EN ISO 8536-1-2011 en Infusion equipment for medical use - Part 1 Infusion glass bottles《医疗用输液设备 第1部分 玻璃输液瓶》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 8536-1:2011Infusion equipment for medicalusePart 1: Infusion glass bottles (ISO8536-1:2011)BS EN ISO 8536-1:2011 BRITISH STANDARDNational forewordThis British Standard

2、is the UK implementation of EN ISO 8536-1:2011. It supersedes BS EN ISO 8536-1:2008 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This publ

3、ication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. BSI 2011ISBN 978 0 580 70688 2ICS 11.040.20Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the

4、 authority of the Standards Policy and Strategy Committee on 30 September 2011.Amendments issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8536-1 September 2011 ICS 11.040.20 Supersedes EN ISO 8536-1:2008English Version Infusion equipment f

5、or medical use - Part 1: Infusion glass bottles (ISO 8536-1:2011) Matriel de perfusion usage mdical - Partie 1: Flacons en verre pour perfusion (ISO 8536-1:2011) Infusionsgerte zur medizinischen Verwendung - Teil 1: Infusionsflaschen aus Glas (ISO 8536-1:2011) This European Standard was approved by

6、CEN on 31 August 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standar

7、ds may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and noti

8、fied to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuani

9、a, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN

10、All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8536-1:2011: EBS EN ISO 8536-1:2011EN ISO 8536-1:2011 (E) 3 Foreword This document (EN ISO 8536-1:2011) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and i

11、njection, and blood processing equipment for medical and pharmaceutical use“. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2012, and conflicting national standards shall be withdrawn at t

12、he latest by March 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 8536-1:2008. According to the

13、 CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,

14、 Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 8536-1:2011 has been approved by CEN as a EN ISO 8536-1:2011 without any modification. BS EN ISO 8536-1:2011ISO 853

15、6-1:2011(E) ISO 2011 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each membe

16、r body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Elec

17、trotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopt

18、ed by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of paten

19、t rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8536-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. This fourth edition cancels and replaces the th

20、ird edition (ISO 8536-1:2006), of which it constitutes a minor revision. The principle changes to the third edition are the updating of normative references to ISO 4802-1 and ISO 4802-2, and the addition of a note at the start of Clause 8. ISO 8536 consists of the following parts, under the general

21、title Infusion equipment for medical use: Part 1: Infusion glass bottles Part 2: Closures for infusion bottles Part 3: Aluminium caps for infusion bottles Part 4: Infusion sets for single use, gravity feed Part 5: Burette infusion sets for single use, gravity feed Part 6: Freeze drying closures for

22、infusion bottles Part 7: Caps made of aluminium-plastics combinations for infusion bottles Part 8: Infusion equipment for use with pressure infusion apparatus Part 9: Fluid lines for use with pressure infusion equipment Part 10: Accessories for fluid lines for use with pressure infusion equipment Pa

23、rt 11: Infusion filters for use with pressure infusion equipment Part 12: Check valves BS EN ISO 8536-1:2011ISO 8536-1:2011(E) iv ISO 2011 All rights reservedIntroduction Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they are administered to th

24、e patient. Due to the direct contact between infusion solution and the primary container components and in view of the extended storage periods, it is essential to avoid possible interactions in order to guarantee the patients safety. Adequate means to achieve this goal include the proper selection

25、of the primary packaging materials, the choice of suitable package design and the availability of specific criteria and methods for testing of individual container systems. BS EN ISO 8536-1:2011INTERNATIONAL STANDARD ISO 8536-1:2011(E) ISO 2011 All rights reserved 1Infusion equipment for medical use

26、 Part 1: Infusion glass bottles 1 Scope This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use. 2 Normative references The following referenced

27、documents are 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. ISO 719:1985, Glass Hydrolytic resistance of glass grains at 98 C Method o

28、f test and classification ISO 720:1985, Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 4802-1:2010, Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO 4802-2:2010, G

29、lassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7458, Glass containers Internal pressure resistance Test methods ISO 7459, Glass containers Thermal shock resistance and thermal shock endurance Test methods

30、 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 4802-1 and ISO 4802-2 apply. BS EN ISO 8536-1:2011ISO 8536-1:2011(E) 2 ISO 2011 All rights reserved4 Dimensions The dimensions of the infusion glass bottle shall meet the requirements of Figure 1 and T

31、ables 1, 2 and 3. Dimensions in millimetres a) General description Figure 1 Infusion glass bottle, showing three typical neck finishes (continued) BS EN ISO 8536-1:2011ISO 8536-1:2011(E) ISO 2011 All rights reserved 3Dimensions in millimetres b) Model A: Infusion bottle with 32 mm neck finish c) Mod

32、el B: Infusion bottle with 28 mm neck finish d) Model C: Infusion bottle with 29 mm neck finish Key 1 ISO logo (optional) 2 bottom surface 3 designation of hydrolytic resistance container class (see 9.1) 4 manufacturers code/designation of mould 5 manufacturers trade mark 6 graduation mark NOTE The

33、marks (optional) or other markings in accordance with the view from below can be placed on the bottom or at the bottom radius, r2, of the infusion bottle. The drawing represents a typical example. aBottom surface may be granular. Figure 1 Infusion glass bottle, showing three typical neck finishes BS

34、 EN ISO 8536-1:2011ISO 8536-1:2011(E) 4 ISO 2011 All rights reservedTable 1 Dimensions and capacity of infusion glass bottles with 32 mm neck finish (model A) Dimensions in millimetres Nominal capacity Approximate brimful capacity aad1d2h1h2h3r1r2r3r4ml ml tol. tol. tol. 50 100 125 250 500 1 000 68

35、128 147 297 584 1 120 5 5 5 8 8 15 1 1,3 1,3 1,6 1,9 3 46 49 54,4 68 86 95 0,8 0,8 0,8 1 1,2 1,5 37 39 38,9 48,9 61,5 69,6 68 104 98 125 147 225 0,7 0,8 0,8 1 1 1,3 58 94 88 114,5137 215 36,5 68,5 63 78 93,4 148 2 3 4,5 7 8 8,5 12 12 20 32 32 55 20,525 17 28 27 52 8 8 12 12 12 22 aThe tolerance a of

36、 the perpendicularity (defined as in ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom part and the axis of the bottle at the upper edge of the flange.Table 2 Dimensions and capacity of infusion glass bottles with 28 mm neck finish (model B) Dimensions in mill

37、imetres Nominal capacity Approximate brimful capacity aad1d2h1h2h3r1r2r3r4ml ml tol. tol. tol. 50 100 125 250 500 1 000 68 128 147 300 584 1 120 5 5 5 8 8 15 1 1,3 1,3 1,6 1,9 3 46 49 54,4 68 86 95 0,8 0,8 0,8 1 1,2 1,5 37 39 38,9 48,9 61,5 69,6 68,7 104,798,7 125 147,7225 0,7 0,8 0,8 1 1 1,3 60,5 9

38、6,5 90,5 117,5139,5216,837 69 62,5 78 93,4 148 2 3 4,5 7 8 8,5 12 12 20 32 32 55 20 25 17 28 27 52 8 8 8 12 13 15 aThe tolerance a of the perpendicularity (defined as in ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom part and the axis of the bottle at the u

39、pper edge of the flange.Table 3 Dimensions and capacity of infusion glass bottles with 29 mm neck finish (model C) Dimensions in millimetres Nominal capacity Approximate brimful capacity aad1d2h1h2h3r1r2r3r4ml ml tol. tol. tol. 50 100 125 250 500 1 000 68 128 147 300 572 1 120 5 5 5 8 8 15 1 1,3 1,3

40、 1,6 1,9 3 46 49 54,4 68 86 95 0,8 0,8 0,8 1 1,2 1,5 37 39 38,9 48,9 61,5 69,6 68 104 98,7 125 147 224,10,7 0,8 0,8 1 1 1,3 60,4 96,4 91,1 117,4139,4216,837,5 68,5 63,7 78 93,4 147,42 3 4,5 7 8 8,5 12 12 20 32 32 55 20,525 17 28 27 52 8 8 10 10 12 15 aThe tolerance a of the perpendicularity (defined

41、 as in ISO 1101) is a limit for the deviation of the plumb-line through the centre of the bottom part and the axis of the bottle at the upper edge of the flange.BS EN ISO 8536-1:2011ISO 8536-1:2011(E) ISO 2011 All rights reserved 55 Designation 5.1 General An infusion glass bottle for medical use co

42、mplying with the requirements laid down in this part of ISO 8536 is designated using the descriptor “Infusion bottle” followed by, in the order given, a reference to this part of ISO 8536, the model of the infusion bottle, the nominal capacity, the colour and the hydrolytic resistance container clas

43、s (see 8.1). EXAMPLE 1 An infusion bottle (model A) with a nominal capacity of 500 ml, made of colourless glass (cl) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows: Infusion bottle ISO 8536-1 A 500 cl HC 2 EXA

44、MPLE 2 An infusion bottle (model C) with a nominal capacity of 500 ml, made of colourless glass (cl) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows: Infusion bottle ISO 8536-1 C 500 cl HC 2 5.2 Location of des

45、ignation marks The designation marks on the bottom, as specified in Figure 1 a), may also be fixed at the body of the bottle but not at the cylindrical part. The manufacturers code can also be placed at the shoulder of the bottle. If marked at the lower bottom radius, r2, or at the shoulder, r3, the

46、 diameter at these places should not exceed the diameter, d1, of the bottle. The designation of hydrolytic resistance container class is abbreviated as given in 9.1. 6 Material Infusion bottles shall be constructed from a) colourless (cl) or amber (br) borosilicate glass (see ISO 4802-1:2010, 3.6, a

47、nd ISO 4802-2:2010, 3.6), 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: ISO 720 HGA 1; ISO 719 HGB 3 or ISO 720 HGA 2. A change in the composition of the glass material or of the colouring oxides shall be notifie

48、d to the user at least nine months in advance. 7 Performance The performance requirements of infusion bottles, such as seed or bubbles, sealing surface, etc., shall comply with existing quality standards, e.g. defect evaluation lists and shall be agreed upon between manufacturer and user. 8 Requirem

49、ents NOTE Other test methods might be required by national or regional regulations. BS EN ISO 8536-1:2011ISO 8536-1:2011(E) 6 ISO 2011 All rights reserved8.1 Hydrolytic resistance When tested in accordance with ISO 4802-1 or ISO 4802-2, the hydrolytic resistance of the internal surface of the bottles shall comply with the requirements for one of the following hydrolytic resistance cont