BS ISO 15190-2003 Medical laboratories - Requirements for safety《医学实验室 安全要求》.pdf

1、BRITISH STANDARD BS ISO 15190:2003 Medical laboratories Requirements for safety ICS 11.100 BS ISO 15190:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 12 November 2003 BSI 12 November 2003 ISBN 0 580 42905 9 National foreword This Briti

2、sh Standard reproduces verbatim ISO 15190:2003 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A list of organizations represented on this committee can be obtained on request t

3、o its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalog

4、ue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the

5、 text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front

6、 cover, an inside front cover, the ISO title page, pages ii to vi, pages 1 to 39 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments Reference number ISO 15190:2003(E) OSI 3002IN

7、TERNATIONAL STANDARD ISO 15190 First edition 2003-10-15 Medical laboratories Requirements for safety Laboratoires de mdecine Exigences pour la scurit BSISO15190:2003IS:09151 O3002(E) DPlcsid Fremia ihTs PDF file mya ctnoian emdebt dedyfepcaes. In ccacnadrow eitA hebods licnesilop gnic,y tihs file mi

8、rp eb yatnde iv roweb detu slahl ton ide ebtlnu deess teh typfecaes wihce era hml era deddebicsnede ti dna onstlalde t noeh comuptfrep reromign tide ehtin.g In wodlnidaot gnihs fil,e trapise atpecc tiereht nser ehnopsiiblity fo nto ifnriigngn Aebods licnesilop gnic.y ehT ISO tneClar Secrteirata cace

9、ptl on siibality in this .aera Ai ebods a tedarmfo kra Aebod SystemI snctaropro.de teDials fo teh sfotwcudorp erats sut deo crtaee tihs PDF file cna f ebi dnuon tlareneG eh Ifnler oatit evt oeh file; tP ehDc-Frtaeino marapterew stpo ereimizde fro irptni.gn Evyre cera neeb sah takne tsne oeru taht te

10、h file is siutlbae fosu re yb ISO memdob rebeis. In tlnu ehikletneve y ttah lborp aem lertait gno it is f,dnuo plsaee ifnrom ttneC ehlar Secterirata ta teh serddaig sleb nevwo. ISO 3002 All irthgs erse.devr lnUeto sswrehise specified, on trap fo this lbupictaion maeb y cudorperro de tuilizi den yna

11、form ro na ybm ynae,s lecetrinoc ro mceinahcla, incliduntohp gcoiypodna gn micrfoilm, wittuoh repmissii now nritign from ietI rehSa Ot tsserdda eh ebolw or ISOs memreb i ydobn the cnuotfo yr ttseuqer ehe.r ISO cirypothg fofice saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14

12、 + 9 74 E-mial coirypthgis.o gro We bwww.is.o groii ISO 3002 Allr ihgtsser edevrBSISO15190:2003IS:09151 O3002(E) I SO 3002 All irhgts seredevr 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 req

13、uirements 4 5.1 Management responsibilities. 4 5.2 Management 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

14、 Procedures 6 7.3 Safety programme audits and inspection 7 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 Cosmeti

15、cs, hair, beards and jewellery 10 11.3 Immunization status . 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

16、clothing outside the laboratory. 11 12.3 Face and body protection 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

17、 14 14.1 Safe work practices with all material of biological origin. 14 14.2 Special requirements for working in microbiology laboratories . 15 BSISO15190:2003IS:09151 O3002(E) iv I SO 3002 All irhgts seredevr15 Aerosols .15 16 Microbiological safety cabinets, chemical safety hoods and cabinets.16 1

18、7 Chemical safety .16 17.1 Measures to avoid chemical contamination.16 17.2 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 Workplac

19、e monitoring 18 18.4 UV and laser light sources (including light from high-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 Fi

20、re safety training programmes .20 19.7 Firefighting equipment .20 20 Emergency 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 sa

21、fety audit25 Annex C (informative) Decontamination, cleaning and disinfection following a spillage.35 Bibliography37 BSISO15190:2003IS:09151 O3002(E) I SO 3002 All irhgts seredevr vForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodie

22、s (ISO member bodies). The work of preparing International Standards is normally carried out 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,

23、 governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates 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

24、/IEC Directives, Part 2. The main task of technical committees is to prepare International 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 m

25、ember bodies casting a vote. Attention is drawn to the possibility that some of the elements 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 labor

26、atory testing and in vitro diagnostic test systems. BSISO15190:2003IS:09151 O3002(E) vi I SO 3002 All irhgts seredevrIntroduction This International Standard specifies requirements to establish and maintain a safe working environment in a medical laboratory. As with all such safety guidelines, there

27、 are requirements to ensure that there is a named person ultimately responsible and that all employees take 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

28、possible. Where this cannot be done, the risk from each hazard is reduced to as low a level as practicable, 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 se

29、condary importance. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, other services and disciplines may find it useful and appropriate. However, medical laboratories handling human pathogens requiring containment le

30、vels 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 regulation

31、s or guidelines may apply to specific topics covered in this International Standard. BSISO15190:2003INTENRATIONAL TSANDADR IS:09151 O3002(E)I SO 3002 All irhgts seredevr 1Medical laboratories Requirements for safety 1 Scope This International Standard specifies requirements for safe practices in the

32、 medical laboratory. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1

33、5189:2003, Medical laboratories Particular requirements for quality and competence 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 15189 and the following apply. 3.1 aerosols system of particles dispersed in a gas, smoke, or fog 3.2 antisepsis method

34、 for avoiding infection in a wound or during a clinical procedure by the use of a chemical agent such as an antiseptic BS 6324-1 3.3 antiseptic chemical germicide formulated to be used on skin or tissue 3.4 biological agent any microorganism, including those which have been genetically modified, cel

35、l cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity NOTE For classification of biological agents into risk groups, see Clause 4. 3.5 cleaning process to remove any type of contamination, visible or not 3.6 control of infection plan set of procedures to

36、 be used to limit spread of infection in either a hospital or a laboratory BSISO15190:2003IS:09151 O3002(E) 2 I SO 3002 All irhgts seredevr3.7 decontamination procedure that eliminates or reduces microbial or toxic agents to a safe level with respect to the transmission of infection or other adverse

37、 effects 3.8 disinfectant agent capable of causing disinfection BS 6324-1 3.9 disinfection process to reduce the number of microorganisms, but not usually of bacterial spores, without necessarily killing or removing all organisms 3.10 ergonomics study of the efficiency of persons in their working en

38、vironment NOTE This term includes biomechanics, work physiology, anthropomorphy and man-machine interfaces. 3.11 extraction hood fume hood cabinet or cover above a laboratory device for the extraction of air or fumes which prevents their general circulation 3.12 hazard potential source of harm IEC 6

39、1010-1:2001 3.13 hazardous waste waste that is potentially flammable, combustible, ignitable, corrosive, toxic, reactive, or injurious to people or the environment 3.14 material safety data sheet MSDS technical bulletin providing detailed hazard and precautionary information 3.15 microbiological saf

40、ety cabinet MSC biological safety cabinet ventilated enclosure, intended to offer protection to the user and the environment from the aerosols arising from handling of potentially hazardous and hazardous microorganisms, with means for filtering air discharged to the atmosphere NOTE Adapted from EN 1

41、2469:2000. 3.16 microorganism microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material BSISO15190:2003IS:09151 O3002(E) I SO 3002 All irhgts seredevr 33.17 noise unwanted sound in the form of acoustic energy which may adversely affect health 3.18 p

42、ersonal protective equipment material, including clothing, used to prevent contamination of a person by chemical or biological matter 3.19 radionuclide natural or synthetically produced unstable nucleus of an atom that emits ionizing radiation 3.20 risk combination of the probability of occurrence o

43、f harm and the severity of that harm 3.21 safety hood covering over a medical laboratory workplace or device intended to reduce risk to a laboratory worker 3.22 spill kit set of equipment used for the removal of chemical or microbiological material from a laboratory surface or apparatus 3.23 splash

44、guard device used to prevent personal contamination by a liquid 3.24 sterilization validated process used to render a product free from microorganisms 3.25 technical area space in a medical laboratory allocated for the preparation or examination of samples 3.26 tissue any coherent collection of anim

45、al or plant specialized cells 4 Risk group classification Biological agents are classified into four risk groups: a) Risk Group I (low individual and community risk) This group includes those microorganisms, bacteria, fungi, viruses and parasites which are unlikely to cause disease in healthy worker

46、s or animals (e.g. non-pathogenic biological agents). b) Risk Group II (moderate individual risk, limited community risk) This group includes pathogens that can cause human or animal disease, but under normal circumstances are unlikely to be a serious hazard to healthy laboratory workers, the commun

47、ity, livestock or the environment (e.g. Staphylococcus aureus, Listeria monocytogenes). Laboratory exposures rarely cause infection leading to serious disease; effective treatment and preventive measures are available and the risk of spread is limited. BSISO15190:2003IS:09151 O3002(E) 4 I SO 3002 Al

48、l irhgts seredevrc) Risk Group III (high individual risk, low community risk) This group includes pathogens that usually cause serious human or animal disease, or which can result in serious economic consequences but do not ordinarily spread by casual contact from one individual to another, or that

49、can be treated by antimicrobial or antiparasitic agents (e.g. Salmonella typhi, prion). d) Risk Group IV (high individual risk, high community risk) This group includes pathogens that usually produce very serious human or animal disease, often untreatable, and may be readily transmitted from one individual to another, or from animal to human or vice-versa, directly or indirectly, or by casual contact (e.g. smallpox virus). Medical labora