1、DEUTSCHE NORM October 1998 Mechanical vibration and shock - Guidance on safety aspects of tests and experiments with people DIN - Part 1 : Exposure to whole-body mechanical vibration and repeated English version of DIN EN IS0 13090-1 EN IS0 13090-1 shock (IS0 13090-1 : 1998) ICs 13.160 Descriptors:
2、Mechanical vibration, shock, human exposure, testing. Mechanische Schwingungen und Ste - Leitfaden zur Sicherheit von Prfungen und Versuchen mit Men- schen - Teil 1 : Einwirkung von mechanischen Ganzkrper-Schwingungen und wiederholten Sten (IS0 13090-1 : 1998) European Standard EN IS0 13090-1 : 1998
3、 has the status of a DIN Standard. A comma is used as the decimal marker. National foreword This standard has been published in accordance with a decision taken by CEN/TC 231 to adopt, without alteration, International Standard IS0 13090-1 as a European Standard. The responsible German body involved
4、 in its preparation was the Normenausschu Akustik, Larmminderung undSchwingungstechnik (Acoustics, Noise Control and Vibration Engineering Standards Committee), Tech- nical Committee Schwingungseinwirkung auf den Menschen. DIN EN 30326-1 is the standard corresponding to International Standard IS0 10
5、326-1 referred to in clause 2 of the EN. National Annex NA Standard referred to (and not included in Normative references and Annex ZA) DIN EN 30326-1 Laboratory method for evaluating vehicle seat vibration - Basic requirements (IS0 10326-1 : 1992) EN comprises 26 pages. No pari of this standard may
6、 be reproduced without the prior permission of Ref. No. DIN EN IS0 13090-1 : 1998-1 V Deutsches Institut fur Normung e. V., Berlin. Luth Verlag GmbH, D-10772 Berlin, has the exclusive right of sale for German Standards (DIN-Normen). English pricegroup 13 Sales No. 1113 04.99 EUROPEAN STANDARD NORME
7、EUROPENNE EUROPISCHE NORM EN IS0 13090-1 June 1998 ICs 13.160 Descriptors: Mechanical vibration, shock, human exposure, testing. English version Mechanical vibration and shock - Guidance on safety aspects of tests and experiments with people Part 1 : Exposure to whole-body mechanical vibration and r
8、epeated shock (IS0 13090-1 : 1998) Vibrations et chocs mcaniques - Lignes directrices concernant les as- pects de scurit des essais et des exprimentations raliss sur des su- jets humains - Partie 1 : Exposition de lensemble du corps aux vibrations Mechanische Schwingungen und Ste - Leitfaden zur Sic
9、herheit von Prfungen und Versuchen mit Men- schen - Teil 1 : Einwirkung von mechanischen Ganzkrper-Schwin- gungen und wiederholten Sten mcaniques et aux chocs rpts (IS0 13090-1 : 1998) (IS0 13090-1 : 1998) This European Standard was approved by CEN on 1998-05-1 4. CEN members are bound to comply wit
10、h the CENKENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national stand- ards may be obtained on application to the Central Secretar
11、iat or to any CEN member. The European Standards exist in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
12、versions. CEN members are the national standards bodies of Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. CEN European Committee for Standardi
13、zation Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1998. CEN - All rights of exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. EN IS0 13090-1 : 1998 E Page 2 EN IS0 13090-1 : 19
14、98 Foreword International Standard IS0 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, which was prepared by ISO/TC 108 Mechanical vibration and shock of the Int
15、ernational Organization for Standardization, has been adopted by Technical Committee CEN/TC 231 Mechanical vibration and shock, the Secretariat of which is held by DIN, as a European Standard. This European Standard shall be given the status of a national standard, either by publication of an identi
16、cal text or by endorsement, and conflicting national standards withdrawn, by December 1998 at the latest. In accordance with the CENKENELEC Internal Regulations, the national standards organizations of the follow- ing countries are bound to implement this European Standard: Austria, Belgium, the Cze
17、ch Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. Endorsement notice The text of the International Standard IS0 13090-1 : 1998 was approved by CEN as a European Standard
18、without any modification. NOTE: Normative references to international publications are listed in Annex ZA (normative). Con tents Page 1 Scope . 4 2 Normative references . 4 3 Definitions . 5 4 Hazards of mechanical vibration and repeated shock experiments on human test subjects 5 5 6 Classifying exp
19、eriments according to severity of vibration exposure . 7 Practice for laboratory tests and experiments 8 7 Selection of human test subjects 11 Annexes A (informative) Severity of exposure . 12 B (informative) Example of consent form for a human test subject in mechanical vibration and repeated shock
20、 experiments . 14 C (informative) Medical contra-indications to participation in experiments involving whole-body mechanical vibration and repeated shock . 15 D E (informative) Design of equipment 19 F (informative) Guidelines for the preparation of an experimental or test protocol for submission to
21、 an Ethical Committee . 23 (informative) Principles pertaining to the use of human subjects 17 G (informative) Bibliography 25 Page 3 EN IS0 13090-1 : 1998 In trod uct ion People may be exposed to mechanical vibration and repeated shock intentionally in the course of experiments to determine their r
22、esponse to such environments and in the course of experiments or tests performed for other purposes. It is widely accepted that exposure to mechanical vibration and repeated shock of sufficient magnitude can cause injury or impair health. In this part of IS0 13090, guidance is provided on the safety
23、 aspects of equipment or procedures which are particular to experiments involving mechanical vibration and repeated shock and which affect the safety of those involved. The purpose of this part of IS0 13090 is to reduce the chance of the subjects, or those monitoring or conducting the experiments, b
24、eing exposed to undue risk of injury or impaired health arising from such exposure, or of injury attributable to the malfunction or poor operation of the equipment used to generate the mechanical vibration and repeated shock. Guidance on the design of equipment is included in annex E. In accordance
25、with accepted practice for experiments in which human subjects are involved, the experimenter should obtain approval from an independent Ethical Committee, or “Human Use Committee“, giving details of the planned experiment together with a written justification. Some guidelines are included in annex
26、F. This part of IS0 13090 represents the best international consensus at this time and may be subject to change in the light of future developments in scientific knowledge and experience. Page 4 EN IS0 13090-1 : 1998 1 Scope This part of IS0 13090 provides guidance on the safety aspects of the desig
27、n of equipment and the conduct of tests and experiments in the laboratory in which human subjects are exposed to mechanical vibration and repeated shock. This part of IS0 13090 is concerned with tests and experiments in which subjects are exposed to whole-body mechanical vibration and repeated shock
28、, as described in IS0 2631 -1. Local vibration is not within the scope of this part of IS0 13090, but some of the general procedures may be applicable. The experiments to which this part of IS0 13090 is applicable include those performed to determine the response of subjects to mechanical vibration
29、and repeated shock stimuli. They also include those experiments in which mechanical 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 mechanical
30、 vibration and repeated shock on the user (e.g. testing of seat suspensions, seat cushions and other attenuating devices, including tests according to IS0 10326-1). NOTE Measures in addition to those described in this part of IS0 13090 may be necessary in those countries which have relevant national
31、 requirements. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 13090. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements bas
32、ed on this part of IS0 13090 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 2041 :1990, Vibration and shock - Vocabulary. IS0 2631 -1 :1997,
33、 Mechanical vibration and shock - Evaluation of human exposure to whole-body vibration - Part 1: General requirements. IS0 5805: 1 997, Mechanical vibration and shock - Human exposure - Vocabulary. IS0 10326-1 :1992, Mechanical vibration - Laboratory method for evaluating vehicle seat vibration - Pa
34、rt 1: Basic requirements. i) Hereinafter referred to as “the subject” or “subjects”. Page 5 EN IS0 13090-1 : 1998 3 Definitions For the purposes of this part of IS0 13090, the definitions given in IS0 2041 and IS0 5805 apply 4 subjects 4.1 General Hazards of mechanical vibration and repeated shock e
35、xperiments on human test Those 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 such experiments, in addition to the general responsibility for s
36、afety, as follows: a) the inherent hazard that exposure to the mechanical vibration or repeated shock which the experiment is intended to reproduce may lead to injury or ill-health, either immediately or at some time in the future (see 4.2); the extraneous hazard that malfunction or inadvertent oper
37、ation of the equipment used to generate the mechanical vibration or repeated shock may cause the subject to be exposed unintentionally to motions so severe as to cause injury or ill-health; b) c) the hazard of injury to the subject, the experimenter, or others in the vicinity arising from any of the
38、 following: 1 ) the relative motion between the vibration equipment and its surroundings, 2) mechanical, electrical or other failures, 3) falling. 4.2 Inherent hazards in mechanical vibration and repeated shock experiments 4.2.1 General The inherent hazard that exposure of a subject to mechanical vi
39、bration 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 otherwis
40、e particularly sensitive to mechanical vibration 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 stimulus The effects on subjects of mechanical vibration and repeated shock depend on the magnitude, frequency cont
41、ent, 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) o
42、r random and, for the purposes of this part of IS0 13090, vibration is restricted to frequencies between 0,5 Hz and 80 Hz. Repeated shocks may be applied with or without the presence of vibration, with various characteristics. Mechanical vibration and repeated shock should be characterized from meas
43、urements of acceleration in three mutually perpendicular axes (see figure 1). R.m.s. values of acceleration should be obtained using frequency weightings according to IS0 2631-1. The r.m.s. value should be determined using linear integration over the full period of exposure. Page 6 EN IS0 13090-1 :
44、1998 / X I l Figure 1 - Basicentric axes of the human body Page 7 EN IS0 13090-1 : 1998 4.3 Extraneous hazards in mechanical vibration and repeated shock experiments Many vibrating devices used in experiments have a large quantity of available or stored energy. An inherent problem in the design of v
45、ibration systems is that the subject may be exposed to unexpected or frightening transients or, at worst, to potentially dangerous magnitudes of mechanical vibration or shock as a result of an equ ipment malf u nction. Equipment design should be such that, in the event of malfunction or emergency st
46、op procedures, the subject should not be exposed to accelerations of hazardous magnitude or duration. Equipment should be designed so that no failure could result in magnitudes of mechanical vibration or shock producing accelerations in excess of an acceptable short-term magnitude, unless the experi
47、ment is designed to study the effects of higher magnitudes. For such 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 as is r
48、easonably practicable that the short-term acceleration does not exceed an acceptable magnitude. 4.4 Physical contact with moving parts 4.4.1 General Mechanical vibration and repeated shock experiments present the following three particular physical hazards: a) the experimenter or another person in t
49、he vicinity of the equipment may receive a blow through inadvertent contact with the moving parts; the subject on a moving pari may receive a blow through inadvertent contact with a fixed object; b) c) anyone on the equipment or in the vicinity may be at risk from pinching or shearing between fixed and moving parts. 4.4.2 Restraint of subjects In experiments where subjects are restrained, special care should be taken to ensure that during normal operation or malfunction the restraint itself does not present a hazard. 5 5.1 General Classifying experiments acc
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