CAN CSA-Z15190-2005 Medical laboratories - Requirements for safety (First Edition).pdf

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1、National Standard of CanadaCAN/CSA-Z15190-05International Standard ISO 15190:2003 (first edition, 2003-10-15) has been adopted with Canadiandeviations (MOD) as CSA Standard CAN/CSA-Z15190-05, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-55397-821-

2、8 March 2005Reference numberISO 15190:2003(E)ISO 2003Medical laboratories Requirements for safety Laboratoires de mdecine Exigences pour la scurit The Canadian Standards Association (CSA), under whose auspices this National Standard has been produced, was chartered in 1919 and accredited by the Stan

3、dards Council of Canada to the National Standards system in 1973. It is a not-for-profit, nonstatutory, voluntary membership association engaged in standards development and certification activities. CSA standards reflect a national consensus of producers and users including manufacturers, consumers

4、, retailers, unions and professional organizations, and governmental agencies. The standards are used widely by industry and commerce and often adopted by municipal, provincial, and federal governments in their regulations, particularly in the fields of health, safety, building and construction, and

5、 the environment. Individuals, companies, and associations across Canada indicate their support for CSAs standards development by volunteering their time and skills to CSA Committee work and supporting the Associations objectives through sustaining memberships. The more than 7000 committee volunteer

6、s and the 2000 sustaining memberships together form CSAs total membership from which its Directors are chosen. Sustaining memberships represent a major source of income for CSAs standards development activities. The Association offers certification and testing services in support of and as an extens

7、ion to its standards development activities. To ensure the integrity of its certification process, the Association regularly and continually audits and inspects products that bear the CSA Mark. In addition to its head office and laboratory complex in Toronto, CSA has regional branch offices in major

8、 centres across Canada and inspection and testing agencies in eight countries. Since 1919, the Association has developed the necessary expertise to meet its corporate mission: CSA is an independent service organization whose mission is to provide an open and effective forum for activities facilitati

9、ng the exchange of goods and services through the use of standards, certification and related services to meet national and international needs.For further information on CSA services, write toCanadian Standards Association5060 Spectrum Way, Suite 100Mississauga, Ontario, L4W 5N6CanadaThe Standards

10、Council of Canada is the coordinating body of the National Standards system, a federation of independent, autonomous organizations working towards the further development and improvement of voluntary standardization in the national interest. The principal objects of the Council are to foster and pro

11、mote voluntary standardization as a means of advancing the national economy, benefiting the health, safety, and welfare of the public, assisting and protecting the consumer, facilitating domestic and international trade, and furthering international cooperation in the field of standards. A National

12、Standard of Canada is a standard which has been approved by the Standards Council of Canada and one which reflects a reasonable agreement among the views of a number of capable individuals whose collective interests provide to the greatest practicable extent a balance of representation of producers,

13、 users, consumers, and others with relevant interests, as may be appropriate to the subject in hand. It normally is a standard which is capable of making a significant and timely contribution to the national interest. Approval of a standard as a National Standard of Canada indicates that a standard

14、conforms to the criteria and procedures established by the Standards Council of Canada. Approval does not refer to the technical content of the standard; this remains the continuing responsibility of the accredited standards development organization. Those who have a need to apply standards are enco

15、uraged to use National Standards of Canada whenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain the latest edition from the organization preparing the standard.The responsibility for approving National Standards of Canada rests with theStanda

16、rds Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaAlthough the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Registered tr

17、ade-mark of Canadian Standards AssociationNameOrganizationAddressCityProvince/StateCountry Postal/Zip CodeE-mailI consent to CSA collecting and using the above information to send me updates relating to this publication.Visit CSAs policy on privacy at www.csagroup.org/legal to find out how we protec

18、t your personal information.CAN/CSA-Z15190-05CSA Standards Update ServiceCAN/CSA-Z15190-05March 2005Title: Medical laboratories Requirements for safetyPagination: 47 pages (CSA/1 and CSA/2, i-vi, and 39 text)Automatic notifications about any updates to this publication are available.To register for

19、e-mail notifications, and/or to download any existing updates in PDF, enter the Online Store at www.ShopCSA.ca and click on My Account on the navigation bar.The List ID for this document is 2017673.To receive printed updates, please complete and return the attached card.AffranchirsuffisammentPlaceSt

20、amp HereASSOCIATION CANADIENNE DENORMALISATIONBUREAU CENTRAL DE LINFORMATION5060, SPECTRUM WAY, BUREAU 100MISSISSAUGA ON L4W 5N6CANADACANADIAN STANDARDSASSOCIATIONCONSOLIDATED MAILING LIST5060 SPECTRUM WAY, SUITE 100MISSISSAUGA ON L4W 5N6CANADACAN/CSA-Z15190-05 Medical laboratories Requirements for

21、safetyMarch 2005 Canadian Standards Association CSA/1CAN/CSA-Z15190-05Medical laboratories Requirements for safetyCSA PrefaceThis is the first edition of CAN/CSA-Z15190, Medical laboratories Requirements for safety, which is an adoption, with Canadian deviations, of the identically titled ISO (Inter

22、national Organization for Standardization) Standard 15190 (first edition, 2003-10-15). At the time of publication, ISO 15190:2003 is available from ISO in English only.This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Medical Laboratory Quality Systems, under the jur

23、isdiction of the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. A list of the members of the Technical Committee is available upon request. This Standard has been approved as a National Standard of Canada by the Standards Council of

24、 Canada. March 2005 Canadian Standards Association 2005All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission ofthe publisher. ISO material is reprinted with permission. Where the words “this International Standard” appear in the text,

25、they should be interpreted as “this National Standard of Canada”.Inquiries regarding this National Standard of Canada should be addressed toCanadian Standards Association5060 Spectrum Way, Suite 100, Mississauga, Ontario, Canada L4W 5N61-800-463-6727 416-747-4044www.csa.caCSA/2 Canadian Standards As

26、sociation March 2005CAN/CSA-Z15190-05 Medical laboratories Requirements for safetyCanadian Deviations7.2 Procedures Add the following note to Item h)Note 1A: In vitro diagnostic (IVD) material producers are not required to provide MSDS.Reference numberISO 15190:2003(E)ISO 2003INTERNATIONAL STANDARD

27、ISO15190First edition2003-10-15Medical laboratories Requirements for safety Laboratoires de mdecine Exigences pour la scurit ISO 15190:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be

28、edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is

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30、 bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mech

31、anical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.is

32、o.org ii ISO 2003 All rights reservedISO 15190:2003(E) ISO 2003 All rights reserved iiiContents Page Foreword. v Introduction . vi 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 1 4 Risk group classification 3 5 Management requirements 4 5.1 Management responsibilities. 4 5.2 Manageme

33、nt of staff health 4 6 Designing for safety 4 6.1 Preliminary considerations 4 6.2 General design requirements 4 6.3 Physical conditions 5 7 Staffing, procedures, documentation, inspection and records . 6 7.1 Laboratory Safety Officer. 6 7.2 Procedures 6 7.3 Safety programme audits and inspection 7

34、7.4 Safety manual 8 7.5 Records 8 8 Identification of hazards. 9 9 Reporting of incidents, injury, accidents and occupational illnesses 9 10 Training 9 11 Personnel responsibilities . 10 11.1 Food, drink and like substances . 10 11.2 Cosmetics, hair, beards and jewellery 10 11.3 Immunization status

35、. 10 11.4 Personal property . 11 11.5 Festive decorations 11 12 Clothing and personal protective equipment (PPE), including gloves, eye, face, foot and respiratory protection. 11 12.1 Protective clothing in the laboratory 11 12.2 Protective clothing outside the laboratory. 11 12.3 Face and body prot

36、ection 11 12.4 Gloves 11 12.5 Footwear 12 12.6 Respiratory protection 12 12.7 Handwashing. 12 12.8 Training 13 12.9 Equipment 13 12.10 Eyewash stations 13 12.11 Emergency showers . 13 13 Good housekeeping practices. 14 14 Safe work practices 14 14.1 Safe work practices with all material of biologica

37、l origin. 14 14.2 Special requirements for working in microbiology laboratories . 15 ISO 15190:2003(E) iv ISO 2003 All rights reserved15 Aerosols .15 16 Microbiological safety cabinets, chemical safety hoods and cabinets.16 17 Chemical safety .16 17.1 Measures to avoid chemical contamination.16 17.2

38、 Emergency measures applicable when chemical contamination has occurred 17 17.3 Discarded chemicals.17 18 Radiation safety.17 18.1 Radionuclides17 18.2 Radiation protection advisors, officers, and supervisors.17 18.3 Workplace monitoring 18 18.4 UV and laser light sources (including light from high-

39、intensity sources) 18 18.5 Microwave equipment.18 19 Fire precautions.19 19.1 Construction 19 19.2 Secondary exits.19 19.3 Alarm systems.19 19.4 Fire risk reduction strategies .19 19.5 Storage of flammable materials.19 19.6 Fire safety training programmes .20 19.7 Firefighting equipment .20 20 Emerg

40、ency evacuations .20 21 Electrical equipment .20 22 Transport of samples21 23 Waste disposal 21 Annex A (informative) Action-plan outline for implementation of this International Standard 23 Annex B (informative) Laboratory safety audit25 Annex C (informative) Decontamination, cleaning and disinfect

41、ion following a spillage.35 Bibliography37 ISO 15190:2003(E) ISO 2003 All rights reserved vForeword 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 o

42、ut 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 c

43、ollaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International

44、 Standards. 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. Attention is drawn to the possibility that some of the elemen

45、ts of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15190 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. ISO 15190:2003(E) vi ISO 2003 All righ

46、ts reservedIntroduction This International Standard specifies requirements to establish and maintain a safe working environment in a medical laboratory. As with all such safety guidelines, there are requirements to ensure that there is a named person ultimately responsible and that all employees tak

47、e personal responsibility for their own safety at work and, the safety of others who may be affected by it. Every task requires risk assessment, with the aim that hazards be eliminated wherever possible. Where this cannot be done, the risk from each hazard is reduced to as low a level as practicable

48、, using the following order of priority: a) by substitution; b) by containment; or c) by the use of personal protective measures and equipment. Safety is the primary consideration; cost is of secondary importance. While this International Standard is intended for use throughout the currently recogni

49、zed disciplines of medical laboratory services, other services and disciplines may find it useful and appropriate. However, medical laboratories handling human pathogens requiring containment levels 3 and 4 will need to meet additional requirements to ensure safety. While this International Standard is not intended to provide guidance on accreditation, it may be used for such purposes by a government, professional, or other authoritative body. International, national or regional regulations or guidelines may apply to