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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS 7893 : 1997 ICS 11.120
2、.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Specification for Pressure sensitive adhesive closing and sealing tapes for use with sterilization packaging materials Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:32:08 GMT+00:00 2
3、006, Uncontrolled Copy, (c) BSI BS 7893 : 1997 This British Standard, having been prepared under the direction of the Sector Board for Materials and Chemicals, was published under the authority of the Standards Board and comes into effect on 15 October 1997 BSI 1997 The following BSI references rela
4、te to the work on this standard: Committee reference LBI/35 Draft for comment 96/121718 DC ISBN 0 580 27345 8 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee L
5、BI/35, Sterilizers, autoclaves and disinfectors, upon which the following bodies were represented: Association of British Health-care Industries Association of Clinical Pathologists British Dental Trade Association Central Sterilising Club Department of Health Health and Safety Executive Infection C
6、ontrol Nurses Association Institute of Healthcare Engineering and Estate Management Institute of Sterile Services Management Medical Sterile Products Association Public Health Laboratory Service Royal College of Pathologists Royal Pharmaceutical Society of Great Britain Society for General Microbiol
7、ogy ABHI Special Interest Section (Sterilizers and Disinfectors) The following bodies were also represented in the drafting of the standard, through subcommittees and panels: British Aluminium Foil Rollers Association European Sterilization Packaging Association (UK) Guild of Hospital Pharmacists Pa
8、per Federation of Great Britain Pira International Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:32:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7893 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover Forewordii Specification 1Scope
9、1 2References1 3Definitions1 4General system requirements1 5Packaging and labelling1 6Tape format2 7Performance2 8Shelf life3 Annexes A(normative) Method for demonstrating the shelf life of the product4 B(normative) Apparatus and exposure conditions for the determination of tape performance after pr
10、ocessing4 C(normative) Method for the determination of the width and length of the tape4 D(normative) Method for the determination of breaking strength and elongation at break4 E(normative) Method for the determination of wet breaking strength5 F(normative) Method for the determination of adhesion t
11、o steel5 G(normative) Method for the determination of adhesive transfer after processing5 H(normative) Method for the determination of the adhesion of tape to wrapping materials6 List of referencesInside back cover Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08
12、 10:32:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS 7893 : 1997 Foreword This British Standard has been prepared by Technical Committee LBI/35. It partly supersedes the Department of Health specification TSS/S/330.013. It is not intended that this British Standard should be considere
13、d an adequate substitute for all the provisions of TSS/S/330.013 and attention is drawn also to BS 7720 : 1995. Users of this British Standard are advised to consider the desirability of third party certification of product conformity to this British Standard, based on testing and continuing product
14、 surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS EN ISO 9000. Enquiries as to the availability of third party certification schemes are forwarded by BSI to the Association of British Certification Bodies. If a third party certifica
15、tion scheme does not already exist, users should consider approaching an appropriate body from the list of association members. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover,
16、 pages i and ii, pages 1 to 6, an inside back cover and a back cover. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:32:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BSI 19971 BS 7893 : 1997 Specification 1 Scope This British Standard specifies requirements
17、for packaging tapes for materials to be sterilized by steam, ethylene oxide, dry heat, irradiation or low temperature steam and formaldehyde processes. This British Standard covers tapes which have a pressure sensitive adhesive backing and is applicable to packaging tapes either with or without a st
18、erilization process indicator applied to their surface. NOTE. Conformity to this British Standard alone is not sufficient for a tape to be suitable for use in the Bowie and Dick test. Products suitable for use in the Bowie and Dick test are specified in BS 7720 and BS EN 867-3. 2 References 2.1 Norm
19、ative references This British Standard incorporates, by dated or undated reference, provisions from other publications. These normative references are made at the appropriate places in the text and the cited publications are listed on the inside back cover. For dated references, only the edition cit
20、ed applies; any subsequent amendments to or revisions of the publications apply to this British Standard only when incorporated in the reference by amendment or revision. For undated references, the latest edition of the cited publication applies, together with any amendments. 2.2 Informative refere
21、nces This British Standard refers to other publications that provide information or guidance. Editions of these publications current at the time of issue of this standard are listed on the inside back cover, but reference should be made to the latest editions. 3 Definitions 3.1 process indicator Ind
22、icator intended for use with individual packs of product to demonstrate that the pack has been exposed to the sterilization process. 3.2 breaking strength Maximum tensile force per unit width that a test piece of tape will withstand before breaking under the conditions defined in the appropriate tes
23、t method. 3.3 wet breaking strength The maximum tensile force per unit width that a test piece of tape will withstand, after soaking in water, before breaking under the conditions defined in the appropriate test method. 4 General system requirements 4.1 Documentation 4.1.1 The manufacturer shall est
24、ablish, document and maintain a formal quality system to cover all operations required by this standard. NOTE. British Standards in the BS 5750 and BS EN ISO 9000 series, BS 7501, BS 7502, BS EN 45003 and BS 7511 to BS 7514 describe requirements for quality systems for manufacture and testing. 4.1.2
25、 Records shall be maintained which ensure that, in the event of a defect arising, faulty batches can be recalled from use. 4.1.3 The manufacturing and distribution records shall be retained for a period of 5 years, or twice the declared shelf life of the product, whichever is greater. These records
26、shall be maintained in accordance with the requirements of 4.16 of BS EN ISO 9001 : 1994. 4.2 Toxicity The manufacturer shall retain documentary evidence that the tape does not release any substance in sufficient quantity to cause a health risk under normal conditions of use before, during or after
27、the sterilization process for which it is designed. 5 Packaging and labelling 5.1 The packaging for one or more rolls of tape shall ensure that the product retains its performance throughout the stated shelf life when stored in accordance with the manufacturers instructions. Conformity shall be dete
28、rmined in accordance with annex A. 5.2 The label of each package of tape and/or the information leaflet supplied with each roll and/or the technical information available upon request shall state: a) the nominal length of the tape on the roll; b) the sterilization process for which the tape is inten
29、ded and any restrictions on its use (see 7.2.3); c) the nominal width of the tape; d) any adverse effect. 5.3 Each roll of tape shall show clearly and permanently: a) the manufacturers or suppliers name; b) the batch number; c) the date of manufacture or the use by date or both. Licensed Copy: Londo
30、n South Bank University, London South Bank University, Fri Dec 08 10:32:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 BSI 1997 BS 7893 : 1997 5.4 For tapes printed with a sterilization process indicator, the process for which the indicator is intended shall be clearly marked on the inner surface o
31、f the core on which the tape is wound, in accordance with 5.4.2 of BS EN 867-1 : 1997. 5.5 The outer carton shall be labelled with the following information: a) the storage conditions; b) the batch number; c) the manufacturers or suppliers name and address; d) a description of the contents (to inclu
32、de quantity); e) the date of manufacture or use by date or both. 5.6 Where a sterilization indicator is printed on the tape the requirements for labelling specified in BS EN 867-1 shall apply in addition to those specified in 5.5. 5.7 Where a date is required on labelling or information supplied wit
33、h the product, this shall be expressed in accordance with BS EN 28601. 6 Tape format 6.1 The tape shall consist of a substrate, evenly coated on one side with a pressure sensitive adhesive not requiring moisture, heat or other special preparation prior to application. 6.2 If the tape is to be employ
34、ed as a sterilization process indicator, the substrate shall be printed on the non-adhesive coated side with a sterilization process indicator meeting the requirements of BS EN 867-2. 6.3 The tape shall be treated to permit writing in permanent ink on its surface, which shall remain legible before a
35、nd after sterilization. Marking made before processing shall remain legible after processing and during storage. Conformity shall be determined by visual examination before and after exposure to the appropriate conditions described in annex B. 6.4 The tolerance on width of tape shall be1 mm for widt
36、hs up to and including 19 mm and1.5 mm for widths greater than 19 mm. The length of tape shall be not less than the nominal length, as stated in accordance with 5.2a. Conformity shall be determined in accordance with annex C. 6.5 The tape shall be one continuous strip with not more than one join per
37、 50 m. The joins shall not impair the utility of the item. 6.6 The tape shall be uniformly and smoothly wound in rolls, with unbroken edges, adhesive side in wards, on cores of sufficient rigidity to prevent distortion under normal conditions of storage, transportation and use. 7 Performance 7.1 Gen
38、eral Where the tape is to be subjected to exposure conditions simulating processing, the conditions specified in annex B shall be used. 7.2 Breaking strength and elongation at break 7.2.1 The breaking strength of the tape before and after processing shall be not less than 65 N per 25 mm width and th
39、e elongation at break before and after processing shall be neither less than 6 % nor greater than 20 %. Conformity shall be determined in accordance with annex D. 7.2.2 The wet breaking strength of the tape shall be not less than 25 N per 25 mm width. Conformity shall be determined in accordance wit
40、h annex E. This sub-clause shall not apply to tapes designed for use in irradiation or dry heat sterilization processes. 7.2.3 For tapes for use in irradiation or dry heat conditions, the manufacturer shall assess the effect of irradiation or dry heat sterilization processes on the breaking strength
41、 of the tape and shall advise the user of any limitations in use brought about by such exposure (see 5.2b). 7.3 Adhesive properties 7.3.1 There shall be no delamination of the adhesive upon unwinding the roll of tape. Conformity shall be determined by visual examination. 7.3.2 The strength of adhesi
42、on of the tape to steel before and after processing shall be not less than 5 N per 25 mm width, when determined in accordance with annex F. 7.3.3 The tape shall not transfer excessive adhesive mass after processing, when determined in accordance with annex G. NOTE. The procedures described in annex
43、G should be carried out immediately after the completion of those described in annex F. 7.3.4 If the tape is required to adhere to a specified wrapping material, its performance before and after processing shall be determined in accordance with annex H. The arithmetic mean of the determinations shal
44、l be calculated and expressed in Newtons per 25 mm width of tape. NOTE 1. No limits on adhesive properties are specified. Sub-clause 7.3 is intended to define test methods to be employed when an adhesive property is to be determined, without defining a level of performance to be attained. NOTE 2. Wh
45、ere the adhesion of the tape is of such a strength that it damages the wrapping material, this fact should be noted with the results. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:32:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BSI 19973 BS 7893 : 1997 8 S
46、helf life Rolls of tape which have been stored in accordance with the manufacturers instructions shall meet the requirements of this standard for at least one year from the date of manufacture and for the shelf life as specified by the manufacturer. Conformity shall be determined in accordance with
47、annex A. Licensed Copy: London South Bank University, London South Bank University, Fri Dec 08 10:32:08 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 7893 : 1997 4 BSI 1997 Annexes Annex A (normative) Method for demonstrating the shelf life of the product A.1 The testing of the product for determina
48、tion of the shelf life shall be performed in accordance with a written protocol which shall be established before the commencement of the study. A.2 The samples of the product shall be stored in their normal packaging at or above the maximum temperature and relative humidity recommended for storage.
49、 These conditions shall be controlled and monitored. NOTE. Accelerated ageing conditions can be employed to establish a shelf life for the product during the initial stages of the study according to the manufacturers written procedure. A.3 All results of the storage trial shall be retained for a period of at least five years from the completion of the trial. After this period, a summary report shall be retained for as long as the product is commercially available. NOTE. Historical data can be employed to support the stated shelf life for the product. Annex B (normative)
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