BS EN 15908:2010 pdf free download Anaesthetic and respiratory equipment — Non- interchangeable screw- threaded (NIST) low-pressure connectors for medical gases
1 Scope
1.1 This European Standard specifies requirements for connectors intended for use with medical gases.1.2This European Standard specities the dimensions and the allocation of non-interchangeable screw-threaded(NIST) connectors intended to be used at nominal operating pressures not greater than 1 400 kPa.NOTE As stated inEN ISO 5359,gas-specific quick-connectors conforming to EN ISO 9170-1 are considered as analtemative to NIST connectors.
1.3The information to be supplied by the manufacturer is excluded from the scope of this EuropeanStandard because information about the use of NIST connectors is supplied by the manufacturer of eachmedical device to which the connectors are permanently fitted.
2Normative references
The following referenced document is indispensable for the application of this document.For datedreferences,only the edition cited applies. For undated references,the latest edition of the referenceddocument (including any amendmentsy applies.
EN ISO 14971,Medical devices — Application of risk management to medical devices (ISO 14971:2007,Corrected version 2007-10-01)
3Terms and definitions
For the purposes of this document, the following terms and definitions apply.3.1
gas-specific
having characteristics which prevent interchangeability, thereby allowing assignment to only one gas serviceor vacuum service
3.2
medical gas
gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylacticpurposes, or for surgical tool applications
NOTE For the purposes of this European Standard, this term includes vacuum airand nitrogen for driving surgicaltools.
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 setof different diameters and a left-or right-hand screw thread to the mating components for each particular gas
4General requirements
4.1Safety
NIST connectors shall, when permanently fitted onto a medical device and operated in normal use andmaintained 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 14971and which are connected with their intended application, in normal condition and in single fault condition.
4.2Materials
Materials in contact with the medical gases during normal use shall be resistant to corrosion and compatiblewith oxygen, the other medical gases and their mixtures.
NOTE1 Corrosion resistance includes resistance against moisture and surrounding materials.
NOTE2 Compatibility with oxygen involves both combustibility and ease of ignition. Materials which burn in air will burnviolently in pure oxygen. Many materials which do not burn 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 materialscan be ignited by adiabatic compression produced when oxygen is rapidly introduced into a system initially at lowpressure.
NOTE3 EN ISO 15001 contains information on selection of metallic and non-metaic materials and other aspects ofcompatibility of equipment with oxygen.
4.3Design, dimensions and allocation of NIST connectors
Design and dimensions of NIST body, nipple and nut shall comply with Figures 1,2 and 3 and Tables 2, 3 and4.
Allocation of NIST connectors shall comply with Table 1.