COMMISSION IMPLEMENTING DECISION (EU) 2020/437
of 24 March 2020
on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC
Article 1
Article 2
Article 3
Article 4
ANNEX I
No |
Reference of the standard |
1. |
EN 285:2006+A2:2009 Sterilization - Steam sterilizers - Large sterilizers |
2. |
EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes |
3. |
EN 455-2:2009+A2:2013 Medical gloves for single use - Part 2: Requirements and testing for physical properties |
4. |
EN 455-3:2006 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
5. |
EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination |
6. |
EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices EN 556-1:2001/AC:2006 |
7. |
EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
8. |
EN 794-3:1998+A2:2009 Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators |
9. |
EN 1041:2008 Information supplied by the manufacturer of medical devices |
10. |
EN 1060-3:1997+A2:2009 Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems |
11. |
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers |
12. |
EN ISO 1135-4:2011 Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010) |
13. |
EN 1282-2:2005+A1:2009 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |
14. |
EN 1422:1997+A1:2009 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
15. |
EN 1618:1997 Catheters other than intravascular catheters - Test methods for common properties |
16. |
EN 1639:2009 Dentistry - Medical devices for dentistry - Instruments |
17. |
EN 1640:2009 Dentistry - Medical devices for dentistry - Equipment |
18. |
EN 1641:2009 Dentistry - Medical devices for dentistry - Materials |
19. |
EN 1642:2011 Dentistry - Medical devices for dentistry - Dental implants |
20. |
EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings |
21. |
EN 1782:1998+A1:2009 Tracheal tubes and connectors |
22. |
EN 1789:2007+A1:2010 Medical vehicles and their equipment - Road ambulances |
23. |
EN 1820:2005+A1:2009 Anaesthetic reservoir bags (ISO 5362:2000, modified) |
24. |
EN 1865-1:2010+A1:2015 Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment |
25. |
EN 1865-2:2010+A1:2015 Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher |
26. |
EN 1865-3:2012 Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher |
27. |
EN 1865-4:2012 Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair |
28. |
EN 1865-5:2012 Patient handling equipment used in road ambulances - Part 5: Stretcher support |
29. |
EN 1985:1998 Walking aids - General requirements and test methods Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
30. |
EN ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets (ISO 3826-2:2008) |
31. |
EN ISO 3826-3:2007 Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826- 3:2006) |
32. |
EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
33. |
EN ISO 4074:2002 Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002) |
34. |
EN ISO 4135:2001 Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
35. |
EN ISO 5359:2008 Low-pressure hose assemblies for use with medical gases (ISO 5359:2008) EN ISO 5359:2008/A1:2011 |
36. |
EN ISO 5360:2009 Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006) |
37. |
EN ISO 5366-1:2009 Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000) |
38. |
EN ISO 5840:2009 Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005) |
39. |
EN ISO 7197:2009 Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007) |
40. |
EN ISO 7376:2009 Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009) |
41. |
EN ISO 7396-1:2007 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007) EN ISO 7396-1:2007/A1:2010 EN ISO 7396-1:2007/A2:2010 |
42. |
EN ISO 7396-2:2007 Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007) |
43. |
EN ISO 7886-3:2009 Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005) |
44. |
EN ISO 7886-4:2009 Sterile hypodermic syringes for single use - Part 4: Syringes with reuse prevention feature (ISO 7886-4:2006) |
45. |
EN ISO 8185:2009 Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007) |
46. |
EN ISO 8359:2009 Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996) EN ISO 8359:2009/A1:2012 |
47. |
EN ISO 8835-2:2009 Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835- 2:2007) |
48. |
EN ISO 8835-3:2009 Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3:2007) EN ISO 8835-3:2009/A1:2010 |
49. |
EN ISO 8835-4:2009 Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835- 4:2004) |
50. |
EN ISO 8835-5:2009 Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004) |
51. |
EN ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum (ISO 9170-1:2008) |
52. |
EN ISO 9170-2:2008 Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008) |
53. |
EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
54. |
EN ISO 9360-2:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) |
55. |
EN ISO 9713:2009 Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002) |
56. |
EN ISO 10079-1:2009 Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999) |
57. |
EN ISO 10079-2:2009 Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999) |
58. |
EN ISO 10079-3:2009 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999) |
59. |
EN ISO 10328:2016 Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016) |
60. |
EN ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524- 1:2006) |
61. |
EN ISO 10524-2:2006 Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005) |
62. |
EN ISO 10524-3:2006 Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005) |
63. |
EN ISO 10524-4:2008 Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524- 4:2008) |
64. |
EN ISO 10535:2006 Hoists for the transfer of disabled persons - Requirements and test methods (ISO 10535:2006) Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
65. |
EN ISO 10555-1:2009 Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004) |
66. |
EN ISO 10651-2:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651- 2:2004) |
67. |
EN ISO 10651-4:2009 Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002) |
68. |
EN ISO 10651-6:2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004) |
69. |
EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) EN ISO 10993-1:2009/AC:2010 |
70. |
EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) |
71. |
EN ISO 10993-4:2009 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
72. |
EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
73. |
EN ISO 10993-6:2009 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
74. |
EN ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) EN ISO 10993-7:2008/AC:2009 |
75. |
EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
76. |
EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017) |
77. |
EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
78. |
EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
79. |
EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001) |
80. |
EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000) |
81. |
EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
82. |
EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
83. |
EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
84. |
EN ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007) |
85. |
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015/A2:2019 |
86. |
EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
87. |
EN ISO 11138-2:2009 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
88. |
EN ISO 11138-3:2009 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
89. |
EN ISO 11140-1:2009 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) |
90. |
EN ISO 11140-3:2009 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007) |
91. |
EN ISO 11197:2009 Medical supply units (ISO 11197:2004) |
92. |
EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
93. |
EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) |
94. |
EN ISO 11608-7:2017 Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
95. |
EN ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN ISO 11737-1:2006/AC:2009 |
96. |
EN ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009) |
97. |
EN ISO 11810-1:2009 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005) |
98. |
EN ISO 11810-2:2009 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007) |
99. |
EN ISO 11979-8:2009 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979- 8:2006) |
100. |
EN ISO 11990:2018 Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018) |
101. |
EN 12006-2:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits |
102. |
EN 12006-3:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices |
103. |
EN 12183:2009 Manual wheelchairs - Requirements and test methods |
104. |
EN 12184:2009 Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
105. |
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators |
106. |
EN 12470-1:2000+A1:2009 Clinical thermometers - Part 1: Metallic liquid- in-glass thermometers with maximum device |
107. |
EN 12470-2:2000+A1:2009 Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers |
108. |
EN 12470-3:2000+A1:2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
109. |
EN 12470-4:2000+A1:2009 Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement |
110. |
EN 12470-5:2003 Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
111. |
EN ISO 12870:2009 Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004) |
112. |
EN 13060:2014 Small steam sterilizers |
113. |
EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
114. |
EN ISO 13408-2:2018 Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018) |
115. |
EN ISO 13408-3:2011 Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006) |
116. |
EN ISO 13408-4:2011 Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005) |
117. |
EN ISO 13408-5:2011 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006) |
118. |
EN ISO 13408-6:2011 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005) |
119. |
EN ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012) |
120. |
EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/AC:2018 |
121. |
EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their component |
122. |
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors |
123. |
EN 13544-3:2001+A1:2009 Respiratory therapy equipment - Part 3: Air entrainment devices |
124. |
EN 13624:2003 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal activity of chemical disinfectants for instruments used in the medical area - Test method and requirements (phase 2, step 1) |
125. |
EN 13718-1:2008 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances |
126. |
EN 13718-2:2015 Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances |
127. |
EN 13726-1:2002 Test methods for primary wound dressings - Part 1: Aspects of absorbency EN 13726-1:2002/AC:2003 |
128. |
EN 13726-2:2002 Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings |
129. |
EN 13727:2012 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity in the medical area - Test method and requirements (phase 2, step 1) |
130. |
EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns |
131. |
EN 13795-2:2019 Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits |
132. |
EN 13867:2002+A1:2009 Concentrates for haemodialysis and related therapies |
133. |
EN 13976-1:2011 Rescue systems - Transportation of incubators - Part 1: Interface conditions |
134. |
EN 13976-2:2018 Rescue systems - Transportation of incubators - Part 2: System requirements |
135. |
EN 14079:2003 Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze |
136. |
EN 14139:2010 Ophthalmic optics - Specifications for ready-to- wear spectacles |
137. |
EN ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011) EN ISO 14155:2011/AC:2011 |
138. |
EN 14180:2003+A2:2009 Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing |
139. |
EN 14348:2005 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1) |
140. |
EN ISO 14408:2009 Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005) |
141. |
EN 14561:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) |
142. |
EN 14562:2006 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2) |
143. |
EN 14563:2008 Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area - Test method and requirements (phase 2, step 2) |
144. |
EN ISO 14602:2011 Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) |
145. |
EN ISO 14607:2009 Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007) |
146. |
EN ISO 14630:2009 Non-active surgical implants - General requirements (ISO 14630:2008) |
147. |
EN 14683:2019+AC:2019 Medical face masks - Requirements and test methods |
148. |
EN ISO 14889:2009 Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003) |
149. |
EN 14931:2006 Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing |
150. |
EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
151. |
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
152. |
EN ISO 15001:2011 Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010) |
153. |
EN ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008) |
154. |
EN ISO 15004-1:2009 Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006) |
155. |
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03) |
156. |
EN ISO 15747:2019 Plastic containers for intravenous injections (ISO 15747:2018) |
157. |
EN ISO 15798:2010 Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010) |
158. |
EN ISO 15883-1:2009 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006) |
159. |
EN ISO 15883-2:2009 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006) |
160. |
EN ISO 15883-3:2009 Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006) |
161. |
EN ISO 15883-4:2018 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018) |
162. |
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalate |
163. |
EN ISO 16061:2009 Instrumentation for use in association with non- active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03- 15) |
164. |
EN ISO 16201:2006 Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006) |
165. |
EN ISO 17510-1:2009 Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
166. |
EN ISO 17510-2:2009 Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007) |
167. |
EN ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017) |
168. |
EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) |
169. |
EN ISO 18777:2009 Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005) |
170. |
EN ISO 18778:2009 Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
171. |
EN ISO 18779:2005 Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005) |
172. |
EN ISO 19054:2006 Rail systems for supporting medical equipment (ISO 19054:2005) |
173. |
EN 20594-1:1993 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986) EN 20594-1:1993/A1:1997 EN 20594-1:1993/AC:1996 |
174. |
EN ISO 21534:2009 Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007) |
175. |
EN ISO 21535:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for hip- joint replacement implants (ISO 21535:2007) |
176. |
EN ISO 21536:2009 Non-active surgical implants - Joint replacement implants - Specific requirements for knee- joint replacement implants (ISO 21536:2007) |
177. |
EN ISO 21649:2009 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006) |
178. |
EN ISO 21969:2009 High-pressure flexible connections for use with medical gas systems (ISO 21969:2009) |
179. |
EN ISO 21987:2017 Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017) |
180. |
EN ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007) |
181. |
EN ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007) |
182. |
EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007) |
183. |
EN ISO 22523:2006 External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006) Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered. |
184. |
EN ISO 22675:2016 Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016) |
185. |
EN ISO 23328-1:2008 Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328- 1:2003) |
186. |
EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002) |
187. |
EN ISO 23747:2009 Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007) |
188. |
EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
189. |
EN ISO 25539-1:2009 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005) EN ISO 25539-1:2009/AC:2011 |
190. |
EN ISO 25539-2:2009 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539- 2:2008) EN ISO 25539-2:2009/AC:2011 |
191. |
EN ISO 26782:2009 Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009) EN ISO 26782:2009/AC:2009 |
192. |
EN 27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985) EN 27740:1992/A1:1997 EN 27740:1992/AC:1996 |
193. |
EN 60118-13:2005 Electroacoustics - Hearing aids - Part 13: Electromagnetic compatibility (EMC) (IEC 60118-13:2004) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
194. |
EN 60522:1999 Determination of the permanent filtration of X- ray tube assemblies (IEC 60522:1999) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
195. |
EN 60580:2000 Medical electrical equipment - Dose area product meters (IEC 60580:2000) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
196. |
EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) EN 60601-1:2006/AC:2010 EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012) |
197. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
198. |
EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014) |
199. |
EN 60601-1-3:2008 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008) EN 60601-1-3:2008/AC:2010 EN 60601-1-3:2008/A11:2016 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
200. |
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) EN 60601-1-4:1996/A1:1999 (IEC 60601-1-4:1996/A1:1999) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
201. |
EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
202. |
EN 60601-1-8:2007 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC 60601-1-8:2006) EN 60601-1-8:2007/AC:2010 EN 60601-1-8:2007/A11:2017 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
203. |
EN 60601-1-10:2008 Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers (IEC 60601-1-10:2007) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
204. |
EN 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
205. |
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) EN 60601-2-1:1998/A1:2002 (IEC 60601-2-1:1998/A1:2002) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
206. |
EN 60601-2-2:2009 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 (IEC 60601-2-2:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
207. |
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) EN 60601-2-3:1993/A1:1998 (IEC 60601-2-3:1991/A1:1998) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
208. |
EN 60601-2-4:2003 Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators (IEC 60601-2-4:2002) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
209. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
210. |
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) EN 60601-2-8:1997/A1:1997 (IEC 60601-2-8:1987/A1:1997) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
211. |
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) EN 60601-2-10:2000/A1:2001 (IEC 60601-2-10:1987/A1:2001) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
212. |
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) EN 60601-2-11:1997/A1:2004 (IEC 60601-2-11:1997/A1:2004) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
213. |
EN 60601-2-12:2006 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators (IEC 60601-2-12:2001) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
214. |
EN 60601-2-13:2006 Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (IEC 60601-2-13:2003) EN 60601-2-13:2006/A1:2007 (IEC 60601-2-13:2003/A1:2006) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
215. |
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) EN 60601-2-16:1998/AC:1999 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
216. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
217. |
EN 60601-2-18:1996 Medical electrical equipment - Part 2-18: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996) EN 60601-2-18:1996/A1:2000 (IEC 60601-2-18:1996/A1:2000) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
218. |
EN 60601-2-19:2009 Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
219. |
EN 60601-2-20:2009 Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators (IEC 60601-2-20:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
220. |
EN 60601-2-21:2009 Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers (IEC 60601-2-21:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
221. |
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) Notice: This European Standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
222. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
223. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
224. |
EN 60601-2-25:1995 Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographs (IEC 60601-2-25:1993) EN 60601-2-25:1995/A1:1999 (IEC 60601-2-25:1993/A1:1999) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
225. |
EN 60601-2-26:2003 Medical electrical equipment - Part 2-26: Particular requirements for the safety of electroencephalographs (IEC 60601-2-26:2002) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
226. |
EN 60601-2-27:2006 Medical electrical equipment - Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment (IEC 60601-2-27:2005) EN 60601-2-27:2006/AC:2006 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
227. |
EN 60601-2-28:2010 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (IEC 60601-2-28:2010) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
228. |
EN 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators (IEC 60601-2-29:2008) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
229. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
230. |
EN 60601-2-33:2010 Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis (IEC 60601-2-33:2010) EN 60601-2-33:2010/A1:2015 (IEC 60601-2-33:2010/A1:2013) EN 60601-2-33:2010/A2:2015 (IEC 60601-2-33:2010/A2:2015) EN 60601-2-33:2010/AC:2016-03 EN 60601-2-33:2010/A12:2016 |
231. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
232. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
233. |
EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
234. |
EN 60601-2-39:2008 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (IEC 60601-2-39:2007) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
235. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
236. |
EN 60601-2-41:2009 Medical electrical equipment - Part 2-41: Particular requirements for basic safety and essential performance of surgical luminaires and luminaires for diagnosis (IEC 60601-2-41:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
237. |
EN 60601-2-43:2010 Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures (IEC 60601-2-43:2010) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
238. |
EN 60601-2-44:2009 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (IEC 60601-2-44:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
239. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
240. |
EN 60601-2-46:1998 Medical electrical equipment - Part 2-46: Particular requirements for the safety of operating tables (IEC 60601-2-46:1998) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
241. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
242. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
243. |
EN 60601-2-50:2009 Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 60601-2-50:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
244. |
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) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
245. |
EN 60601-2-52:2010 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009) EN 60601-2-52:2010/AC:2011 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
246. |
EN 60601-2-54:2009 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (IEC 60601-2-54:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
247. |
EN 60627:2001 Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001) EN 60627:2001/AC:2002 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
248. |
EN 60645-1:2001 Electroacoustics - Audiological equipment - Part 1: Pure-tone audiometers (IEC 60645-1:2001) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
249. |
EN 60645-2:1997 Audiometers - Part 2: Equipment for speech audiometry (IEC 60645-2:1993) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
250. |
EN 60645-3:2007 Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration (IEC 60645-3:2007) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
251. |
EN 60645-4:1995 Audiometers - Part 4: Equipment for extended high-frequency audiometry (IEC 60645-4:1994) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
252. |
EN 61217:2012 Radiotherapy equipment - Coordinates, movements and scales (IEC 61217:2011) |
253. |
EN 61676:2002 Medical electrical equipment - Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology (IEC 61676:2002) EN 61676:2002/A1:2009 (IEC 61676:2002/A1:2008) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
254. |
EN 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
255. |
EN 62220-1:2004 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency (IEC 62220-1:2003) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
256. |
EN 62220-1-2:2007 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography (IEC 62220-1-2:2007) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
257. |
EN 62220-1-3:2008 Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging (IEC 62220-1-3:2008) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
258. |
EN 62304:2006 Medical device software - Software life-cycle processes (IEC 62304:2006) EN 62304:2006/AC:2008 Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
259. |
EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
260. |
EN 80601-2-35:2009 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 (IEC 80601-2-35:2009) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
261. |
EN 80601-2-58:2009 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 (IEC 80601-2-58:2008) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
262. |
EN 80601-2-59:2009 Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening (IEC 80601-2-59:2008) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC. |
263. |
EN ISO 81060-1:2012 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007) |
264. |
EN ISO 81060-2:2019 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type (ISO 81060-2:2018) |
ANNEX II
No |
Reference of the standard |
1. |
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006) |
2. |
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
3. |
EN ISO 11990-1:2014 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011) |
4. |
EN ISO 11990-2:2014 Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010) |
5. |
EN ISO 13408-2:2011 Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003) |
6. |
EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) EN ISO 13485:2016/AC:2016 |
7. |
EN 13976-2:2011 Rescue systems - Transportation of incubators - Part 2: System requirements |
8. |
EN 14683:2005 Surgical masks - Requirements and test methods |
9. |
EN ISO 15747:2011 Plastic containers for intravenous injections (ISO 15747:2010) |
10. |
EN ISO 15883-4:2009 Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008) |
11. |
EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004) |
12. |
EN ISO 21987:2009 Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009) |