European Standardisation Organisation (1) Reference and title of the standard Reference document Reference of the superseded standard Date of cessation of presumption of conformity of the superseded standard Note 1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 Note 3 —

Amendment A13:1996 to EN 60601-1:1990 Note 3 Date expired (01.07.1996)

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 Date expired (01.12.2003)

CENELEC EN 60601-1-2:1993 Medical electrical equipment -- Part 1: General requirements for safety --2. Collateral standard: Electromagnetic compatibility - Requirements and tests IEC 60601-1-2:1993 NONE —

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 01.11.2004

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 (01.12.2002)

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 01.06.2005

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 (01.08.2003)

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 (01.07.2001)

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 (01.06.1998)

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 01.11.2004

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 (01.03.1997)

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 (01.08.2003)

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 (13.06.1998)

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 (13.06.1998)

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 (01.01.2003)

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 (01.05.2002)

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 01.03.2006

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 Date expired (01.04.2002)

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 (01.02.2003)

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 (01.01.2001)

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 (13.06.1998)

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 01.07.2005

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 (01.11.2003)

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 (01.01.2003)

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 60601-2-44:1999 Medical electrical equipment -- Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography IEC 60601-2-44:1999 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 01.07.2004

Amendment A1:2003 to EN 60601-2-44:2001 IEC 60601-2-44:2001 /A1:2002 Note 3 01.12.2005

CENELEC EN 60601-2-45:1998 Medical electrical equipment -- Part 2-45: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices IEC 60601-2-45:1998 NONE —

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 01.07.2004

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 60645-1:1994 Audiometers -- Part 1: Pure-tone audiometers IEC 60645-1:1992 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 01.10.2004

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 (01.12.2003)

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 —