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)

Dieser Teil von ISO 13090 enthält Leitlinien zu Sicherheitsregeln für die Gestaltung von Anlagen und die Durchführung von Prüfungen und Versuchen im Labor, bei denen Menschen1), mechanischen Schwingungen und wiederholten Stößen ausgesetzt werden. Dieser Teil von ISO 13090 gilft für Prüfungen und Versuche, bei denen mechanische Schwingungen und wiederholte Stöße auf die Versuchsperson als Ganzes einwirken (Ganzkörper-Schwingungen nach ISO 2631-1).

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)

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Status
Published
Publication Date
14-Jun-1998
Current Stage
9093 - Decision to confirm - Review Enquiry
Start Date
31-Aug-2006
Completion Date
31-Aug-2006

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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
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 exp
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