1、November 2015 English price group 11No 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 11.080.01!%GR.“2364711www.din.d
2、eDIN EN 556-2Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices;English version EN 556-2:2015,English translation of DIN EN 556-2:2015-11Sterilisation von Medizinprodukten Anforderungen an Medizinp
3、rodukte, die als “STERIL“ gekennzeichnet werden Teil 2: Anforderungen an aseptisch hergestellte Medizinprodukte;Englische Fassung EN 556-2:2015,Englische bersetzung von DIN EN 556-2:2015-11Strilisation des dispositifs mdicaux Exigences relatives aux dispostifs mdicaux en vue dobtenir ltiquetage “STR
4、ILE“ Partie 2: Exigences pour les dispositifs mdicaux soumis un procd aseptique;Version anglaise EN 556-2:2015,Traduction anglaise de DIN EN 556-2:2015-11SupersedesDIN EN 556-2:2004-03www.beuth.deDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered au
5、thoritative.Document comprises 18 pages 10.15 DIN EN 556-2:2015-11 2 A comma is used as the decimal marker. National foreword This document (EN 556-2:2015) has been prepared by Technical Committee CEN/TC 204 “Sterilization of medical devices” (Secretariat: BSI, United Kingdom). The responsible Germa
6、n body involved in its preparation was the DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-07 AA Sterilisation von Medizinprodukten. DIN EN 556 consists of the following parts, under the general title Sterilization of medical devices Requirements for medic
7、al devices to be designated “STERILE”: Part 1: Requirements for terminally sterilized medical devices Part 2: Requirements for aseptically processed medical devices Amendments This standard differs from DIN EN 556-2:2004-03 as follows: a) normative references and the Bibliography have been updated;
8、b) terms and definitions have been aligned with ISO/TS 11139 and EN ISO 13408-7, and the terms “performance qualification”, “process simulation”, “requalification” and “validation” have been added; c) requirements (see Clause 4) have been extensively revised and the content brought in line with curr
9、ent EN ISO Standard; d) Table 1 on acceptance limits and actions for occurrence of non-sterile units in process simulations in initial performance qualification has been added; e) Table 2 on acceptance limits and actions for occurrence of non-sterile units in process simulations in periodic requalif
10、ication has been added; f) the “Z” Annexes have been revised to refect the above-mentioned changes; g) the standard has been editorially revised. Previous editions DIN EN 556-2: 2004-03 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 556-2 September 2015 ICS 11.080.01 Supersedes EN 556-2:2003En
11、glish Version Sterilization of medical devices - Requirements for medical devices to be designated STERILE“ - Part 2: Requirements for aseptically processed medical devices Strilisation des dispositifs mdicaux - Exigences relatives aux dispositifs mdicaux en vue dobtenir ltiquetage “ STRILE “ - Part
12、ie 2 : Exigences pour les dispositifs mdicaux soumis un traitement aseptiqueSterilisation von Medizinprodukten - Anforderungen an Medizinprodukte, die als STERIL gekennzeichnet werden - Teil 2: Anforderungen an aseptisch hergestellte Medizinprodukte This European Standard was approved by CEN on 24 J
13、uly 2015. 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 standards may be obt
14、ained 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 notified to the C
15、EN-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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Irelan
16、d, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre
17、: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 556-2:2015 EEN 556-2:2015 (E) 2 Contents Page European foreword 3 Introduction 4 1 Scope . 5 2 Normative references . 5 3 Terms and definition
18、s . 6 4 Requirements 8 4.1 Validation and routine control 8 4.2 Compliance 10 4.3 Documentation and records 10 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC on active implantable medical devices 11 Annex ZB (informative)
19、Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices. 12 Annex ZC (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98/79/EC on in vitro diagnostic medical devices 13 Bibliograph
20、y 15 DIN EN 556-2:2015-11 EN 556-2:2015 (E) 3 European foreword This document (EN 556-2:2015) has been prepared by Technical Committee CEN/TC 204 “Sterilization of medical devices”, the secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, eith
21、er by publication of an identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or C
22、ENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 556-2:2003. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Direc
23、tive(s). For relationship with EU Directive(s), see informative Annexes ZA, ZB and ZC, which are integral parts of this document. EN 556, Sterilization of medical devices Requirements for medical devices to be designated STERILE“, is currently composed with the following parts: Part 1: Requirements
24、for terminally sterilized medical devices; Part 2: Requirements for aseptically processed medical devices this document. The following amendments have been made in updating the document from EN 556-2:2003: a) normative references have been updated; b) terms and definitions have been aligned with ISO
25、/TS 11139 and EN ISO 13408-1; c) requirements on validation and routine control have been revised; d) Table 1 and Table 2 on acceptance limits and actions for occurrence of non-sterile units in process simulations in initial performance qualification and in periodic requalification, respectively, ha
26、ve been added; e) editorial revision according to the CEN Internal Regulations. Annexes designated informative are given only for information. In this standard Annexes ZA, ZB and ZC are informative. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the follow
27、ing 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, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, No
28、rway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. DIN EN 556-2:2015-11 EN 556-2:2015 (E) 4 Introduction Medical devices designated STERILE are prepared using appropriate and validated methods. Whenever possible, sterile medical devices ar
29、e terminally-sterilized using a properly validated and controlled sterilization process (see EN 556-1, EN ISO 11135, EN ISO 11137-1, EN ISO 14160, EN ISO 14937, EN ISO 17665-1, EN ISO 20857 and EN ISO 25424). When a medical device is intended to be sterile but cannot be terminally-sterilized, asepti
30、c processing is the method of manufacture (see EN ISO 13408-1). Aseptic processing necessitates that either: a) the entire product is sterilized and then introduced into a sterilized package; or b) components of the product are sterilized, then further processed/assembled, and the final product pack
31、ed into a sterilized package. Processing/assembly and packaging are carried out in a manner that minimizes the opportunity for items to become re-contaminated by carrying out these operations in a controlled environment in which microbial and particulate levels are maintained at or below defined lim
32、its and human intervention is minimized. NOTE EN ISO 15223-1 specifies the label applied to aseptically processed medical devices as STERILE A. DINEN 556-2:2015-11EN 556-2:2015(E)5 1 Scope This European Standard specifies the requirements for an aseptically processed medical device to be designated
33、STERILE. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is STERILE is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are
34、 specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for it
35、s application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development, validation and rout
36、ine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11137-1:2015, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013
37、) EN ISO 13408-2:2011, Aseptic processing of health care products Part 2: Filtration (ISO 13408-2:2003) EN ISO 13408-5:2011, Aseptic processing of health care products Part 5: Sterilization in place (ISO 13408-5:2006) EN ISO 13485:2012, Medical devices Quality management systems Requirements for reg
38、ulatory purposes (ISO 13485:2003) EN ISO 14160:2011, Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilizatio
39、n process for medical devices (ISO 14160:2011) EN ISO 14937:2009, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) EN ISO 17665-1:
40、2006, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006) EN ISO 20857:2013, Sterilization of health care products Dry heat Requirements for the development, valida
41、tion and routine control of a sterilization process for medical devices (ISO 20857:2010) EN ISO 25424:2011, Sterilization of medical devices Low temperature steam and formaldehyde Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2
42、009) DINEN 556-2:2015-11EN 556-2:2015 (E) 6 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 aseptic processing handling of sterile product, containers and/or devices in a controlled environment, in which the air supply, materials, equipment a
43、nd personnel are regulated to maintain sterility SOURCE: EN ISO 13408-1:2015, 3.4 3.2 bioburden population of viable microorganisms on or in product and/or sterile barrier system SOURCE: ISO/TS 11139:2006, 2.2 3.3 medical device instrument, apparatus, implement, machine, appliance, implant, in vitro
44、 reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitor
45、ing, treatment, alleviation of or compensation for an injury, investigation, replacement, modification or support of the anatomy or of a physiological process, supporting or sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means o
46、f in vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means SOURCE: EN ISO 13485:2012, 3.7 3.4 performance
47、qualification PQ process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification SOURCE: ISO/TS 11139:2006, 2.30
48、 DINEN 556-2:2015-11EN 556-2:2015(E)7 3.5 process simulation exercise that simulates the manufacturing process or portions of the process in order to demonstrate the capability of the aseptic process to prevent biological contamination SOURCE: ISO 13408-7:2012, 3.2 Note 1 to entry: Other terms for p
49、rocess simulation include media fill, simulated process fill, simulated filling operation, broth trial, broth fill. 3.6 requalification repetition of part of validation for the purpose of confirming the continued acceptability of a specified process SOURCE: ISO/TS 11139:2006, 2.40 3.7 sterility state of being free from viable micro-organisms SOURCE: ISO/TS 11139:2006, 2.45 3.8 st
