© ISO 2016 Washer disinfectors — Part 7 Requirements and tests for washer disinfectors employing chemical disinfection for non invasive, non critical thermolabile medical devices and healthcare equipm[.]
INTERNATIONAL STANDARD ISO 15883-7 First edition 2016-02-01 Washer-disinfectors — Part 7: Requirements and tests for washerdisinfectors employing chemical disinfection for non-invasive, noncritical thermolabile medical devices and healthcare equipment Laveurs désinfecteurs — Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la désinfection chimique pour les dispositifs médicaux et les équipements de soins thermosensibles non invasifs et non critiques Reference number ISO 15883-7:2016(E) © ISO 2016 ISO 883 -7: 01 6(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise specified, no part o f this publication 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 ISO’s member body in the country o f the requester ISO copyright o ffice Ch de Blandonnet • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii © ISO 2016 – All rights reserved ISO 15883-7:2016(E) Contents Page Foreword v Introduction vi Scope Normative references Terms and definitions Performance requirements 4.1 4.2 4.3 4.4 4.5 4.7 General Cleaning Disinfection Final rinsing Self-disinfection Water treatment equipment 4.7.1 General 4.7.2 Disinfection of water treatment equipment 4.7.3 Maintenance of piping D rying Mechanical requirements Testing for conformity 6.1 General 6.2 Test load 6.2.1 Loading with standard goods 6.2.2 Loading with special goods 6.3 Water used for rinsing following disinfection 6.4.1 General 6.4.2 Procedure 6.4.3 Results 6.5 Thermometric tests 6.5.1 General 6.5.2 Load temperature test 6.6 Chemical dosing tests 6.6.1 General 6.6.2 Reused process chemicals f f 6.7.1 General 6.7.2 Materials 6.7.3 Procedure 10 6.7.4 Results 10 f f f 10 6.8.1 General 10 f 10 6.8.3 Self-disinfection tests 11 6.8.4 Chemical disinfection of the load 12 Documentation 12 Information to be provided by the manufacturer 12 Marking, labelling, and packaging 13 10 Information to be requested from the purchaser by the manufacturer 13 Annex A (normative) Summary of test programmes 14 M aterials — D es ign, manu facture, and as s emb ly Pro ces s verificatio n 6.4 Lo ad drynes s 6.7 Tes ts o 6.8 Tes t o cleaning e ficacy dis in ectio n e ficacy Preliminary tes ts o n chemical dis in ectants © ISO 2016 – All rights reserved iii ISO 15883-7:2016(E) Annex B (normative) Methods for microbiological evaluation of disinfection of liquid transport system 16 Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water 21 Annex D (normative) Preparation and evaluation of indicators for microbiological testing 22 Annex E (informative) Examples of test locations for the tests with biological indicators 26 Bibliography 30 o iv f t h e e f f i c a c y o f c h e m i c a l d i s i n f e c t i o n o f t h e l o a d © ISO 2016 – All rights reserved ISO 15883-7:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work o f preparing International Standards is normally 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 the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f electrotechnical standardization The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part In particular the different approval criteria needed for the di fferent types o f ISO documents should be noted This document was dra fted in accordance with the editorial rules of the ISO/IEC Directives, Part (see www.iso.org/directives) Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f patent rights ISO shall not be held responsible for identi fying any or all such patent rights Details o f any patent rights identified during the development o f the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents) Any trade name used in this document is in formation given for the convenience o f users and does not constitute an endorsement For an explanation on the meaning o f ISO specific terms and expressions related to formity assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary in formation ISO 15883-7 was prepared by the European Committee for Standardization (CEN) Technical Committee CEN/TC 102, , in collaboration with Technical Committee ISO/TC 198, , in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement) 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 surgical Sterilizers for medical purposes Sterilization of health care products 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 for thermolabile endoscopes Part 5: Test soils and methods for demonstrating cleaning efficacy [Technical Specification] Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment © ISO 2016 – All rights reserved v ISO 15883-7:2016(E) Introduction I t i s i ntende d th at th i s i ntro duc tion i s to b e re ad i n conj u nc tion with the i ntro duc tion to I S O 8 -1 T h i s p ar t o f I S O 8 i s the s eventh o f a s erie s s p e c i fyi ng the p er formance o f wa sher- d i s i n fe c tors I t s p e c i fie s the p ar tic u lar re qu i rements for p er forma nce appl ic able to was her- d i s i n fe c tors employi ng chemical disinfection for non-invasive, non-critical thermolabile medical devices, and healthcare f f f f thermolabile equipment for use without further treatment in healthcare settings Such reusable equipment needs to be cleaned and disinfected, but processing in a washer-disinfector for surgical instruments (see ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes (see ISO 15883-4), or for non-invasive, non-critical medical devices, and healthcare equipment e qu ipment I ts re qui rements apply to was her- d i s i n e c tors used or cle an i ng and d i s i n e c tion o emp loyi ng therma l d i s i n fe c tion (s e e I S O 8 - 6) i s i nappropri ate and/or i mprac tic a l E xample s o f s uch e qu ipment are b e d s te ad s and b e d s ide fu rn itu re, footwear, wheelchairs, or aids for the disabled Re qu i rements for wa sher- d i s i n fe c tors for trol leys a nd tran s p or t c a r ts , op erati ng table s , o ther appl ic ation s are s p e ci fie d i n o ther p ar ts o f I S O 8 I n re s p e c t to a ny p o tenti a l advers e e ffe c ts on the qua l ity o f water i ntende d for hu man s u mp tion cau s e d b y u s e o f the wa sher- d i s i n fe c tor, it i s no tewor thy that a) u nti l veri fiab le i nternationa l criteri a a re adop te d, the exi s ti ng nationa l regu lation s concern i ng the use and/or characteristics of the washer-disinfector remain in force (e.g the requirement of b ackflow prevention) , a nd b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector may b e u s e d without re s tric tion i n a ny o f the I S O memb er s tate s vi © ISO 2016 – All rights reserved INTERNATIONAL STANDARD ISO 15883-7:2016(E) Washer-disinfectors — Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment Scope T h i s p ar t o f I S O 8 s p e c i fie s the p ar tic u l ar re qu i rements be used for for wa sher- d i s i n fe c tors ( WD) i ntende d to the cle an i ng and chem ica l d i s i n fe c tion, i n a s i ngle op erati ng c ycle, o f reu s able item s s uch a s the following: a) bedframes; b) bedside tables; c) transport carts; d) containers; e) surgical tables; f) sterilization containers; g) surgical clogs; h) wheelchairs, aids for the disabled T h i s p a r t o f I S O 8 a l s o s p e ci fie s the p er formance re qu i rements for the cle an i ng and d i s i n fe c tion o f the wa sher- d i s i n fe c tor and its comp onents and acce s s orie s wh ich may b e ne ce s s a r y i n order to ach ieve the required performance D evice s identi fie d with i n the s cop e s o f I S O 8 -2 , I S O 8 -3 , I S O I 8 - 4, a nd I S O 8 - no t fall within the scope of this part of ISO 15883 I n add ition, the me tho d s are s p e c i fie d , as wel l a s i n s tr umentation and i n s truc tion s re qu i re d te s ti ng , works te s ti ng , va l idation (i n s ta l lation, op eration, a nd p er formance qua l i fication for typ e on fi rs t i n s ta l lation) , routi ne control, and mon itori ng , as wel l a s re qua l i fic ation s re qu i re d to b e c arrie d out p erio d ic a l ly a nd a fter e s s entia l rep a i rs NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection o f o ther ther mol ab i le a nd reu s ab le de vice s a s re com mende d b y the de vice m a nu fac tu rer T he p er formance re qu i rements s p e ci fie d i n th i s p a r t o f I S O 8 may no t en s u re the i nac tivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies Normative references T he fol lowi ng i nd i s p en s able c u ments , i n whole or i n p ar t, are normatively re ference d i n th i s c u ment a nd are for its appl ic ation For date d re ference s , on ly the e d ition cite d appl ie s For u ndate d re ference s , the late s t e d ition o f the re ference d c u ment (i nclud i ng any amend ments) appl ie s © ISO 2016 – All rights reserved ISO 15883-7:2016(E) ISO 15883-1:2006+A1:2014, definitions and tests Washer-disinfectors — Part 1: General requirements, terms and ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes ISO 15883-6, Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment ISO/TS 15883-5:2005, cleaning e fficacy Washer-disinfectors — Part 5: Test soils and methods for demonstrating EN 10088-1, Stainless steels — Part 1: List of stainless steels EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion resisting steels for general purposes IEC 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials Terms and definitions For the purposes o f this document, the terms and definitions given in ISO 15883-1, ISO 15883-4, and ISO 15883-6 apply Performance requirements 4.1 General The WD shall conform to ISO 15883-1:2006+A1:2014 except for the following subclauses: — 4.3.1 (which refers to thermal disinfection); 4.1.1 — 5.9 [process temperature control limits, excluding 5.9 d) and e)]; — 5.11 (process verification) 4.1.2 The WD shall be designed to clean and chemically disin fect the range o f reusable items specified 4.1.3 When necessary, the WD shall be provided with means to facilitate the correct alignment o f the 4.1.4 The means to control the volume of the process chemical(s) admitted (see ISO 15883- load in the washing chamber 1:2006+A1:2014, 5.7.4 and 5.7.5) shall be adjustable by means o f a key, code, or tool The accuracy o f the dosing system shall be at least ±10 % or as specified and tested for formity (see 6.6) The automatic controller shall ensure that the final concentration o f disin fectants are within the limits specified 4.1.5 NOTE Confirmation o f the concentration o f disin fectant can include the measurement o f the volume o f disin fectant and water admitted together with a certificate o f formity from the disin fectant supplier for the concentration o f the disin fectant, together with data to support the shel f li fe, expiry date, etc © ISO 2016 – All rights reserved ISO 15883-7:2016(E) 4.2 Cleaning Cleaning shall be tested in accordance with the requirements of ISO 15883-1 using the test soils and methods described in ISO/TS 15883-5 that are relevant to the loads to be processed 4.2.1 During the washing stage: a) the washing stage starts when the temperature at the control sensor of the WD is not less than the 4.2.2 s p e c i fie d was h i ng temp eratu re; b) the was h i ng temp eratu re b and sh a l l h ave the lower l i m it defi ne d by the wa sh i ng temp eratu re a nd an upp er l i m it of no t gre ater ISO 15883-1:2006+A1:2014, 4.2.3) tha n the s p e c i fie d wa s h i ng temp eratu re +10 °C (s e e 6.7 4.2.3 C leaning e fficacy s hall b e determined in acco rdance with 4.2.4 If the WD is designed to allow the reuse of the cleaning solution on two or more consecutive o p erating cycles , then care s hall b e taken to ens ure that the e fficacy and s a fety (e g accumulatio n o f fo reign material, device co mp atib ility) o f the cleaning s o lutio n is no t imp aired This s hall include at leas t the following: a) s p eci fied methods which shall be used to ens ure that the cleaning solution has retained the required cleaning e fficac y T hes e metho ds shal l b e based on validation s tudies , which would normally be carried out by the cleaning solution manu fac turer, to determine a s uitable p arameter, parameters and/or indicators/markers that may be monitored Suitable p arameters may include the concentration o f the ac tive ingredient and other ingredients that may also a ffec t p er formance (e g pH ) ; NO TE M i nor ch a n ge s i n for mu l ation o f the cle a n i ng s olution c a n h ave a s ign i fic a nt e ffe c t on its s tab i l ity, cle a n i n g e ffic ac y, e tc b) re com mendation s to the u s er for the ma xi mum p erio d or nu mb er o f op erati ng c ycle s for wh ich the cle an i ng s olution m ay b e u s e d T h i s sh a l l b e b as e d on va l idate d exp eri menta l data; c) where va l idate d u s e cond ition s (ma xi mu m p erio d or nu mb er o f op erati ng c ycle s) a re exce e de d, the automatic controller shall — op erate a n aud ible a nd vi s ible a la rm and prevent the u s e o f the op erati ng c ycle u nti l the cle an i ng solution is changed, or — effect an automatic change of the cleaning solution in the WD 4.3 4.3.1 Disinfection The cycle s hall include a chemical dis in fectio n s tage, which may b e co mb ined with the cleaning and shall be deemed to have been achieved when testing requirements in 6.8 are met The requirements and tests in this part of ISO 15883 are based on the use of aqueous disinfectant These shall include the following: a) disinfectant(s) to be used, for which in vitro f published standards; 4.3.2 s o lutio ns O ther sys tems b as ed o n gas eo us dis in fectants are no t excluded; equivalent tes ts are required e fic ac y s b e en demon s trate d b as e d on releva nt © ISO 2016 – All rights reserved ISO 883 -7: 01 6(E) For the purpose o f e fficacy testing, a validated neutralization method shall be used This method can be provided by the disin fectant manu facturer b) when tested on surfaces for the minimum exposure time at the minimum concentration and the minimum temperature to be used in the WD, the disinfectant demonstrates the following: 1) at least a log10 inactivation of vegetative bacteria; 2) at least a log10 inactivation o f yeast-like fungi; 3) at least a log10 inactivation of enveloped viruses NOTE National Regulatory Authorities can require higher inactivation values and/or e fficacy against a NOTE E fficacy tests against vegetative bacteria can exclude mycobacteria See also f) wider range of microorganisms c) the compatibility o f the cleaning and disin fection solutions are indicated, including any impact on disin fection e fficacy from carryover o f cleaning solution; d) the experimental conditions o f tests intended to demonstrate the microbicidal e fficacy o f the disinfectant in vitro shall reflect the conditions o f use of the disin fectant Thus, when cleaning and disinfection is combined, the disinfectant shall be tested in the presence of applicable interfering substances that shall include soiling typically found in the loads to be processed The temperature of the disinfectant solution throughout the disinfection stage shall be monitored temperature limits for the device(s) to be processed 4.3 to ensure that it remains within the specified limits o f the disin fectant and be compatible with the This shall be achieved either by controlling the temperature o f the disin fectant solution or where the temperature in the WD is not controlled that the operation o f the WD is prevented outside the specified disinfectant temperature range 4.3 If the WD is designed to allow the reuse of the disinfectant solution on two or more consecutive operating cycles, then care shall be taken to ensure that the e fficacy and safety (e.g accumulation o f foreign material, device compatibility) o f the disin fectant solution is not impaired This shall include at least the following: a) the means which shall be used to ensure that the disinfectant solution has retained the required antimicrobial disin fection e fficacy These means shall be based on validation studies, which would normally be carried out by the disin fectant manu facturer, to determine a suitable parameter, or parameters and/or indicators/markers that may be monitored to indicate the antimicrobial e fficacy o f the disin fectant Suitable parameters may include the concentration o f the active ingredient and other ingredients that may also a ffect per formance (e.g pH, stability, etc.); NOTE Minor changes in formulation o f the disin fectant can have a significant e ffect on storage li fe, antimicrobial e fficacy, etc b) recommendations to the user for the maximum period or number o f operating cycles for which the disin fectant may be used This shall be based on validated experimental data; c) when validated use conditions (maximum period or number o f operating cycles) are exceeded, the automatic controller shall provide an audible and/or visible indication and prevent the use of the operating cycle until the disin fectant solution is changed (manually or automatically); d) provide a method for the user to monitor the disinfectant using a chemical indicator or other method specific for the disin fectant to show that the disin fectant is at or above the minimum recommended concentration NOTE The minimum recommended concentration is the lowest concentration of active and other ingredients to meet the label claim of a reusable disinfectant © ISO 2016 – All rights reserved