1、BSI Standards Publication PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2PD CEN ISO/TS 16775:2014 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of CEN ISO/TS 16775:2014. Th
2、e UK participation 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 contr
3、act. Users are responsible for its correct application. The British Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 74178 4 ICS 11.080.30 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under t
4、he authority of the Standards Policy and Strategy Committee on 31 May 2014. Amendments/corrigenda issued since publication Date T e x t a f f e c t e d TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 16775 May 2014 ICS 11.080.30 English Version Packaging for termin
5、ally sterilized medical 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
6、 sterilisierte Medizinprodukte - 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
7、 years the members 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
8、 national level in 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, Bulgari
9、a, Croatia, Cyprus, 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, Turke
10、y and United Kingdom. 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. Re
11、f. No. CEN ISO/TS 16775:2014 E PD CEN ISO/TS 16775:2014PD CEN ISO/TS 16775:2014 CEN 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
12、“Sterilizers for medical 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
13、to the CEN-CENELEC 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,
14、 Greece, 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/TS 16775:2014 has been approved by CEN as CEN ISO/TS 1677
15、5:2014 without any modification. PD CEN ISO/TS 16775:2014ISO/TS 16775:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword v Introduction vi 1 Scope . 1 2 T erms and definitions . 1 3 Guidance for health care facilities . 2 3.1 Test methods . 2 3.2 Guidance for conformance to ISO 11607-1
16、2 3.3 Guidance on conformance to ISO 11607-2, Validation requirements for forming, sealing and assembly processes .10 3.4 Quality system 19 4 Guidance for industry 20 4.1 General guidance 20 4.2 Design inputs .20 4.3 Selection and evaluation of materials 21 4.4 Sterile barrier system and protective
17、packaging design (packaging system development) .22 4.5 Packaging process feasibility evaluation .24 4.6 Sterile barrier system design feasibility evaluation 25 4.7 Validation of sterile barrier system manufacturing process 26 4.8 Packaging system design validation 28 4.9 Revalidation 29 Annex A (in
18、formative) Selection, evaluation and testing of packaging materials and sterile barrier systems Guidance for industry and health care facilities 31 Annex B (informative) Sterilization considerations Guidance for industry and health care facilities39 Annex C (informative) Examples of wrapping methods
19、 Guidance for health care facilities 47 Annex D (informative) Validation plan documents Guidance for health care facilities 54 Annex E (informative) Installation qualification documentation Guidanc e for health care facilities68 Annex F (informative) Oper ational qualification documentation Guidanc
20、e for health care facilities73 Annex G (informative) P erformanc e qualification documentation Guidanc e for health care facilities77 Annex H (informative) Addressing worst-case requirements Guidance for industry and health care facilities81 Annex I (informative) Gener ating a final packaging s y st
21、 em v alidation pr ot oc ol Guidanc e for industry .83 Annex J (informative) Design inputs Medical device attributes Guidance for industry 86 Annex K (informative) Risk analysis tools Guidance for industry and health care facilities 91 Annex L (informative) Considerations for sampling plans Guidance
22、 for health care facilities 93 Annex M (informative) Stability testing (ISO 11607-1:2006, 6.4) Guidance for industry 95 Annex N (informative) Use of the Internet Guidance for industry and health care facilities 96 Annex O (informative) Test method validation Guidance for industry 97 Annex P (informa
23、tive) Use of contract packagers Guidance for industry and health care facilities98PD CEN ISO/TS 16775:2014ISO/TS 16775:2014(E)iv ISO 2014 All rights reserved Annex Q (informative) Guidance on establishing process parameters Guidance for industry .99 Annex R (informative) Investigation failure Guidan
24、ce for industry and health care facilities .105 Annex S (informative) Packaging manufacturing process and packaging system design feasibility evaluation Guidance for industry .108 Bibliography .111PD CEN ISO/TS 16775:2014ISO/TS 16775:2014(E) Foreword ISO (the International Organization for Standardi
25、zation) 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 member body interested in a subject for which a technical committee has been established has the right to b
26、e 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 Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used
27、to develop this document and those intended for its further maintenance 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
28、the ISO/IEC Directives, Part 2. www.iso.org/directives 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. Details of any patent rights identified during
29、 the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any 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
30、 ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information The committee responsible for this document is ISO/TC 198, Ster
31、ilization of health care products. ISO 2014 All rights reserved vPD CEN ISO/TS 16775:2014ISO/TS 16775:2014(E) Introduction Sterile 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
32、of handling, distribution or storage, may provide adequate protection for the sterile 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 s
33、ystem. Each establishment should evaluate the performance of each sterile barrier 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 ed
34、ucation on how to store, handle and transport sterile items. Regional differences 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
35、 ensure that its personnel are aware of the relevance and importance of their packaging 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 syste
36、m design and evaluation of that design, ISO 11607-2 specifies the requirements for 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 ea
37、ch of these standards applies to health care facilities and wherever medical devices 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 m
38、anufacturer or reprocessor. The conditions of use of this guidance may vary widely 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 fac
39、ility compliance to the series ISO 11607 is a national or regional regulatory requirement, 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 demon
40、strated but not conformance to ISO 11607-2, which requires process validation by the 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 documen
41、t is applicable to health care facilities and Clause 4 is applicable to industry. Further 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 des
42、igned and used as a tool for demonstrating compliance with the relevant essential requirements 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 gui
43、dance document already considers the revised versions with the understanding that specific 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 16775:2014Pack
44、aging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607- 2 1 Scope This 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 requiremen
45、ts of ISO 11607-1 and/or ISO 11607-2. This is an informative document, not normative. It 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
46、 and illustrates some of the variety of methods and approaches available for meeting the 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, pr
47、eformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on 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 indus
48、try (see Clause 4). It does not provide guidance for applications of packaging materials and 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 T erms a nd definiti ons For the
49、 purposes of this document, the terms and definitions given in ISO 11607-1 and ISO 11607-2 and the following apply. 2.1 packaging system combination of the sterile barrier system and protective packaging SOURCE: ISO/TS 11139:2006, 2.28 Note 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
