|
AAMI HE48 : 1993
|
HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
|
IEC 60601-2-19:2009+AMD1:2016 CSV
|
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
|
ISO 3744:2010
|
Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
|
EN 15986:2011
|
Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
|
ISO 10651-2:2004
|
Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients |
|
ISO 10651-6:2004
|
Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices |
|
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
|
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 5356-1:2015
|
Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
|
ISO 10651-4:2002
|
Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
|
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 |
|
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 |
|
ISO 5367:2014
|
Anaesthetic and respiratory equipment — Breathing sets and connectors |
|
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 |
|
ISO 10651-3:1997
|
Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators |
|
ISO 8185:2007
|
Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
|
ISO/TR 16142:2006
|
Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
|
IEC 62304:2006+AMD1:2015 CSV
|
Medical device software - Software life cycle processes |
|
ISO 14159:2002
|
Safety of machinery — Hygiene requirements for the design of machinery |
|
ISO 80369-1:2010
|
Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
|
ISO 9360-1:2000
|
Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml |
|
ISO 10780:1994
|
Stationary source emissions — Measurement of velocity and volume flowrate of gas streams in ducts |
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
|
ISO 7000:2014
|
Graphical symbols for use on equipment Registered symbols |
|
ISO 4135:2001
|
Anaesthetic and respiratory equipment Vocabulary |
|
ISO 9360-2:2001
|
Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml |
|
ISO 10524-1:2006
|
Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
|
IEC 60601-2-12:2001
|
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators |
|
ISO 594-2:1998
|
Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
|
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 594-1:1986
|
Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
|
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
|
ISO 27427:2013
|
Anaesthetic and respiratory equipment — Nebulizing systems and components |
|
ISO 7396-1:2016
|
Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |