ISO 5361:2012 pdf download.Anaesthetic and respiratory equipment一Tracheal tubes and connectors.
ISO 5361 provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in ISO 5361.
Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from the scope of ISO 5361.
Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are outside the scope of this International Standard.
NOTE ISO/TR 11991, ISO 11990-1, ISO 11990-2, and ISO 14408 cover this[1ll2113ll41.
2 Normative references
The following referenced documents are indispensable for the application of this document. 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 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets ISO 7000, Graphical symbols for use on equipment — Index and synopsis1)
Iso 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for 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 14155, Clinical investigation of medical devices for human subjects — Good clinical practice ISO 14971, 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
EN 556-1:2001, Sterilization of medical devices – Requirements for medical devices to be designated USTERILE
-Part 1: Requirements for terminally sterilized medical devices
EN 980, Symbols for use in the labelling of medical devices
EN 1041, Terminology, symbols and information provided with medical devices: In formation supplied by the manufacturer of medical devices
ASTM F640-2007, Standard test methods for radiopacity for medical use
ASTM D3002-2007, Standard guide for evaluation of coatings applied to plastics
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4j35[5] and ISO 14971 and the following apply.
3.1
angle of bevel
acute angle between the plane of the bevel and the longitudinal axis of the tracheal tube at the patient end.ISO 5361 pdf download.