ISO 8536-1-2011 pdf download

ISO 8536-1-2011 pdf download.Infusion equipment for medical use – Part 1: Infusion glass bottles. 5 Designation 5.1 G.n.cal An Inluslon glass bottle for medical use oytflg eath the reIrements laid down Ii this pail of ISO 0536 Is d..ignated using ti. d.ecriptor iniuon bottle fow.d by, in Ii. ord.r giv.n, a reference Is pat 01 ISO 836, the model of the nfuslon bot, me novnfrial capacity, the colour and the hy&olybc resetance contiorchestsee 8.1). EXALE I An Intusion bot li’iod.I A) 1 e nonhinal capacIty Cl 500 ml. made Cl outeea gbos (d) Cl hydrytlc riaistaice cmtia’ clasa tIC 2 complyIng a4t Pie mqierlienls lad doen ii this part Cl ISO 5036 desIgnated as letu&oa bottle 150 8536-1 – A – 500 – it – MC 2 E)(AJLE 2 An elusion boiSe (o0el C) sah a ncwnlr.aI capac*yol 500 irf, made Cl oolu1ss glass (ci) Cl hydrcaybc r.s4*aic. citan.r dsss MC 2 complyIng witi Pie mqurele.nb lad doer a this part of ISO 0536 a designeled as Infusion bottle ISO 0536-1 – C -500- ci – MC 2 5.2 LocatIon ol designation marks The d.signadon marks on the bottom, as specified a Figure 1 a), may also be Iliad .t tti. body of the bottle biA not a (tie cylindrical part The manufacture(s code can also be placed at the shoulder of the bottle If marked at the lower bottom radsis. or at the shotider. r3 the diameter at these places sliolid not exceed the diameter, S1. of the bottle The designation of hydrolytic reestance container class Is abbreiated as given in 9.1 6 Material Infusion bottles shall be constructed from a) colourless (d) or amber (by) borosPicate glass (ese ISO 4802-12010. 3.6. aid ISO 4802-22010. 36). or b) soda-lime-silica glass (see ISO 4802.1:2010.3,7. and ISO 4802.2.2010. 3.7) of the following hydrolytic resistance grain class SO 720 – HGA 1 ISO 719- HG8 3 or ISO 720- HGA 2. A change In Ut. oomposltton of the glass material or Cl the cclcx,ing asides shat be notified the usw least nine months ii advance 7 Performance Th. performance r.qu.rernertts Cl i,*aiion bottlus. audi as seed at b,ble.. sealing surface, etc.. shall comply wtth existing quality standards, e g defect evaluation lists and shell be agreed ttion between manufacturer and user. 8 RequIrements NOTE Other tetr methods mighi be required by nelionel ci regional agifebons.ISO 8536-1 pdf download.