1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1644-1 : 1997 The E
2、uropean Standard EN 1644-1 : 1997 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 1. Nonwovens used in the manufacture of compressesBS EN 1644-1 : 1997 This British Sta
3、ndard, having been prepared under the direction of the Materials and Chemicals Sector Board, was published under the authority of the Standards Board and comes into effect on 15 August 1997 BSI 1997 The following BSI references relate to the work on this standard: Committee reference TCI/24 Draft fo
4、r comment 94/108987 DC ISBN 0 580 27934 0 Amendments issued since publication Amd. No. Date Text affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee TCI/24, Physical testing of textiles, upon which the following bodi
5、es were represented: Association of Consulting Scientists Association of Suppliers to the British Clothing Industry British Apparel and Textile Confederation British Measurement and Testing Association British Polyolefin Textiles Association British Retail Consortium British Textile Machinery Associ
6、ation British Textile Technology Group British Throwsters Association Furniture Industry Research Association International Wool Secretariat Ministry of Defence Royal Pharmaceutical Society of Great Britain SATRA Footwear Technology Centre Soap and Detergent Industry Association Society of Dyers and
7、 Colourists Textile Finishers Association Textile Institute United Kingdom Accreditation Service The following bodies were also represented in the drafting of the standard, through subcommittees and panels: Department of Health European Sterilization Packaging Association (UK) Guild of Hospital Phar
8、macists Institute of Sterile Services Management Medical Sterile Products Association Surgical Dressings Manufacturers AssociationBS EN 1644-1 : 1997 BSI 1997 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Text of EN 1644-1 3ii BSI 1997 BS EN 1644-1 : 1997
9、National foreword This British Standard has been prepared by Technical Committee TCI/24, and is the English language version of EN 1644-1 : 1997 Test methods for nonwoven compresses for medical use Part 1: Nonwovens used in the manufacture of compresses, published by the European Committee for Stand
10、ardization (CEN). Cross-references Publication referred to Corresponding British Standard EN 29073-3 : 1992 BS EN 29073 Methods of test for nonwovens Part 3 : 1992 Determination of tensile strength and elongation ISO 3696 : 1995 BS EN ISO 3696 : 1995 Water for analytical laboratory use. Specificatio
11、n and test methods 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, pages i and ii, the EN title page, pages 2 to 8, an inside back cover and a back cover.CEN European Committe
12、e for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 Copyright reserved to CEN members Ref. No. EN 1644-1 : 1997 E EUROPEAN STANDARD EN 1644-1 NORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS 11.
13、120.20 Descriptors: Medical equipment, bandages, materials, nonwoven fabrics, manufacturing, physical tests, chemical tests, estimation, characteristics, testing conditions, conditioning English version Test methods for nonwoven compresses for medical use Part 1: Nonwovens used in the manufacture of
14、 compresses Me thodes dessai pour compresses en nontisse a usage me dical Partie 1: Nontisse s utilise s pour la fabrication des compresses Pru fverfahren fu r medizinische Vliesstoffkompressen Teil 1: Vliesstoffe zur Herstellung von Kompressen This European Standard was approved by CEN on 1997-01-0
15、5. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for 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 o
16、n application to the Central Secretariat or to any CEN member. This European Standard exists in three official 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 Secretaria
17、t has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 1644-1 : 1997 BSI
18、1997 Foreword This European Standard has been prepared by Technical Committee CEN/TC 205, Non-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
19、 latest by August 1997, and conflicting national standards shall be withdrawn at the latest by August 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Fin
20、land, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, 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 cond
21、itions 3 5 Physical properties 3 6 Chemical properties 3 Annexes A (normative) Test method for conditioning 4 B (normative) Test method for determination of liquid absorbency time 4 C (normative) Test method for determination of liquid absorptive capacity 5 D (normative) Test method for determinatio
22、n of water soluble substances 6 E (normative) Test method for determination of fluorescence 6 F (normative) Test method for determination of acidity or alkalinity of aqueous extracts 7 G (normative) Test method for determination of substances soluble in non-polar solvents 7 H (normative) Test method
23、 for determination of surface-active substances 8Page 3 EN 1644-1 : 1997 BSI 1997 Introduction Nonwovens used for the manufacture of compresses should not constitute a hazard to health nor release under the conditions of intended use substances in quantities that will produce such a hazard, before a
24、nd after sterilization. The nonwoven should be stable with or without agents which are commonly used in wound management including antiseptics and cleaning solutions. Generally, only physical and chemical tests will be necessary for routine quality control once biological test requirements have been
25、 fulfilled. If changes are made to the nonwoven, biological retesting may be necessary. NOTE 1. Biocompatibility aspects for materials used in medical devices are covered by the EN 30993 Series of Standards prepared by CEN/TC 206. NOTE 2. Specific tests for finished compresses are covered in Part 2
26、of this European Standard. 1 Scope This Part of EN 1644 specifies physical and chemical test methods for the evaluation of nonwovens used as materials for compresses for medical use. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publi
27、cations. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revisio
28、n. For undated references the latest edition of the publication referred to applies. EN 29073-3 : 1992 Textiles Test methods for nonwovens Part 3: Determination of tensile strength and elongation ISO 565 : 1990 Test sieves Metal wire cloth, perforated metal plate and electroformed sheet Nominal size
29、s of openings ISO 3696 Water for analytical laboratory use Specification and test methods 3 Definition For the purposes of this standard the following 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: f
30、or cleansing skin or wounds; for absorbing body exudates during surgical procedures; for use with agents commonly used in wound management; to support organs, tissue, etc. during surgical procedures. 4 Test conditions Condition the sample and carry out tests under the conditions given in annex A. 5
31、Physical properties 5.1 Methods are given for determination of the following properties: liquid absorbency time: according to annex B; liquid absorptive capacity: according to annex C. 5.2 Measure the tensile strength of nonwovens according to EN 29073-3. NOTE. In order to deal with an important pro
32、perty of compresses, which is their ability adequately to cleanse wounds, the inclusion of abrasiveness among these physical properties was considered. It was envisaged to adapt a kinetic friction test (used in the paper industry) to this particular situation. However, in the absence of validation o
33、f such a test in this specific context, it was preferred not to delay the publication of the standard while undertaking further research work. 6 Chemical properties Methods are given for determination of the following properties: water soluble substances: according to annex D; fluorescence: accordin
34、g to annex E; acidity/alkalinity of aqueous extract: according to annex F; non-polar soluble substances: according to annex G; surface-active substances: according to annex H. NOTE. Results of tests on nonwovens are not necessarily comparable with the results of similar tests performed on gauze: som
35、e tests usually performed on gauze have been found irrelevant for nonwovens and are therefore not listed here.Page 4 EN 1644-1 : 1997 BSI 1997 Annex A (normative) Test method for conditioning A.1 Principle The object of this procedure is to specify the conditioning atmosphere and the method of condi
36、tioning nonwovens before and during testing. A.2 Conditioning atmosphere A.2.1 Temperature: (20 2) C. A.2.2 Relative humidity: (65 5) % r.h. A.3 Equipment A.3.1 Test chamber and measuring instrumentation, provided with automatic equipment for bringing the air to conditions of relative humidity and t
37、emperature given in A.2 and so circulating it that the conditions at all relevant points are uniformly maintained. NOTE. It is recommended that a recording hygrometer, periodically checked by a standard method (e.g. with wet and dry bulb thermometers), be kept in the test chamber to allow the air co
38、nditions to be checked. A.4 Procedure A.4.1 Preliminary treatment The equilibrium moisture content of a nonwoven is achieved by absorption. Hold test specimens at (20 to 35) % relative humidity and not more than 40 C until the test specimen is in a state to absorb water from the atmosphere specified
39、 in A.2 (24 h will usually suffice). This preconditioning can be omitted where it is demonstrated that to do so will not lead to unacceptable errors. A.4.2 Conditioning A.4.2.1 Place the test specimen in the conditioning atmosphere. A.4.2.2 Suspend or support the test specimen so that the conditioni
40、ng atmosphere has free access to its whole surface. A.4.2.3 Weigh the test specimen at intervals of not less than 2 h. A.4.2.4 Retain the test specimen in the conditioning atmosphere until the two last weighings do not differ by more than 0,25 % of the total mass of the test specimen. A.4.3 Testing
41、Unless otherwise specified, carry out all tests under the conditions given in A.2. Annex B (normative) Test method for determination of liquid absorbency time B.1 Principle This test method evaluates the liquid absorbency time of nonwovens, i.e. the time required for a test specimen of nonwoven to b
42、ecome completely wetted by the test liquid and imbibe test liquid into its interior structure. The liquid absorbency time test measures the time required for the complete wetting of a test specimen (of mass 5 g) loosely rolled into a cylindrical wire basket (of mass 3 g) and dropped onto the surface
43、 of the liquid from a height of 25 mm. In this method the liquid comes into contact with all surfaces of the test specimen. B.2 Equipment B.2.1 Cylindrical wire basket, open at one end, of height (80 1) mm, diameter (50 1) mm, mass (3 0,1) g, and constructed of suitable gauge wire to achieve a mass
44、of 3 g (e.g. 0,5 mm diameter stainless steel wire) and having a mesh size of approximately 20 mm3 20 mm. B.2.2 Container for liquid. B.2.3 Stop-watch. B.2.4 Test liquid, of known surface tension. Unless otherwise specified, distilled or deionized water of grade 3 conforming with ISO 3696. B.3 Proced
45、ure B.3.1 Either: a) cut five test specimens in the machine direction of width (76 1) mm and of sufficient length such that they each weigh (5 0,1) g. Space these strips equally across the sheet of nonwoven; or b) if the nonwoven is produced in insufficient width to allow a test specimen of 76 mm wi
46、dth to be taken, cut test specimens of the maximum width possible such that they each weigh (5 0,1) g. B.3.2 Condition the test specimens and carry out the test under conditions according to annex A. B.3.3 Loosely roll a test specimen and place it in the wire basket (see B.2.1). B.3.4 Drop the baske
47、t, on its side, from a height of approximately 25 mm from the liquid surface, into a container (see B.2.2) of test liquid (see B.2.4) at room temperature, starting the stop-watch (see B.2.3) when the basket enters the liquid.Page 5 EN 1644-1 : 1997 BSI 1997 B.3.5 Record the time taken for the basket
48、 to sink completely below the surface of the liquid. B.3.6 Repeat B.3.3 to B.3.5 with the four other test specimens. B.3.7 Determine the temperature of the test liquid. B.4 Calculation of results Calculate the average liquid absorbency time. B.5 Test report The report shall include at least the foll
49、owing information: a) type of nonwoven; b) dimensions of the test specimens; c) test method used and any deviations from the standard method; d) type, surface tension (specifying measurement method for this) and temperature of test liquid; e) individual and average liquid absorbency times. Annex C (normative) Test method for determination of liquid absorptive capacity C.1 Principle This test method evaluates the liquid absorptive capacity of nonwovens, i.e. the mass of liquid absorbed per
