BS EN ISO 08836 pdf free download

BS EN ISO 08836-2014 pdf free download.Suction catheters for use in the respiratory tract (ISO 8836:2014).
This International Standard specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract. Angled-tip suction catheters (e.g. Coudé catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of this International Standard. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this International Standard. NOTE See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway. [6]
2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable to its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
ISO 594-2, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5367:— 1) , Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7000, Graphical symbols for use on equipment — Registered symbols 2)
ISO 10079-1, Medical suction equipment — Part 1: Electrically powered suction equipment
ISO 10079-2, Medical suction equipment — Part 2: Manually powered suction equipment
ISO 10079-3, Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance
IEC 62366-1, Medical devices — Part 1: Application of usability engineering to medical devices
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices
EN 1041, Information supplied by the manufacturer of medical devices
EN 15986, Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
ASTM D3002:2007, Standard Guide for Evaluation of Coatings Applied to Plastics
ASTM F640, Standard Test Methods for Determining Radiopacity for Medical Use
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135 [1] and ISO 14971 and the following apply.
3.1adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible components
[SOURCE: ISO 4135:2001, 4.2.3.1]
3.2connector
fitting to join together two or more components
[SOURCE: ISO 4135:2001, 4.2.2.1]
3.3closed suction catheter
suction catheter enclosed within a protective sleeve and patient end adaptor that allows its use
within the airway without opening the breathing system directly to atmosphere
3.4 eye side hole near the patient end of the suction catheter
[SOURCE: ISO 4135:2001, 8.3.6].BS EN ISO 08836 pdf download.