1、BSI Standards PublicationPD ISO/TS 13004:2013Sterilization of health care products Radiation Substantiation of selected sterilization dose: Method VDmaxSDCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking per
2、mitted without license from IHS-,-,-PD ISO/TS 13004:2013 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of ISO/TS 13004:2013.The UK participation in its preparation was entrusted to Technical Committee CH/198, Sterilization of medical devices.A list of organizati
3、ons 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. Users are responsible for its correct application. The British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN
4、 978 0 580 75161 5ICS 11.080.01Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 28 February 2014.Amendments/corrigenda issued since publicationDate T e x t a f
5、f e c t e dCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 13004:2013 ISO 2013Sterilization of health care products Radiation Substantiation of selected ste
6、rilization dose: Method VDmaxSDStrilisation des produits de sant Irradiation Justification de la dose de strilisation choisie: mthode VDmaxSDTECHNICAL SPECIFICATIONISO/TS13004First edition2013-05-01Reference numberISO/TS 13004:2013(E)Copyright British Standards Institution Provided by IHS under lice
7、nse with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 13004:2013ISO/TS 13004:2013(E)ii ISO 2013 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2013All rights reserved. Unless otherwise specified, no part of this publication
8、 may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of
9、the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction
10、 or networking permitted without license from IHS-,-,-PD ISO/TS 13004:2013ISO/TS 13004:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 11.1 Inclusions . 11.2 Exclusions 11.3 Application . 12 Normative references 13 Terms and definitions . 14 Definition and mai
11、ntenance of product families for sterilization dose substantiation and sterilization dose auditing . 54.1 General . 54.2 Defining product families 54.3 Designation of product to represent a product family 64.4 Maintaining product families . 74.5 Consequence of failure of sterilization dose substanti
12、ation or sterilization dose audit . 85 Selection and testing of product for substantiating and auditing a selected sterilization dose 85.1 Nature of product . 85.2 Sample item portion (SIP) . 95.3 Manner of sampling . 105.4 Microbiological testing 115.5 Irradiation 116 Method VDSDmax Substantiation
13、of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5, or 35 kGy .116.1 Rationale 116.2 Procedure for Method VDSDmaxfor multiple production batches 126.3 Procedure for Method VDSDmaxfor a single production batch 177 Maintaining process effectiveness 217.1 General 217.2 Determination of
14、bioburden 227.3 Sterilization dose audit . 228 Tables of values for SIP equal to 1,0 VDmaxSD, SIP dose reduction factor and augmentation dose corresponding to applicable values of average bioburden for selected sterilization doses of 17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy .279 Worked examples .53
15、9.1 Substantiation of a selected sterilization dose of 17,5 kGy (SIP less than 1,0) 539.2 Substantiation of a selected sterilization dose of 30 kGy (SIP equal to 1,0) .549.3 Sterilization dose audit for a sterilization dose substantiated using Method VDmax22,5, the findings from which necessitated a
16、ugmentation of the sterilization dose 55Bibliography .57Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 13004:2013ISO/TS 13004:2013(E)ForewordISO (the Inter
17、national 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 committee has
18、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 electrotechnical st
19、andardization.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 member bodies fo
20、r voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.In other circumstances, particularly when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document:
21、 an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents a
22、n agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote.An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further three years, revised to be
23、come an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn.Attention is drawn to the possibility that some of the elements of this do
24、cument may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO/TS 13004 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.iv ISO 2013 All rights reservedCopyright British Standards Institution Provid
25、ed by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 13004:2013ISO/TS 13004:2013(E)IntroductionThis Technical Specification is intended to be used in conjunction with ISO 11137-1, Sterilization of health car
26、e products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. One of the activities encompassed within process definition in ISO 11137-1 is the option to select and substantiate a sterilization dose to be applied to health c
27、are products.ISO 11137-2 includes Method VDmaxfor the substantiation of 25 kGy as a sterilization dose (termed Method VDmax25) for product with an average bioburden less than or equal to 1 000 and Method VDmax15for the substantiation of 15 kGy as a sterilization dose for product with an average biob
28、urden less than or equal to 1,5.This Technical Specification extends the methods of selection and substantiation of a sterilization dose specified in ISO 11137-2. It provides a methodology for the substantiation of selected sterilization doses of 17,5, 20, 22,5, 27,5, 30, 32,5 and 35 kGy, each of wh
29、ich is valid only for a specified upper limit of average bioburden.NOTE Selected sterilization doses of 25 kGy and 15 kGy are not included in this Technical Specification. The seven methods in this Technical Specification follow the same technical steps as the methods given in ISO 11137-2 for select
30、ion and substantiation of sterilization doses of 25 kGy and 15 kGy. However, the descriptive text in this Technical Specification has been modified to better communicate the methods and hence the text occasionally differs from that in ISO 11137-2.The method described in this Technical Specification
31、is for substantiation of a selected sterilization dose to achieve a sterility assurance level (SAL) of 106or less at that dose, (e.g. Method VDmax20for a selected sterilization dose of 20 kGy). The application of the method is not limited by production batch size or production frequency, and the num
32、ber of product items irradiated in the verification dose experiment remains constant. The method is founded on and embodies the following three principles: existence of a direct link between the outcome of the verification dose experiment and the attainment of an SAL of 106at the selected sterilizat
33、ion dose; possession of a level of conservativeness at least equal to that of the standard distribution of resistances (SDR); for a given bioburden, use of a maximal verification dose (VDmax) corresponding to substantiation of a selected sterilization dose.This approach to sterilization dose substan
34、tiation was first outlined by Kowalski and Tallentire6and, from subsequent evaluations involving computational techniques (Kowalski, Aoshuang and Tallentire7) and field evaluations (Kowalski et al8), it was concluded that the method is soundly based. An overview of the method and aspects of putting
35、it into practice are provided in Kowalski and Tallentire.910Application of the Method VDmaxapproach to doses other than 25 kGy is discussed in Kowalski and Tallentire.1112The method described here and designated Method VDSDmaxprocedurally comprises elements that closely parallel those of dose settin
36、g Method 1 described in ISO 11137-2. One key area of difference is the number of product items used in the verification dose experiment. In the computer evaluations referred to above, changing the verification SAL value had little effect on the substantiation outcome and this finding led to a sample
37、 size of 10 product items being chosen for subsequent field evaluations and, ultimately, for inclusion in this document.Manufacturers of health care products who intend to use this specification are reminded that the requirements contained in ISO 11137 apply to the manufacture and control of product
38、ion batches destined for radiation sterilization. In particular, one requirement states that products have to be manufactured in circumstances such that the bioburden is controlled. Compliance with the requirements for controlling the quality of raw materials, the manufacturing environment, the heal
39、th, hygiene and attire of personnel and for establishing the basic properties of packaging material is essential. ISO 2013 All rights reserved vCopyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted wit
40、hout license from IHS-,-,-PD ISO/TS 13004:2013Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 13004:2013Sterilization of health care products Radiation Subs
41、tantiation of selected sterilization dose: Method VDmaxSD1 Scope1.1 InclusionsThis Technical Specification describes a method for substantiating a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5 or 35 kGy that achieves a sterility assurance level (SAL) of 106or less for radiation steri
42、lization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.NOTE Selection and substantiation of the sterilization dose is used to meet the requirements for
43、establishing the sterilization dose within process definition in ISO 11137-1.1.2 ExclusionsThis method is for the substantiation of a selected sterilization dose of 17,5, 20, 22,5, 27,5, 30, 32,5, or 35 kGy only and is not used to substantiate other sterilization doses. The method is not used for th
44、e substantiation of a selected sterilization dose if the average bioburden of the entire product item exceeds the limit specified for the selected sterilization dose (see Table 3).NOTE The methods for substantiation of selected sterilization doses of 25 kGy and 15 kGy are not included in this Techni
45、cal Specification; they are described in ISO 11137-2.1.3 ApplicationIf the decision is made to use this method of sterilization dose establishment, the method is to be followed according to the requirements (shall) and guidance (should) stipulated herein.2 Normative referencesThe following reference
46、d 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 11137-1:2006, Sterilization of health care products Radiation Part 1:
47、 Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11737-1, Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on productsISO 11737-2, Sterilization of medical devices Microbiol
48、ogical methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process3 Terms and definitionsFor the purposes of this document, the following abbreviations, terms and definitions apply.TECHNICAL SPECIFICATION ISO/TS 13004:2013(E) ISO 2013 All rights reserved 1Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Not for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD ISO/TS 13004:2013ISO/TS 13004:2013(E)3.1batchdefined qua
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