1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1644-2:2000 The Eur
2、opean Standard EN 1644-2:2000 has the status of a British Standard ICS 11.120.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Test methods for nonwoven compresses for medical use Part 2: Finished compressesThis British Standard, having been prepared under the direction of t
3、he Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 April 2000 BSI 04-2000 ISBN 0 580 35943 3 BS EN 1644-2:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the o
4、fficial English language version of EN 1644-2:2000. The UK participation in its preparation was entrusted by Technical Committee CH/117, Medical textiles, to Subcommittee CH/117/1, Test methods for nonwovens for use in compresses, which has the responsibility to: aid enquirers to understand the text
5、; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this subcommittee can be obt
6、ained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find”
7、facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal ob
8、ligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 13 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.CEN European Committee for Standardization Comite Europe en de
9、Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 1644-2:2000 E EUROPEAN STANDARD EN 1644-2 NORME EUROPE ENNE EUROPA ISCHE
10、 NORM January 2000 ICS 11.120.20 English version Test methods for nonwoven compresses for medical use Part 2: Finished compresses This European Standard was approved by CEN on 27 November 1999. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions f
11、or giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three officia
12、l versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Bel
13、gium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 1644-2:2000 BSI 04-2000 Foreword This European Standard has been prepared by Technical Committee CEN/TC 205, No
14、n-active medical devices, the Secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 2000, and conflicting national standards shall be withdrawn at the latest by
15、 July 2000. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands,
16、 Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Annexes A, B, C, D, E, F, G and H are normative. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definition 3 4 Test conditions 3 5 Physical properties 3 6 Chemical properties 3 Annex A (normative) Tes
17、t method for absorbent capacity 4 Annex B (normative) Test method for rate of absorption 4 Annex C (normative) Test method for constructional strength 4 Annex D (normative) Test method for bursting strength (dry and wet) 5 Annex E (normative) Test method for conformability 5 Annex F (normative) Test
18、 method for wet linting 7 Annex G (normative) Test method for dry linting 7 Annex H (normative) Test method for conditioning 12 Bibliography 13Page 3 EN 1644-2:2000 BSI 04-2000 Introduction Compresses should not constitute a hazard to health nor release, under the conditions of intended use, substan
19、ces in quantities that will produce such a hazard, before and after sterilization. The compress should be stable with or without agents which are commonly used in wound management including antiseptics and cleansing solutions. Generally, only physical and chemical tests will be necessary for routine
20、 quality control once biological test requirements have been fulfilled. If changes are made to the product, biological retesting may be necessary. NOTE 1 Specific tests for nonwovens used in the manufacture of compresses are covered in EN 1644-1:1997. NOTE 2 Biocompatibility aspects for materials us
21、ed in medical devices are covered by the EN 30993 series of standards prepared by CEN/TC 206. NOTE 3 Bioburden determination methods for medical devices are covered by the work of CEN/TC 204. 1 Scope This part of EN 1644 specifies physical and chemical tests for the evaluation of finished nonwoven c
22、ompresses. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments t
23、o or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. EN 1644-1:1997, Test methods for nonwoven compresses for medical use Part 1: Nonwovens
24、used in the manufacture of compresses. EN 29073-3, Textiles Test methods for nonwovens Part 3: Determination of tensile strength and elongation. EN ISO 3696:1995, Water for analytical laboratory use Specification and test methods. (ISO 3696:1987) 3 Definition For the purposes of this standard the fo
25、llowing definition applies. 3.1 compress piece or pieces of material(s), in any shape, form or size that is used for one or more of the following purposes: for cleansing skin or wounds; for absorbing body exudates during surgical procedures; for use with agents commonly used in wound management; to
26、support organs, tissue etc. during surgical procedures. 4 Test conditions Condition the sample and test it according to annex H (which is the same as annex A of EN 1644-1:1997). If the product is to be used sterile, the samples shall be sterilized according to the manufacturers instructions prior to
27、 testing. 5 Physical properties 5.1 Methods are given for the determination of the following properties which shall be considered: absorbent capacity: according to annex A; rate of absorption: according to annex B; construction strength: according to annex C; burst strength (dry and wet) for flat pl
28、ied compresses: according to annex D; conformability for flat compresses: according to annex E; wet linting: according to annex F; dry linting: according to annex G. NOTE In order to deal with an important property of compresses, which is their ability to cleanse wounds adequately, the inclusion of
29、“abrasiveness” among these physical properties was considered. Due to the large variety in shapes and forms, and the different ways of application, the coefficient of kinetic friction cannot reliably be determined on the final product; the coefficient determined for the surface material after final
30、treatment, if any, can give an indication. It was envisaged to adapt a kinetic friction test (used in the paper industry) in EN 1644-1:1997. However, in the absence of validation of such a test in this specific context, it was preferred not to delay the publication of the standard while undertaking
31、further research work. 5.2 Measure the tensile strength of compresses according to EN 29073-3. NOTE The tensile strength of the finished product is adequately covered by testing both the tensile strength of the material (as in EN 29073-3) and constructional strength of the finished product (as in an
32、nex C of this European Standard). 6 Chemical properties Methods are given in EN 1644-1:1997 for the determination of the following properties: water soluble substances; fluorescence; acidity/alkalinity of aqueous extract; non-polar soluble substances; surface-active substances. These properties of t
33、he compress can be determined from the results obtained on the nonwovens and other materials used in the compress, or by application of the methods in EN 1644-1:1997 to compresses, in which case adaptation of the volumes and masses specified therein is necessary. NOTE If processing the materials cha
34、nges their chemical properties, tests for chemical properties should be performed on either the processed material or the compress.Page 4 EN 1644-2:2000 BSI 04-2000 Annex A (normative) Test method for absorbent capacity A.1 Intended application and principle This test method covers the evaluation of
35、 one aspect of the behaviour of nonwoven compresses in the presence of liquids, i.e. absorbent capacity, or water-retention capacity. The absorbent capacity test measures the water retention of the compress by difference of mass before immersion of the compress in water and after immersion, draining
36、 and compression. A.2 Equipment A.2.1 Stainless steel tank. A.2.2 Stainless steel tray, having a perforated metal base which can be suspended in the stainless steel tank, permitting a wet compress laid upon its surface to drain freely through the perforations. The base is perforated with circular ho
37、les, 3 mm in diameter, evenly spaced, so that the centre of each hole is 5 mm from the centres of those adjoining it. A.2.3 Metal weight, of suitable non-corrodible material that exerts a pressure of 2 kNm 22 (20 gfcm 22 ). A.3 Procedure A.3.1 Weigh the whole compress and place it on the stainless s
38、teel tray with the surface intended for tissue or wound contact in direct contact with the perforated surface. A.3.2 Immerse the tray and material in deionized water, of grade 3 conforming to EN ISO 3696:1995, at (18 to 22)8C for 10 s. A.3.3 Transfer the tray and material to the stainless steel tank
39、 and allow the contents to drain for 10 s. A.3.4 Place the metal weight on the surface of the compress such that a force of 2 kNm 22 is applied evenly over the surface of the sample, leave for 30 s and then remove the weight carefully. A.3.5 Transfer the compress immediately to a tared dish by means
40、 of forceps, taking care not to lose any water in the process. Weigh and calculate the water-retention capacity of the compress fabric. NOTE For practical reasons, e.g. the shape or size of the compress, more than one compress can be used. A.3.6 Repeat A.3.1 to A.3.5 twice, each time on a fresh comp
41、ress. A.4 Test report Record the results expressed in grams of absorbed liquid per compress in each of the three determinations and report the mean water-retention capacity. Any deviations from the test method shall be recorded. Annex B (normative) Test method for rate of absorption B.1 Intended app
42、lication and principle This method is used to determine the rate of absorption of the compresses. A compress is lightly dropped on the surface of water contained in a container. The time for the compress to sink or to be completely wetted is a measure of the absorbency rate of the compress. B.2 Equi
43、pment B.2.1 A container, at least 15 cm high and with a diameter large enough to allow a compress to be placed flat on the water surface without it touching the sides of the container. B.2.2 Forceps. B.2.3 Stopwatch. B.3 Procedure B.3.1 Fill the container with deionized water of grade 3 conforming t
44、o EN ISO 3696:1995 at (18 to 22)8C, to a depth of approximately 10 cm. B.3.2 Using the forceps, drop the compress on the water surface, without splashing or submerging it. B.3.3 Using the stopwatch, measure the time taken in seconds for the upper surface of the compress to be completely wetted or fo
45、r the compress to sink completely below the surface of the water. B.3.4 Repeat B.3.1 to B.3.3 twice. B.4 Test report Report the results in seconds and calculate the mean of the three measurements. Any deviations from the test method shall be recorded. Annex C (normative) Test method for construction
46、al strength C.1 Intended application and principle This test is used to determine the reliability of the construction of the compress and needs only to be performed if the compress is constructed of different parts which can accidentally or intentionally come apart during the intended use in the wet
47、 and dry states. The test is based on determining the force needed to tear or separate the different parts from the compress in both wet and dry conditions. NOTE An X-ray detectable component, if present, is considered a different part. C.2 Equipment C.2.1 Equipment, as described for the rate of abs
48、orption test procedure in annex B. C.2.2 A stretch/tear (tensile strength) bench,a s specified in EN 29073-3. C.3 Procedure C.3.1 Code the separate parts of the compress as A, B, C, D etc.Page 5 EN 1644-2:2000 BSI 04-2000 C.3.2 Using the bench set to a speed of 100 mm/min, determine the forces requi
49、red to tear the compress or separate its parts. C.3.3 Perform the test at least three times for each combination of parts ( e.g. A and B, A and C, A and D, B and C, B and D, C and D) with both dry and wet samples. Wet the samples using the procedure described in the rate of absorption procedure in annex B. C.4 Test report Using a drawing of the compress, identify the different parts and list their codes. For every combination of parts, calculate the mean of the test results. Report the results of the dry and wet tests
