EN ISO 8871-1-2004 en Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1 Extractables in aqueous autoclavates《非肠道及制药设备用弹性件 第1部分 水蒸汽中的提取物 ISO 8871-1-2.pdf

1、BRITISH STANDARD BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates The European Standard EN ISO 8871-1:2004 has the status of a British Standard ICS 11.040.20 BS EN ISO 8871-1:2004 This British Standard was pub

2、lished under the authority of the Standards Policy and Strategy Committee on 8 September 2004 BSI 8 September 2004 ISBN 0 580 44418 X National foreword This British Standard is the official English language version of EN ISO 8871-1:2004. It is identical with ISO 8871-1:2003. Together with Parts 2 an

3、d 3, it partially supersedes BS EN ISO 8871:1997 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-re

4、ferences The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of Brit

5、ish Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; presen

6、t to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an in

7、side front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 19, the Annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments iss

8、ued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO88711 September2004 ICS11.040.20 SupersedesENISO8871:1997 Englishversion Elastomericpartsforparenteralsandfordevicesfor pharmaceuticalusePart1:Extractablesinaqueous autoclavates(ISO88711:2003) Elmentsenla

9、stomrepouradministrationparentraleet dispositifsusagepharmaceutiquePartie1:Substances extractiblesparautoclavageenmilieuaqueux(ISO8871 1:2003) ThisEuropeanStandardwasapprovedbyCENon15July2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEuro

10、pe an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlangu

11、agemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,It

12、aly,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploit

13、ationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO88711:2004:E Foreword The text of ISO 8871-1:2003 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use“ of the International Organization fo

14、r Standardization (ISO) and has been taken over as EN ISO 8871- 1:2004 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

15、the 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,

16、France, 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 8871-1:2004 has been approved by CEN as EN ISO 8871-1:2004 wit

17、hout any modifications. NOTE Normative references to International Standards are listed in annex ZA (normative). ENISO88711:2004 Reference number ISO 8871-1:2003(E)INTERNATIONAL STANDARD ISO 8871-1 First edition 2003-10-01 Elastomeric parts for parenterals and for devices for pharmaceutical use Part

18、 1: Extractables in aqueous autoclavates lments en lastomre pour administration parentrale et dispositifs usage pharmaceutique Partie 1: Substances extractibles par autoclavage en milieu aqueux ENISO88711:2004DPlcsid Fremia ihTs PDF file mya ctnoian emdebt dedyfepcaes. In ccacnadrow eitA hebods licn

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23、947 22 1 11 xaF0 947 22 14 + 9 74 E-mial coirypthgis.o gro We bwww.is.o gro Pulbisdehi n Switlrez dnaii ENISO88711:2004 iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Classification. 2 4 Requirements 2 5 Sampling 2 6 Apparatus and reagents. 3 7 Preparation of test

24、 solutions . 4 Annex A (normative) Appearance of solution . 5 Annex B (normative) Acidity or alkalinity 9 Annex C (normative) Absorbance 10 Annex D (normative) Reducing substances 11 Annex E (normative) Extractable heavy metals 12 Annex F (normative) Extractable zinc 14 Annex G (normative) Extractab

25、le ammonia. 15 Annex H (normative) Residue on evaporation 16 Annex I (normative) Volatile sulfides .17 Annex J (informative) Conductivity 18 Bibliography . 19 ENISO88711:2004iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (I

26、SO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, gov

27、ernmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC

28、 Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted 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 membe

29、r bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 8871-1 was prepared by Technical Committee ISO/TC 76, Transfusion, infus

30、ion and injection equipment for medical and pharmaceutical use. Together with the other parts (see below), this part of ISO 8871 cancels and replaces ISO 8871:1990, which has been technically revised. ISO 8871 consists of the following parts, under the general title Elastomeric parts for parenterals

31、 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 ENISO88711:2004 vIntroductio

32、n 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, since the composition of rubber materials may vary considerably. The base elastomer and the type of vulcanizati

33、on 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 on the overall properties. The effectiveness, purity, stability and safe handling of a drug preparation may be aff

34、ected adversely during manufacture, storage and administration if the rubber part used has not been properly selected and validated (approved). ENISO88711:2004INTENRATIONAL TSANDADR IS-1788 O1:(3002E)1Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aq

35、ueous autoclavates 1 Scope 1.1 This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.

36、 It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates (see Clause 4) and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant Intern

37、ational Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements. 1.2 This part of ISO 8871 is applicable for the categories of elastomeric parts given in Clause 3; specific requirements, however, are laid down in the relevant International Standards

38、dealing with the items or devices listed in Clause 3. Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time. 1.3 Compatibility studies with the intended prepar

39、ation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated re

40、ferences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 8362-2:1988, Injection containers for injectables and accessories Part 2: Closures for injection vials ISO 8362-5:1995, Injection containers for inj

41、ectables and accessories Part 5: Freeze drying closures for injection vials ISO 8536-2:2001, Infusion equipment for medical use Part 2: Closures for infusion bottles ISO 8536-6:1995, Infusion equipment for medical use Part 6: Freeze drying closures for infusion bottles ISO 11040-2:1994, Prefilled sy

42、ringes Part 2: Plungers and discs for dental local anaesthetic cartridges ISO 11040-5:2001, Prefilled syringes Part 5: Plungers for injectables ENISO88711:20042 3 Classification Elastomeric parts exist in various designs and sizes depending on the intended end-use. These parts serve different purpos

43、es depending on the item or device in which they are incorporated. Elastomeric parts have, therefore, been classified into the following categories: elastomeric parts for injection vials (see ISO 8362-2); elastomeric parts for infusion bottles (see ISO 8536-2); elastomeric parts for prefilled syring

44、es (see ISO 11040-2 and ISO 11040-5); elastomeric parts for medical devices for pharmaceutical use (excluding gloves and probes); elastomeric parts for freeze-dried products (see ISO 8362-5 and ISO 8536-6). 4 Requirements 4.1 Resistance to steam sterilization Elastomeric parts shall not lose their r

45、equired biological, chemical and physical properties after being sterilized twice in saturated steam at (121 2) C for 30 min each time. 4.2 Chemical requirements Elastomeric parts shall comply with the chemical requirements specified in Table 1. Elastomers are divided into the following types: Type

46、I elastomer: this meets the strictest requirements and is the preferred type. Type II elastomer: this does not meet these severe requirements as a result of its different chemical composition which is necessary to give the mechanical properties required for special applications (e.g. multiple pierci

47、ng). The methods to be used to determine the chemical characteristics of the elastomeric parts are specified in Annex A to Annex J. 5 Sampling Take a random sample of the elastomeric parts which is representative of each delivery, with the parts in their original state. The number of elastomeric par

48、ts taken shall be as specified in the relevant International Standards (see Clause 3). ENISO88711:2004 3Table 1 Chemical requirements for testing aqueous autoclavates Characteristic Requirements Test as described in Clause/Annex Turbidity Type l: Not more turbid than reference suspension II A.1 Type Il: Not more turbid than reference suspension III Colour Type I and II: Not more intensely coloured than reference solution GY 5A.2 Acidity/alkalinity Type I and II: u 0,3 ml so