oSIST prEN IEC 61010-2-040:2020

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

IEC 61010-2-040:2020 is available as IEC 61010-2-040:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 61010-2-040:2020 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4. Examples of such equipment include the following: - sterilizers and disinfectors using steam and/or hot water as the sterilant; - sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant; - sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and - washer-disinfectors. 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: - it is established on the basis of the third edition (2010) of IEC 61010‑1 and its Amendment 1 (2016); - added tolerance for stability of a.c. voltage test equipment to 6.8.3.1; - the status of a Group Safety Publication has been removed (this does not change the technical requirements in the document).

Sicherheitsbestimmungen für elektrische Mess-, Steuer-, Regel- und Laborgeräte - Teil 2-040: Besondere Anforderungen an Sterilisatoren und Reinigungs-Desinfektionsgeräte für die Behandlung medizinischen Materials

Règles de sécurité pour appareils électriques de mesurage, de régulation et de laboratoire - Partie 2-040: Exigences particulières pour stérilisateurs et laveurs désinfecteurs utilisés pour traiter le matériel médical

IEC 61010-2-040:2020 est disponible sous forme de IEC 61010-2-040:2020 RLV qui contient la Norme internationale et sa version Redline, illustrant les modifications du contenu technique depuis l'édition précédente.L'IEC 61010-2-040:2020 définit les exigences de sécurité pour les appareils électriques destinés à la stérilisation, au lavage et à la désinfection du matériel médical dans les domaines médicaux, vétérinaires, pharmaceutiques et de laboratoire, lorsqu'ils sont utilisés dans les conditions d'environnement de 1.4. Exemples de ce type d'appareils: - les stérilisateurs et désinfecteurs utilisant la vapeur et/ou l'eau chaude comme agent stérilisant; - les stérilisateurs et désinfecteurs utilisant le gaz toxique, l'aérosol toxique, ou la vapeur toxique comme agent stérilisant; - les stérilisateurs et désinfecteurs utilisant de l'air chaud ou du gaz inerte chaud comme agent stérilisant; et - les laveurs désinfecteurs. 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: - elle est établie sur la base de la troisième édition (2010) de l'IEC 61010-1 et son Amendement 1 (2016); - tolérance ajoutée pour la stabilité des matériels d'essai sous tension alternative spécifiés en 6.8.3.1; - le statut de publication groupée de sécurité a été supprimé (ce qui ne modifie pas les exigences techniques du document).

Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko uporabo - 2-040. del: Posebne zahteve za sterilizatorje in pralnike-dezinfektorje, ki se uporabljajo za obdelavo medicinskih materialov

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Dec-2019
• ICS: 11.080.10 - Sterilizing equipment
• ICS: 19.080 - Electrical and electronic testing
• ICS: 71.040.10 - Chemical laboratories. Laboratory equipment
• Technical Committee: MOV - Measuring equipment for electromagnetic quantities
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 28-Feb-2022
• Due Date: 05-May-2022
• Directive: 2014/35/EU - Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits
• Mandate: M/511 - Mandate to CEN, CENELEC and ETSI relating to harmonised standards in the field of the Low Voltage Directive
• Ref Project: EN IEC 61010-2-040:2021 - 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

RELATIONS

• Revised: SIST EN 61010-2-040:2016 - 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 (IEC 61010-2-040:2015)
• Effective Date: 02-Jul-2019
• Replaces: SIST EN 61010-2-040:2016 - 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 (IEC 61010-2-040:2015)
• Effective Date: 30-Nov-2021

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN IEC 61010-2-040:2019
01-december-2019
Varnostne zahteve za električno opremo za meritve, nadzor in laboratorijsko

uporabo - 2-040. del: Posebne zahteve za sterilizatorje in pralnike-dezinfektorje, ki

se uporabljajo za obdelavo medicinskih materialov

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
Règles de sécurité pour appareils électriques de mesurage, de régulation et de

laboratoire - Partie 2-040: Exigences particulières pour stérilisateurs et laveurs

désinfecteurs utilisés pour traiter le matériel médical
Ta slovenski standard je istoveten z: prEN IEC 61010-2-040:2019
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
19.080 Električno in elektronsko Electrical and electronic
preskušanje testing
71.040.10 Kemijski laboratoriji. Chemical laboratories.
Laboratorijska oprema Laboratory equipment
oSIST prEN IEC 61010-2-040:2019 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN IEC 61010-2-040:2019
66/699/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 61010-2-040 ED3
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2019-10-04 2019-12-27
SUPERSEDES DOCUMENTS:
66/696/RR
IEC TC 66 : SAFETY OF MEASURING, CONTROL AND LABORATORY EQUIPMENT
SECRETARIAT: SECRETARY:
United Kingdom Mr David Hyde
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
SC 62D
Other TC/SCs are requested to indicate their interest, if
any, in this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft
for Vote (CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of

which they are aware and to provide supporting documentation.
TITLE:

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
PROPOSED STABILITY DATE: 2023
NOTE FROM TC/SC OFFICERS:

This CDV is intended only to align IEC 61010-2-040:2015 with IEC 61010-1:2010 and its amendment

1:2016 and provide minor editorial corrections. With this revision IEC 61010-2-040 will be in line with

Copyright © 2019 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to

download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National

Committee positions. You may not copy or "mirror" the file or printed version of the document, or any part of it, for

any other purpose without permission in writing from IEC.
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the latest requirements of IEC 61010-1 + A1.

This document contains no technical changes to already accepted base documents (IEC 61010-1:2010

and its amendment 1:2016 and IEC 61010-2-040:2015) but two;

1. Clause 6.8.3.1 is modified because otherwise it would need a specific European deviation in order to

be harmonised to the LVD 2014/35/EU (ref. NAC assessment of IEC 61010-1/A1).

2. In 15.1 as an alternative method, for interlock systems containing electric/electronic or

programmable components (E/E/P components) the reliability and design requirements can be

determined by applying, for example IEC 62061 (SIL) or ISO 13849 (PL).

Further technical development is reserved for a new amendment or edition to be initiated separately as

necessary.

This alignment is realised as a new 3rd edition of IEC 61010-2-040 simply because of document

control; the previous edition 2.0 is based on the third edition of IEC 61010-1:2010 (without the

Amendment 1:2016) and amending it to incorporate the contents of IEC 61010-1 Amendment 1 would

need an unnecessary repeating of the requirements in that amendment 1 that are not particular for the

equipment in the scope of IEC 61010-2-040 . Furthermore, technically, one would need to follow 4

documents in parallel to get the full text of this part 2 (61010-1:2010, 61010-1 A1:2016, 61010-2-

040:2015, and 61010-2-040 A1).With this approach, and when the consolidated version of IEC 61010-

1:2010/A1:2016 conveniently is published, only two documents are needed.
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1 CONTENTS

2 FOREWORD ........................................................................................................................... 6

3 1 Scope and object ............................................................................................................. 8

4 1.1.1Equipment included in scope ...................................................................................... 8

5 1.1.2Equipment excluded from scope ................................................................................. 8

6 1.2.1Aspects included in scope .......................................................................................... 9

7 1.2.2Aspects excluded from scope ..................................................................................... 9

8 2 Normative references ...................................................................................................... 9

9 3 Terms and definitions ...................................................................................................... 9

10 4 Tests ............................................................................................................................. 10

11 4.3.2.4Covers and removable parts .................................................................................. 10

12 4.3.2.12Duty cycle ............................................................................................................ 11

13 4.3.2.101Non-electrical supplies and services .................................................................. 11

14 4.4.2.1General ................................................................................................................. 11

15 4.4.2.5Motors ................................................................................................................... 11

16 4.4.2.13Interlocks ............................................................................................................. 11

17 4.4.2.101Pressure controllers ........................................................................................... 11

18 4.4.2.102Failure, or partial failure, of the MAINS supply ..................................................... 12

19 4.4.2.103Failure, or partial failure, of other supplies and services .................................... 12

20 5 Marking and documentation ........................................................................................... 12

21 5.1.2Identification ............................................................................................................. 12

22 5.1.101Overpressure safety device .................................................................................. 12

23 5.1.102PRESSURE VESSELS and shell boilers ...................................................................... 12

24 5.2Warning markings ........................................................................................................ 13

25 5.4.1General .................................................................................................................... 13

26 5.4.2Equipment ratings..................................................................................................... 13

27 5.4.3Equipment installation .............................................................................................. 13

28 5.4.3.101Special systems ................................................................................................. 14

29 5.4.4Equipment operation ................................................................................................ 15

30 5.4.5Equipment maintenance and service ........................................................................ 16

31 5.4.101OPERATOR training ................................................................................................. 16

32 5.4.101.1General ............................................................................................................. 16

33 5.4.101.2Procedures for potentially hazardous actions ..................................................... 17

34 6 Protection against electric shock ................................................................................... 17

35 6.2.2Examination ............................................................................................................. 17

36 6.8.3.1The a.c. voltage test .............................................................................................. 17

37 6.9.2Insulating materials .................................................................................................. 17

38 7 Protection against mechanical HAZARDS ......................................................................... 17

39 7 Protection against mechanical HAZARDS and against HAZARDS related to

40 mechanical functions ..................................................................................................... 18

41 7.1General ....................................................................................................................... 18

42 7.4Stability ....................................................................................................................... 18

43 7.5.101Transfer of LOADS into and out of the CHAMBER...................................................... 18

44 7.101Doors, conveyors, etc .............................................................................................. 18

45 7.102 Access to the CHAMBER ......................................................................................... 19

46 7.103 Prevention of entry of gases, steam or liquids ....................................................... 19

47 7.104 Prevention of new OPERATING CYCLE ...................................................................... 19

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48 7.105 Pressure-retaining parts of a door ......................................................................... 20

49 7.106 Doors of equipment for use with fluids in containers .............................................. 20

50 7.107Double-ended equipment ......................................................................................... 20

51 7.108Transport and packaging ......................................................................................... 21

52 7.109Guards and panelling ............................................................................................... 21

53 7.110Emergency shut-down device .................................................................................. 21

54 8 Mechanical resistance to shock and impact ................................................................... 22

55 9 Protection against the spread of fire .............................................................................. 22

56 9.1 General ................................................................................................................. 22

57 9.5.101Requirements for equipment containing or using flammable gases ....................... 22

58 10 Equipment temperature limits and resistance to heat ..................................................... 23

59 10.1Surface temperature limits for protection against burns ............................................. 23

60 10.3Other temperature measurements ............................................................................. 23

61 10.5.101Other materials ................................................................................................... 23

62 11 Protection against HAZARDS from fluids and solid foreign objects ................................... 24

63 11.1General ..................................................................................................................... 24

64 11.7.2Leakage and rupture at high pressure ..................................................................... 24

65 11.7.4Overpressure safety device .................................................................................... 24

66 11.101Discharge to atmosphere ....................................................................................... 25

67 11.102Instruments and indicating devices ........................................................................ 25

68 11.103Protection of hot and cold water services ............................................................... 26

69 11.104Equipment with inflatable or pressure-activated seals ............................................ 26

70 12 Protection against radiation, including laser sources, and against sonic and

71 ultrasonic pressure ........................................................................................................ 26

72 12.5Sonic and ultrasonic pressure .................................................................................... 27

73 12.5.1Sound level ............................................................................................................ 27

74 13 Protection against liberated gases, substances, explosion and implosion ...................... 27

75 13.1Poisonous and injurious gases and substances ......................................................... 27

76 13.1.101CHAMBER discharge systems ............................................................................... 28

77 13.1.101.1Discharge from the CHAMBER ............................................................................ 28

78 13.1.101.2Failure of a CHAMBER exhaust system .............................................................. 28

79 13.1.101.3Protection from gases liberated from a drain .................................................... 28

80 13.1.101.4Local exhaust ventilation .................................................................................. 29

81 13.1.102LOAD access after a fault ..................................................................................... 29

82 13.1.103HAZARDS arising from the use of toxic sterilant .................................................... 29

83 13.1.103.1CHAMBER leakage ............................................................................................. 29

84 13.1.103.2Protection against gases liberated from the LOAD ............................................. 29

85 13.1.103.3Failure of room ventilation system .................................................................... 30

86 13.1.103.4Materials in contact with sterilant ..................................................................... 30

87 13.1.104Pathogenic substances ....................................................................................... 30

88 13.2Explosion and implosion ............................................................................................ 30

89 13.2.101Materials in contact with sterilant ........................................................................ 30

90 13.2.102Explosion, implosion and fire of toxic gas sterilizers............................................ 31

91 13.2.102.1Flammable sterilants ........................................................................................ 31

92 13.2.102.2Heating of flammable liquid sterilant ................................................................ 31

93 13.101Other HAZARDS arising from the use of toxic sterilants ............................................ 31

94 13.101.1Opening or disconnecting a sterilant supply system ............................................ 32

95 13.101.2Gas blending ...................................................................................................... 32

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96 13.101.3Sterilant supply ................................................................................................... 32

97 13.101.4Supply from sterilant cartridges........................................................................... 32

98 13.101.5Isolation of any part of the sterilant supply system .............................................. 32

99 13.101.6Failure of a sterilant supply control system ......................................................... 32

100 13.102Chemical dosing systems ...................................................................................... 33

101 14 Components .................................................................................................................. 33

102 14.101PRESSURE VESSELS and shell boilers ....................................................................... 33

103 14.102Access ports .......................................................................................................... 33

104 14.103Control systems ..................................................................................................... 33

105 14.104Microprocessors .................................................................................................... 34

106 14.105Asbestos................................................................................................................ 34

107 15 Protection by interlocks ................................................................................................. 34

108 16 HAZARDS resulting from application ................................................................................ 34

109 17 RISK assessment ........................................................................................................... 35

110 Annexes ............................................................................................................................... 36

111 Annex G (informative) Leakage and rupture from fluids under pressure ......................... 36

112 Annex L (informative) Index of defined terms .................................................................... 37

113 Bibliography .......................................................................................................................... 38

114
115
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116 INTERNATIONAL ELECTROTECHNICAL COMMISSION
117 ____________
118
119 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
120 MEASUREMENT, CONTROL, AND LABORATORY USE –
121
122 Part 2-040: Particular requirements for sterilizers and
123 washer-disinfectors used to treat medical materials
124
125 FOREWORD

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

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

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

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

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

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

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

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

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

135 agreement between the two organizations.

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

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

138 interested IEC National Committees.

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

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

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

142 misinterpretation by any end user.

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

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

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

146 the latter.

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

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

149 services carried out by independent certification bodies.

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

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

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

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

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

155 Publications.

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

157 indispensable for the correct application of this publication.

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

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

160 International Standard IEC 61010-2-040 has been prepared by IEC technical committee 66:

161 Safety of measuring, control and laboratory equipment.

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

163 constitutes a technical revision.

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

165 edition:

166 a) It is established on the basis of the third edition (2010) of IEC 61010-1 and its amendment

167 1 (2016)
168 b) Adaptation of text changes introduced by Amendment 1 of IEC 61010-1:2010;

169 c) Added tolerance for stability of a.c. voltage test equipment to Clause 6.8.3.1;

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170 The text of this standard is based on the following documents:
FDIS Report on voting
66/xxx/FDIS 66/xxx/RVD
171

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

173 the report on voting indicated in the above table.

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

175 A list of all parts in the IEC 61010 series, published under the general title Safety

176 requirements for electrical equipment for measurement, control, and laboratory use, can be

177 found on the IEC website.

178 This Part 2-040 is intended to be used in conjunction with the latest edition of IEC 61010-1. It

179 was established on the basis of the third edition (2010) of IEC 61010-1 and its amendment 1

180 (2016), hereinafter referred to as Part 1.

181 This Part 2-040 supplements or modifies the corresponding clauses in Part 1 so as to convert

182 that publication into the IEC standard: Particular requirements for sterilizers and washer-

183 disinfectors used to treat medical materials.

184 Where a particular subclause of Part 1 is not mentioned in this Part 2-040, that subclause

185 applies as far as is applicable. Where this Part 2-040 states “addition”, “modification”,

186 “replacement”, or “deletion”, the relevant requirement, test specification or note in Part 1 shall

187 be adapted accordingly.
188 In this standard:
189 1) the following print types are used:
190 – requirements: in roman type;
191 – NOTES: in small roman type;
192 – conformity and tests: in italic type;

193 – terms used throughout this standard which have been defined in Clause 3: SMALL

194 ROMAN CAPITALS.

195 2) subclauses, figures, and tables which are additional to those in Part 1 are numbered

196 starting from 101; additional annexes are lettered starting from AA and additional list

197 items are lettered from aa).

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

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

200 related to the specific publication. At this date, the publication will be
201 • reconfirmed,
202 • withdrawn,
203 • replaced by a revised edition, or
204 • amended.
205
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206 SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR
207 MEASUREMENT, CONTROL, AND LABORATORY USE –
208
209 Part 2-040: Particular requirements for sterilizers and
210 washer-disinfectors used to treat medical materials
211
212
213
214 1 Scope and object
215 This clause of Part 1 is applicable except as follows:
216 1.1.1 Equipment included in scope
217 Replacement:
218 Replace the existing text with the following:

219 This part of IEC 61010 specifies safety requirements for electrical equipment intended for

220 sterilization, washing, and disinfection of medical materials in the medical, veterinary,

221 pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4.

222 Examples of such equipment include the following:

223 a) sterilizers and disinfectors using steam, and/or hot water as the sterilant;

224 b) sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;

225 c) sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and

226 d) washer disinfectors.
227 1.1.2 Equipment excluded from scope
228 Addition:
229 Add the following note to item f):
230 NOTE IEC 60601-1 defines medical electrical equipment as follows:

231 Electrical equipment, provided with not more than one connection to a particular supply MAINS and intended by its

232 manufacturer to be used in the diagnosis, treatment, or monitoring of a patient; and that makes physical or

233 electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or

234 from the patient.
235 Addition:
236 Add the following new second paragraph:
237 This part of IEC 61010 does not apply to the following types of equipment:

238 aa) equipment for use in hazardous atmospheres (see IEC 60079) but does apply to an

239 atmosphere created inside equipment by a flammable sterilizing agent (see 13.0);

240 bb) laboratory equipment for the heating of materials for other purposes than sterilization or

241 disinfection (see IEC 61010-2-010);
242 cc) laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and
243 ISO 10472), unless designed for disinfecting medical materials;
244 dd) dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).
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245 1.2.1 Aspects included in scope
246 Replacement:
247 Replace item g) with the following new text:

248 g) liberated gases (including the non-intentional escape of toxic gas), pathogenic

249 substances, explosion and implosion (see Clause 13).
250 1.2.2 Aspects excluded from scope
251 Addition:
252 Add the following two new items:

253 aa) special requirements for protection against chemical and high-risk micro-biological

254 HAZARDS associated with the LOAD;

255 bb) general requirements for the design of calorifiers, shell boilers and PRESSURE VESSELS.

256 NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and

257 (see 14.101).
PRESSURE VESSELS
258 2 Normative references
259 This clause of Part 1 is applicable except as follows:
260 Addition:
261 Add the following new references:

262 IEC 61770, Electric appliances connected to the water mains — Avoidance of back-siphonage

263 and failure of hose-sets
264 ISO 3585, Borosilicate glass 3.3 — Properties
265 ISO 4126-1, Safety devices
...