ISO 8836-2014 pdf free.Suction catheters for use in the respiratory tract.
ISO 8836 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.16l
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.
lSO 594-1, Conicalfittings with a 6 % (Luer) taper forsyringes, needles and certain other medical equipment — Part 1: General requirements
lSO 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:_i), Anaesthetic and respiratory equipment — Breathing sets and connectors
ISO 7000, Graphical symbols for use on equipment — Registered symbols2)
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
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.
3.1 adaptor specialized connector to establish functional continuity between otherwise disparate or incompatible components [SOURCE: ISO 4135:2001,]
3.2 connector fitting to join together two or more components [SOURCE: IS0 4135:2001,].ISO 8836 pdf free download.