BS EN 15908:2010 pdf download
BS EN 15908:2010 pdf download.Anaesthetic and respiratory equipment – Non-
interchangeable screw- threaded (NIST) low-pressure connectors for medical gases.
NOTE As stated wi EN ISO 5359, gas.specific quick-connectors oonlomiing to EN ISO 9170-1 are considered as au alternative to NIST connectors.
1.3 The information to be supplied by the manufacturer is excluded from the scope of this European Standard because information about me use of NIST connectors is supplied by the manufacturer of each medical device to which the connectors are permanently fitted.
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 — App1ication ci risk management to medical devices (ISO 149712007. Corrected vers.iobrt 2007- tO-Of)
3 Terms 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 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 ol this European Sandard, this term wckides vacuum, air and nitrogen for dflvlng surgical tools.
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 combusttility and ease of ignition. Materials which bum in air will bum violentty in pure oxygen. Many matenals which do not bum in a— will do so in pure oxygen, particularly under pressure. Similarly, materials wtcl’i can be ignited in air reiire lower ignition energies for ignition in oxygen. Many such materials can be ignited by adiabatic compression produced Mien oxygen s rapidly introduced into a system irxtially at low pressure.
NOTE 3 EN ISO 15001 contains inlormation on setection of metallic and non.metallic materials and other aspects ci oompatibdity of equipment with oxygen.
4.3 Design, dimensions and allocation of NIST connectors
Design and dimensions of NIST body. nipple and nut shall comply with Figures I. 2 and 3 and Tables 2, 3 and 4.
Allocation of NIST connectors shall comply with Table 1.
5 Marking
The connectors shall be durably and legibly marked with the symbol of the relevant gas in accordance with
Table 5.
NOTE
In addition to the symbol, the name of the gas may be used.
The test for the durabilityt of markings is given in Clause 6.
The marking shall be legible to a person having visual acuity (corrected it necessary) of 1 standing 0,5 m from
the connector at an iluminance ol 215 lux.
6 Test for durability of markings
Rub the markings by hand, without undue pressure, first for 15 s with a cloth rag soaked with disiled water, then for 15s with a cloth rag soaked with methylated spirit and then for 15s with a cloth rag soaked with isopropyl alcohol. Carry out these tests at ambient temperature. Verifty that the markings are still legible.
