Document ID: 02021D1195-20220107
Language: ENG

02021D1195 — EN — 07.01.2022 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>COMMISSION IMPLEMENTING DECISION (EU) 2021/1195</p><p>of 19&#160;July 2021</p><p><a>on the harmonised standards for<span>in vitro</span> diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council</a></p><p>(OJ L 258 20.7.2021, p. 50)</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) 2022/15&#160;of 6&#160;January 2022</a></p></td><td><p>&#160;&#160;L&#160;4</p></td><td><p>16</p></td><td><p>7.1.2022</p></td></tr></table>
COMMISSION IMPLEMENTING DECISION (EU) 2021/1195
of 19 July 2021
on the harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Article 1
The references of harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 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 11135:2014</p><p>Sterilization of health-care products &#8211; Ethylene oxide &#8211; 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>2.</p></td><td><p>EN ISO 11137-1:2015</p><p>Sterilization of health care products &#8211; Radiation &#8211; 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>3.</p></td><td><p>EN ISO 11737-2:2020</p><p>Sterilization of health care products &#8211; Microbiological methods &#8211; 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>4.</p></td><td><p>EN ISO 25424:2019</p><p>Sterilization of health care products &#8211; Low temperature steam and formaldehyde &#8211; 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>5.</p></td><td><p>EN ISO 11737-1:2018</p><p>Sterilization of health care products &#8211; Microbiological methods &#8211; 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>6.</p></td><td><p>EN ISO 13408-6:2021</p><p>Aseptic processing of health care products &#8211; Part 6: Isolator systems (ISO 13408-6:2021)</p></td></tr><tr><td><p>7.</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/A11:2021</p></td></tr><tr><td><p>8.</p></td><td><p>EN ISO 15223-1:2021</p><p>Medical devices &#8211; Symbols to be used with information to be supplied by the manufacturer &#8211; Part 1: General requirements (ISO 15223-1:2021)</p></td></tr><tr><td><p>9.</p></td><td><p>EN ISO 17511:2021</p><p><span>In vitro</span> diagnostic medical devices &#8211; Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)</p></td></tr></tbody></table>