SIST EN ISO 13090-1:2000

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Mechanical vibration and shock - Guidance on safety aspects of tests and experiments with people - Part 1: Exposure to whole-body mechanical vibration and repeated shock (ISO 13090-1:1998)Mechanische Schwingungen und Stöße - Leitfaden zur Sicherheit von Prüfungen und Versuchen mit Menschen - Teil 1: Einwirkung von mechanischen Ganzkörper-Schwingungen und wiederholten Stößen (ISO 13090-1:1998)Vibrations et chocs mécaniques - Lignes directrices concernant les aspects de sécurité des essais et des expérimentations réalisés sur des sujets humains - Partie 1: Exposition de l'ensemble du corps aux vibrations mécaniques et aux chocs répétés (ISO 13090-1:1998)Mechanical vibration and shock - Guidance on safety aspects of tests and experiments with people - Part 1: Exposure to whole-body mechanical vibration and repeated shock (ISO 13090-1:1998)13.160Vpliv vibracij in udarcev na ljudiVibration and shock with respect to human beingsICS:Ta slovenski standard je istoveten z:EN ISO 13090-1:1998SIST EN ISO 13090-1:2000en01-december-2000SIST EN ISO 13090-1:2000SLOVENSKI
STANDARD



SIST EN ISO 13090-1:2000



SIST EN ISO 13090-1:2000



SIST EN ISO 13090-1:2000



SIST EN ISO 13090-1:2000



SIST EN ISO 13090-1:2000



AReference numberISO 13090-1:1998(E)INTERNATIONALSTANDARDISO13090-1First edition1998-06-15Mechanical vibration and shock —Guidance on safety aspects of tests andexperiments with people —Part 1:Exposure to whole-body mechanical vibrationand repeated shockVibrations et chocs mécaniques — Lignes directrices concernantles aspects de sécurité des essais et des expérimentations réalisés sur dessujets humains —Partie 1: Exposition de l’ensemble du corps aux vibrations mécaniques etaux chocs répétésSIST EN ISO 13090-1:2000



ISO 13090-1:1998(E)©
ISO 1998All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronicor mechanical, including photocopying and microfilm, without permission in writing from the publisher.International Organization for StandardizationCase postale 56 · CH-1211 Genève 20 · SwitzerlandInternetiso@iso.chPrinted in SwitzerlandiiContentsPage1
Scope .12
Normative references .13
Definitions .24
Hazards of mechanical vibration and repeated shock experiments on human test subjects .25
Classifying experiments according to severity of vibration exposure .46
Practice for laboratory tests and experiments .57
Selection of human test subjects .8AnnexesA
(informative) Severity of exposure .9B
(informative) Example of consent form for a human test subject in mechanical vibrationand repeated shock experiments .11C
(informative) Medical contra-indications to participation in experiments involvingwhole-body mechanical vibration and repeated shock .12D
(informative) Principles pertaining to the use of human subjects .14E
(informative) Design of equipment .16F
(informative) Guidelines for the preparation of an experimental or test protocolfor submission to an Ethical Committee .20G
(informative) Bibliography .23SIST EN ISO 13090-1:2000



© ISOISO 13090-1:1998(E)iiiForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.International Standard ISO 13090-1 was prepared by Technical Committee ISO/TC 108, Mechanical vibration andshock, Subcommittee SC 4, Human exposure to mechanical vibration and shock.ISO 13090 consists of the following parts, under the general title Mechanical vibration and shock — Guidance onsafety aspects of tests and experiments with people:—Part 1: Exposure to whole-body mechanical vibration and repeated shock—Part 2: Exposure to whole-body impactAnnexes A to G of this part of ISO 13090 are for information only.SIST EN ISO 13090-1:2000



ISO 13090-1:1998(E)© ISOivIntroductionPeople may be exposed to mechanical vibration and repeated shock intentionally in the course of experiments todetermine their response to such environments and in the course of experiments or tests performed for otherpurposes. It is widely accepted that exposure to mechanical vibration and repeated shock of sufficient magnitudecan cause injury or impair health.In this part of ISO 13090, guidance is provided on the safety aspects of equipment or procedures which areparticular to experiments involving mechanical vibration and repeated shock and which affect the safety of thoseinvolved.The purpose of this part of ISO 13090 is to reduce the chance of the subjects, or those monitoring or conducting theexperiments, being exposed to undue risk of injury or impaired health arising from such exposure, or of injuryattributable to the malfunction or poor operation of the equipment used to generate the mechanical vibration andrepeated shock. Guidance on the design of equipment is included in annex E.In accordance with accepted practice for experiments in which human subjects are involved, the experimentershould obtain approval from an independent Ethical Committee, or "Human Use Committee", giving details of theplanned experiment together with a written justification. Some guidelines are included in annex F.This part of ISO 13090 represents the best international consensus at this time and may be subject to change in thelight of future developments in scientific knowledge and experience.SIST EN ISO 13090-1:2000



INTERNATIONAL STANDARD
© ISOISO 13090-1:1998(E)1Mechanical vibration and shock —Guidance on safety aspects of tests and experimentswith people —Part 1:Exposure to whole-body mechanical vibration and repeated shock1ScopeThis part of ISO 13090 provides guidance on the safety aspects of the design of equipment and the conduct of testsand experiments in the laboratory in which human subjects1) are exposed to mechanical vibration and repeatedshock.This part of ISO 13090 is concerned with tests and experiments in which subjects are exposed to whole-bodymechanical vibration and repeated shock, as described in ISO 2631-1. Local vibration is not within the scope of thispart of ISO 13090, but some of the general procedures may be applicable.The experiments to which this part of ISO 13090 is applicable include those performed to determine the response ofsubjects to mechanical vibration and repeated shock stimuli. They also include those experiments in whichmechanical vibration and repeated shock are part of the environment in which other investigations are performed,and to experiments or tests to compare the attributes of equipment intended to alleviate the effects of mechanicalvibration and repeated shock on the user (e.g. testing of seat suspensions, seat cushions and other attenuatingdevices, including tests according to ISO 10326-1).NOTE
Measures in addition to those described in this part of ISO 13090 may be necessary in those countries which haverelevant national requirements.2Normative referencesThe following standards contain provisions which, through reference in this text, constitute provisions of this part ofISO 13090. At the time of publication, the editions indicated were valid. All standards are subject to revision, andparties to agreements based on this part of ISO 13090 are encouraged to investigate the possibility of applying themost recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently validInternational Standards.ISO 2041:1990, Vibration and shock — Vocabulary.ISO 2631-1:1997, Mechanical vibration and shock — Evaluation of human exposure to whole-body vibration —Part 1: General requirements.ISO 5805:1997, Mechanical vibration and shock — Human exposure — Vocabulary.ISO 10326-1:1992, Mechanical vibration — Laboratory method for evaluating vehicle seat vibration — Part 1: Basicrequirements.
1)
Hereinafter referred to as "the subject" or "subjects".SIST EN ISO 13090-1:2000



ISO 13090-1:1998(E)© ISO23DefinitionsFor the purposes of this part of ISO 13090, the definitions given in ISO 2041 and ISO 5805 apply.4Hazards of mechanical vibration and repeated shock experiments on human testsubjects4.1GeneralThose who engage in experiments which involve exposing subjects to mechanical vibration and repeated shock,and those who supply equipment for such experiments, should address three types of hazard specific to suchexperiments, in addition to the general responsibility for safety, as follows:a)the inherent hazard that exposure to the mechanical vibration or repeated shock which the experiment isintended to reproduce may lead to injury or ill-health, either immediately or at some time in the future (see 4.2);b)the extraneous hazard that malfunction or inadvertent operation of the equipment used to generate themechanical vibration or repeated shock may cause the subject to be exposed unintentionally to motions sosevere as to cause injury or ill-health;c)the hazard of injury to the subject, the experimenter, or others in the vicinity arising from any of the following:1)
the relative motion between the vibration equipment and its surroundings,2)
mechanical, electrical or other failures,3)
falling.4.2Inherent hazards in mechanical vibration and repeated shock experiments4.2.1
GeneralThe inherent hazard that exposure of a subject to mechanical vibration or repeated shock may lead to injury or ill-health depends on the following two possible causes:a)use of mechanical vibration or repeated shock that is too severe in terms of magnitude or duration, see 4.2.2;b)failure to exclude from the test a subject who is medically unfit or otherwise particularly sensitive to mechanicalvibration or shock.NOTE
Precautions to be taken with subjects are given in clause 7 and annex D.4.2.2
Severity of mechanical vibration or shock stimulusThe effects on subjects of mechanical vibration and repeated shock depend on the magnitude, frequency content,direction of action and duration of the stimuli, all of which should be included in assessing the severity.In all cases, the mechanical vibration is to be measured at the interface of the subject with the vibrating surface.Vibration may be characterized as deterministic (including periodic) or random and, for the purposes of this part ofISO 13090, vibration is restricted to frequencies between 0,5 Hz and 80 Hz. Repeated shocks may be applied withor without the presence of vibration, with various characteristics.Mechanical vibration and repeated shock should be characterized from measurements of acceleration in threemutually perpendicular axes (see figure 1).R.m.s. values of acceleration should be obtained using frequency weightings according to ISO 2631-1. The r.m.s.value should be determined using linear integration over the full period of exposure.SIST EN ISO 13090-1:2000



© ISOISO 13090-1:1998(E)3Figure 1 — Basicentric axes of the human bodySIST EN ISO 13090-1:2000



ISO 13090-1:1998(E)© ISO44.3
Extraneous hazards in mechanical vibration and repeated shock experimentsMany vibrating devices used in experiments have a large quantity of available or stored energy. An inherentproblem in the design of vibration systems is that the subject may be exposed to unexpected or frighteningtransients or, at worst, to potentially dangerous magnitudes of mechanical vibration or shock as a result of anequipment malfunction.Equipment design should be such that, in the event of malfunction or emergency stop procedures, the subjectshould not be exposed to accelerations of hazardous magnitude or duration. Equipment should be designed so thatno failure could result in magnitudes of mechanical vibration or shock producing accelerations in excess of anacceptable short-term magnitude, unless the experiment is designed to study the effects of higher magnitudes. Forsuch experiments, the magnitude during failure conditions should be only slightly in excess of those being studied.The equipment should be tested under simulated fault conditions (e.g. as suggested in annex E), to ensure so far asis reasonably practicable that the short-term acceleration does not exceed an acceptable magnitude.4.4Physical contact with moving parts4.4.1
GeneralMechanical vibration and repeated shock experiments present the following three particular physical hazards:a)the experimenter or another person in the vicinity of the equipment may receive a blow through inadvertentcontact with the moving parts;b)the subject on a moving part may receive a blow through inadvertent contact with a fixed object;c)anyone on the equipment or in the vicinity may be at risk from pinching or shearing between fixed and movingparts.4.4.2
Restraint of subjectsIn experiments where subjects are restrained, special care should be taken to ensure that during normal operationor malfunction the restraint itself does not present a hazard.5Classifying experiments according to severity of vibration exposure5.1GeneralThe recommendations in this part of ISO 13090 provide for two categories of experiment which are differentiated,according to the degree of risk, as to whether or not a physician or medical doctor should be in attendance or oncall. The decision is based on an assessment of the degree of severity of mechanical vibration or repeated shock towhich the subjects are to be exposed.An independent Ethical Committee (see annex F) shall be required to review any proposed experiment involving theexposure of human subject to vibration. This committee shall decide whether an experiment carries "greater thanminimal risk", and what is required by way of medical supervision.5.2Experiments involving minimal riskEthical Committees may not require that a physician or medical doctor be in attendance or on call for tests orexperiments in which the subjects are exposed to magnitudes of mechanical vibration or repeated shockcomparable to those found in common forms of transportation and in any but the most severe of civilian workingenvironments (see annex A).SIST EN ISO 13090-1:2000



© ISOISO 13090-1:1998(E)55.3Experiments involving some inherent riskFor experiments in which any subject is exposed to mechanical vibration or repeated shock in excess of that whichwould be consistent with the safe exposure of workers (see annex A) a physician or medical doctor should be inattendance or on call (see 6.2.4). Prior advice should also be sought from a relevant medical specialist on theinherent risk of the experiment and on the criteria for the selection of subjects (see clause 7).It is recognized that for certain tests or experiments involving the exposure of subjects to vibrations which simulatereal work conditions, the above criterion may require the continuous attendance of a physician or medical doctorwhen this would be neither expected, nor practicable in the work conditions themselves. In such cases, the adviceof the Ethical Committee should be sought as to whether or not the presence of the physician or medical doctor iswarranted.6Practice for laboratory tests and experiments6.1GeneralThe risk of injury in experiments involving human test subjects can be reduced by observing good practices. Theseinclude the selection and training of personnel, adherence to well-defined procedures, and the discipline ofmaintaining adequate records.6.2ManningFor any experiments in which a subject is on apparatus capable of causing mechanical vibration or shock stimulus,there should be an operator at the control panel for that apparatus who has a clear view of, or otherwise maintainscontact with, both the subject and the apparatus. In some circumstances it may be desirable for a second person tobe present as an observer.For experiments involving greater than minimal risk, i.e. in which the subjects are exposed to mechanical vibrationand repeated shock whose severity exceeds that which is consistent with the safe exposure of workers (seeannex A), the Ethical Committee may require that a physician or medical doctor be in attendance (see 5.3).At the time of any test or experiment, there should be, within the laboratory or in close proximity to it, a persontrained in first aid, and a means of communicating with the local emergency services.6.2.1
ExperimenterIn any test or experiment, one of those present should be designated as the person responsible for the test orexperiment and be recognized as such by all concerned.6.2.2
OperatorIt is imperative that the operator has received training in operation of the equipment either from the manufacturer orfrom a responsible person experienced in the use of the equipment. The main need is for experience andproficiency in running the equipment, but the operator should also be fully conversant with emergency procedures.The operator should be backed by an adequate maintenance staff.6.2.3
ObserverThe observer should have a good understanding of the test or experiment being conducted and be familiar withemergency procedures for the equipment.SIST EN ISO 13090-1:2000



ISO 13090-1:1998(E)© ISO66.2.4
Physician or medical doctorThe physician or medical doctor should be a qualified medical practitioner, fully conversant with possible effects ofmechanical vibration and shock on human subjects. The physician or medical doctor should be concerned primarilywith the well-being of the subjects and should have absolute discretion to halt the experiment or any part of it.6.3Procedures6.3.1
GeneralProcedures should be defined for start-up of the equipment and general pre-trial checks, as well as for the operatingsequence for each particular trial. These procedures should be displayed where they can be seen clearly from theposition of the operator, who should have practised them thoroughly, without a human subject, before starting anytrials in which such a subject is used.It is recommended that the sequences detailed in 6.3.2 and 6.3.3 be included in laboratory procedures.6.3.2
Start-up and pre-trial checksA start-up sequence should be formalized to include checks on all monitoring equipment and limiting systems, andon the integrity of the controls and input circuits.The intended magnitudes of stimulus should be checked to assess the severity of exposure, and the equipmentshould be operated without a human subject to ensure that the intended stimulus is reproduced correctly. If thedynamic response of the equipment is affected significantly by the presence of a human subject, this check shouldbe made with a substitute. This substitute may be a simple mass, but may in some cases be required to have morerepresentative dynamic properties.All emergency stop devices should be tested for correct functioning.Support and restraint features (e.g. seats and harnesses) should be checked.At regular intervals, and at least before and after each series of trials, the calibration of transducers and circuitsused for feed-back control and for monitoring should be checked, as should the accuracy with which the equipmentreproduces the full range of stimuli used in the series of trials.6.3.3
Normal operating sequenceThe normal operating sequence for each trial should follow a predetermined routine which is familiar to the operatorand to any observer. This should include the sequence of stimuli and their durations, the sequence of any activitiesin which the subject is to be engaged, and the times at which responses are required of him/her, or at whichobjective measurements are to be made (e.g. of attributes of his/her physiological state).The normal operating sequence should also include the times for regular checks that the magnitudes of stimuli inuse are within predetermined limits. Preferably, the signals from transducers used to monitor stimuli should berecorded so that any unplanned incident can be assessed against accepted indicators of the severity of mechanicalvibration and shock.The subject(s) should enter or mount the equipment only when it is stationary and in a safe condition. Whereappropriate the physician or medical doctor, otherwise the operator or observer, should check that the subject is fitto take part, either by reference to records of previous trials and/or with the requirements of clause 7. It is essentialthat no trials be made with any subject who has not been checked and authorized as being fit for mechanicalvibration and shock experiments by a physician or medical doctor (see 5.3) or another person able to assess therisk.SIST EN ISO 13090-1:2000



© ISOISO 13090-1:1998(E)7The operator or observer should also check that the subject is familiar with the experimental procedure and, inparticular, that for emergency shut-down, and that the subject is adequately supported and, when necessary,restrained.The operator should maintain observation of, or otherwise maintain contact with, the subject and any otherpersonnel in the experimental area throughout any period when the equipment is in motion.The equipment should be brought to rest and made safe before the subject leaves or dismounts.6.3.4
SubjectThe subject should have complete freedom to resign from the experiment, and to stop the experiment during anypart of it.The subject should be provided with an opportunity to report any adverse reaction to the mechanical vibration andrepeated shock.6.4Documentation6.4.1
Documentation associated with mechanical vibration and repeated shock experiments on human subjectsshould include the following:a)an operational record of the use of mechanical vibration and shock equipment: durations of use andcharacteristics of the mechanical vibration and repeated shock used; results of start-up and pre-trial checks(see 6.3.2); servicing and maintenance;b)an experimental protocol of the experiment conducted and documentation of the authorization to proceed;c)a record of each exposure of any subject to mechanical vibration and repeated shock;d)check lists for start-up and operational sequence for current trials;e)a list of people authorized to operate the mechanical vibration and shock equipment;f)copies of the consent forms as a record that each subject has been questioned or examined with regard tofitness to participate;g)report of any unexpected reactions or incidents.6.4.2
The record of exposure of each subject to mechanical vibration and shock should include the following:a)purpose of the experiment;b)date of the experiment;c)identification of the subject;d)any medical certification provided;e)nature of mechanical vibration and shock exposure (frequency or bandwidth, acceleration magnitude, duration,whether random or periodic, direction and point of application on the subject);f)any unusual reactions or after-effects noticed, either by the subject or by the experimental team;g)name of the experimenter(s);SIST EN ISO 13090-1:2000



ISO 13090-1:1998(E)© ISO8h)name of the operator in charge of the test or experimental run;i)name of the observer (if present);j)name of the physician or medical doctor (if present);k)name of the chaperone/parent/guardian (if present); children can only be subjects in non-hazardousexperiments because of problems with proper informed consent.NOTE
Information regarding the subject should be considered to be confidential and treated appropriately.7Selection of human test subjectsIt is the duty of the experimenter (in consultation with the physician or medical doctor where appropriate) to ensurethat no subject is at risk as a result of being, for example, pregnant, medically unfit or otherwise particularlysensitive to mechanical vibration or shock (see annex C).For those experiments in which the exposure to mechanical vibration or repeated shock is not so severe as towarrant the attendance of a physician or medical doctor, subjects should be at least fit to travel in public transportwithout assistance and to accept the stress of a normal day's work. The experimenter should ensure that allsubjects understand in general terms the medical conditions which would render them unfit for the experiment priorto obtaining their consent (see annex B and annex D). Care is required in this because some subjects ignore orforget their own weaknesses in their desire to take part in an activity which they perceive as more interesting thantheir routine. Experimenters also need to be particularly careful if the experiments involve exposure to mechanicalvibration or shock which, even though of low magnitude, may be greatly different from that to which the subjects areaccustomed.For those experiments in which the exposure to mechanical vibration or repeated shock involves more than minimalrisk (i.e. is so severe as to warrant the attendance of a physician or medical doctor), a higher degree of fitness maybe required. It is the responsibility of the physician or medical doctor to assess this fitness. The physician or medicaldoctor should question potential subjects to ascertain this fitness, having cognizance of the contra-indications listedannex C, and should decide on any need for medical examinations and certification.Occasionally it may be necessary to conduct experiments using people who would normally be ruled as unfit assubjects for mechanical vibration and repeated shock experiments. It is essential that competent medical advice besought before undertaking such work, that the Ethical Committee should approve it, and that a physician or medicaldoctor be in attendance.All participation of human test subjects should be on the basis of written informed consent.SIST EN ISO 13090-1:2000



© ISOISO 13090-1:1998(E)9Annex A(informative)Severity of exposureIn planning a test or experiment involving the exposure of human subjects to mechanical vibration or repeatedschock, severity of exposure is the measure on which is based the criterion for deciding whether or not a physicianor medical doctor should be in attendance.The criterion is a combination of vibration magnitude and duration of exposure, such that an increase in one wouldrequire a decrease in the other. This criterion is taken from the health caution zones in ISO 2631-1:1997, annex B,which apply to people in normal health who are regularly exposed to vibration (see figure A.1).These are mainly based on exposures in the range of 4 h to 8 h, for which most occupational observations exist.Most tests and experimental work involve the exposure of human subjects on an occasional, rather than a long-termdaily basis. For this reason, the criterion is based on the upper limit in figure A.1. For any tests or experiments inwhich human subjects are to be exposed to mechanical vibration regularly over an extended period, greater cautionmay be required.Figure A.1 — Health guidance caution zones (from ISO 2631-1:1997, annex B)Note that exposure in the most severe civilian working environments is above the upper limit at the 4 h to 8 hduration.For exposure durations shorter than 4 h per day, or longer than 8 h per day, the guidance of ISO 2631-1:1997,annex B, is tentative. The guidance states that there are not sufficient data to show a quantitative relationshipbetween vibration exposure and risk of health effects. However, it does include two possible relationships, which areused to develop the alternative caution zones in figure A.1.SIST EN ISO 13090-1:2000



ISO 13090-1:1998(E)© ISO10These are:aw1×T11/2 = aw2×T21/2
(A.1)andaw1×T11/4 = aw2×T21/4
(A.2)Concern has been expressed about the magnitudes of vibration for short durations which would be considered asnot involving any inherent risk. According to equation (A.1), these could be as much as 6 m/s2 for 10 min. For thisreason, the guidance proposed in table A.1 is based on equation (A.2).Table A.1 — Exposure to vibration and repeated shock requiring attendance of a physicianor medical doctorDuration of exposure in any one24 h period16 min1 h4 h8 hAcceleration magnitude, m/s2(frequency-weighted r.m.s.acceleration)2,21,61,10,9NOTE
Repeated shock is quantified only very approximately by r.m.s. accel
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