BS EN 15908-2010 pdf download.Anaesthetic and respiratory equipment Noninterchangeable screwthreaded (NIST) low-pressure connectors for medical gases.
2 Normative references
The following referenced document is 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.
EN ISO 14971, Medical devices — Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
gas-specific
having characteristics which prevent interchangeability, thereby allowing assignment to only one gas service or vacuum service
3.2
medical gas
gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic purposes, or for surgical tool applications
NOTE For the purposes of this European Standard, this term includes vacuum, air and nitrogen for dnvlng surgical tooIs
3,3
NIST connector
non-interchangeable screw-threaded connector
any of a range of male and female components intended to maintain gas-specificity by the allocation of a set of different diameters and a left-or right-hand screw thread to the mating components for each particular gas
4 General requirements
4.1 Safety
NIST connectors shall, when permanently fitted onto a medical device and operated in normal use and maintained according to the instructions of the manufacturer of the medical device, present no risks that are not reduced to an acceptable level by using risk management procedures in accordance with EN ISO 14971 and which are connected with their intended application, in normal condition and in single fault condition.
4.2 Materials
Materials in contact with the medical gases during normal use shall be resistant to corrosion and compatible with oxygen, the other medical gases and their mixtures.
NOTE 1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE 2 Compatibility with oxygen involves both combustibility and ease of ignition, Materials which bum in air will burn violently in pure oxygen. Many materials which do not bum in air will do so In pure oxygen, particularly under pressure. Similarly, materials which can be ignited In air require lower ignition energies for ignition In oxygen. Many such materials can be ignited by adiabatic compession produced Mien oxygen is rapidly introduced into a system initially at low pressure.
NOTE 3 EN ISO 15001 contains Information on selection of metallic and non-metallic materials and other aspects of compatibility of equipment with oxygen.
4.3 Design, dimensions and allocation of NIST connectors
Design and dimensions of NIST body, nipple and nut shalt comply with Figures 1, 2 and 3 and Tables 2. 3 and
4.
Allocation of NIST connectors shall comply with Table 1.BS EN 15908-2010 pdf download.