ISO/DIS 15883-2

Washer-disinfectors

Laveurs désinfecteurs

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD ISO/DIS 15883-2
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on
2003-01-16 2003-06-16

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION

Washer-disinfectors —
Part 2:
Requirements and tests for washer disinfectors employing
thermal disinfection for surgical instruments, anaesthetic
equipment, hollowware, utensils, glassware, etc.
Laveurs désinfecteurs —

Partie 2: Exigences et essais pour laveurs désinfecteurs destinés à la désinfection thermale des instruments

chirurgicaux, du matériel d'anesthésie, des récipients, des ustensiles et de la verrerie, etc.

ICS 11.080.10
ISO/CEN PARALLEL ENQUIRY

This draft International Standard is a draft European Standard developed within the European

Committee for Standardization (CEN) and processed under the CEN-lead mode of collaboration as

defined in the Vienna Agreement. The document has been transmitted by CEN to ISO for circulation

for ISO member body voting in parallel with CEN enquiry. Comments received from ISO member

bodies, including those from non-CEN members, will be considered by the appropriate CEN

technical body. Accordingly, ISO member bodies who are not CEN members are requested to

send a copy of their comments on this DIS directly to CEN/TC 102 (DIN, Burggrafenstraße 6,

D-10787 Berlin) as well as returning their vote and comments in the normal way to the ISO

Central Secretariat. Should this DIS be accepted, a final draft, established on the basis of

comments received, will be submitted to a parallel two-month FDIS vote in ISO and formal vote in

CEN.

In accordance with the provisions of Council Resolution 15/1993 this document is circulated

in the English language only.

Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est

distribué en version anglaise seulement.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO

AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.

IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT

INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH

REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2003
---------------------- Page: 1 ----------------------
DRAFT
EUROPEAN STANDARD
prEN ISO 15883-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2002
ICS
English version
Washer-disinfectors - Part 2: Requirements and tests for
washer-disinfectors employing thermal disinfection for surgical
instruments, anaesthetic equipment, hollowware, utensils,
glassware, etc. (ISO/DIS 15883-2:2003)
Reinigungs-/Desinfektionsgeräte - Teil 2: Anforderungen an
und Prüfungen von Reinigungs-/Desinfektionsgeräten mit
thermischer Desinfektion für chirurgische Instrumente,
Anästhesiegeräte, Gefäße, Utensilien, Glasgeräte usw.
(ISO/DIS 15883-2:2003)

This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee

CEN/TC 102.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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 Management Centre has the same

status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United

Kingdom.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and

shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2002 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 15883-2:2002 E

worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
prEN ISO 15883-2:2003 (E)
Contents

Foreword......................................................................................................................................................................3

Introduction .................................................................................................................................................................4

1 Scope ..............................................................................................................................................................4

2 Normative references ....................................................................................................................................5

3 Terms and definitions....................................................................................................................................5

4 Performance requirements ...........................................................................................................................6

4.1 General............................................................................................................................................................6

4.2 Cleaning..........................................................................................................................................................6

4.3 Disinfecting.....................................................................................................................................................7

4.4 Temperature of internal surfaces of processed devices ...........................................................................7

5 Mechanical and control requirements .........................................................................................................7

5.1 Load connectors ............................................................................................................................................7

5.2 Control systems.............................................................................................................................................8

5.3 Process verification.......................................................................................................................................8

6 Testing ............................................................................................................................................................8

6.1 General............................................................................................................................................................8

6.2 Tests for soil removal from chamber walls, load carrier and load ...........................................................8

6.3 Thermometric tests........................................................................................................................................8

7 Information to be supplied by the manufacturer......................................................................................11

8 Information to be requested from the purchaser by the supplier of the WD.........................................11

Annex A (informative) Summary of test programmes ...........................................................................................12

Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other

provisions of EU Directives. .......................................................................................................................13

Bibliography ..............................................................................................................................................................14

---------------------- Page: 3 ----------------------
prEN ISO 15883-2:2003 (E)
Foreword

This document (prEN ISO 15883-2:2003) has been prepared by Technical Committee CEN/TC 102, "Sterilizers for

medical purposes", the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 198

"Sterilization of health care products".
This document is currently submitted to the parallel Enquiry.

EN ISO 15883 consists of the following parts under the general title Washer-disinfectors:

— Part 1: General requirements, definitions and tests

— Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments,

anaesthetic equipment, hollowware, 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 thermo-labile

endoscopes

Fields of application within the scope of EN ISO 15883 include laboratory, veterinary, dental and pharmaceutical

applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts and the

disinfection of crockery and cutlery intended for use with immunologically compromised patients.

This document has been prepared under a mandate given to CEN by the European Commission and the European

Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.

In respect of the potential adverse effects on the quality of water intended for human consumption caused by the

washer-disinfector:

a) this standard provides no information as to whether the washer-disinfector may be used without restriction in

any of the member states of the EU or EFTA;

b) it should be noted that, until verifiable European criteria are adopted, existing national regulations concerning

the use and/or the characteristics of the washer-disinfector remain in force.
Annexes A and ZA are given for information only.
---------------------- Page: 4 ----------------------
prEN ISO 15883-2:2003 (E)
Introduction

It is recommended that this introduction be read in conjunction with the Introduction to prEN ISO 15883-1.

This part of prEN ISO 15883 is the second of a series specifying the performance of washer-disinfectors and

specifies the general requirements for performance applicable to instrument washer-disinfectors. The requirements

given in this part apply to washer-disinfectors used for the cleaning and thermal disinfection of medical devices

intended for re-use such as:
- surgical instruments;
- powered devices;
- instrument trays;
- instruments for minimally invasive surgery;
- rigid endoscopes;
- anaesthetic and respiratory equipment;
- hollowware;
- glassware;
- containers for transit.

Requirements for washer-disinfectors for other applications are specified in other parts of this standard.

When processed in the instrument washer-disinfector, the medical devices may be intended for immediate use or

may be intended to be packed and sterilised. In both cases the efficacy of the cleaning and disinfection is of major

importance. In the first case this is for the well being of the patient, in the latter case it is for the safety of the staff

who handle the instruments in the process of inspecting, testing and packing the instruments.

The efficacy of disinfection may be impaired if soil removal is incomplete before the start of the disinfection

process. Users should be aware that some medical devices may require pre-treatment e.g. soaking, brushing, ultra

sonic pre-cleaning, lumen irrigation or any combination of these techniques. A number of medical devices may be

excluded from processing in a washer-disinfector altogether. Manufacturers of washer-disinfectors are

recommended to be very clear about the medical devices that can not be processed in the washer-disinfector.

Reference should be made to the medical device manufacturer’s instructions for reprocessing (see also

prEN ISO 17664).
Safety requirements for washer-disinfectors are given in IEC 61010-2-045.
1 Scope

This part of prEN ISO 15883 specifies particular requirements for washer disinfectors (WD) that are intended to be

used for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as

surgical instruments, anaesthetic equipment, hollowware, utensils and glassware.

NOTE Thermal disinfection may be achieved by rinsing the load with hot water, exposure to steam or combination of the

two.

The requirements in this part apply in addition to the general requirements specified in prEN ISO 15883-1:2002.

---------------------- Page: 5 ----------------------
prEN ISO 15883-2:2003 (E)
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 to 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 (including amendments).

EN 1281-1:1997, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets.

EN 1782:1998, Tracheal tubes and connector.
EN 1820:1997, Anaesthetic reservoir bags.

EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip for general

purposes.

EN 12342:1998, Breathing tubes intended for use with anaesthetic apparatus and ventilators.

EN ISO 4017:2000, Hexagon head screws; product grades A and B.

prEN ISO 15883-1:2002, Washer-disinfectors — General requirements, definitions and tests.

3 Terms and definitions

For the purposes of this part of prEN ISO 15883, the terms and definitions given in prEN ISO 15883-1:2002 and

the following apply.
3.1
anaesthetic and respiratory accessories

respiratory tubes, re-breathing bags and other anaesthetic products that will not be sufficiently flushed by rotating

spray nozzles, but which require positioning over fixed spray/jet nozzles
3.2
hollowware
bowls, dishes and receivers intended to contain liquids
3.3
lumen devices

devices which consist of tubes, pipes (either single or coaxial combined) which require connecting to the washer-

disinfector by means of dedicated connectors
3.4
powered devices

surgical instruments which give a rotating and/or oscillating movement to other surgical instruments

NOTE The power applied to the driven instrument may be mechanical (from a motor, either through direct coupling, flexible

axle or belt) or by the flow of a pressurised fluid.
EXAMPLES Dental hand pieces, orthopaedic saws and drills.
3.5
washing time

period for which the cycle variables (e.g. temperature of the load, detergent concentration in the chamber) are

maintained at or above the values specified for washing
3.6
washing temperature
minimum temperature of the washing temperature band
---------------------- Page: 6 ----------------------
prEN ISO 15883-2:2003 (E)
3.7
washing temperature band

range of temperatures, expressed as the washing temperature and the maximum allowable temperature which may

prevail throughout the load during the washing time
4 Performance requirements
4.1 General
4.1.1 The requirements of prEN ISO 15883-1:2002 apply with the exception of
- subclause 4.3.2 (which refers to chemical disinfection; see Scope);
- subclause 5.
...