ANSI/AAMI/ISO 8836-2015 pdf download.Suction catheters for use in the respiratory tract.
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 1 1 991 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:—0F 1 , Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7000, Graphical symbols for use on equipment — Registered symbols 2
ISO 1 0079-1 , Medical suction equipment — Part 1: Electrically powered suction equipment
ISO 1 0079-2, Medical suction equipment — Part 2: Manually powered suction equipment
ISO 1 0079-3, Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source
ISO 1 0993-1 , Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 1 1 1 35, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 1 1 1 37-1 , Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 1 1 607-1 , Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 1 1 607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ISO 1 41 55, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 1 4971 :2007, Medical devices — Application of risk management to medical devices
ISO 1 5223-1 , Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 1 5223-2, 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 1 041 , Information supplied by the manufacturer of medical devices
EN 1 5986, 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 1 4971 and the following
apply.
3.1 ADAPTOR
specialized connector to establish functional continuity between otherwise disparate or incompatible components
[ISO 41 35:2001 , 4.2.3.1 ]
3.2 CONNECTOR
fitting to join together two or more components
[ISO 41 35:2001 , 4.2.2.1 ].ANSI/AAMI/ISO 8836 pdf download.