
Article 1 
The references of the harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annex I to this Decision are hereby published in the Official Journal of the European Union.
Article 2 
Commission communication 2017/C 389/03 is repealed. It shall continue to apply until 30 September 2021 in respect of the references of the standards listed in Annex II to this Decision.
Article 3 
The harmonised standards for medical devices drafted in support of Directive 93/42/EEC and listed in Annexes I and II to this Decision may not be used to confer presumption of conformity with the requirements of Regulation (EU) 2017/745.
Article 4 
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
It shall apply until 26 May 2024.
Done at Brussels, 24 March 2020.
For the Commission
The President
Ursula VON DER LEYEN
ANNEX I

No Reference of the standard
1. EN 285:2006+A2:2009Sterilization - Steam sterilizers - Large sterilizers
2. EN 455-1:2000Medical gloves for single use - Part 1: Requirements and testing for freedom from holes
3. EN 455-2:2009+A2:2013Medical gloves for single use - Part 2: Requirements and testing for physical properties
4. EN 455-3:2006Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
5. EN 455-4:2009Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
6. EN 556-1:2001Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devicesEN 556-1:2001/AC:2006
7. EN 556-2:2015Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
8. EN 794-3:1998+A2:2009Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators
9. EN 1041:2008Information supplied by the manufacturer of medical devices
10. EN 1060-3:1997+A2:2009Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems
11. EN 1060-4:2004Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers
12. EN ISO 1135-4:2011Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2010)
13. EN 1282-2:2005+A1:2009Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified)
14. EN 1422:1997+A1:2009Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
15. EN 1618:1997Catheters other than intravascular catheters - Test methods for common properties
16. EN 1639:2009Dentistry - Medical devices for dentistry - Instruments
17. EN 1640:2009Dentistry - Medical devices for dentistry - Equipment
18. EN 1641:2009Dentistry - Medical devices for dentistry - Materials
19. EN 1642:2011Dentistry - Medical devices for dentistry - Dental implants
20. EN 1707:1996Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
21. EN 1782:1998+A1:2009Tracheal tubes and connectors
22. EN 1789:2007+A1:2010Medical vehicles and their equipment - Road ambulances
23. EN 1820:2005+A1:2009Anaesthetic reservoir bags (ISO 5362:2000, modified)
24. EN 1865-1:2010+A1:2015Patient handling equipment used in road ambulances - Part 1: General stretcher systems and patient handling equipment
25. EN 1865-2:2010+A1:2015Patient handling equipment used in road ambulances - Part 2: Power assisted stretcher
26. EN 1865-3:2012Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
27. EN 1865-4:2012Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair
28. EN 1865-5:2012Patient handling equipment used in road ambulances - Part 5: Stretcher support
29. EN 1985:1998Walking aids - General requirements and test methodsNotice: 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 3826-2:2008Plastics 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 3826-3:2007Plastics collapsible containers for human blood and blood components - Part 3: Blood bag systems with integrated features (ISO 3826- 3:2006)
32. EN ISO 3826-4:2015Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
33. EN ISO 4074:2002Natural latex rubber condoms - Requirements and test methods (ISO 4074:2002)
34. EN ISO 4135:2001Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001)
35. EN ISO 5359:2008Low-pressure hose assemblies for use with medical gases (ISO 5359:2008)EN ISO 5359:2008/A1:2011
36. EN ISO 5360:2009Anaesthetic vaporizers - Agent-specific filling systems (ISO 5360:2006)
37. EN ISO 5366-1:2009Anaesthetic and respiratory equipment - Tracheostomy tubes - Part 1: Tubes and connectors for use in adults (ISO 5366-1:2000)
38. EN ISO 5840:2009Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)
39. EN ISO 7197:2009Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
40. EN ISO 7376:2009Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)
41. EN ISO 7396-1:2007Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2007)EN ISO 7396-1:2007/A1:2010EN ISO 7396-1:2007/A2:2010
42. EN ISO 7396-2:2007Medical gas pipeline systems - Part 2: Anaesthetic gas scavenging disposal systems (ISO 7396-2:2007)
43. EN ISO 7886-3:2009Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)
44. EN ISO 7886-4:2009Sterile hypodermic syringes for single use - Part 4: Syringes with reuse prevention feature (ISO 7886-4:2006)
45. EN ISO 8185:2009Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007)
46. EN ISO 8359:2009Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)EN ISO 8359:2009/A1:2012
47. EN ISO 8835-2:2009Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835- 2:2007)
48. EN ISO 8835-3:2009Inhalational 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 8835-4:2009Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835- 4:2004)
50. EN ISO 8835-5:2009Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
51. EN ISO 9170-1:2008Terminal 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 9170-2:2008Terminal units for medical gas pipeline systems - Part 2: Terminal units for anaesthetic gas scavenging systems (ISO 9170-2:2008)
53. EN ISO 9360-1:2009Anaesthetic 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 9360-2:2009Anaesthetic 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 9713:2009Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
56. EN ISO 10079-1:2009Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements (ISO 10079-1:1999)
57. EN ISO 10079-2:2009Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)
58. EN ISO 10079-3:2009Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)
59. EN ISO 10328:2016Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
60. EN ISO 10524-1:2006Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524- 1:2006)
61. EN ISO 10524-2:2006Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)
62. EN ISO 10524-3:2006Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (ISO 10524-3:2005)
63. EN ISO 10524-4:2008Pressure regulators for use with medical gases - Part 4: Low-pressure regulators (ISO 10524- 4:2008)
64. EN ISO 10535:2006Hoists 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 10555-1:2009Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)
66. EN ISO 10651-2:2009Lung 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 10651-4:2009Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
68. EN ISO 10651-6:2009Lung 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 10993-1:2009Biological 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 10993-3:2014Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
71. EN ISO 10993-4:2009Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
72. EN ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
73. EN ISO 10993-6:2009Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
74. EN ISO 10993-7:2008Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)EN ISO 10993-7:2008/AC:2009
75. EN ISO 10993-9:2009Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
76. EN ISO 10993-11:2018Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
77. EN ISO 10993-12:2012Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
78. EN ISO 10993-13:2010Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
79. EN ISO 10993-14:2009Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
80. EN ISO 10993-15:2009Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
81. EN ISO 10993-16:2010Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
82. EN ISO 10993-17:2009Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
83. EN ISO 10993-18:2009Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
84. EN ISO 11135-1:2007Sterilization 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 11137-1:2015Sterilization 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 11137-2:2015Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
87. EN ISO 11138-2:2009Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)
88. EN ISO 11138-3:2009Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)
89. EN ISO 11140-1:2009Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)
90. EN ISO 11140-3:2009Sterilization 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 11197:2009Medical supply units (ISO 11197:2004)
92. EN ISO 11607-1:2009Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
93. EN ISO 11607-2:2006Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
94. EN ISO 11608-7:2017Needle-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 11737-1:2006Sterilization 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 11737-2:2009Sterilization 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 11810-1:2009Lasers 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 11810-2:2009Lasers 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 11979-8:2009Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979- 8:2006)
100. EN ISO 11990:2018Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shaft and tracheal cuffs (ISO 11990:2018)
101. EN 12006-2:1998+A1:2009Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
102. EN 12006-3:1998+A1:2009Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
103. EN 12183:2009Manual wheelchairs - Requirements and test methods
104. EN 12184:2009Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
105. EN 12342:1998+A1:2009Breathing tubes intended for use with anaesthetic apparatus and ventilators
106. EN 12470-1:2000+A1:2009Clinical thermometers - Part 1: Metallic liquid- in-glass thermometers with maximum device
107. EN 12470-2:2000+A1:2009Clinical thermometers - Part 2: Phase change type (dot matrix) thermometers
108. EN 12470-3:2000+A1:2009Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device
109. EN 12470-4:2000+A1:2009Clinical thermometers - Part 4: Performance of electrical thermometers for continuous measurement
110. EN 12470-5:2003Clinical 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 12870:2009Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
112. EN 13060:2014Small steam sterilizers
113. EN ISO 13408-1:2015Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
114. EN ISO 13408-2:2018Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)
115. EN ISO 13408-3:2011Aseptic processing of health care products - Part 3: Lyophilization (ISO 13408-3:2006)
116. EN ISO 13408-4:2011Aseptic processing of health care products - Part 4: Clean-in-place technologies (ISO 13408-4:2005)
117. EN ISO 13408-5:2011Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)
118. EN ISO 13408-6:2011Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
119. EN ISO 13408-7:2015Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
120. EN ISO 13485:2016Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)EN ISO 13485:2016/AC:2018
121. EN 13544-1:2007+A1:2009Respiratory therapy equipment - Part 1: Nebulizing systems and their component
122. EN 13544-2:2002+A1:2009Respiratory therapy equipment - Part 2: Tubing and connectors
123. EN 13544-3:2001+A1:2009Respiratory therapy equipment - Part 3: Air entrainment devices
124. EN 13624:2003Chemical 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 13718-1:2008Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
126. EN 13718-2:2015Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances
127. EN 13726-1:2002Test methods for primary wound dressings - Part 1: Aspects of absorbencyEN 13726-1:2002/AC:2003
128. EN 13726-2:2002Test methods for primary wound dressings - Part 2: Moisture vapour transmission rate of permeable film dressings
129. EN 13727:2012Chemical 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 13795-1:2019Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
131. EN 13795-2:2019Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
132. EN 13867:2002+A1:2009Concentrates for haemodialysis and related therapies
133. EN 13976-1:2011Rescue systems - Transportation of incubators - Part 1: Interface conditions
134. EN 13976-2:2018Rescue systems - Transportation of incubators - Part 2: System requirements
135. EN 14079:2003Non-active medical devices - Performance requirements and test methods for absorbent cotton gauze and absorbent cotton and viscose gauze
136. EN 14139:2010Ophthalmic optics - Specifications for ready-to- wear spectacles
137. EN ISO 14155:2011Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011)EN ISO 14155:2011/AC:2011
138. EN 14180:2003+A2:2009Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
139. EN 14348:2005Chemical 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 14408:2009Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information (ISO 14408:2005)
141. EN 14561:2006Chemical 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 14562:2006Chemical 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 14563:2008Chemical 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 14602:2011Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
145. EN ISO 14607:2009Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
146. EN ISO 14630:2009Non-active surgical implants - General requirements (ISO 14630:2008)
147. EN 14683:2019+AC:2019Medical face masks - Requirements and test methods
148. EN ISO 14889:2009Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)
149. EN 14931:2006Pressure vessels for human occupancy (PVHO) - Multi-place pressure chamber systems for hyperbaric therapy - Performance, safety requirements and testing
150. EN ISO 14937:2009Sterilization 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 14971:2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
152. EN ISO 15001:2011Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)
153. EN ISO 15002:2008Flow-metering devices for connection to terminal units of medical gas pipeline systems (ISO 15002:2008)
154. EN ISO 15004-1:2009Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
155. EN ISO 15223-1:2016Medical 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 15747:2019Plastic containers for intravenous injections (ISO 15747:2018)
157. EN ISO 15798:2010Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
158. EN ISO 15883-1:2009Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2006)
159. EN ISO 15883-2:2009Washer-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 15883-3:2009Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2006)
161. EN ISO 15883-4:2018Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2018)
162. EN 15986:2011Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalate
163. EN ISO 16061:2009Instrumentation for use in association with non- active surgical implants - General requirements (ISO 16061:2008, Corrected version 2009-03- 15)
164. EN ISO 16201:2006Technical aids for disabled persons - Environmental control systems for daily living (ISO 16201:2006)
165. EN ISO 17510-1:2009Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)
166. EN ISO 17510-2:2009Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)
167. EN ISO 17664:2017Processing 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 17665-1:2006Sterilization 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 18777:2009Transportable liquid oxygen systems for medical use - Particular requirements (ISO 18777:2005)
170. EN ISO 18778:2009Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
171. EN ISO 18779:2005Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
172. EN ISO 19054:2006Rail systems for supporting medical equipment (ISO 19054:2005)
173. EN 20594-1:1993Conical 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/A1:1997EN 20594-1:1993/AC:1996
174. EN ISO 21534:2009Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
175. EN ISO 21535:2009Non-active surgical implants - Joint replacement implants - Specific requirements for hip- joint replacement implants (ISO 21535:2007)
176. EN ISO 21536:2009Non-active surgical implants - Joint replacement implants - Specific requirements for knee- joint replacement implants (ISO 21536:2007)
177. EN ISO 21649:2009Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
178. EN ISO 21969:2009High-pressure flexible connections for use with medical gas systems (ISO 21969:2009)
179. EN ISO 21987:2017Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017)
180. EN ISO 22442-1:2007Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007)
181. EN ISO 22442-2:2007Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007)
182. EN ISO 22442-3:2007Medical 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 22523:2006External 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 22675:2016Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2016)
185. EN ISO 23328-1:2008Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 23328- 1:2003)
186. EN ISO 23328-2:2009Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
187. EN ISO 23747:2009Anaesthetic and respiratory equipment - Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans (ISO 23747:2007)
188. EN ISO 25424:2019Sterilization 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 25539-1:2009Cardiovascular 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 25539-2:2009Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539- 2:2008)EN ISO 25539-2:2009/AC:2011
191. EN ISO 26782:2009Anaesthetic 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 27740:1992Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)EN 27740:1992/A1:1997EN 27740:1992/AC:1996
193. EN 60118-13:2005Electroacoustics - 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 60522:1999Determination 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 60580:2000Medical 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 60601-1:2006Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)EN 60601-1:2006/AC:2010EN 60601-1:2006/A1:2013 (IEC 60601-1:2005/A1:2012)
197. EN 60601-1-1:2001Medical 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 60601-1-2:2015Medical 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 60601-1-3:2008Medical 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:2010EN 60601-1-3:2008/A11:2016Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
200. EN 60601-1-4:1996Medical 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 60601-1-6:2010Medical 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 60601-1-8:2007Medical 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:2010EN 60601-1-8:2007/A11:2017Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
203. EN 60601-1-10:2008Medical 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 60601-1-11:2010Medical 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 60601-2-1:1998Medical 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 60601-2-2:2009Medical 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 60601-2-3:1993Medical 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 60601-2-4:2003Medical 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 60601-2-5:2000Medical 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 60601-2-8:1997Medical 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 60601-2-10:2000Medical 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 60601-2-11:1997Medical 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 60601-2-12:2006Medical 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 60601-2-13:2006Medical 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 60601-2-16:1998Medical 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:1999Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
216. EN 60601-2-17:2004Medical 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 60601-2-18:1996Medical 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 60601-2-19:2009Medical 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 60601-2-20:2009Medical 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 60601-2-21:2009Medical 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 60601-2-22:1996Medical 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 60601-2-23:2000Medical 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 60601-2-24:1998Medical 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 60601-2-25:1995Medical 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 60601-2-26:2003Medical 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 60601-2-27:2006Medical 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:2006Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
227. EN 60601-2-28:2010Medical 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 60601-2-29:2008Medical 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 60601-2-30:2000Medical 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 60601-2-33:2010Medical 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:2016-03EN 60601-2-33:2010/A12:2016
231. EN 60601-2-34:2000Medical 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 60601-2-36:1997Medical 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 60601-2-37:2008Medical 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 60601-2-39:2008Medical 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 60601-2-40:1998Medical 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 60601-2-41:2009Medical 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 60601-2-43:2010Medical 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 60601-2-44:2009Medical 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 60601-2-45:2001Medical 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 60601-2-46:1998Medical 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 60601-2-47:2001Medical 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 60601-2-49:2001Medical 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 60601-2-50:2009Medical 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 60601-2-51:2003Medical 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 60601-2-52:2010Medical 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:2011Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
246. EN 60601-2-54:2009Medical 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 60627:2001Diagnostic X-ray imaging equipment - Characteristics of general purpose and mammographic anti-scatter grids (IEC 60627:2001)EN 60627:2001/AC:2002Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
248. EN 60645-1:2001Electroacoustics - 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 60645-2:1997Audiometers - 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 60645-3:2007Electroacoustics - 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 60645-4:1995Audiometers - 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 61217:2012Radiotherapy equipment - Coordinates, movements and scales (IEC 61217:2011)
253. EN 61676:2002Medical 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 62083:2009Medical 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 62220-1:2004Medical 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 62220-1-2:2007Medical 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 62220-1-3:2008Medical 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 62304:2006Medical device software - Software life-cycle processes (IEC 62304:2006)EN 62304:2006/AC:2008Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.
259. EN 62366:2008Medical 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 80601-2-35:2009Medical 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 80601-2-58:2009Medical 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 80601-2-59:2009Medical 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 81060-1:2012Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type (ISO 81060-1:2007)
264. EN ISO 81060-2:2019Non-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 10993-11:2009Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
2. EN ISO 11137-1:2015Sterilization 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 11990-1:2014Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011)
4. EN ISO 11990-2:2014Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2010)
5. EN ISO 13408-2:2011Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)
6. EN ISO 13485:2016Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)EN ISO 13485:2016/AC:2016
7. EN 13976-2:2011Rescue systems - Transportation of incubators - Part 2: System requirements
8. EN 14683:2005Surgical masks - Requirements and test methods
9. EN ISO 15747:2011Plastic containers for intravenous injections (ISO 15747:2010)
10. EN ISO 15883-4:2009Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
11. EN ISO 17664:2004Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
12. EN ISO 21987:2009Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2009)