1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-19688-2 SANS 11607-1:2007Edition 1ISO 11607-1:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Packaging for terminally sterilized medical dev
4、ices Part 1: Requirements for materials, sterile barrier systems and packaging systems This national standard is the identical implementation of ISO 11607-1:2006 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan
5、 road groenkloof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 11607-1:2007 Edition 1 ISO 11607-1:2006 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was appro
6、ved by National Committee StanSA SC 5140.37D, Medical devices Sterilization of healthcare products, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. This part of SANS 11607 was published in May 2007. This SANS document supersedes SANS 1160
7、7:2006 (edition 1) in part. Reference numberISO 11607-1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11607-1First edition2006-04-15Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems Emballages des dispositifs mdicaux stri
8、liss au stade terminal Partie 1: Exigences relatives aux matriaux, aux systmes de barrire strile et aux systmes demballage SANS 11607-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-1:2006(E) PDF disclaimer This PDF file may c
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13、ht office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reservedSANS 11607-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of th
14、e SABS .ISO 11607-1:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms and definitions. 1 4 General requirements. 5 4.1 General. 5 4.2 Quality systems 5 4.3 Sampling 6 4.4 Test methods. 6 4.5 Documentation 6 5 Materials and
15、 preformed sterile barrier systems 7 5.1 General requirements. 7 5.2 Microbial barrier properties . 9 5.3 Compatibility with the sterilization process. 10 5.4 Compatibility with the labelling system . 10 5.5 Storage and transport 10 6 Design and development requirements for packaging systems . 11 6.
16、1 General. 11 6.2 Design 11 6.3 Packaging-system performance testing. 12 6.4 Stability testing . 12 7 Information to be provided 13 Annex A (informative) Guidance on medical packaging 14 Annex B (informative) Standardized test methods and procedures that may be used to demonstrate compliance with th
17、e requirements of this part of ISO 11607 17 Annex C (normative) Test method for resistance of impermeable materials to the passage of air 21 Bibliography . 22 SANS 11607-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-1:2006(E
18、) iv ISO 2006 All rights reservedForeword ISO (the International Organization for Standardization) 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 inte
19、rested in a subject for which a technical committee has been established has the right to be 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 Electrotechnica
20、l Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the t
21、echnical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member 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. I
22、SO shall not be held responsible for identifying any or all such patent rights. ISO 11607-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products. ISO 11607-1 and ISO 11607-2 cancel and replace ISO 11607:2003, which has been technically revised. ISO 11607 consists of
23、the following parts, under the general title Packaging for terminally sterilized medical devices: Part 1: Requirements for materials, sterile barrier systems and packaging systems Part 2: Validation requirements for forming, sealing and assembly processes SANS 11607-1:2007This s tandard may only be
24、used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-1:2006(E) ISO 2006 All rights reserved vIntroduction The process of designing and developing a packaging system for terminally sterilized medical devices is a complicated and critical endeavour. The device compo
25、nents and the packaging system should be combined to create a product that performs efficiently, safely, and effectively in the hands of the user. This part of ISO 11607 specifies the basic attributes required of materials and pre-formed systems intended for use in packaging systems for terminally s
26、terilized medical devices, while considering the wide range of potential materials, medical devices, packaging system designs, and sterilization methods. ISO 11607-2 describes the validation requirements for forming, sealing and assembly processes. This part of ISO 11607 is harmonized with EN 868-1
27、and specifies general requirements for all packaging materials whereas EN 868 Parts 2 to 10 specify particular requirements for a range of commonly used materials. Both parts of ISO 11607 were designed to meet the Essential Requirements of the European Medical Device Directives. European standards t
28、hat provide requirements for particular materials and preformed sterile barrier systems are available and known as the EN 868 series. This part of ISO 11607 has been developed as a means to show compliance with the relevant Essential Requirements of the European Directives concerning medical devices
29、. Compliance with EN 868 Parts 2 to 10 can be used to demonstrate compliance with one or more of the requirements of this part of ISO 11607. The goal of a terminally sterilized medical device packaging system is to allow sterilization, provide physical protection, maintain sterility up to the point
30、of use and allow aseptic presentation. The specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials. One significant barrier to harmonization was terminology. T
31、he terms “package”, “final package”, “final pack”, “primary pack”, and “primary package” all have different connotations around the globe, and choosing one of these terms to be the harmonized basis for this part of ISO 11607 was considered a barrier to successful completion of this document. As a re
32、sult, the term “sterile barrier system” was introduced to describe the minimum packaging required to perform the unique functions required of medical packaging: to allow sterilization, to provide an acceptable microbial barrier, and to allow for aseptic presentation. “Protective packaging” protects
33、the sterile barrier system, and together they form the packaging system. “Preformed sterile barrier systems” would include any partially assembled sterile barrier systems such as pouches, header bags or hospital packaging reels. An overview of sterile barrier systems can be found in Annex A. The ste
34、rile barrier system is essential to ensure the safety of terminally sterilized medical devices. Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of a medical device. Preformed sterile barrier systems sold to healthcare
35、 facilities for use in internal sterilization are considered as medical devices in many parts of the world. SANS 11607-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 11607-1:2007This s tandard may only be used and printed by appro
36、ved subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 11607-1:2006(E) ISO 2006 All rights reserved 1Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems 1 Scope This part of ISO 11607 specifie
37、s the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. This part of ISO 11607 is applicable to industry, to health car
38、e facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be neces
39、sary for drug/device combinations. This part of ISO 11607 does not describe a quality assurance system for control of all stages of manufacture. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition ci
40、ted applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 5636-5:2003, Paper and board Determination of air permeance and air resistance (medium range) Part 5: Gurley method 3 Terms and definitions For the purposes of this document, th
41、e following terms and definitions apply. 3.1 aseptic presentation introduction and transfer of a sterile product using conditions and procedures that exclude microbial contamination 3.2 bioburden population of viable microorganisms on or in a product or sterile barrier system ISO/TS 11139:2006 SANS
42、11607-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-1:2006(E) 2 ISO 2006 All rights reserved3.3 closure means used to close a sterile barrier system where no seal is formed NOTE For example, a sterile barrier system can be c
43、losed by a reusable container gasket or sequential folding to construct a tortuous path. 3.4 closure integrity characteristics of the closure, which ensures that it prevents the ingress of microorganisms under specified conditions NOTE See also 3.8. 3.5 expiry date indication of the date, by which t
44、he product should be used, expressed at least as the year and month 3.6 labelling written, printed, electronic or graphic matter affixed to a medical device or its packaging system; or accompanying a medical device NOTE Labelling is related to identification, technical description and use of the med
45、ical device but excludes shipping documents. 3.7 medical device any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other related article, intended by the manufacturer to be used, alone or in combination, for human beings for one o
46、r more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy or of a physiological process, supporting or
47、 sustaining life, control of conception, disinfection of medical devices, providing information for medical purposes by means of 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, immunolog
48、ical or metabolic means, but which may be assisted in its function by such means ISO 13485:2003 NOTE This definition from ISO 13485:2003 has been developed by the Global Harmonization Task Force (GHTF 2002). 3.8 microbial barrier property of the sterile barrier system that prevents the ingress of mi
49、croorganisms under specified conditions 3.9 packaging material any material used in the fabrication or sealing of a packaging system SANS 11607-1:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-1:2006(E) ISO 2006 All rights reserved 33.10 packaging system combination of the sterile barrier system and protective packaging ISO/TS 11139:2006 3.11 preformed sterile barrier system sterile barrier system (3.22) that is supplied partially assembl
