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 978-0-626-19689-9 SANS 11607-2:2007Edition 1ISO 11607-2:2006Edition 1SOUTH AFRICAN NATIONAL STANDARD Packaging for terminally sterilized medical dev
4、ices Part 2: Validation requirements for forming, sealing and assembly processes This national standard is the identical implementation of ISO 11607-2:2006 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan road
5、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 11607-2:2007 Edition 1 ISO 11607-2:2006 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by
6、 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 11607:2006
7、 (edition 1) in part. Reference numberISO 11607-2:2006(E)ISO 2006INTERNATIONAL STANDARD ISO11607-2First edition2006-04-15Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes Emballages des dispositifs mdicaux striliss au stad
8、e terminal Partie 2: Exigences de validation pour les procds de formage, scellage et assemblage SANS 11607-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-2:2006(E) PDF disclaimer This PDF file may contain embedded typefaces.
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13、H-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 11607-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-2:2006(E)
14、 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. 4 4.1 Quality systems 4 4.2 Sampling 4 4.3 Test methods. 4 4.4 Documentation 5 5 Validation of packaging processes. 5 5.1 General. 5 5.2
15、 Installation qualification (IQ) . 6 5.3 Operational qualification (OQ). 6 5.4 Performance qualification (PQ) . 7 5.5 Formal approval of the process validation 8 5.6 Process control and monitoring . 8 5.7 Process changes and revalidation 8 6 Packaging system assembly . 8 7 Use of reusable sterile ba
16、rrier systems 9 8 Sterile fluid-path packaging. 9 Annex A (informative) Process development 10 Bibliography . 11 SANS 11607-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 11607-2:2006(E) iv ISO 2006 All rights reservedForeword ISO
17、(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 interested in a subject for which a technical comm
18、ittee 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 Electrotechnical Commission (IEC) on all matters of electrote
19、chnical 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 technical committees are circulated to the memb
20、er 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. ISO shall not be held responsible for identifyi
21、ng any or all such patent rights. ISO 11607-2 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 the following parts, under the general title P
22、ackaging 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 11607-2:2007This s tandard may only be used and printed by approved subscription and
23、freemailing clients of the SABS .ISO 11607-2:2006(E) ISO 2006 All rights reserved vIntroduction Medical devices delivered in a sterile state should be designed, manufactured and packed to ensure that they are sterile when placed on the market and remain sterile, under documented storage and transpor
24、t conditions, until the sterile barrier system is damaged or opened. Additionally, medical devices delivered in a sterile state should have been manufactured and sterilized by an appropriate, validated method. One of the most critical characteristics of a sterile barrier system and packaging system
25、for sterile medical devices is the assurance of sterility maintenance. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is attained and will remain so until opened by the users of sterile medical devices. There should be a documented p
26、rocess validation program demonstrating the efficacy and reproducibility of all sterilization and packaging processes. Along with the sterilization process, some of the packaging operations that can affect sterile barrier system integrity are forming, sealing, capping or other closure systems, cutti
27、ng and process handling. This part of ISO 11607 provides the framework of activities and requirements to develop and validate the process used to make and assemble the packaging system. ISO 11607-1 and ISO 11607-2 are designed to meet the Essential Requirements of the European Medical Device Directi
28、ves. One significant barrier to harmonization was terminology. The 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 consider
29、ed a barrier to successful completion of this document. As a result, 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 a
30、llow for aseptic presentation. “Protective packaging” protects 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. The ster
31、ile 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
32、facilities for use in internal sterilization are considered as medical devices in many parts of the world. SANS 11607-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 11607-2:2007This s tandard may only be used and printed by approv
33、ed subscription and freemailing clients of the SABS .INTERNATIONAL STANDARD ISO 11607-2:2006(E) ISO 2006 All rights reserved 1Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes 1 Scope This part of ISO 11607 specifies the r
34、equirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. This part of ISO 11607 is applicable to in
35、dustry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations. 2 Normative
36、 references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 11607-1, Packaging for terminally
37、 sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 expiry date indication of the date, by which the product should be used, expressed a
38、t least as the year and month 3.2 installation qualification IQ process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification ISO/TS 11139:2006 SANS 11607-2:2007This s tandard may only be used and printed by approved subscription an
39、d freemailing clients of the SABS .ISO 11607-2:2006(E) 2 ISO 2006 All rights reserved3.3 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 a
40、nd use of the medical device but excludes shipping documents. 3.4 operational qualification OQ process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures ISO/TS 11139:2006 3.5 packaging system co
41、mbination of the sterile barrier system and protective packaging ISO/TS 11139:2006 3.6 performance 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 predeter
42、mined criteria and thereby yields product meeting its specification ISO/TS 11139:2006 3.7 preformed sterile barrier system sterile barrier system that is supplied partially assembled for filling and final closure or sealing EXAMPLE Pouches, bags and open reusable containers ISO/TS 11139:2006 3.8 pro
43、cess development establishing the nominal values and limit(s) for critical process parameters 3.9 product result of a process ISO 9000:2000 NOTE For the purpose of sterilization standards, product is tangible and can be raw material(s), intermediate(s), sub-assembly(ies) and health care product(s).
44、ISO/TS 11139:2006 3.10 protective packaging configuration of materials designed to prevent damage to the sterile barrier system and its contents until the point of use ISO/TS 11139:2006 SANS 11607-2:2007This s tandard may only be used and printed by approved subscription and freemailing clients of t
45、he SABS .ISO 11607-2:2006(E) ISO 2006 All rights reserved 33.11 repeatability closeness of the agreement between the results of successive measurements of the same particular quantity subject to measurement (measurand) carried out under the same conditions of measurement NOTE 1 These conditions are
46、called repeatability conditions. NOTE 2 Repeatability conditions can include the following: the same measurement procedure; the same observer; the same measuring instrument, used under the same conditions; the same location; and repetition over a short period of time. NOTE 3 Repeatability may be exp
47、ressed quantitatively in terms of the dispersion characteristics of the results. NOTE 4 Adapted from International Vocabulary of Basic and General Terms in Metrology,1993, definition 3.6. 3.12 reproducibility closeness of the agreement between the results of measurements of the same particular quant
48、ity subject to measurement (measurand) carried out under changed conditions of measurement NOTE 1 A valid statement of reproducibility requires specification of the conditions changed. NOTE 2 The changed conditions may include: principle of measurement; method of measurement; observer; measuring ins
49、trument; reference standard; location; conditions of use; and time. NOTE 3 Reproducibility may be expressed quantitatively in terms of the dispersion characteristics of the results. NOTE 4 Adapted from International Vocabulary of Basic and General Terms in Metrology,1993, definition 3.7. 3.13 reusable container rigid sterile barrier system designed to be repeatedly used 3.14 sterile barrier system minimum package that prevents ingress of microorganisms and allows aseptic presentation of product
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