Document ID: 02021D1182-20220517
Language: ENG

02021D1182 — EN — 17.05.2022 — 002.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION IMPLEMENTING DECISION (EU) 2021/1182</p><p>of 16&#160;July 2021</p><p><a>on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council</a></p><p>(OJ L 256 19.7.2021, p. 100)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>COMMISSION IMPLEMENTING DECISION (EU) 2022/6&#160;of 4&#160;January 2022</a></p></td><td><p>&#160;&#160;L&#160;1</p></td><td><p>11</p></td><td><p>5.1.2022</p></td></tr><tr><td><p><a>&#9658;M2</a></p></td><td><p><a>COMMISSION IMPLEMENTING DECISION (EU) 2022/757&#160;of 11&#160;May 2022</a></p></td><td><p>&#160;&#160;L&#160;138</p></td><td><p>27</p></td><td><p>17.5.2022</p></td></tr></table>
COMMISSION IMPLEMENTING DECISION (EU) 2021/1182
of 16 July 2021
on the harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 of the European Parliament and of the Council
Article 1
The references of harmonised standards for medical devices drafted in support of Regulation (EU) 2017/745 and listed in the Annex to this Decision are hereby published in the Official Journal of the European Union .
Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
ANNEX
<table><col/><col/><tbody><tr><td><p>No</p></td><td><p>Reference of the standard</p></td></tr><tr><td><p>1.</p></td><td><p>EN ISO 10993-23:2021</p><p>Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)</p></td></tr><tr><td><p>2.</p></td><td><p>EN ISO 11135:2014</p><p>Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)</p><p>EN ISO 11135:2014/A1:2019</p></td></tr><tr><td><p>3.</p></td><td><p>EN ISO 11137-1:2015</p><p>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)</p><p>EN ISO 11137-1:2015/A2:2019</p></td></tr><tr><td><p>4.</p></td><td><p>EN ISO 11737-2:2020</p><p>Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)</p></td></tr><tr><td><p>5.</p></td><td><p>EN ISO 25424:2019</p><p>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)</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p>6.</p></td><td><p>EN ISO 10993-9:2021</p><p>Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)</p></td></tr><tr><td><p>7.</p></td><td><p>EN ISO 10993-12:2021</p><p>Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)</p></td></tr><tr><td><p>8.</p></td><td><p>EN ISO 11737-1:2018</p><p>Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)</p><p>EN ISO 11737-1:2018/A1:2021</p></td></tr><tr><td><p>9.</p></td><td><p>EN ISO 13408-6:2021</p><p>Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)</p></td></tr><tr><td><p><a>&#9660;M2</a></p></td></tr><tr><td><p>10.</p></td><td><p>EN ISO 13485:2016</p><p>Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes (ISO 13485:2016)</p><p>EN ISO 13485:2016/AC:2018</p><p>EN ISO 13485:2016/A11:2021</p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p>11.</p></td><td><p>EN ISO 14160:2021</p><p>Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)</p></td></tr><tr><td><p>12.</p></td><td><p>EN ISO 15223-1:2021</p><p>Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)</p></td></tr><tr><td><p>13.</p></td><td><p>EN ISO 17664-1:2021</p><p>Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)</p></td></tr><tr><td><p>14.</p></td><td><p>EN IEC 60601-2-83:2020</p><p>Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment</p><p>EN IEC 60601-2-83:2020/A11:2021</p></td></tr><tr><td><p><a>&#9660;M2</a></p></td></tr><tr><td><p>15.</p></td><td><p>EN 285:2015+A1:2021</p><p>Sterilization &#8211; Steam sterilizers &#8211; Large sterilizers</p></td></tr><tr><td><p>16.</p></td><td><p>EN ISO 14971:2019</p><p>Medical devices &#8211; Application of risk management to medical devices (ISO 14971:2019)</p><p>EN ISO 14971:2019/A11:2021</p></td></tr></tbody></table>