ISO/DIS 15883-3.2

Washer-disinfectors

Laveurs désinfecteurs

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD ISO/DIS 15883-3.2
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on
2003-01-16 2003-03-16

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

Washer-disinfectors —
Part 3:
Requirements and tests for washer-disinfectors employing
thermal disinfection for human waste containers
Laveurs désinfecteurs —

Partie 3: Exigences et essais pour les laveurs désinfecteurs destinés à la désinfection thermale de récipients à

déjections humaines
ICS 11.180.10
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 15883-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2003
ICS
English version
Washer-disinfectors - Part 3: Requirements and tests for
washer-disinfectors employing thermal disinfection for human
waste containers (ISO/DIS 15883-3:2003)

Laveurs désinfecteurs - Partie 3: Exigences et essais pour Reinigungs-/Desinfektionsgeräte - Teil 3: Anforderungen an

les laveurs désinfecteurs de récipients à déjections und Prüfungen von Reinigungs-/Desinfektionsgeräten mit

humaines (ISO/DIS 15883-3:2003) thermischer Desinfektion für Behälter für menschliche

Ausscheidungen (ISO/DIS 15883-3:2003)

This draft European Standard is submitted to CEN members for second 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

© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 15883-3:2003 E

worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
prEN ISO 15883-3:2003 (E)
Contents

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

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

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

2 Normative references ....................................................................................................................................4

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

4 Performance requirements ...........................................................................................................................5

4.1 General............................................................................................................................................................5

4.2 Chemical dosing systems.............................................................................................................................5

4.3 Emptying.........................................................................................................................................................6

4.4 Cleaning..........................................................................................................................................................6

4.5 Disinfecting.....................................................................................................................................................6

4.6 Rinsing............................................................................................................................................................7

4.7 Drying..............................................................................................................................................................7

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

5.1 Instrumentation and control .........................................................................................................................7

5.2 Process ...........................................................................................................................................................7

5.3 Venting, draining and purging......................................................................................................................7

5.4 Water quality...................................................................................................................................................8

6 Testing for conformity...................................................................................................................................8

6.1 Test for drain seal integrity...........................................................................................................................8

6.2 Test for flushing of non-absorbent materials .............................................................................................8

6.3 Test for flushing of absorbent material (toilet tissue)................................................................................8

6.4 Test for loading/emptying of containers .....................................................................................................8

6.5 Tests for soil removal from chamber walls, load carrier and load ...........................................................9

7 Information to be supplied by the manufacturer........................................................................................9

8 Information to be requested from the purchaser by the supplier of the WD...........................................9

Annex A (normative) Specification for toilet tissue for use in tests on washer-disinfectors for human-

waste containers..........................................................................................................................................10

Annex B (normative) Measurement of water absorbency of toilet tissue by the basket method.....................11

Annex C (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 ..............................................................................................................................................................15

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

This document (prEN ISO 15883-3:2003) 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 second 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 B are normative. Annexes C and ZA are given for information only.
---------------------- Page: 4 ----------------------
prEN ISO 15883-3:2003 (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 third of a series specifying the performance of washer-disinfectors and specifies

the general requirements for performance applicable to bed pan washer-disinfectors. The requirements given in

this part apply to washer-disinfectors used for emptying, flushing, cleaning and thermally disinfecting human waste

containers intended for re-use such as:
- portable sanitary pans;
- supports for single-use bed pans;
- hospital hollowware, e.g. bowls;
- urine bottles;
- suction bottles; and
- products similar to the above and used for similar purposes.

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

Bed-pan washer disinfectors are loaded manually. In order to reduce the risk of spillage and the generation of

aerosols most machines incorporate means to empty human waste containers automatically eg by the action of

closing the door.

Where equipment does not provide automatic emptying facilities, extra care is needed by the user to avoid

exposure to human waste and contamination of the work environment including the generation of aerosols.

The reliability of a bed-pan washer-disinfector may be adversely affected if the machine is connected to a poorly

designed or constructed drainage system, and the purchaser is therefore recommended to ensure that the

drainage system complies with the manufacturer’s recommendations in all respects.

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 emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal

by one operating cycle.

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

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).

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

---------------------- Page: 5 ----------------------
prEN ISO 15883-3:2003 (E)
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
human waste
excretions and body fluids including faeces, urine, blood, pus, vomit and mucus
3.2
human waste container
re-usable vessel for holding and transporting human waste
3.3
emptying
discharging the contents of a container by gravity
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 refer to chemical disinfection, see Scope);

- subclause 4.3.3 (which refers to the maximum range of temperatures permitted on the load items, see 4.1.4

below);

- subclause 5.3.1.2 (which refers to the use of a machine purging and disinfection);

- csublause 5.8 (which refers to load temperature protection);

- subclause 5.9 (which refers to control of temperatures on the load and chamber walls, see 4.6.3 and 4.6.4

below); and
- subclause 6.8.5 (which refers to tests for load temperature protection).

4.1.2 The washer-disinfector shall be designed to process either one type of human waste container or a variety

of types of human waste container and the re-usable supports for single-use bedpans.

NOTE This may require the use of two or more types of load carrier.

4.1.3 The washer-disinfector shall be designed to process either one human waste container per cycle, or

several human waste containers per cycle

4.1.4 The temperature attained on the surfaces of the load during the disinfection stage shall be not less than the

disinfection temperature.
4.2 Chemical dosing systems

4.2.1 Provision shall be made for the installation of a chemical dosing system, when specified by the purchaser,

to allow for the injection of a descalant, detergent o
...