| Spec: | Title: |
|---|
| EN 556-1 |
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices |
| EN 556-2 |
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices |
| EN 980 |
Symbols for use in the labelling of medical devices |
| EN 1041 |
Information supplied by the manufacturer of medical devices |
| EN ISO 10993-1 |
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009) |
| EN ISO 10993-4 |
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006) |
| EN ISO 10993-5 |
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) |
| EN ISO 10993-6 |
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007) |
| EN ISO 10993-7 |
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
| EN ISO 10993-9 |
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
| EN ISO 10993-11 |
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
| EN ISO 10993-12 |
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2007) |
| EN ISO 10993-13 |
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010) |
| EN ISO 10993-16 |
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010) |
| EN ISO 10993-17 |
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) |
| EN ISO 10993-18 |
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005) |
| EN ISO 11135-1 |
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) |
| EN ISO 11137-1 |
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) |
| EN ISO 11137-2 |
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006) |
| EN ISO 11137-3 |
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006) |
| EN ISO 11140-1 |
Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) |
| EN ISO 11607-1 |
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) |
| EN ISO 11737-1 |
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) |
| EN ISO 11737-2 |
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) |
| EN ISO 13485 |
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) |
| EN 13824 |
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements |
| EN ISO 14937 |
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) |
| EN ISO 14971 |
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| EN ISO 17665-1 |
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) |
| EN 45502-1 |
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer |
| EN 45502-2-1 |
Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers) |
| EN 45502-2-2 |
Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators) |
| EN 45502-2-3 |
Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems |
| EN 60601-1 |
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance IEC 60601-1:2005 |
| EN 60601-1-6 |
Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 60601-1-6:2010 |
| EN 62304 |
Medical device software - Software life-cycle processes IEC 62304:2006 |