OVE/ONORM EN 60601-1 : 2014
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012)
Published date
12-01-2013
Superseded date
23-01-2023
Superseded by
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Diese ÖVE/ÖNORM gilt für die BASISSICHERHEIT und die WESENTLICHEN LEISTUNGSMERKMALE von MEDIZINISCHEN ELEKTRISCHEN GERÄTEN und MEDIZINISCHEN ELEKTRISCHEN SYSTEMEN, nachfolgend als ME-GERÄTE und ME-SYSTEME bezeichnet. Diese Norm kann auch auf Geräte angewendet werden, die zur Kompensation oder Linderung einer Krankheit, Verletzung oder Behinderung verwendet werden. In-vitro-Diagnosegeräte, die in der Normenreihe IEC 61010 (alle Teile) behandelt werden, fallen nicht unter den Begriff ME-GERÄTE. Diese Norm gilt nicht für die in der Normenreihe ISO 14708-1 behandelten implantierbaren Teile von aktiven implantierbaren medizinischen Geräten.
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| IEC 60601-1:2005+AMD1:2012 CSV | Identical |
| EN 60601-1:2006/A12:2014 | Identical |
| ONORM EN ISO 10993-17 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES |
| ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ONORM EN ISO 10993-7 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ONORM EN ISO 13857 : 2008 | SAFETY OF MACHINERY - SAFETY DISTANCES TO PREVENT HAZARD ZONES BEING REACHED BY UPPER AND LOWER LIMBS |
| ISO 23529:2016 | Rubber — General procedures for preparing and conditioning test pieces for physical test methods |
| ISO 9614-1:1993 | Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points |
| ONORM EN ISO 7010 : 2015 AMD 7 2017 | GRAPHICAL SYMBOLS - SAFETY COLOURS AND SAFETY SIGNS - REGISTERED SAFETY SIGNS (ISO 7010:2011 + AMD 1:2012 + AMD 2:2012 + AMD 3:2012 + AMD 4:2013 + AMD 5:2014) |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| ONORM EN ISO 10993-12 : 2012 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) |
| IEC 60079-5:2015 RLV | Explosive atmospheres - Part 5: Equipment protection by powder filling "q" |
| ONORM EN ISO 10993-11 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 11135-1:2007 | Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ONORM EN ISO 10993-9 : 2010 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| ONORM EN ISO 10993-18 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS |
| ONORM EN ISO 10993-5 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY |
| ONORM EN ISO 10993-15 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS |
| ISO 3746:2010 | Acoustics — Determination of sound power levels and sound energy levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane |
| ISO 10993-10:2010 | Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization |
| ISO 780:2015 | Packaging — Distribution packaging — Graphical symbols for handling and storage of packages |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ONORM EN ISO 10993-10 : 2014 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010) |
| ONORM EN ISO 10993-2 : 2006 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| IEC 60695-11-10:2013 | Fire hazard testing - Part 11-10: Test flames - 50 W horizontal and vertical flame test methods |
| IEC 60079-6:2015 | Explosive atmospheres - Part 6: Equipment protection by liquid immersion "o" |
| IEC 60079-0:2011 | Explosive atmospheres - Part 0: Equipment - General requirements |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 13857:2008 | Safety of machinery — Safety distances to prevent hazard zones being reached by upper and lower limbs |
| ISO 2878:2017 | Rubber, vulcanized or thermoplastic — Antistatic and conductive products — Determination of electrical resistance |
| ONORM EN ISO 10993-1 : 2011 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 1853:2011 | Conducting and dissipative rubbers, vulcanized or thermoplastic — Measurement of resistivity |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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