1、Safety of machinery - Relationship with ISO 12100Part 1: How ISO 12100 relates to type-B and type-C standards (ISO/TR 22100-1:2015)PD CEN ISO/TR 22100-1:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN ISO
2、/TR 22100-1 June 2017 ICS 13.110 English Version Safety of machinery - Relationship with ISO 12100 - Part 1: How ISO 12100 relates to type-B and type-C standards (ISO/TR 22100-1:2015) Scurit des machines - Relation avec lISO 12100 - Partie 1: Relation entre lISO 12100 et les normes de type B et type
3、 C (ISO/TR 22100-1:2015) This Technical Report was approved by CEN on 27 June 2017. It has been drawn up by the Technical Committee CEN/TC 114. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Rep
4、ublic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN
5、 DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TR 22100-1:2017 ENational forewordThis Published Document i
6、s the UK implementation of CEN ISO/TR 22100-1:2017. It is identical to ISO/TR 22100-1:2015. It supersedes PD ISO/TR 22100-1:2015, which is withdrawnThe UK participation in its preparation was entrusted to Technical Committee MCE/3, Safeguarding of machinery.A list of organizations represented on thi
7、s committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 94042 2ICS
8、13.110Compliance with a British Standard cannot confer immunity from legal obligations.This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 November 2017.Amendments/corrigenda issued since publicationDate Text affected30 November 2017 This co
9、rrigendum renumbers PD ISO/TR 22100-1:2015 as PD CEN ISO/TR 22100-1:2017PUBLISHED DOCUMENTPD CEN ISO/TR 221001:2017TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN ISO/TR 22100-1 June 2017 ICS 13.110 English Version Safety of machinery - Relationship with ISO 12100 - Part 1: How ISO 12100
10、relates to type-B and type-C standards (ISO/TR 22100-1:2015) Scurit des machines - Relation avec lISO 12100 - Partie 1: Relation entre lISO 12100 et les normes de type B et type C (ISO/TR 22100-1:2015) This Technical Report was approved by CEN on 27 June 2017. It has been drawn up by the Technical C
11、ommittee CEN/TC 114. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Nether
12、lands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN
13、All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TR 22100-1:2017 EPD CEN ISO/TR 221001:2017CEN ISO/TR 22100-1:2017 (E) 3 European foreword This document (CEN ISO/TR 22100-1:2017) has been prepared by Technical Committee ISO/TC 199
14、“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 identi
15、fying any or all such patent rights. 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. For relationship with EU Directive, see informative Annex ZA, which is an integra
16、l part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to announce this Technical Report: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of
17、 Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TR 22100-1:2015 has b
18、een approved by CEN as CEN ISO/TR 22100-1:2017 without any modification. PD CEN ISO/TR 221001:2017CEN ISO/TR 22100-1:2017 (E) 4 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 22100-1:2015) provides for the f
19、irst time 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 tol
20、erable risk should be read as residual risk as defined in ISO 12100-1 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
21、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 U
22、nion (EU) machinery safety standards are developed by CEN and CENELEC within the legal framework of the New Approach (New Legislative Framework)1)to provide presumption of conformity with relevant Essential Requirements of the EU Machinery Directive 2006/42/EC2). Those standards are harmonized and p
23、rovide presumption of conformity to 2006/42/EC when cited in the Official Journal of the EU3). 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 ma
24、chine 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 Directiv
25、e 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 signif
26、icant hazards covered by the standard correspond with his actual machinery. Further practical guidance is provided by ISO/TR 22100-1:2015.“ 1) Further information to the New Approach (New Legislative Framework) are provided in the Blue Guide: http:/ec.europa.eu/DocsRoom/documents/18027 2) http:/eur-
27、lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A32006L0042 3) Example for a citation of Harmonized Standards to 2006/42/EC see http:/eur-lex.europa.eu/legal-content/DE/TXT/?uri=uriserv:OJ.C_.2016.173.01.0001.01.DEU type-B standards (generic safety standards) dealing with one safety aspect or one typ
28、e 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
29、 machinery and applies to all machinery.CBe.g. ISO 13857, ISO 14122ISO 12100AFigure 1 General structure of the system of machinery safety standards5 System of type-A, type-B and type-C standards5.1 Type-A standard (ISO 12100)The type-A standard ISO 12100 specifies the principle strategy for safety o
30、f 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 (s
31、ee 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 w
32、hether 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 Technical Report, the terms “protective measure” (see ISO 12100:2010, 3.19) and “risk reduction
33、 measure” are synonymous and referred to any action or means used to eliminate hazards and/or reduce risks.2 ISO 2015 All rights reservedPD CEN ISO/TR 221001:2017ISO/TR 22100-1:2015(E)Actions a) to d) are related to risk assessment and action e) to risk reduction.Risk assessment is a series of logic
34、al 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
35、 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 impl
36、emented 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 c
37、lause 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 follo
38、wing 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 machine.NOTE 2 The ideal application of these principles requires
39、 knowledge of the machine design and its intended use, the practical use of the machine, the accident history and health records, available risk reduction techniques, and the legal framework in which the machine is intended to be used (placed on the market). ISO 2015 All rights reserved 3PD CEN ISO/
40、TR 221001:2017ISO/TR 22100-1:2015(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 machine
41、ry.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
42、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 imp
43、lemented 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 th
44、e 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
45、 usability of the machine; the manufacturing, operational and dismantling costs of the machine.NOTE 2 The ideal application of these principles requires knowledge of the machine design and its intended use, the practical use of the machine, the accident history and health records, available risk red
46、uction techniques, and the legal framework in which the machine is intended to be used (placed on the market). ISO 2015 All rights reserved 3 ISO/TR 22100-1:2015(E)KeyaThe first time the question is asked, it is answered by the result of the initial risk assessment.For further information, see Figur
47、e A.1.Figure 2 Schematic representation of risk assessment and risk reduction process including iterative three-step method according to ISO 12100:2010, Figure 14 ISO 2015 All rights reservedPD CEN ISO/TR 221001:2017ISO/TR 22100-1:2015(E)Risk assessment(based on deg976ined limits and intended use of
48、 the machine)Protective measures implemented by thedesigner (see Figure 2)Step 1 : Inherently safe design measuresStep 2 : Safeguarding andcomplementaryprotective measuresStep 3 : Information for useg389 at the machine- warning signs, signals- warning devices in the instruction handbookUser inputg39
49、0 Designer inputProtective measures implemented by theuserg391including those based on theinformation for use provided by the designer Organization- safe working procedures- supervision- permit-to-work systems Provision and use ofadditional safeguardsg392 Use of personal protectiveequipment Training, etc.RISKResidual riskafterprotectivemeasuresimplementedby thedesignerResidual riskafter allprotectivemeasureshave beenimplementedKeyaProviding proper information for use is part of the designers contribution to risk reductio