1、 Reference number ISO/TS 15883-5:2005(E) ISO 2005TECHNICAL SPECIFICATION ISO/TS 15883-5 First edition 2005-11-15 Washer-disinfectors Part 5: Test soils and methods for demonstrating cleaning efficacy Laveurs dsinfecteurs Partie 5: Terrains dessai et mthodes pour dmontrer lefficacit de nettoyage ISO/
2、TS 15883-5:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In down
3、loading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the
4、 General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address
5、given below. ISO 2005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs mem
6、ber body in the country of the requester. ISO copyright office Case postale 56 CH-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 2005 All rights reservedISO/TS 15883-5:2005(E) ISO 2005 All rights reserved iii Conten
7、ts Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Applicability. 1 Annex A (normative) Test soil and method for surgical instruments (Austria). 4 Annex B (normative) Test soil and method for anaesthesia equipment (Austria) 8 Annex C (normative) Test soil and method for bedp
8、ans (Austria) . 11 Annex D (normative) Test soil and method for urine bottles (Austria) 14 Annex E (normative) Test soil and method for flexible endoscopes (Austria) 16 Annex F (normative) Test soil and method for flexible endoscopes (France). 21 Annex G (normative) Test soil and method for surgical
9、 instruments, glassware and anaesthesia equipment (Germany). 25 Annex H (normative) Test soil and method for bedpans (Germany) 31 Annex I (normative) Test soil and method for flexible endoscopes (Germany) 37 Annex J (normative) Test soil and method for surgical instruments and flexible endoscopes, P
10、eroxidase test (Germany) 45 Annex K (normative) Test soil and method for stainless steel items including surgical instruments (Netherlands) . 48 Annex L (normative) Test soil and method for surrogate devices for endoscope channels (Netherlands). 51 Annex M (normative) Test soils and methods for surg
11、ical instruments, wash bowls, bedpans, urine bottles, anaesthesia equipment, baby bottles and suction bottles (Sweden) 54 Annex N (normative) Test soil and method for surgical instruments, surgical instrument trays bowls, dishes and receivers (UK) . 59 Annex O (normative) Test soil and method for an
12、aesthetic accessories (UK) 62 Annex P (normative) Test soil and method for bedpans and commode pans (UK) 64 Annex Q (normative) Test soil and method for urine bottles (UK) 66 Annex R (normative) Test soil and method for flexible endoscopes (UK). 68 Annex S (informative) Test soil and method for reus
13、able medical instruments (USA) 70 Bibliography . 71 ISO/TS 15883-5:2005(E) iv ISO 2005 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is nor
14、mally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee 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
15、the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical 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 prepar
16、e International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly when ther
17、e is an urgent market requirement for such documents, a technical committee may decide to publish other types of normative document: 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 ap
18、proved by more than 50 % of the members of the parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an 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
19、/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 become 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
20、transformed into an International Standard or be withdrawn. 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 identifying any or all such patent rights. ISO/TS 15883-5 was prepared by Technical
21、Committee ISO/TC 198, Sterilization of health care products. ISO 15883 consists of the following parts, under the general title Washer-disinfectors: Part 1: General requirements, terms and definitions and tests Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for
22、 surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection fo
23、r thermolabile endoscopes Part 5: Test soils and methods for demonstrating cleaning efficacy Technical Specification ISO/TS 15883-5:2005(E) ISO 2005 All rights reserved v Introduction Verification of cleaning efficacy is a key aspect of establishing satisfactory performance of a washer- disinfector.
24、 The current state of knowledge has not permitted development of a single internationally acceptable test method. As an interim measure, the Technical Committees responsible for the ISO 15883 series of standards on washer-disinfectors (ISO/TC 198 and CEN/TC 102) have decided that the cleaning effica
25、cy of washer-disinfectors claiming compliance with the ISO 15883 series of standards be demonstrated by referring to the test soils and methods that are currently used in a number of different countries. For the convenience of the user of the ISO 15883 series of standards, these test soils and metho
26、ds are described in this Technical Specification. It should be noted that it remains the intention of the Technical Committees to develop a single test method. TECHNICAL SPECIFICATION ISO/TS 15883-5:2005(E) ISO 2005 All rights reserved 1 Washer-disinfectors Part 5: Test soils and methods for demonst
27、rating cleaning efficacy 1 Scope This Technical Specification includes the test soils and methods that can be used to demonstrate the cleaning efficacy of washer-disinfectors (WD) according to the ISO 15883 series of standards. The inclusion of the test soils and methods in this Technical Specificat
28、ion does not indicate that they are of equivalent sensitivity in their determination of cleaning efficacy. Acceptance criteria are included, based on visual inspection and/or a microbiological end-point as stated for each method. Where chemical detection of residual soiling is required/sought, metho
29、ds can be complemented by the specific determination of a residual component of the applied test soil. NOTE 1 The test soils and methods included in this Technical Specification are sourced from national standards and published documents submitted by member bodies of the Technical Committee preparin
30、g this Technical Specification. They have been edited only to provide a uniform format within this Technical Specification. NOTE 2 An example of this is the use of the peroxidase test (see Annex J) to detect residual blood (haemoglobin) from the test soil applied to surgical instruments or flexible
31、endoscopes (e.g. using the method described in Annex G). See also ISO 15883-1:2005, Annex D. 2 Normative 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 edit
32、ion of the referenced document (including any amendments) applies. ISO 3166-1, Codes for the representation of names of countries and their subdivisions Part 1: Country codes ISO 15883-1:2005, Washer-disinfectors Part 1: General requirements, terms and definitions and tests 3 Applicability 3.1 Where
33、 any of the test methods specified below deviate from the test method for cleaning efficacy specified in ISO 15883-1, the method given in ISO 15883-1 shall be used (see ISO 15883-1:2005, 6.10). Cleaning efficacy, for example, shall be determined after exposure to only the cleaning part of the operat
34、ing cycle. 3.2 Table 1 includes a summary of the test soils which are included in this Technical Specification. The test soils are listed for the specific type of WD loads for which they were specified; the same test soils may be used also for other types of loads: for example, soils specified for s
35、urgical instrument may be used for other metal components. ISO/TS 15883-5:2005(E) 2 ISO 2005 All rights reservedTable 1 Summary of test soils including their allocation to the type of load Load type Country code aReference in Bibliography Constituents of soil Annex in this Technical Specification AT
36、 34 Heparinzed sheep blood coagulated with protamine Annex A DE 32, 33 Sheep blood, E. faecium bEgg yolk, E. faecium bSemolina, butter, sugar, milk powder, E. faecium bAnnex G DE 41, 42, 43 Tetramethylbenzidine, hydrogen peroxide solution, bovine haemoglobin Annex J NL 39 Bovine serum albumin fracti
37、on 5, porcine gastric mucin type 3, bovine fibrinogen fraction 1, bovine thrombin Annex K SE 24 Citrated cattle blood coagulated with calcium chloride Annex M UK 28, 30 Defibrinated horse/sheep blood, egg yolk, dehydrated hog mucin Annex N Surgical instruments (including rigid endoscopes) US 31 47 P
38、rotein/organic soil (user preference), B. atrophaeus endospores Albumin, haemoglobin, fibrinogen, thrombin Annex S SE 24 Citrated cattle blood coagulated with calcium chloride Annex M Bowls, dishes, receivers UK 28, 30 Defibrinated horse/sheep blood, egg yolk, dehydrated hog mucin Annex N AT 36 Nigr
39、osin, wheat flour, hens egg Annex B DE 32, 33 Sheep blood, E. faecium bAnnex G SE 24 Citrated cattle blood coagulated with calcium chloride Annex M Anaesthesia equipment / accessories UK 28, 30 Glycerol, dehydrated hog mucin, horse serum, unbleached plain flour, aqueous safranine solution, water Ann
40、ex O Infant feeding bottles DE 32, 33 Sheep blood, E. faecium begg yolk, E. faecium bsemolina, butter, sugar, milk powder, E. faecium bAnnex G Baby bottles and suction bottles SE 24 Citrated cattle blood coagulated with calcium chloride Annex M ISO/TS 15883-5:2005(E) ISO 2005 All rights reserved 3 T
41、able 1 (continued) Load type Country code aReference in Bibliography Constituents of soil Annex in this Technical Specification AT 36 Nigrosin, wheat flour, hens egg, instant potato flakes, Annex C DE 22, 23, 38 Bovine albumin, mucin, maize starch E. faecium bAnnex H SE 24 Citrated cattle blood coag
42、ulated with calcium chloride Annex M Bedpans UK 27, 30 Unbleached plain flour, water soluble adhesive wallpaper paste, hens egg, black Indian ink, water Annex P AT 36 Nigrosin, wheat flour, hens egg Annex D SE 24 Citrated cattle blood coagulated with calcium chloride Annex M Urine bottles UK 27, 30
43、Defibrinated horse/sheep blood, water soluble adhesive wallpaper paste, hens egg, black Indian ink, water Annex Q AT 34, 44 Nigrosin, wheat flour, hens egg, E. faecium bAnnex E DE 34, 35 Blood, E. faecium bAnnex I DE 41, 42, 43 Tetramethylbenzidine, hydrogen peroxide solution, bovine haemoglobin Ann
44、ex J FR 37 Biofilm formed by Pseudomonas aeruginosa Annex F NL 40 Bovine serum albumin, procine mucin, bovine thrombin, bovine fibrinogen Annex L UK 30 Glycerol, dehydrated hog mucin, horse serum, unbleached plain flour, aqueous safranine solution, water Annex R Flexible endoscopes US 31 47 Protein/
45、organic soil (user preference), B. atrophaeus endospores Bacteria, protein, carbohydrate, endotoxin, haemoglobin Annex S Stainless steel items (including bedpans, urine bottles) NL 39 Bovine albumin fraction 5, porcine gastric mucin type 3, bovine fibrinogen fraction 1, bovine thrombin Annex K Wash
46、bowls SE 24 Calcium stearate generated in situ from soap and calcium chloride solution Annex M Reusable medical instruments including flexible endoscopes US 31 Protein/organic soil (user preference), B. atrophaeus endospores Annex S aCountry code as specified in ISO 3166-1. bThe test soils and metho
47、ds may also be used for microbial testing of disinfection efficacy of WDs according to the ISO 15883 series when requested by the user. ISO/TS 15883-5:2005(E) 4 ISO 2005 All rights reservedAnnex A (normative) Test soil and method for surgical instruments (Austria) A.1 Reference The test methods usin
48、g a heparinized blood test soil for testing and evaluating the cleaning efficacy of automated WDs for surgical instruments as an optional type test and operational test are based on Reference 34 and were adapted or complemented for the presentation in this Technical Specification. A.2 Materials Bloo
49、d from a laboratory sheep. Heparin 1) . Protamine sulphate or hydrochloride 1) . Optional: Cleaning-indicators for ordinary surgical instruments 1) . Cleaning-indicators for instruments for minimally invasive surgery 1) . A.3 Apparatus Normal laboratory equipment. Paintbrush, 25 mm in width and 4 mm of thickness. Syringes, of 20 ml capacity. A.4 Preparation of test soil A.4.1 Heparinized sheep blood Add
