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Norm
ÖVE/ÖNORM EN 60601-1
Issue date: 2014 02 01
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.:2006 + Cor.:2007 + A1:2012) (english version)
Withdrawn: 2024 10 01
Publisher:
Austrian Standards International
Format:
Digital | 456 Pages
Language:
English
Currently valid:
OVE EN 60601-1
2023 01 01
Medical electrical equipment -- Part 1: General requirements for basic safety and essential perform...
Norm
OVE EN 60601-1
2023 01 01
Medical electrical equipment -- Part 1: General requirements for basic safety and essential perform...
Norm
ÖVE/ÖNORM EN 60601-1
2014 02 01
Medical electrical equipment - Part 1: General requirements for basic safety and essential performan...
Norm
↖
ÖVE/ÖNORM EN 60601-1
2007 09 01
Medical electrical equipment - Part 1: General requirements for basic safety and essential performan...
Norm
ÖVE EN 60601-1
1996 03
Medical electrical equipment - Part 1: General requirements for safety
Technische Regel
Norm
Issue date :
2010 10 22
Rubber — General procedures for preparing and conditioning test pieces for physical test methods
Norm
Issue date :
1999 03 31
Fire hazard testing Test flames -- 50 W horizontal and vertical flame test methods
Draft
Issue date :
2014 08 14
Packaging — Distribution packaging — Graphical symbols for handling and storage of packages
Norm
Issue date :
2011 08 02
Conducting and dissipative rubbers, vulcanized or thermoplastic — Measurement of resistivity
Norm
Issue date :
2011 09 12
Rubber, vulcanized or thermoplastic — Antistatic and conductive products — Determination of electrical resistance
Norm
Issue date :
2010 11 25
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
Norm
Issue date :
1993 06 03
Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points
Norm
Issue date :
2010 01 01
Acoustics - Determination of sound power levels of noise sources using sound intensity - Part 1: Measurement at discrete points (ISO 9614-1:1993)
Norm
Issue date :
2006 11 01
Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
Norm
Issue date :
1999 06 01
Packaging - Pictorial marking for handling of goods (ISO 780:1997)
Norm
Issue date :
2009 12 01
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Norm
Issue date :
2009 12 01
Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
Norm
Issue date :
2009 09 15
Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
Norm
Issue date :
2009 09 15
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
Norm
Issue date :
2009 09 15
Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
Norm
Issue date :
2013 12 15
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 + Amd 1:2013) (consolidated version)
Norm
Issue date :
2009 09 15
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
Norm
Issue date :
2006 11 01
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)
Norm
Issue date :
2009 09 15
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Norm
Issue date :
2008 08 01
Safety of machinery - Safety distances to prevent hazard zones being reached by upper and lower limbs (ISO 13857:2008)
Norm
Issue date :
2010 12 15
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008 + Cor 1:2009) (consolidated version)
Norm
Issue date :
2010 10 01
Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
Norm
Issue date :
2012 10 01
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
Norm
Issue date :
2010 06 15
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
Norm
Issue date :
2015 01 01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Norm
Issue date :
2009 08 15
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
Norm
Issue date :
2010 04 15
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
Norm
Issue date :
2011 03 01
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 3746:2010)
Norm
Issue date :
2013 03 01
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
Norm
Issue date :
2011 03 15
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009 + Cor 1:2010) (consolidated version)
Norm
Issue date :
2014 10 15
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2013)
Norm
Issue date :
2012 10 15
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
Norm
Issue date :
2014 07 01
Graphical symbols - Safety colours and safety signs - Registered safety signs (ISO 7010:2011 + Amd 1:2012 + Amd 2:2012 + Amd 3:2012) (consolidated version)
Norm
Issue date :
2015 02 15
Quantities and units - Part 1: General (ISO 80000-1:2009 + Cor 1:2011) (consolidated version)
Norm
Issue date :
2010 10 22
Rubber — General procedures for preparing and conditioning test pieces for physical test methods
Norm
Issue date :
2006 04 19
Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Norm
Issue date :
2008 03 03
Safety of machinery — Safety distances to prevent hazard zones being reached by upper and lower limbs
Norm
Issue date :
2007 02 28
Medical devices — Application of risk management to medical devices (Corrected version 2007-09)
Norm
Issue date :
2012 06 25
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
Norm
Issue date :
2006 08 17
Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Norm
Issue date :
2016 10 27
Rubber — General procedures for preparing and conditioning test pieces for physical test methods
Norm
Issue date :
2003 08 25
Fire hazard testing – Part 11-10: Test flames – 50 W horizontal and vertical flame test methods
Norm
Issue date :
1999 03 31
Fire hazard testing Test flames -- 50 W horizontal and vertical flame test methods
Norm
Issue date :
1992 11 12
SI units and recommendations for the use of their multiples and of certain other units
Norm
Issue date :
2018 07 17
Conducting and dissipative rubbers, vulcanized or thermoplastic — Measurement of resistivity
Norm
Issue date :
2017 06 12
Rubber, vulcanized or thermoplastic — Antistatic and conductive products — Determination of electrical resistance
Norm
Issue date :
1979 12 01
Rubber, vulcanized — Antistatic and conductive products for hospital use — Electrical resistance limits
Norm
Issue date :
2010 11 25
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
Norm
Issue date :
2002 06 20
Graphical symbols — Safety colours and safety signs — Part 1: Design principles for safety signs in workplaces and public areas (Corrected version 2003-12)
Norm
Issue date :
2009 05 20
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
Norm
Issue date :
2007 04 04
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Norm
Issue date :
2008 10 13
Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
Norm
Issue date :
2009 11 30
Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products
Norm
Issue date :
2010 07 27
Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
Norm
Issue date :
2006 08 15
Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
Norm
Issue date :
2012 06 29
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
Issue date :
2010 06 04
Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
Norm
Issue date :
2001 11 22
Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
Norm
Issue date :
2000 11 30
Biological evaluation of medical devices — Part 15: Identification and quantification of degradation products from metals and alloys (Corrected version 2001-03)
Norm
Issue date :
2010 02 09
Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
Norm
Issue date :
2002 11 27
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
Norm
Issue date :
2005 06 30
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Technische Regel
Issue date :
2006 05 19
Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials
Technische Regel
Issue date :
2006 08 03
Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
Norm
Issue date :
2007 04 27
Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Corrected version 2007-10)
Norm
Issue date :
2004 01 12
Graphical symbols for use on equipment — Index and synopsis
Norm
Issue date :
2011 05 27
Graphical symbols — Safety colours and safety signs — Registered safety signs
Norm
Issue date :
1993 06 03
Acoustics — Determination of sound power levels of noise sources using sound intensity — Part 1: Measurement at discrete points
Norm
Issue date :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
Issue date :
2003 10 22
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2002 10 22
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
Norm
Issue date :
2006 07 21
Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
Norm
Issue date :
2023 01 01
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance (german version)
Norm
Issue date :
2023 01 01
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance ( IEC 60601-1:2005) (english version)
