Table of Codes ↑

Public Safety Standards
Republic of Ireland

In order to promote public education and public safety, equal justice for all, a better informed citizenry, the rule of law, world trade and world peace, this legal document is hereby made available on a noncommercial basis, as it is the right of all humans to know and speak the laws that govern them.

StandardYearLanguageTitleReferenceAuthority
I.S. EN 556-1 (pdf)
I.S. EN 556-1 (html)
2002EnglishSterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devicesEN 556-1Dir. 90/385/EEC
I.S. EN 556-2 (pdf)
I.S. EN 556-2 (html)
2004EnglishSterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devicesEN 556-2Dir. 90/385/EEC
I.S. EN 980 (pdf)
I.S. EN 980 (html)
2008EnglishSymbols for use in the labelling of medical devicesEN 980Dir. 90/385/EEC
I.S. EN 1041 (pdf)
I.S. EN 1041 (html)
2008EnglishInformation supplied by the manufacturer of medical devicesEN 1041Dir. 90/385/EEC
I.S. EN 45502-1 (pdf)
I.S. EN 45502-1 (html)
1998EnglishActive implantable medical devices -- Part 1: General requirements for safety, marking and information to be provided by the manufacturerEN 45502-1Dir. 90/385/EEC
I.S. EN 45502-2-1 (pdf)
I.S. EN 45502-2-1 (html)
2004EnglishActive implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)EN 45502-2-1Dir. 90/385/EEC
I.S. EN 45502-2-2 (pdf)
I.S. EN 45502-2-2 (html)
2008EnglishActive implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)EN 45502-2-2Dir. 90/385/EEC
I.S. EN 45502-2-3 (pdf)
I.S. EN 45502-2-3 (html)
2010EnglishActive implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systemsEN 45502-2-3Dir. 90/385/EEC
I.S. EN ISO 10993-1 (pdf)
I.S. EN ISO 10993-1 (html)
2009EnglishBiological evaluation of medical devices - Part 1: Evaluation and testing within a risk management processISO 10993-1 (2009)Dir. 90/385/EEC
I.S. EN ISO 10993-4 (pdf)
I.S. EN ISO 10993-4 (html)
2009EnglishBiological evaluation of medical devices - Part 4: Selection of tests for interactions with bloodISO 10993-4 (2006)Dir. 90/385/EEC
I.S. EN ISO 10993-5 (pdf)
I.S. EN ISO 10993-5 (html)
2009EnglishBiological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicityISO 10993-5 (2009)Dir. 90/385/EEC
I.S. EN ISO 10993-6 (pdf)
I.S. EN ISO 10993-6 (html)
2009EnglishBiological evaluation of medical devices - Part 6: Tests for local effects after implantationISO 10993-6 (2007)Dir. 90/385/EEC
I.S. EN ISO 10993-7 (pdf)
I.S. EN ISO 10993-7 (html)
2008EnglishBiological evaluation of medical devices - Part 7: Ethylene oxide sterilization residualsISO 10993-7 (2008)Dir. 90/385/EEC
I.S. EN ISO 10993-9 (pdf)
I.S. EN ISO 10993-9 (html)
2009EnglishBiological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation productsISO 10993-9 (2009)Dir. 90/385/EEC
I.S. EN ISO 10993-11 (pdf)
I.S. EN ISO 10993-11 (html)
2009EnglishBiological evaluation of medical devices - Part 11: Tests for systemic toxicityISO 10993-11 (2006)Dir. 90/385/EEC
I.S. EN ISO 10993-12 (pdf)
I.S. EN ISO 10993-12 (html)
2012EnglishBiological evaluation of medical devices - Part 12: Sample preparation and reference materialsISO 10993-12 (2007)Dir. 90/385/EEC
I.S. EN ISO 10993-13 (pdf)
I.S. EN ISO 10993-13 (html)
2010EnglishBiological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devicesISO 10993-13 (2010)Dir. 90/385/EEC
I.S. EN ISO 10993-16 (pdf)
I.S. EN ISO 10993-16 (html)
2010EnglishBiological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachablesISO 10993-16 (2010)Dir. 90/385/EEC
I.S. EN ISO 10993-17 (pdf)
I.S. EN ISO 10993-17 (html)
2009EnglishBiological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substancesISO 10993-17 (2002)Dir. 90/385/EEC
I.S. EN ISO 10993-18 (pdf)
I.S. EN ISO 10993-18 (html)
2009EnglishBiological evaluation of medical devices - Part 18: Chemical characterization of materialsISO 10993-18 (2005)Dir. 90/385/EEC
I.S. EN ISO 11135-1 (pdf)
I.S. EN ISO 11135-1 (html)
2007EnglishSterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11135-1 (2007)Dir. 90/385/EEC
I.S. EN ISO 11137-1 (pdf)
I.S. EN ISO 11137-1 (html)
2006EnglishSterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1 (2006)Dir. 90/385/EEC
I.S. EN ISO 11137-2 (pdf)
I.S. EN ISO 11137-2 (html)
2012EnglishSterilization of health care products - Radiation - Part 2: Establishing the sterilization doseISO 11137-2 (2012)Dir. 90/385/EEC
I.S. EN ISO 11138-2 (pdf)
I.S. EN ISO 11138-2 (html)
2009EnglishSterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processesISO 11138-2 (2006)Dir. 90/385/EEC
I.S. EN ISO 11138-3 (pdf)
I.S. EN ISO 11138-3 (html)
2009EnglishSterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processesISO 11138-3 (2006)Dir. 90/385/EEC
I.S. EN ISO 11140-1 (pdf)
I.S. EN ISO 11140-1 (html)
2009EnglishSterilization of health care products - Chemical indicators - Part 1: General requirementsISO 11140-1 (2005)Dir. 90/385/EEC
I.S. EN ISO 11607-1 (pdf)
I.S. EN ISO 11607-1 (html)
2009EnglishPackaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-1 (2006)Dir. 90/385/EEC
I.S. EN ISO 11737-1 (pdf)
I.S. EN ISO 11737-1 (html)
2006EnglishSterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on productsISO 11737-1 (2006)Dir. 90/385/EEC
I.S. EN ISO 11737-2 (pdf)
I.S. EN ISO 11737-2 (html)
2009EnglishSterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processISO 11737-2 (2009)Dir. 90/385/EEC
I.S. EN ISO 13408-1 (pdf)
I.S. EN ISO 13408-1 (html)
2011EnglishAseptic processing of health care products - Part 1: General requirementsISO 13408-1 (2008)Dir. 90/385/EEC
I.S. EN ISO 13408-2 (pdf)
I.S. EN ISO 13408-2 (html)
2011EnglishAseptic processing of health care products - Part 2: FiltrationISO 13408-2 (2003)Dir. 90/385/EEC
I.S. EN ISO 13408-3 (pdf)
I.S. EN ISO 13408-3 (html)
2011EnglishAseptic processing of health care products - Part 3: LyophilizationISO 13408-3 (2006)Dir. 90/385/EEC
I.S. EN ISO 13408-4 (pdf)
I.S. EN ISO 13408-4 (html)
2011EnglishAseptic processing of health care products - Part 4: Clean-in-place technologiesISO 13408-4 (2005)Dir. 90/385/EEC
I.S. EN ISO 13408-5 (pdf)
I.S. EN ISO 13408-5 (html)
2011EnglishAseptic processing of health care products - Part 5: Sterilization in placeISO 13408-5 (2006)Dir. 90/385/EEC
I.S. EN ISO 13408-6 (pdf)
I.S. EN ISO 13408-6 (html)
2011EnglishAseptic processing of health care products - Part 6: Isolator systemsISO 13408-6 (2005)Dir. 90/385/EEC
I.S. EN ISO 13485 (pdf)
I.S. EN ISO 13485 (html)
2012EnglishMedical devices - Quality management systems - Requirements for regulatory purposesISO 13485 (2003)Dir. 90/385/EEC
I.S. EN ISO 14155 (pdf)
I.S. EN ISO 14155 (html)
2011EnglishClinical investigation of medical devices for human subjects - Good clinical practiceISO 14155 (2011)Dir. 90/385/EEC
I.S. EN ISO 14937 (pdf)
I.S. EN ISO 14937 (html)
2009EnglishSterilization 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 devicesISO 14937 (2009)Dir. 90/385/EEC
I.S. EN ISO 14971 (pdf)
I.S. EN ISO 14971 (html)
2012EnglishMedical devices - Application of risk management to medical devicesISO 14971 (2007)Dir. 90/385/EEC
I.S. EN ISO 17665-1 (pdf)
I.S. EN ISO 17665-1 (html)
2006EnglishSterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 17665-1 (2006)Dir. 90/385/EEC
IST EN 60601-1 (pdf)2006EnglishMedical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1 (2005)MDD (93/42/EEC), AIMD (90/385/EEC)
IST EN 60601-1a (pdf)2011EnglishMedical electrical equipment - Part 1: General requirements for basic safety and essential performance (Appendix)IEC 60601-1 (2005)MDD (93/42/EEC), AIMD (90/385/EEC)
IST EN 62304 (pdf)2006EnglishMedical device software - Software life-cycle processesIEC 62304 (2006)MDD (93/42/EEC), AIMD (90/385/EEC), IVD (98/79/EC)
IST EN 10256 (pdf)2003EnglishHead and face protection for use in ice hockeyISO 10256 (2003)Directive 89/686/EEC

Last Updated: December 31, 2012


Published by Public.Resource.Org