CELEX: 
Language: en
Date: 2020-03-24 00:00:00
Title: COMMISSION IMPLEMENTING DECISION (EU) …/… on the harmonised standards for medical devices drafted in support of Council Directive 93/42/EEC

EUROPEAN
                           COMMISSION
                                                   Brussels, 24.3.2020
                                                   C(2020) 1901 final
                COMMISSION IMPLEMENTING DECISION (EU) …/…
                                       of 24.3.2020
   on the harmonised standards for medical devices drafted in support of Council Directive
                                        93/42/EEC
EN                                                                                         EN
 ---pagebreak---                     COMMISSION IMPLEMENTING DECISION (EU) …/…
                                                 of 24.3.2020
   on the harmonised standards for medical devices drafted in support of Council Directive
                                                 93/42/EEC
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the
   Council of 25 October 2012 on European standardisation, amending Council Directives
   89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC,
   98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European
   Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No
   1673/2006/EC of the European Parliament and of the Council1, and in particular Article 10(6)
   thereof,
   Whereas:
   (1)     In accordance with Article 5(1) of Council Directive 93/42/EEC2, Member States are
           to presume compliance with the essential requirements referred to in Article 3 of that
           Directive in respect of medical devices which are in conformity with the relevant
           national standards adopted pursuant to the harmonized standards the references of
           which have been published in the Official Journal of the European Union.
   (2)     By letters BC/CEN/CENELEC/09/89 of 19 December 1991, M/023 -
           BC/CEN/03/023/93-08 of 5 August 1993 and M/295 of 9 September 1999, the
           Commission made requests to the European Committee for Standardisation (CEN) and
           the European Committee for Electrotechnical Standardisation (Cenelec) for the
           drafting of new harmonised standards and the revision of existing harmonised
           standards in support of Directive 93/42/EEC.
   (3)     On the basis of the request M/295 of 9 September 1999, CEN revised the harmonised
           standards EN ISO 10993-11:2009, EN 14683:2005 and EN ISO 15747:2011, the
           references of which have been published in the Official Journal of the European
           Union3, in order to include the latest technical and scientific progress. This resulted in
           the adoption of the harmonised standards EN ISO 10993-11:2018, EN
           14683:2019+AC:2019 and EN ISO 15747:2019.
   (4)     The Commission together with CEN has assessed whether standards EN ISO 10993-
           11:2018, EN 14683:2019+AC:2019 and EN ISO 15747:2019 comply with the request.
   (5)     The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN
           ISO 15747:2019 satisfy the requirements which they aim to cover and which are set
           out in Directive 93/42/EEC. It is therefore appropriate to publish the references of
           those standards in the Official Journal of the European Union.
   1
           OJ L 316, 14.11.2012, p. 12.
   2
           Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
   3
           OJ C 389, 17.11.2017, p. 29.
EN                                                     1                                                       EN
 ---pagebreak---    (6)  The harmonised standards EN ISO 10993-11:2018, EN 14683:2019+AC:2019 and EN
        ISO 15747:2019 replace the harmonised standards EN ISO 10993-11:2009, EN
        14683:2005 and EN ISO 15747:2011 respectively. It is therefore necessary to
        withdraw the references of standards EN ISO 10993-11:2009, EN 14683:2005 and EN
        ISO 15747:2011 from the Official Journal of the European Union.
   (7)  On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN
        revised the harmonised standards EN ISO 11137-1:2015, EN ISO 13408-2:2011 and
        EN ISO 13485:2016, the references of which have been published in the Official
        Journal of the European Union4, in order to include the latest technical and scientific
        progress. This resulted in the adoption of the harmonised standards EN ISO 11137-
        1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO
        13485:2016/AC:2018.
   (8)  The Commission together with CEN has assessed whether standards EN ISO 11137-
        1:2015/A2:2019 and EN ISO 13408-2:2018 and the corrigendum EN ISO
        13485:2016/AC:2018 comply with the request.
   (9)  The harmonised standards EN ISO 11137-1:2015/A2:2019 and EN ISO 13408-2:2018
        and the corrigendum EN ISO 13485:2016/AC:2018 satisfy the requirements which
        they aim to cover and which are set out in Directive 93/42/EEC. It is therefore
        appropriate to publish the references of those standards and of the corrigendum in the
        Official Journal of the European Union.
   (10) The harmonised standard EN ISO 13408-2:2018 and the corrigendum EN ISO
        13485:2016/AC:2018 replace the harmonised standard EN ISO 13408-2:2011 and the
        corrigendum EN ISO 13485:2016/AC:2016 respectively. It is therefore necessary to
        withdraw the reference of standard EN ISO 13408-2:2011 and of corrigendum EN ISO
        13485:2016/AC:2016 from the Official Journal of the European Union.
   (11) On the basis of the request M/023 - BC/CEN/03/023/93-08 of 5 August 1993, CEN
        revised the harmonised standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN
        13976-2:2011, EN ISO 15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009,
        the references of which have been published in the Official Journal of the European
        Union5, in order to include the latest technical and scientific progress. This resulted in
        the adoption of the harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN
        ISO 15883-4:2018, EN ISO 17664:2017 and EN ISO 21987:2017.
   (12) The Commission together with CEN has assessed whether standards EN ISO
        11990:2018, EN 13976-2:2018, EN ISO 15883-4:2018, EN ISO 17664:2017 and EN
        ISO 21987:2017 comply with the request.
   (13) The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-
        4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 satisfy the requirements which
        they aim to cover and which are set out in Directive 93/42/EEC. It is therefore
        appropriate to publish the references of those standards in the Official Journal of the
        European Union.
   (14) The harmonised standards EN ISO 11990:2018, EN 13976-2:2018, EN ISO 15883-
        4:2018, EN ISO 17664:2017 and EN ISO 21987:2017 replace the harmonised
        standards EN ISO 11990-1:2004, EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO
        15883-4:2009, EN ISO 17664:2004 and EN ISO 21987:2009 respectively. It is
   4
        OJ C 389, 17.11.2017, p. 29.
   5
        OJ C 389, 17.11.2017, p. 29.
EN                                               2                                                 EN
 ---pagebreak---         therefore necessary to withdraw the references of standards EN ISO 11990-1:2004,
        EN ISO 11990-2:2004, EN 13976-2:2011, EN ISO 15883-4:2009, EN ISO
        17664:2004 and EN ISO 21987:2009 from the Official Journal of the European
        Union.
   (15) On the basis of the request M/295 of 9 September 1999, CEN drafted the new
        harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019 and EN
        ISO 81060-2:2019. The Commission together with CEN has assessed whether those
        standards comply with the request.
   (16) The harmonised standards EN 11608-7:2017, EN 13795-1:2019, EN 13795-2:2019
        and EN ISO 81060-2:2019 satisfy the requirements which they aim to cover and
        which are set out in Directive 93/42/EEC. It is therefore appropriate to publish the
        references of those standards in the Official Journal of the European Union.
   (17) On the basis of the request BC/CEN/CENELEC/09/89 of 19 December 1991, CEN
        drafted the new harmonised standard EN ISO 25424:2019. The Commission together
        with CEN has assessed whether that standard complies with the request.
   (18) The harmonised standard EN ISO 25424:2019 satisfies the requirements, which it
        aims to cover and which are set out in Directive 93/42/EEC. It is therefore appropriate
        to publish the reference of that standard in the Official Journal of the European Union.
   (19) In order to give manufacturers sufficient time to adapt their products to the revised
        specifications in standards and the corrigendum published by this Decision, it is
        necessary to defer the withdrawal of the reference of the standards and the
        corrigendum that are replaced.
   (20) In the interests of clarity and legal certainty, a complete list of references of
        harmonised standards drafted in support of Directive 93/42/EEC and satisfying the
        essential requirements they aim to cover should be published in one act. The other
        references of standards published in the Commission communication 2017/C 389/036
        should therefore also be included in this Decision. That Communication should
        therefore be repealed from the date of entry into force of this Decision. However, it
        should continue to apply in respect of the references of the standards that are
        withdrawn by this Decision, given that it is necessary to defer withdrawal of those
        references.
   (21) In accordance with the second subparagraph of Article 120(2) of Regulation (EU)
        2017/745 of the European Parliament and of the Council7, certificates issued by
        notified bodies in accordance with Directive 93/42/EEC from 25 May 2017 are to
        remain valid until the end of the period indicated on the certificate, which is not to
        exceed five years from its issuance. They are to however become void at the latest on
        27 May 2024. In accordance with the first subparagraph of Article 120(3) of
        Regulation (EU) 2017/745 a device which is a class I device pursuant to Directive
        93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May
        2020 and for which the conformity assessment procedure pursuant to this Regulation
        requires the involvement of a notified body, or which has a certificate that was issued
        in accordance with Directive 93/42/EEC and that is valid by virtue of Article 120(2),
   6
        Commission communication in the framework of the implementation of Council Directive 93/42/EEC
        concerning medical devices (2017/C 389/03) (OJ C 389, 17.11.2017, p. 29).
   7
        Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical
        devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No
        1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
EN                                                   3                                                    EN
 ---pagebreak---             may be placed on the market or put into service until 26 May 2024, provided that from
            26 May 2020 it continues to comply with Directive 93/42/EEC, and provided there are
            no significant changes in the design and intended purpose. This Decision should
            therefore apply only until 26 May 2024.
   (22)     The requirements for medical devices laid down in Directive 93/42/EEC are different
            from those laid down in Regulation (EU) 2017/745. The standards drafted in support
            of Directive 93/42/EEC should therefore not be used to demonstrate conformity with
            requirements of Regulation (EU) 2017/745.
   (23)     Compliance with a harmonised standard confers a presumption of conformity with the
            corresponding essential requirements set out in Union harmonisation legislation from
            the date of publication of the reference of such standard in the Official Journal of the
            European Union. This Decision should therefore enter into force on the date of its
            publication,
   HAS ADOPTED THIS DECISION:
                                                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, 24.3.2020
                                                  For the Commission
                                                  The President
                                                  Ursula VON DER LEYEN
EN                                                  4                                                EN
 ---documentbreak---                            EUROPEAN
                           COMMISSION
                                                   Brussels, 24.3.2020
                                                   C(2020) 1901 final
                                                   ANNEXES 1 to 2
                                       ANNEXES
                                           to the
                   Commission Implementing Decision (EU) .../... of XXX
   on the harmonised standards for medical devices drafted in support of Council Directive
                                        93/42/EEC
EN                                                                                         EN
 ---pagebreak---                                             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)
EN                                              1                                               EN
 ---pagebreak---    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
EN                                            2                                                 EN
 ---pagebreak---    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)
EN                                             3                                              EN
 ---pagebreak---    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)
EN                                            4                                                  EN
 ---pagebreak---    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)
EN                                             5                                                 EN
 ---pagebreak---    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                                              6                                                  EN
 ---pagebreak---        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
EN                                              7                                               EN
 ---pagebreak---    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
EN                                              8                                                 EN
 ---pagebreak---         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
EN                                              9                                                EN
 ---pagebreak---         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
EN                                            10                                                EN
 ---pagebreak---    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
EN                                              11                                                EN
 ---pagebreak---    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
EN                                               12                                               EN
 ---pagebreak---    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)
EN                                              13                                               EN
 ---pagebreak---    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                                              14                                               EN
 ---pagebreak---         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)
EN                                             15                                                  EN
 ---pagebreak---    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.
EN                                              16                                                 EN
 ---pagebreak---    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
EN                                             17                                             EN
 ---pagebreak---         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)
EN                                              18                                                 EN
 ---pagebreak---         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.
EN                                                19                                              EN
 ---pagebreak---    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
EN                                             20                                              EN
 ---pagebreak---         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)
EN                                            21                                               EN
 ---pagebreak---         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.
EN                                            22                                               EN
 ---pagebreak---    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)
EN                                            23                                               EN
 ---pagebreak---         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.
EN                                            24                                                EN
 ---pagebreak---    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.
EN                                            25                                                  EN
 ---pagebreak---    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)
EN                                            26                                               EN
 ---pagebreak---                                           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)
EN                                             27                                               EN
 ---pagebreak--- EN 28 EN