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12/30244415 DC : DRAFT APR 2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

BS ISO 27427 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - NEBULIZING SYSTEMS AND COMPONENTS

Published date

23-11-2012

Superseded date

28-02-2014

Superseded by

BS ISO 27427:2013

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BS ISO 27427

Committee
CH/121/5
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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ENV 737-6:2003 Medical gas pipeline systems - Part 6: Dimensions and allocation of probes for terminal units for compressed medical gases and vacuum
ISO 80601-2-13:2011 Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
ISO 9276-1:1998 Representation of results of particle size analysis — Part 1: Graphical representation
ISO 14160:2011 Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
ISO 15002:2008 Flow-metering devices for connection to terminal units of medical gas pipeline systems
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 11737-2:2009 Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006 Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products
ISO 15001:2010 Anaesthetic and respiratory equipment — Compatibility with oxygen
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
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ISO 14937:2009 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/TR 14969:2004 Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
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
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
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
ISO 80601-2-12:2011 Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
ISO 8185:2007 Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
ISO 10524-3:2005 Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
EN 15908:2010 Anaesthetic and respiratory equipment - Non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
ISO 10993-1:2009 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements
NFPA 53M : 1990 FIRE HAZARDS IN OXYGEN-ENRICHED ATMOSPHERES
CGA V 5 : 2008(R2013) DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS)
ISO 11607:2003 Packaging for terminally sterilized medical devices
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 5361:2016 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
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ISO 14971:2007 Medical devices — Application of risk management to medical devices
ISO 10524-1:2006 Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
EN 13544-2:2002+A1:2009 Respiratory therapy equipment - Part 2: Tubing and connectors
ISO 9276-2:2014 Representation of results of particle size analysis — Part 2: Calculation of average particle sizes/diameters and moments from particle size distributions
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
ISO 15223:2000 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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