CEN ISO/TR 22100-1:2021

SLOVENSKI STANDARD
01-junij-2021
Nadomešča:
SIST-TP CEN ISO/TR 22100-1:2018
Varnost strojev - Povezava z ISO 12100 - 1. del: Povezava med ISO 12100 in
standardi tipov B in C (ISO/TR 22100-1:2021)
Safety of machinery - Relationship with ISO 12100 - Part 1: How ISO 12100 relates to
type-B and type-C standards (ISO/TR 22100-1:2021)
Sicherheit von Maschinen - Beziehung zu ISO 12100 -Teil 1: Wie ISO 12100 und Typ-B-
und Typ-C-Normen zusammenhängen (ISO/TR 22100-1:2021)
Sécurité des machines - Relation avec l'ISO 12100 - Partie 1: Relation entre l'ISO 12100
et les normes de type B et type C (ISO/TR 22100-1:2021)
Ta slovenski standard je istoveten z: CEN ISO/TR 22100-1:2021
ICS:
13.110 Varnost strojev Safety of machinery
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TR 22100-1
TECHNICAL REPORT
RAPPORT TECHNIQUE
February 2021
TECHNISCHER BERICHT
ICS 13.110 Supersedes CEN ISO/TR 22100-1:2017
English Version
Safety of machinery - Relationship with ISO 12100 - Part 1:
How ISO 12100 relates to type-B and type-C standards
(ISO/TR 22100-1:2021)
Sécurité des machines - Relation avec l'ISO 12100 - Sicherheit von Maschinen - Beziehung zu ISO 12100 -
Partie 1: Relation entre l'ISO 12100 et les normes de Teil 1: Wie ISO 12100 und Typ-B- und Typ-C-Normen
type B et type C (ISO/TR 22100-1:2021) zusammenhängen (ISO/TR 22100-1:2021)

This Technical Report was approved by CEN on 26 January 2021. It has been drawn up by the Technical Committee CEN/TC 114.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 10 March 2021.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 22100-1:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relation of this document to the Machinery Directive 2006/42/EC . 4

European foreword
This document (CEN ISO/TR 22100-1:2021) has been prepared by Technical Committee ISO/TC 199
"Safety of machinery" in collaboration with Technical Committee CEN/TC 114 “Safety of machinery” the
secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TR 22100-1:2017.
For relation of this document to the Machinery Directive 2006/42/EC see informative Annex ZA.
Endorsement notice
The text of ISO/TR 22100-1:2021 has been approved by CEN as CEN ISO/TR 22100-1:2021 without any
modification.
Annex ZA
(informative)
Relation of this document to the Machinery Directive 2006/42/EC
ZA.1 General
CEN ISO/TR 22100-1 (identical to ISO/TR 22100-1) provides a transparent guideline how to choose the
appropriate machinery safety standard(s) representing the state of the art and to apply it/them
correctly in order to achieve at a given time a level of tolerable risk by adequate risk reduction for an
actual machine. In this document, the term tolerable risk should be read as residual risk as defined in
ISO 12100-to be compliant with European Union (EU) legislation.
NOTE While the residual risk is defined as the risk remaining after risk reduction measures have been
implemented (see ISO/IEC Guide 51:2014, 3.8), tolerable risk is the level of risk that is accepted in a given context
based on the current values of society (see 3.2). It is generally accepted that the residual risk is equal or lower
than the tolerable risk.
Compared to the international level (where no common legal framework for machinery safety exists) at
the European Union (EU) machinery safety standards are developed by CEN and CENELEC within the
1)
legal framework of the New Approach (New Legislative Framework) to provide presumption of
2)
conformity with relevant Essential Requirements of the EU Machinery Directive 2006/42/EC .
Those standards are harmonized and provide presumption of conformity to 2006/42/EC when cited in
3)
the Official Journal of the EU .
ZA.2 Special relevance of this document for harmonized standards (type-C)
providing presumption of conformity
The methodology as specified in Clause 6 of this document provides detailed guidance for the machine
manufacturer how to choose and evaluate harmonised standards (type-C) in order to achieve
presumption of conformity with Essential Requirements of 2006/42/EC for his actual machine in
accordance with the following statement given in §111 of the Guide to the application of the Machinery
Directive 2006/42/EC:
"Application of the specifications of a C-type standard confers a presumption of conformity with the
essential health and safety requirements of the Machinery Directive covered by the standard provided
the manufacturer has determined in his risk assessment that the scope and the significant hazards
covered by the standard correspond with his actual machinery. Further practical guidance is provided
by ISO/TR 22100-1."
1)
Further information to the New Approach (New Legislative Framework) are provided in the Blue Guide:
https://ec.europa.eu/docsroom/documents/38022
2)
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006L0042
3)
Example for a citation of Harmonized Standards to 2006/42/EC see: https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=uriserv:OJ.L_.2019.075.01.0108.01.ENG&toc=OJ:L:2019:075:TOC
TECHNICAL ISO/TR
REPORT 22100-1
Second edition
2021-01
Safety of machinery — Relationship
with ISO 12100 —
Part 1:
How ISO 12100 relates to type-B and
type-C standards
Sécurité des machines — Relation avec l'ISO 12100 —
Partie 1: Relation entre l'ISO 12100 et les normes de type B et type C
Reference number
ISO/TR 22100-1:2021(E)
©
ISO 2021
ISO/TR 22100-1:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO/TR 22100-1:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General structure of the system of machinery safety standards . 2
5 System of type-A, type-B and type-C standards . 2
5.1 Type-A standard (ISO 12100) . 2
5.2 Type-B standards . 6
5.2.1 General. 6
5.2.2 Type-B1 standards . 6
5.2.3 Type-B2 standards . 6
5.3 Type-C standards . 6
5.3.1 General. 6
5.3.2 Content provided by type-C standards . 7
5.3.3 Deviations in a type-C standard from a type-B standard . 7
6 Practical application of ISO 12100, type-B and type-C standards in order to design a
machine to achieve a level of tolerable risk by adequate risk reduction .7
6.1 General . 7
6.2 Application of an appropriate type-C standard . 8
6.2.1 General. 8
6.2.2 Steps to be followed . 9
7 Navigating appropriate type-B machinery safety standards .10
Annex A (informative) Iterative process of risk assessment and risk reduction .12
Annex B (informative) Types of ISO documents .13
Bibliography .14
ISO/TR 22100-1:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www. iso. org/d irectives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www. iso. org/p atents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www. iso. org/i so/f oreword. html.
This document was prepared by Technical Committee ISO/TC 199, Safety of machinery.
This second edition cancels and replaces the first edition (ISO/TR 22100-1:2015), which has been
technically revised.
The main changes compared to the previous edition are as follows.
— the wording "…, hazardous situation(s) or hazardous event(s)" has been deleted from 5.3.2 (NOTE
and last paragraph) and 6.2.2 (subheading "Step 4B"and the following two paragraphs as well as
Step 4C, fifth paragraph), eight times, in total;
— in 6.2.1, second paragraph, second sentence "this part of ISO 22100" has been corrected to "that
type-C standard";
— the sentence given in 6.2.2, Step 4C, as paragraph below the Note has also been inserted as new
penultimate paragraph to Step 4B.
A list of all parts in the ISO/TR 22100 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved

ISO/TR 22100-1:2021(E)
Introduction
This document is written to assist the designer/manufacturer of machinery and related components
in understanding and navigating the different types of ISO machinery safety standards. It presents
the different ISO deliverables (see Annex B) and explains the type-A, type-B and type-C structure of
machinery safety standards and their interrelationship with regard to the practical design of machinery
subjected to adequate risk reduction to achieve tolerable risk.
This document can be helpful for standard writing committees (type-B and type-C), too. However, it
does not provide specification of the general content that is expected to be included in the different
types of machinery safety standards. This specification is given in ISO Guide 78.
This document includes a visual representation of many ISO machinery safety standards to assist in
improving understanding of the interrelationships and linkages between these documents.
TECHNICAL REPORT ISO/TR 22100-1:2021(E)
Safety of machinery — Relationship with ISO 12100 —
Part 1:
How ISO 12100 relates to type-B and type-C standards
1 Scope
This document provides assistance to the designer/manufacturer of machinery and related components
as to how the system of existing type-A, type-B and type-C machinery safety standards should be
applied in order to design a machine to achieve a level of tolerable risk by adequate risk reduction.
This document explains the general principles of ISO 12100 and how this type-A standard is used for
practical cases in conjunction with type-B and type-C machinery safety standards.
This document provides assistance to standards-writing committees on how ISO 12100 and type-B and
type-C standards relate and explains their function in the risk assessment and risk reduction process
according to ISO 12100.
This document includes an overview of existing categories of type-B standards to assist standards
readers and writers to navigate the many standards.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 12100:2010, Safety of machinery — General principles for design — Risk assessment and risk reduction
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 12100 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
adequate risk reduction
risk reduction that is at least in accordance with legal requirements, taking into consideration the
current state of the art
[SOURCE: ISO 12100:2010, 3.18, modified — Note 1 to entry has been removed.]
3.2
tolerable risk
level of risk that is accepted in a given context based on the current values of society
Note 1 to entry: The terms “acceptable risk” and “tolerable risk” are considered to be synonymous.
[SOURCE: ISO/IEC Guide 51:2014, 3.15, modified — In Note 1 to entry, the words “For the purpose of
this Guide” have been deleted.]
ISO/TR 22100-1:2021(E)
4 General structure of the system of machinery safety standards
Standards on safety of machinery have the following structure:
— type-A standards (basic safety standards) giving basic concepts, principles for design, and general
aspects that can be applied to machinery;
— type-B standards (generic safety standards) dealing with one safety aspect or one type of safeguard
that can be used across a wide range of machinery;
— type-C standards (machine safety standards) dealing with detailed safety requirements for a
particular machine or group of machines.
As shown in Figure 1, ISO 12100 is the type-A standard specifying the general principles for safety of
machinery and applies to all machinery.
Figure 1 — General structure of the system of machinery safety standards
5 System of type-A, type-B and type-C standards
5.1 Type-A standard (ISO 12100)
ISO 12100 specifies the principle strategy for safety of machinery. Risk assessment and adequate
risk reduction by an iterative three-step method are the imperative measures to design a machine to
achieve a level of tolerable risk.
To implement risk assessment and risk reduction, the following actions should be taken by the designer
in the order given (see Figure 2):
a) determine the limits of the machinery, which includes the intended use and any reasonably
foreseeable misuse thereof;
b) identify the hazards and associated hazardous situations;
c) estimate the risk for each identified hazard and hazardous situation;
d) evaluate the risk and decision whether a risk reduction is needed or not;
e) eliminate the hazard or reduction of the risk associated with the hazard by means of protective
measures/risk reduction measures.
NOTE 1 For the purposes of this document, the terms “protective measure” (see ISO 12100:2010, 3.19) and
“risk reduction measure” are synonymous and referred to any action or means used to eliminate hazards and/or
reduce risks.
2 © ISO 2021 – All rights reserved

ISO/TR 22100-1:2021(E)
Actions a) to d) are related to risk assessment and action e) to risk reduction.
Risk assessment is a series of logical steps to enable, in a systematic way, the identification of hazards
as well as the estimation and evaluation of the risks associated with machinery.
As a result of the risk assessment, the hazards requiring risk reduction are determined. Iteration of the
process of risk assessment can be necessary to eliminate newly generated hazards as far as reasonably
practicable or to adequately reduce associated risks by the implementation of protective measures/risk
reduction measures in order to achieve tolerable risk.
Protective measures/risk reduction measures are the combination of the measures implemented by the
designer and the user in accordance with Figure 3. Measures which can be incorporated at the design
stage are preferable to those implemented by the user and usually prove more effective.
The objective to be met is the greatest practicable risk reduction. The strategy defined in this clause
is represented by the flowchart in Figure 2. The process itself is iterative and several successive
applications can be necessary to reduce the risk, making the best use of available technology. In
carrying out this process, it is necessary to take into account these four factors, in the following order
of preference:
— the safety of the machine during all the phases of its life cycle;
— the ability of the machine to perform its function;
— the usability of the machine;
— the manufacturing, operational and dismantling costs of the mach
...