1、August 2014 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS
2、 11.040.20!%:;:“2232423www.din.deDDIN EN ISO 8871-2Elastomeric parts for parenterals and for devices for pharmaceuticaluse Part 2: Identification and characterization (ISO 8871-2:2003 +Amd.1:2005);English version EN ISO 8871-2:2004 + A1:2014,English translation of DIN EN ISO 8871-2:2014-08Elastomere
3、 Teile fr Parenteralia und fr Gerte zur pharmazeutischen Verwendung Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003 + Amd.1:2005);Englische Fassung EN ISO 8871-2:2004 + A1:2014,Englische bersetzung von DIN EN ISO 8871-2:2014-08lments en lastomre pour administration parentrale et dispo
4、sitifs usagepharmaceutique Partie 2: Identification et caractrisation (ISO 8871-2:2003 + Amd.1:2005);Version anglaise EN ISO 8871-2:2004 + A1:2014,Traduction anglaise de DIN EN ISO 8871-2:2014-08SupersedesDIN EN ISO 8871-2:2004-11www.beuth.deDocument comprises pagesIn case of doubt, the German-langu
5、age original shall be considered authoritative.3007.14 DIN EN ISO 8871-2:2014-08 2 A comma is used as the decimal marker. National foreword This document (EN ISO 8871-2:2004 + A1:2014) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equip
6、ment for medical and pharmaceutical use” (Secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Medizin (DIN Standards Committee Medical
7、 Devices), Working Committee NA 063-02-15 AA Elastomere Pharmapackmittel und zugehrige Komponenten. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. (EN) ISO 8871 consists of the following parts, under the general title Elastomeric parts for parent
8、erals and for devices for pharmaceutical use: Part 1: Extractables in aqueous autoclavates Part 2: Identification and characterization Part 3: Determination of released-particle count Part 4: Biological requirements and test methods Part 5: Functional requirements and testing The DIN Standards corre
9、sponding to the International Standards referred to in this document are as follows: ISO 48 DIN ISO 48 ISO 2781 DIN EN ISO 1183-1 ISO 8871-1 DIN EN ISO 8871-1 Amendments This standard differs from DIN EN ISO 8871-2:2004-11 as follows: a) Subclause 3.5 “Infra-red spectrum” has been revised; b) Annex
10、H (informative) “Determination of a fingerprint by surface infrared spectroscopy (ATR, attenuated total reflection)” has been added. Previous editions DIN 58367-1: 1975-08, 1984-04, 1986-04 DIN 58367-2: 1975-08, 1996-06 DIN ISO 8871: 1990-11 DIN EN ISO 8871-2: 2004-11 DIN EN ISO 8871-2:2014-08 3 Nat
11、ional Annex NA (informative) Bibliography DIN ISO 48, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD) DIN EN ISO 1183-1, Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and
12、titration method DIN EN ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates DIN EN ISO 8871-2:2014-08 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 8871-2 September 2004 + A1 J
13、une 2014 ICS 11.040.20 English Version Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003 + Amd.1:2005) lments en lastomre pour administration parentrale et dispositifs usage pharmaceutique - Partie 2: Identificatio
14、n et caractrisation (ISO 8871-2:2003 + Amd.1:2005) Elastomere Teile fr Parenteralia und fr Gerte zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003 + Amd.1:2005) EN ISO 8871-2:2004 was approved by CEN on 2004-07-15 and Amendment A1:2014 on 2014-05-24. CE
15、N 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 standards may be obtained on app
16、lication 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 notified to the CEN-CENELEC M
17、anagement 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, La
18、tvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1
19、000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 8871-2:2004 + A1:2014 EContents Page Foreword to EN ISO 8871-2:2003 3 Foreword to EN ISO 8871-2:2004/A1:2014 .3 Introduction .4 1 Scope 5 2 Normative references
20、5 3 Tests 5 3.1 General 5 3.2 Hardness .6 3.3 Density 6 3.4 Ash 6 3.5 Infra-red spectrum .6 3.6 Compression set 6 3.7 Swelling 6 3.8 Development of a fingerprint by gas chromatography 6 3.9 Detection of volatile substances by gas chromatography 7 3.10 Determination of residual moisture .7 3.11 Deter
21、mination of fingerprint by thermogravimetric analysis (TGA) .7 3.12 Determination of extractables in aqueous autoclavates .7 4 Preparation of samples for testing 7 4.1 Treatment before testing .7 4.2 Number of samples needed for the tests 8 5 Reagents and materials 8 Annex A (informative) Identifica
22、tion of elastomeric material by pyrolysis IR .9 Annex B (informative) Determination of compression set 11 Annex C (informative) Swelling behaviour in oils 13 Annex D (informative) Development of a fingerprint by gas chromatography .15 Annex E (informative) Analysis of volatile components by headspac
23、e gas chromatography .17 Annex F (informative) Determination of residual moisture .19 Annex G (informative) Determination of a fingerprint by thermal gravimetry (TG) 20 Annex H (informative) Determination of a fingerprint by surface infrared spectroscopy (ATR, attenuated total reflection) 24 Bibliog
24、raphy 26 2 EN ISO 8871-2:2004 + A1:2014 (E) DIN EN ISO 8871-2:2014-08 Foreword to EN ISO 8871-2:2003 The text of ISO 8871-2:2003 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for
25、 Standardization (ISO) and has been taken over as EN ISO 8871-2:2004 by CMC. 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 2005, and conflicting national standards shall be withdrawn at th
26、e latest by March 2005. This document supersedes EN ISO 8871:1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, Fr
27、ance, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 8871-2:2003 has been approved by CEN as EN ISO 8871-2:2004 witho
28、ut any modifications. ! Foreword to EN ISO 8871-2:2004/A1:2014 This document (EN ISO 8871-2:2004/A1:2014) has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use” in collaboration with Technical Commit
29、tee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 8871-2:2004 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2014, and conflict
30、ing national standards shall be withdrawn at the latest by December 2014. 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. According to
31、 the 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece
32、, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 8871-2:2003/Amd 1:2005 has been approved by CEN as EN ISO 8871-2
33、:2004/A1:2014 without any modification.“ 3 EN ISO 8871-2:2004 + A1:2014 (E) DIN EN ISO 8871-2:2014-08 Introduction The elastomeric parts specified in the various parts of this International Standard are produced from a material which is usually called “rubber”. However, rubber is not a unique entity
34、, since the composition of rubber materials may vary considerably. The base elastomer and the type of vulcanization have a major influence on the principle characteristics of an individual rubber material, as do additives such as fillers, softeners and pigments. These may have a significant effect o
35、n the overall properties. The effectiveness, purity, stability and safe handling of a drug preparation may be affected adversely during manufacture, storage and administration if the rubber part used has not been properly selected and validated (approved). 4 EN ISO 8871-2:2004 + A1:2014 (E) DIN EN I
36、SO 8871-2:2014-08 1 Scope This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies.
37、 The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate se
38、t of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards. 2 Normative references The following referenced documents are indispensable for the ap
39、plication 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 48:1994, Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRH
40、D) ISO 247:1990, Rubber Determination of ash ISO 2781:1988, Rubber, vulcanized Determination of density ISO 8871-1:2003, Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates 3 Tests 3.1 General Rubber is a complex material and not gene
41、rally definable. The only property which all elastomeric materials have in common is a special type of resilience or elasticity. When a strip of rubber is stretched, it will extend by up to many times its original length without breaking. On release of the stretching force, it snaps back to its orig
42、inal size and shape virtually unaltered. Similarly, one can squeeze it, twist it or distort it in any direction comparatively easily, and it will spring back again to its original shape unchanged. Owing to its three-dimensional network, achieved by chemical cross-linking of the polymer chains during
43、 vulcanization, rubber is practically insoluble in solvents such as tetrahydrofuran, although considerable reversible swelling may occur; this characteristic differentiates rubber from pseudo-elastic materials, such as poly(vinyl chloride) and certain thermoplastic elastomers. In view of the complex
44、ity of rubber, the identity of a given elastomeric material cannot be verified just by applying a single physical or chemical test, and a set of tests is needed for reliable identification. The manufacturer shall guarantee that all elastomeric parts of current supplies have been produced from the sa
45、me formulation and that they exhibit the same characteristics as the samples which have been given to the user first and the suitability of which has been proved. 5 EN ISO 8871-2:2004 + A1:2014 (E) DIN EN ISO 8871-2:2014-08 3.2 Hardness Hardness shall be determined in accordance with ISO 48. 3.3 Den
46、sity Density shall be determined in accordance with the procedure described in ISO 2781:1988, method A. 3.4 Ash The inorganic residue after combustion shall be determined as described in ISO 247:1990, method A. 3.5 Infra-red spectrum !A very simple method to create a fingerprint of a rubber material
47、 is to record an infrared (IR) spectrum. The two common methods for obtaining an IR spectrum of a rubber material are pyrolysis IR and surface IR/ATR (attenuated total reflectance)-technique. The pyrolysis IR can be obtained as described in Annex A. The surface IR/ATR can be obtained as described in
48、 Annex H. The spectra should be compared to a spectrum obtained by the same IR-method on a reference sample of the material. In practice, pyrolysis IR requires a time-consuming sample preparation and in addition needs the cautious handling of hazardous vapours and oils. In contrast to this, the surface IR/ATR offers the possibility to obtain a fingerprint from an elastomeric part with minimum or no sample preparation.“ 3.6 Compression set The compression set indicates the degree of permanent deformation r
