1、BSI Standards PublicationPD CEN ISO/TS 16775:2014Packaging for terminallysterilized medical devices Guidance on the application ofISO 11607-1 and ISO 11607-2PD CEN ISO/TS 16775:2014 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN ISO/TS 16775:2014.The UK pa
2、rticipation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. User
3、s are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 74178 4ICS 11.080.30Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority o
4、f the Standards Policy and Strategy Committee on 31 May 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dTECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 16775 May 2014 ICS 11.080.30 English Version Packaging for terminally sterilized m
5、edical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO 16775:2014) Emballages des dispositifs mdicaux striliss au stade terminal - Lignes directrices relatives lapplication de lISO 11607-1 et lISO 11607-2 (ISO 16775:2014) Verpackungen fr in der Endanwendung sterilisierte Me
6、dizinprodukte - Leitfaden fr die Anwendung von ISO 11607-1 und ISO 11607-2 (ISO 16775:2014) This Technical Specification (CEN/TS) was approved by CEN on 18 February 2014 for provisional application. The period of validity of this CEN/TS is limited initially to three years. After two years the member
7、s of CEN will be requested to submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard. CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available promptly at national level i
8、n an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cypru
9、s, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United King
10、dom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS
11、 16775:2014 EPD CEN ISO/TS 16775:2014PD CEN ISO/TS 16775:2014CEN ISO/TS 16775:2014 (E) 3 Foreword This document (CEN ISO/TS 16775:2014) has been prepared by Technical Committee ISO/TC 198 “Sterilization of health care products“ in collaboration with Technical Committee CEN/TC 102 “Sterilizers for me
12、dical purposes” the secretariat of which is held by DIN. 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 the CEN-CENELEC
13、Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, I
14、celand, 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/TS 16775:2014 has been approved by CEN as CEN ISO/TS 16775:2014 without any
15、modification. PD CEN ISO/TS 16775:2014ISO/TS 16775:2014(E) ISO 2014 All rights reserved iiiContents PageForeword vIntroduction vi1 Scope . 12 Terms and definitions . 13 Guidance for health care facilities . 23.1 Test methods . 23.2 Guidance for conformance to ISO 11607-1 23.3 Guidance on conformance
16、 to ISO 11607-2, Validation requirements for forming, sealing and assembly processes . 103.4 Quality system 194 Guidance for industry 204.1 General guidance 204.2 Design inputs . 204.3 Selection and evaluation of materials 214.4 Sterile barrier system and protective packaging design (packaging syste
17、m development) . 224.5 Packaging process feasibility evaluation . 244.6 Sterile barrier system design feasibility evaluation 254.7 Validation of sterile barrier system manufacturing process 264.8 Packaging system design validation 284.9 Revalidation 29Annex A (informative) Selection, evaluation and
18、testing of packaging materials and sterile barrier systems Guidance for industry and health care facilities 31Annex B (informative) Sterilization considerations Guidance for industry and health care facilities39Annex C (informative) Examples of wrapping methods Guidance for health care facilities 47
19、Annex D (informative) Validation plan documents Guidance for health care facilities 54Annex E (informative) Installation qualification documentation Guidance for health care facilities68Annex F (informative) Operational qualification documentation Guidance for health care facilities73Annex G (inform
20、ative) Performance qualification documentation Guidance for health care facilities77Annex H (informative) Addressing worst-case requirements Guidance for industry and health care facilities81Annex I (informative) Generating a final packaging system validation protocol Guidance for industry .83Annex
21、J (informative) Design inputs Medical device attributes Guidance for industry 86Annex K (informative) Risk analysis tools Guidance for industry and health care facilities 91Annex L (informative) Considerations for sampling plans Guidance for health care facilities 93Annex M (informative) Stability t
22、esting (ISO 11607-1:2006, 6.4) Guidance for industry 95Annex N (informative) Use of the Internet Guidance for industry and health care facilities 96Annex O (informative) Test method validation Guidance for industry 97Annex P (informative) Use of contract packagers Guidance for industry and health ca
23、re facilities98PD CEN ISO/TS 16775:2014ISO/TS 16775:2014(E)iv ISO 2014 All rights reservedAnnex Q (informative) Guidance on establishing process parameters Guidance for industry .99Annex R (informative) Investigation failure Guidance for industry and health care facilities .105Annex S (informative)
24、Packaging manufacturing process and packaging system design feasibility evaluation Guidance for industry . 108Bibliography . 111PD CEN ISO/TS 16775:2014ISO/TS 16775:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO mem
25、ber 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, governmen
26、tal 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.The procedures used to develop this document and those intended for its further maintenance
27、are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is drawn
28、 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on th
29、e ISO list of patent declarations received. www.iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as we
30、ll as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 198, Sterilization of health care products. ISO 2014 All rights reserved vPD CEN ISO/
31、TS 16775:2014ISO/TS 16775:2014(E)IntroductionSterile barrier systems need to ensure the sterility of their contents until opened for use and ensure aseptic presentation.The sterile barrier system, depending on conditions of handling, distribution or storage, may provide adequate protection for the s
32、terile medical device. In circumstances where the packaged and sterilized device undergoes repeated handling, additional protective packaging may need to be combined with the sterile barrier system to create a packaging system.Each establishment should evaluate the performance of each sterile barrie
33、r system or packaging system before selection and implementation to ensure conditions for sterilization, storage, and handling can be met. Each establishment that manages sterile items should have a documented plan of education on how to store, handle and transport sterile items.Regional differences
34、 in quality management systems and other requirements exist and these might involve different approaches to human resource management. In any case however a sound education process is a key element and facilities should ensure that its personnel are aware of the relevance and importance of their pac
35、kaging and sterilization activities for the safety of the patient.ISO 11607-1 specifies the requirements for materials, sterile barrier systems, and packaging systems, including the qualification of the packaging system design and evaluation of that design, ISO 11607-2 specifies the requirements for
36、 packaging process validation. Both of these documents provide standards to ensure medical device protection, the ability to sterilize, maintenance of sterile package integrity and aseptic presentation. The scope of each of these standards applies to health care facilities and wherever medical devic
37、es are packaged and sterilized. It is recognized that the circumstances of the application of these standards will be different when they are used in a health care facility from when they are used by a medical device manufacturer or reprocessor.The conditions of use of this guidance may vary widely
38、around the world. ISO 11607-1 and ISO 11607-2 and this guidance document provide a guideline for use, subject to interpretation by circumstance and regulatory environments. In some regions of the world health care facility compliance to the series ISO 11607 is a national or regional regulatory requi
39、rement, in some regions the series ISO 11607 is considered guidance for health care facilities. For instance, it is recognized that in certain regions or regulatory applications conformance to ISO 11607-1 may be demonstrated but not conformance to ISO 11607-2, which requires process validation by th
40、e user. In other regions, where compliance to both ISO 11607-1 and ISO 11607-2 is a national regulatory requirement, this document will also provide guidance on performing validation. Clause 3 of this guidance document is applicable to health care facilities and Clause 4 is applicable to industry. F
41、urther guidance is given in Annexes A to S that may be applicable to health care facilities and/or industry, as indicated.In Europe ISO 11607-1 assists the conformity assessment procedure for manufacturers and is designed and used as a tool for demonstrating compliance with the relevant essential re
42、quirements of the Medical Device Directive. Compliance with the standard is always voluntary.At the time of publication of this document, Amendments to ISO 11607-1 and ISO 11607-2 are in the ballot process. This guidance document already considers the revised versions with the understanding that spe
43、cific references to numbering may have changed. Annex B of ISO 11607-1 on test methods has been extensively revised and should be considered when available.vi ISO 2014 All rights reservedPD CEN ISO/TS 16775:2014Packaging for terminally sterilized medical devices Guidance on the application of ISO 11
44、607-1 and ISO 11607-21 ScopeThis Technical Specification provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and/or ISO 11607-2. This is an informative document, not normative. It
45、 does not include requirements to be used as basis of regulatory inspection or certification assessment activities.The guidance can be used to better understand the requirements of ISO 11607-1 and/or ISO 11607-2 and illustrates some of the variety of methods and approaches available for meeting the
46、requirements of those International Standards. It is not required that this document be used to demonstrate compliance with them.Guidelines are given for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance o
47、n validation requirements for forming, sealing and assembly processes is also given.This Technical Specification provides information for health care facilities (see Clause 3) and for the medical devices industry (see Clause 4).It does not provide guidance for applications of packaging materials and
48、 systems after their opening. In the use of packaging for other purposes such as a “sterile field” or transport of contaminated items, other regulatory standards will apply.2 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11607-1 and ISO 11607-2 and th
49、e following apply.2.1packaging systemcombination of the sterile barrier system and protective packagingSOURCE: ISO/TS 11139:2006, 2.28Note 1 to entry: The packaging system includes the sterile barrier system and the protective packaging. However, if the sterile barrier system protects the medical device, facilitates aseptic presentation, and is resilient enough not to require additional protective packaging, the sterile barrier system would also fulfil the requirements of a packaging system. Protective packaging is
