 60601-2-11:1997 Medical electrical equipment — Part 2-11: Particular requirements for the safety of gamma beam therapy equipment (IEC 60601-2-11:1997) None —

CENELEC EN 60601-2-16:1998 Medical electrical equipment — Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (IEC 60601-2-16:1998) None —

CENELEC EN 60601-2-17:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of remote-controlled automatically-driven gamma-ray after-loading equipment (IEC 60601-2-17:1989) None —

Amendment A1:1996 to EN 60601-2-17:1996 (IEC 60601-2-17:1989/A1:1996) Note 3 Date expired (1.3.1997)

CENELEC EN 60601-2-17:2004 Medical electrical equipment — Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004) EN 60601-2-17:1996 and its amendment Note 2.1 1.3.2007

CENELEC EN 60601-2-18:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996) None —

Amendment A1:2000 to EN 60601-2-18:1996 (IEC 60601-2-18:1996/A1:2000) Note 3 Date expired (1.8.2003)

CENELEC EN 60601-2-19:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of baby incubators (IEC 60601-2-19:1990) None —

Amendment A1:1996 to EN 60601-2-19:1996 (IEC 60601-2-19:1990/A1:1996) Note 3 Date expired (13.6.1998)

CENELEC EN 60601-2-20:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of transport incubators (IEC 60601-2-20:1990 + A1:1996) None —

CENELEC EN 60601-2-21:1994 Medical electrical equipment — Part 2: Particular requirements for the safety of infant radiant warmers (IEC 60601-2-21:1994) None —

Amendment A1:1996 to EN 60601-2-21:1994 (IEC 60601-2-21:1994/A1:1996) Note 3 Date expired (13.6.1998)

CENELEC EN 60601-2-22:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment (IEC 60601-2-22:1995) None —

CENELEC EN 60601-2-23:2000 Medical electrical equipment — Part 2-23: Particular requirements for the safety, including essential performance, of transcutaneous partial pressure monitoring equipment (IEC 60601-2-23:1999) EN 60601-2-23:1997 Note 2.1 Date expired (1.1.2003)

CENELEC EN 60601-2-24:1998 Medical electrical equipment — Part 2-24: Particular requirements for the safety of infusion pumps and controllers (IEC 60601-2-24:1998) None —

CENELEC EN 60601-2-25:1995 Medical electrical equipment — Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993) None —

Amendment A1:1999 to EN 60601-2-25:1995 (IEC 60601-2-25:1993/A1:1999) Note 3 Date expired (1.5.2002)

CENELEC EN 60601-2-26:1994 Medical electrical equipment — Part 2: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:1994) None —

CENELEC EN 60601-2-26:2003 Medical electrical equipment — Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002) EN 60601-2-26:1994 Note 2.1 1.3.2006

CENELEC EN 60601-2-27:1994 Medical electrical equipment — Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment (IEC 60601-2-27:1994) None —

CENELEC EN 60601-2-28:1993 Medical electrical equipment — Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:1993) None —

CENELEC EN 60601-2-29:1999 Medical electrical equipment — Part 2-29: Particular requirements for the safety of radiotherapy simulators (IEC 60601-2-29:1999) EN 60601-2-29:1995 +A1:1996 Note 2.1 Date expired (1.4.2002)

CENELEC EN 60601-2-30:2000 Medical electrical equipment — Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment (IEC 60601-2-30:1999) EN 60601-2-30:1995 Note 2.1 Date expired (1.2.2003)

CENELEC EN 60601-2-31:1995 Medical electrical equipment — Part 2-31: Particular requirements for the safety of external cardiac pacemakers with internal power source (IEC 60601-2-31:1994) None —

Amendment A1:1998 to EN 60601-2-31:1995 (IEC 60601-2-31:1994/A1:1998) Note 3 Date expired (1.1.2001)

CENELEC EN 60601-2-32:1994 Medical electrical equipment — Part 2: Particular requirements for the safety of associated equipment of X-ray equipment (IEC 60601-2-32:1994) None —

CENELEC EN 60601-2-33:1995 Medical electrical equipment — Part 2: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:1995) None —

Amendment A11:1997 to EN 60601-2-33:1995 Note 3 Date expired (13.6.1998)

CENELEC EN 60601-2-33:2002 Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2002) EN 60601-2-33:1995 and its amendment Note 2.1 1.7.2005

CENELEC EN 60601-2-34:2000 Medical electrical equipment — Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment (IEC 60601-2-34:2000) EN 60601-2-34:1995 Note 2.1 Date expired (1.11.2003)

CENELEC EN 60601-2-35:1996 Medical electrical equipment — Part 2: Particular requirements for the safety of blankets, pads and mattresses, intended for heating in medical use (IEC 60601-2-35:1996) None —

CENELEC EN 60601-2-36:1997 Medical electrical equipment — Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy (IEC 60601-2-36:1997) None —

CENELEC EN 60601-2-37:2001 Medical electrical equipment — Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2001) None —

CENELEC EN 60601-2-38:1996 Medical electrical equipment — Part 2-38: Particular requirements for the safety of electrically operated hospital beds (IEC 60601-2-38:1996) None —

Amendment A1:2000 to EN 60601-2-38:1996 (IEC 60601-2-38:1996/A1:1999) Note 3 Date expired (1.1.2003)

CENELEC EN 60601-2-39:1999 Medical electrical equipment — Part 2-39: Particular requirements for the safety of peritoneal dialysis equipment (IEC 60601-2-39:1999) None —

CENELEC EN 60601-2-40:1998 Medical electrical equipment — Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment (IEC 60601-2-40:1998) None —

CENELEC EN 60601-2-41:2000 Medical electrical equipment — Part 2-41: Particular requirements for the safety of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2000) None —

CENELEC EN 60601-2-43:2000 Medical electrical equipment — Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures (IEC 60601-2-43:2000) None —

CENELEC EN 60601-2-44:2001 Medical electrical equipment — Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography (IEC 60601-2-44:2001) EN 60601-2-44:1999 Note 2.1 Date expired (1.7.2004)

Amendment A1:2003 to EN 60601-2-44:2001 (IEC 60601-2-44:2001/A1:2002) Note 3 1.12.2005

CENELEC EN 60601-2-45:2001 Medical electrical equipment — Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices (IEC 60601-2-45:2001) EN 60601-2-45:1998 Note 2.1 Date expired (1.7.2004)

CENELEC EN 60601-2-46:1998 Medical electrical equipment — Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998) None —

CENELEC EN 60601-2-47:2001 Medical electrical equipment — Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001) None —

CENELEC EN 60601-2-49:2001 Medical electrical equipment — Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment (IEC 60601-2-49:2001) None —

CENELEC EN 60601-2-50:2002 Medical electrical equipment — Part 2-50: Particular requirements for the safety of infant phototherapy equipment (IEC 60601-2-50:2000) None —

CENELEC EN 60601-2-51:2003 Medical electrical equipment — Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs (IEC 60601-2-51:2003) None —

CENELEC EN 60627:2001 Diagnostic X-ray imaging equipment — Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001) None —

CENELEC EN 60645-1:2001 Electroacoustics — Audiological equipment — Part 1: Pure-tone audiometers (IEC 60645-1:2001) EN 60645-1:1994 Note 2.1 Date expired (1.10.2004)

CENELEC EN 60645-2:1997 Audiometers — Part 2: Equipment for speech audiometry (IEC 60645-2:1993) None —

CENELEC EN 60645-3:1995 Audiometers — Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes (IEC 60645-3:1994) None —

CENELEC EN 60645-4:1995 Audiometers — Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994) None —

CENELEC EN 61217:1996 Radiotherapy equipment — Coordinates, movements and scales (IEC 61217:1996) None —

Amendment A1:2001 to EN 61217:1996 (IEC 61217:1996/A1:2000) Note 3 Date expired (1.12.2003)

CENELEC EN 61223-3-1:1999 Evaluation and routine testing in medical imaging departments — Part 3-1: Acceptance tests — Imaging performance of X-ray equipment for radiographic and radioscopic systems (IEC 61223-3-1:1999) None —

CENELEC EN 61223-3-4:2000 Evaluation and routine testing in medical imaging departments — Part 3-4: Acceptance tests — Imaging performance of dental X-ray equipment (IEC 61223-3-4:2000) None —

CENELEC EN 61676:2002 Medical electrical equipment — Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002) None —

CENELEC EN 62083:2001 Medical electrical equipment — Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2000) None —