Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

IEC 61010-2-101:2018 is also available as IEC 61010-2-101:2018 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC 61010-2-101:2018 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. It has the status of a group safety publication, as specified in IEC Guide 104. This document has been prepared in close collaboration with Working Group CENELEC BTTF 88.1. This third edition cancels and replaces the second edition published in 2015. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:
- adaptation of changes introduced by Amendment 1 of IEC 61010-1;
- added tolerance for stability of AC voltage test equipment to Clause 6.
This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on the basis of the third edition (2010) and its Amendment 1 (2016).

Exigences de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-101: Exigences particulières pour le matériel médical de diagnostic in vitro (DIV)

IEC 61010-2-101:2018 est disponible sous forme de IEC 61010-2-101:2018 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.
L’IEC 61010-2-101:2018 s’applique aux appareils destinés aux applications médicales de diagnostic in vitro (DIV), y compris aux appareils médicaux d'autotest DIV. Elle a le statut d'une publication groupée de sécurité conformément au Guide IEC 104. Ce document a été élaboré en étroite collaboration avec le groupe de travail CENELEC BTTF 88.1. Cette troisième édition annule et remplace la deuxième édition parue en 2015. Cette édition constitue une révision technique. Cette édition inclut les modifications techniques majeures suivantes par rapport à l'édition précédente:
- adaptation des modifications introduites par l’Amendement 1 de l’IEC 61010-1;
- ajout à l’Article 6 de la tolérance pour la stabilité du matériel d’essai en tension alternative.
Cette Partie 2-101 est destinée à être utilisée conjointement avec l’IEC 61010-1. Elle a été établie sur la base de la troisième édition (2010) et de son Amendement 1 (2016).

General Information

Status
Published
Publication Date
04-Oct-2018
Current Stage
PPUB - Publication issued
Completion Date
05-Oct-2018
Ref Project

Buy Standard

Standard
IEC 61010-2-101:2018 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
English and French language
34 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

IEC 61010-2-101
Edition 3.0 2018-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control and
laboratory use –
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
Exigences de sécurité pour appareils électriques de mesurage, de régulation et
de laboratoire –
Partie 2-101: Exigences particulières pour le matériel médical de diagnostic in
vitro (DIV)
IEC 61010-2-101:2018-10(en-fr)
---------------------- Page: 1 ----------------------
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2018 IEC, Geneva, Switzerland

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 IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC

copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or

your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite

ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie

et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des

questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez

les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.

IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC

The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes

International Standards for all electrical, electronic and related technologies.
About IEC publications

The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the

latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org

The stand-alone application for consulting the entire The world's leading online dictionary of electronic and

bibliographical information on IEC International Standards, electrical terms containing 21 000 terms and definitions in

Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional

documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical

iPad. Vocabulary (IEV) online.

IEC publications search - webstore.iec.ch/advsearchform IEC Glossary - std.iec.ch/glossary

The advanced search enables to find IEC publications by a 67 000 electrotechnical terminology entries in English and

variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of

committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been

and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
IEC Just Published - webstore.iec.ch/justpublished

Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc

details all new publications released. Available online and If you wish to give us your feedback on this publication or

also once a month by email. need further assistance, please contact the Customer Service

Centre: sales@iec.ch.
A propos de l'IEC

La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des

Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC

Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la

plus récente, un corrigendum ou amendement peut avoir été publié.
Catalogue IEC - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
Application autonome pour consulter tous les renseignements
Le premier dictionnaire en ligne de termes électroniques et
bibliographiques sur les Normes internationales,
électriques. Il contient 21 000 termes et définitions en anglais
Spécifications techniques, Rapports techniques et autres
et en français, ainsi que les termes équivalents dans 16
documents de l'IEC. Disponible pour PC, Mac OS, tablettes
langues additionnelles. Egalement appelé Vocabulaire
Android et iPad.
Electrotechnique International (IEV) en ligne.
Recherche de publications IEC -
Glossaire IEC - std.iec.ch/glossary
webstore.iec.ch/advsearchform
67 000 entrées terminologiques électrotechniques, en anglais

La recherche avancée permet de trouver des publications IEC et en français, extraites des articles Termes et Définitions des

en utilisant différents critères (numéro de référence, texte, publications IEC parues depuis 2002. Plus certaines entrées

comité d’études,…). Elle donne aussi des informations sur les antérieures extraites des publications des CE 37, 77, 86 et

projets et les publications remplacées ou retirées. CISPR de l'IEC.

IEC Just Published - webstore.iec.ch/justpublished Service Clients - webstore.iec.ch/csc

Restez informé sur les nouvelles publications IEC. Just Si vous désirez nous donner des commentaires sur cette

Published détaille les nouvelles publications parues. publication ou si vous avez des questions contactez-nous:

Disponible en ligne et aussi une fois par mois par email. sales@iec.ch.
---------------------- Page: 2 ----------------------
IEC 61010-2-101
Edition 3.0 2018-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
GROUP SAFETY PUBLICATION
PUBLICATION GROUPÉE DE SÉCURITÉ
Safety requirements for electrical equipment for measurement, control and
laboratory use –
Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
Exigences de sécurité pour appareils électriques de mesurage, de régulation et
de laboratoire –
Partie 2-101: Exigences particulières pour le matériel médical de diagnostic in
vitro (DIV)
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.55; 19.080 ISBN 978-2-8322-6062-3

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 61010-2-101:2018 © IEC 2018
CONTENTS

FOREWORD ......................................................................................................................... 3

1 Scope and object ........................................................................................................... 5

2 Normative references..................................................................................................... 6

3 Terms and definitions .................................................................................................... 6

4 Tests ............................................................................................................................. 6

5 Marking and documentation ........................................................................................... 7

6 Protection against electric shock .................................................................................. 11

7 Protection against mechanical HAZARDS ........................................................................ 11

8 Resistance to mechanical stresses ............................................................................... 13

9 Protection against the spread of fire ............................................................................. 13

10 Equipment temperature limits and resistance to heat .................................................... 13

11 Protection against HAZARDS from fluids and solid foreign objects ................................... 13

12 Protection against radiation, including laser sources, and against sonic and

ultrasonic pressure ...................................................................................................... 14

13 Protection against liberated gases and substances, explosion and implosion ................ 14

14 Components and subassemblies .................................................................................. 14

15 Protection by interlocks ................................................................................................ 14

16 HAZARDS resulting from application............................................................................... 15

17 RISK assessment ......................................................................................................... 15

Annexes ............................................................................................................................. 15

Annex L (informative) Index of defined terms ...................................................................... 16

Bibliography ....................................................................................................................... 17

Table 1 – Symbols ................................................................................................................ 8

---------------------- Page: 4 ----------------------
IEC 61010-2-101:2018 © IEC 2018 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL AND LABORATORY USE –
Part 2-101: Particular requirements for
in vitro diagnostic (IVD) medical equipment
FOREWORD

1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To

this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,

Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC

Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested

in the subject dealt with may participate in this preparatory work. International, governmental and non-

governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely

with the International Organization for Standardization (ISO) in accordance with conditions determined by

agreement between the two organizations.

2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

consensus of opinion on the relevant subjects since each technical committee has representation from all

interested IEC National Committees.

3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

misinterpretation by any end user.

4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

transparently to the maximum extent possible in their national and regional publications. Any divergence

between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in

the latter.

5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

services carried out by independent certification bodies.

6) All users should ensure that they have the latest edition of this publication.

7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

members of its technical committees and IEC National Committees for any personal injury, property damage or

other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

Publications.

8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

indispensable for the correct application of this publication.

9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

International Standard IEC 61010-2-101 has been prepared by IEC technical committee 66:

Safety of measuring, control and laboratory equipment.
It has the status of a group safety publication, as specified in IEC Guide 104.
This document has been prepared in close collaboration with Working Group
CENELEC BTTF 88.1.

This third edition cancels and replaces the second edition published in 2015. This edition

constitutes a technical revision.

This edition includes the following significant technical changes with respect to the previous

edition:
---------------------- Page: 5 ----------------------
– 4 – IEC 61010-2-101:2018 © IEC 2018
a) adaptation of changes introduced by Amendment 1 of IEC 61010-1;
b) added tolerance for stability of AC voltage test equipment to Clause 6.
The text of this International Standard is based on the following documents:
CDV Report on voting
66/644/CDV 66/669/RVC

Full information on the voting for the approval of this International Standard can be found in

the report on voting indicated in the above table.

This document has been drafted in accordance with the ISO/IEC Directives, Part 2.

A list of all parts of the IEC 61010 series, under the general title: Safety requirements for

electrical equipment for measurement, control, and laboratory use, may be found on the IEC

website.

This Part 2-101 is intended to be used in conjunction with IEC 61010-1. It was established on

the basis of the third edition (2010) and its Amendment 1 (2016).

This Part 2-101 supplements or modifies the corresponding clauses in IEC 61010-1 so as to

convert that publication into the IEC standard: Particular requirements for in vitro diagnostic

(IVD) medical equipment.

Where a particular subclause of Part 1 is not mentioned in this Part 2, that subclause applies

as far as is reasonable. Where this part states “addition”, “modification”, “replacement”, or

“deletion” the relevant requirement, test specification or note in Part 1 should be adapted

accordingly.
In this standard:
1) the following print types are used:
– requirements: in roman type;
– NOTES: in smaller roman type;
– conformity and test: in italic type;
– terms used throughout this standard which have been defined in clause 3: SMALL
ROMAN CAPITALS;

2) subclauses, figures, tables and notes which are additional to those in part 1 are numbered

starting from 101. Additional annexes are lettered starting from AA and additional list

items are lettered from aa).

The committee has decided that the contents of this document will remain unchanged until the

stability date indicated on the IEC website under "http://webstore.iec.ch" in the data related to

the specific document. At this date, the document will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
---------------------- Page: 6 ----------------------
IEC 61010-2-101:2018 © IEC 2018 – 5 –
SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
MEASUREMENT, CONTROL AND LABORATORY USE –
Part 2-101: Particular requirements for
in vitro diagnostic (IVD) medical equipment
1 Scope and object
This clause of Part 1 is applicable except as follows:
1.1.1 Equipment included in scope
Replacement:
Replace the text, except the first paragraph, with the following new text:

This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical

purposes, including self-test IVD medical purposes.
IVD medical equipment, whether used alone or in combination, is intended by the

manufacturer to be used in vitro for the examination of specimens, including blood and tissue

samples, derived from the human body, solely or principally for the purpose of providing

information concerning one or more of the following:
• a physiological or pathological state; or
• a congenital abnormality;
• the determination of safety and compatibility with potential recipients;
• the monitoring of therapeutic measures.

Self-test IVD medical equipment is intended by the manufacturer for use by lay persons in a

home environment.

NOTE If all or part of the equipment falls within the scope of one or more other Part 2 standards of the IEC 61010

series as well as within the scope of this document, consideration is given to those other Part 2 standards.

1.1.2 Equipment excluded from scope
Addition:
Add the following new item:

aa) equipment within the scope of IEC 61010-2-081 unless it is specifically intended by the

manufacturer to be used for in vitro diagnostic examination.
1.2 Object
1.2.1 Aspects included in scope
Addition:
Add the following two new items:
aa) biohazards;
bb) hazardous chemical substances.
---------------------- Page: 7 ----------------------
– 6 – IEC 61010-2-101:2018 © IEC 2018
1.2.2 Aspects excluded from scope
Addition:
Add the following new item and note:

aa) the handling or manipulation outside the equipment of material under analysis.

NOTE Requirements covering these subjects are the responsibility of committees preparing the relevant

standards.
2 Normative references
This clause of Part 1 is applicable except as follows:
Addition:
Add the following new references to the list:
ISO 14971, Medical devices – Application of risk management to medical devices

ISO 18113-5, In vitro diagnostic medical devices – Information supplied by the manufacturer

(labelling) – Part 5: In vitro diagnostic instruments for self-testing
3 Terms and definitions
This clause of Part 1 is applicable except as follows:
3.1 Equipment and states of equipment
Addition:
Add the following new terms:
3.1.101
SAMPLE ZONE
area where OPERATOR access is typically unintended

Note 1 to entry: The inside of this zone presents mechanical HAZARDS and a more likely probability of

biohazardous human skin puncture.
3.1.102
LOADING ZONE
area of automated equipment where an OPERATOR handles sample or reagent material
3.5.12 RESPONSIBLE BODY
Addition:
Add the following new note:
Note 1 to entry: This is not the European Union's responsible authority.
4 Tests
This clause of Part 1 is applicable.
---------------------- Page: 8 ----------------------
IEC 61010-2-101:2018 © IEC 2018 – 7 –
5 Marking and documentation
This clause of Part 1 is applicable except as follows:
5.1.1 General
Replacement:
Replace the third paragraph with the following new text:

Letter symbols for quantities and units shall be in accordance with IEC 60027 (all parts).

Internationally recognized symbols, including those of Table 1, shall be used as far as

possible. If other additional symbols are required, it shall not be possible to confuse them with

the internationally recognized symbols. There are no colour requirements for symbols.

Graphic symbols shall be explained in the documentation.
5.1.2 Identification
Replacement:
Replace the text with the following new text:
Equipment shall, as a minimum, be marked with the following information:

a) manufacturer’s name or trade mark, and the address. The address shall include at least

the city and country;

NOTE 1 National regulation may require more details on the address than required in a).

b) model number, name, or other means of identifying the equipment.

The following additional information shall be marked on the equipment or packaging or in the

instructions for use:

1) the serial number, for example SN XXXX or alternatively the batch code, preceded by

‘LOT’, using symbol 102 of Table 1;
2) the following information:
i) a clear indication that the equipment is IVD medical equipment;

ii) if applicable, a clear indication that the equipment is self-test IVD medical

equipment;

iii) if a potential RISK is posed, the identification of detachable components by the

manufacturer and the part identification, and where appropriate the batch code,
etc.;

3) instructions for use requiring that the OPERATOR only use consumables that are within

their expiration date. Where this is required by regulation, the name and address of the

authorized representative of the manufacturer.

NOTE 2 For example, in the European Union this is the natural or legal person as established within

the European Community.
---------------------- Page: 9 ----------------------
– 8 – IEC 61010-2-101:2018 © IEC 2018
Table 1 – Symbols
Addition:
Add the following new symbols to Table 1:
Number Symbol Publication Description
Background colour
– optional;
Symbol colour
101 ISO 7000- 0659 (2004-01) Biological RISKS
– optional;
Outline / outline colour
– optional;
102 ISO 7000- 2492 (2004-01) Batch code
5.1.5 TERMINALS, connections and operating devices
Addition:
Add the following new subclause:
5.1.5.101 Gas and liquid connections

If necessary for safety, the equipment shall be clearly marked near the connector on the

equipment with:

a) a means of identifying the gas or liquid to be used. Where no internationally recognized

symbol (including chemical formulae) exists, the equipment shall be marked with
symbol 14 of Table 1;

b) the maximum permitted pressure, or alternatively symbol 14 of Table 1 (see 5.4.3).

Conformity is checked by inspection.
Addition:
Add the following new subclause:
5.1.101 Transport and storage

Packaging of equipment shall be labelled to indicate any special conditions for transport or

storage (see 5.4.102).
Conformity is checked by inspection.
5.3 Durability of markings
Replacement:
Replace the first paragraph with the following new text:
---------------------- Page: 10 ----------------------
IEC 61010-2-101:2018 © IEC 2018 – 9 –

Markings required by 5.1.2 to 5.2 shall remain clear and legible under conditions of NORMAL

USE, and resist the effects of temperature and rubbing, and of solvent and reagents likely to

be encountered in NORMAL USE, including cleaning and decontaminating agents specified by

the manufacturer.
Addition:
Add, after the second paragraph, the following new text:

If a solvent or reagent specified for use with the equipment could affect the durability of a

particular marking, that marking is also rubbed for 30 s with the most frequently used and/or

aggressive solvent or reagent to which the equipment is likely to be exposed in NORMAL USE.

A representative sample of groups of solvents or reagents likely to have a similar effect can

optionally be used.
5.4.1 General
Deletion:
Delete Note 2.
5.4.3 Equipment installation
Replacement:
Replace the title and text with the following new title and text:
5.4.3 Equipment transportation, installation and assembly instructions

Documentation for the RESPONSIBLE BODY shall include the following, if applicable:

a) instructions for transportation after delivery to the RESPONSIBLE BODY;
b) floor loading requirements;
NOTE Mass and dimensions are sufficient information for floor loading.
c) individual mass of heavy units;

d) location and mounting instructions, including the space required for ventilation, and for

safe and efficient OPERATOR maintenance;
e) assembly instructions;
f) instructions for protective earthing;
g) the sound data required by 12.5.1;

h) instructions relating to the handling, containment and exhaust of hazardous substances,

including any requirements for preventing back-syphonage;

i) any drainage systems required where a HAZARD could occur from the discharge of

biological and chemical substances and hot fluids;

j) details of protective measures relating to hazardous radiation (see Clause 12);

k) connections to the supply;
l) for PERMANENTLY CONNECTED EQUIPMENT only:

1) MAINS supply requirements and details of connections, including the RATED temperature

of the cable required at maximum RATED ambient temperature;

2) requirements for any external switch or circuit-breaker (see 6.11.3.1) and external

overcurrent protection devices (see 9.6.1) and a recommendation that the switch or

circuit-breaker be near the equipment if this is necessary for safety;
---------------------- Page: 11 ----------------------
– 10 – IEC 61010-2-101:2018 © IEC 2018

m) requirements and safety characteristics for special external services, for example:

maximum and minimum temperature, pressure, or flow of air or cooling liquid.
Conformity is checked by inspection of the documentation.
5.4.4 Equipment operation
Replacement:
Replace the first paragraph with the following new text:
Instructions for use shall include, if applicable:

a) details of operating controls and their use in all operating modes, with any sequence of

operation;
NOTE 1 IEC 60073 gives guidance on colours and symbols of operating controls.

b) an instruction not to position the equipment in such a way that it is difficult to operate the

disconnecting device (see 6.11);

c) instructions for interconnections to accessories and other equipment, including details of

suitable accessories, detachable parts and any special consumable materials;
d) limits for intermittent operation;

e) an explanation of symbols used on the equipment and, where HAZARDS are involved, the

reason for using a symbol in each particular case;

f) instructions for any actions to be taken by an OPERATOR to deal with a HAZARD resulting

from equipment spills, lock-ups, container breakage and similar malfunctions;

g) instructions and recommendations for cleaning and decontamination, with materials

recommended (see 11.2);
h) instructions for the disposal of hazardous waste;

i) if NORMAL USE involves the handling of hazardous chemical substances, instructions on

correct use and any need for training or personal protection measures;

j) appropriate instruction to use personal protective equipment (e.g. gloves, gowns) where

there could be contact with the skin when handling potentially infectious substances or

surfaces (such as human samples or reagents);

k) appropriate instructions and requirements for protection of the mouth, nose or eyes shall

be given where the equipment could emit hazardous aerosol vapours in NORMAL USE;

l) appropriate instructions and requirements for protective devices, such as protective

glasses shall be given where potentially hazardous visible or invisible radiation could be

emitted;

m) detailed instructions about RISK reduction procedures relating to flammable liquids (see

9.5 c));

n) details of methods of reducing the RISKS of burns from surfaces permitted to exceed the

temperature limits of 10.1;

o) appropriate warnings to reduce RISK during loading and unloading of samples and

reagents (see 7.3.101);

p) instructions for the RESPONSIBLE BODY to ensure that all retaining hardware (e.g. screws,

fasteners) are in place on removable PROTECTIVE BARRIERS, and the removable PROTECTIVE

BARRIERS are in place on the instrument during normal operation;

q) a statement that, if a TOOL is required to remove a fixed PROTECTIVE BARRIER and/or

ENCLOSURE guarding a SAMPLE ZONE, access to that tool should be controlled by the

RESPONSIBLE BODY;
r) a statement listing the tools to be controlled by the RESPONSIBLE BODY.

NOTE 2 Information on decontaminants, their use, dilution and potential application is contained in the Laboratory

Biosafety Manual, published by the World Health Organization and the Biosafety in Microbiological and Biomedical

---------------------- Page: 12 ----------------------
IEC 61010-2-101:2018 © IEC 2018 – 11 –

Laboratories, published by Centers for Disease Control and Prevention and National Institutes of Health,

Washington. There are also national guidelines that cover these areas.

NOTE 3 Cleaning and decontamination can be necessary as a safeguard when equipment and its accessories are

maintained, repaired or transferred. Preferably manufacturers provide a format for the RESPONSIBLE BODY to certify

to those maintaining, repairing or transferring equipment that such a treatment has been carried out.

Conformity is checked by inspection of the documentation.
Addition:
Add the following new subclauses:
5.4.4.101 Instructions for use of self-test IVD medical equipment

Instructions for use of self-test IVD medical equipment shall comply with ISO 18113-5.

5.4.101 Removal of equipment from use for repair or disposal

Instructions shall be provided for the RESPONSIBLE BODY for eliminating or reducing HAZARDS

involved in removal from use, transpo
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.