Complete list of the Harmonized Standards for 90/385/eec
List of European Harmonized Standards For Directive 90/385/EEC, Active Implantable Medical Devices (with links to the Official English Language Edition of each)
EN-ISO-11607-1Packaging for terminally sterilized medical devices 2020/A1 EDITION. Issued: NOV. 6, 2023. 84 pages. CURRENT Show EN-ISO-11607-1 revision history |
$372.50 |
|
EN-ISO-11737-1Sterilization of health care products. Microbiological methods 2018/A1 EDITION. Issued: JUNE 18, 2021. 70 pages. CURRENT Show EN-ISO-11737-1 revision history |
$325.00 |
|
EN-ISO-11737-2Sterilization of health care products. Microbiological methods 2020 EDITION. Issued: MAY 19, 2020. 28 pages. CURRENT Show EN-ISO-11737-2 revision history |
$267.50 |
|
EN-ISO-13485Medical devices. Quality management systems. Requirements for regulatory purposes 2016/A11 EDITION. Issued: SEPT. 30, 2021. 90 pages. CURRENT Show EN-ISO-13485 revision history |
$350.00 |
|
EN-13824Sterilization of medical devices. Aseptic processing of liquid medical devices. Requirements Show EN-13824 revision history |
||
EN-ISO-14937Sterilization 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 2009 EDITION. Issued: MARCH 31, 2010. 52 pages. CURRENT Show EN-ISO-14937 revision history |
$317.50 |
|
EN-ISO-14971Medical devices. Application of risk management to medical devices 2019/A11 EDITION. Issued: DEC. 15, 2021. 56 pages. CURRENT Show EN-ISO-14971 revision history |
$325.00 |
|
EN-ISO-17665-1Sterilization of health care products. Moist heat 2006 EDITION. Issued: SEPT. 29, 2006. 52 pages. CURRENT |
$317.50 |
|
EN-45502-1Implants for surgery. Active implantable medical devices 2015 EDITION. Issued: JUNE 30, 2015. 64 pages. CURRENT Show EN-45502-1 revision history |
$317.50 |
|
EN-45502-2-1Active implantable medical devices 2003 EDITION. Issued: JAN. 20, 2004. 98 pages. CURRENT |
$342.50 |
|
EN-45502-2-2Active implantable medical devices 2008 EDITION. Issued: OCT. 31, 2008. 108 pages. CURRENT Show EN-45502-2-2 revision history |
$365.00 |
|
EN-45502-2-3Active implantable medical devices 2010 EDITION. Issued: MARCH 31, 2010. 48 pages. CURRENT |
$300.00 |
|
EN-60601-1Medical electrical equipment 2006/A2 EDITION. Issued: NOV. 2, 2021. 458 pages. CURRENT Show EN-60601-1 revision history |
$564.00 |
|
EN-60601-1-6Medical electrical equipment 2010/A2 EDITION. Issued: AUG. 13, 2021. 26 pages. CURRENT Show EN-60601-1-6 revision history |
$241.80 |
|
EN-62304Medical device software. Software life-cycle processes 2006/A1 EDITION. Issued: NOV. 1, 2015. 88 pages. CURRENT Show EN-62304 revision history |
$342.50 |