ISO INTERNATIONAL STANDARD 15190 Second edition 2020-02 Medical laboratories Requirements for safety Laboratoires de biologie medicale - Exigences pour la sécurité Reference number IS0 15190:2020(E) Tso @IS02020 IS0 15190:2020(E) COPYRIGHTPROTECTEDDOCUMENT @ ISO 2020 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office CP 401 : Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +41 22 749 01 11 Fax: +41 22 749 09 47 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2020 - All rights reserved IS0 15190:2020(E) Contents Page Foreword ..vii Introduction. ..vili 1 Scope. 2 Normative references 3 Terms and definitions 4 Designing for safety 4.1 Preliminary considerations. 4 4.2 General design requirements. .5 4.3 Laboratory security. .6 4.3.1 General. 4.3.2 Risk assessment and security program .6 4.3.3 Physical security 4.3.4 Inventory. 7 4.3.5 Information management and security ..7 4.3.6 Incident and emergency response .7 5 Safety management program .7 5.1 General considerations. ..7 5.2 Management requirements. .8 5.3 Management responsibilities. .8 5.3.1 General. 5.3.2 Scientific manager ..8 5.4 Management of staff health. 5.4.1 General. 9 5.4.2 Immunization 5.4.3 Psychological hazards ..10 5.4.4 Employee impairment .10 5.5 Laboratory safety officer. ..11 5.6 Safety manual ..12 5.7 Safety program audits and inspection. .13 5.8 Records ..14 5.8.1 General ..14 5.8.2 Occupational health and safety, injury and adverse incident records ..14 5.8.3 Hazardous waste records ..14 5.9 Safety Training and orientation. .14 5.9.1 Scope of personnel safety training ..14 5.9.2 Safety Training programme. ..14 5.9.3 Fire prevention and control training. ..15 5.9.4 First aid training. ..15 6 Hazard identification and Risk Assessment ..15 6.1 Hazard identification .15 6.2 Job hazard assessment 6.3 Risk assessment .16 6.4 Risk reduction. ..17 7 Biosafety and biosecurity hazards .18 7.1 General ..18 7.1.1 Work Practices. ..18 7.1.2 Engineering controls ..18 7.1.3 Administrative controls .18 7.1.4 Biosafety policies. .19 7.2 Hazard groups. 20 7.3 Containment levels. .20 7.4 Aerosols 21 @ IS0 2020 - All rights reserved ii IS0 15190:2020(E) 7.5 Decontamination 21 7.6 Standard precautions, routine practices and additional precautions 21 7.7 Biological safety cabinets. 22 7.8 Biological spills. 22 Chemical hazards. 22 8.1 General, 22 8.2 Chemical classification and labelling 23 8.2.1 Hazard identification and control 23 8.2.2 Safety data sheets. .23 8.3 Toxic chemicals. 24 8.4 Oxidizing and corrosive materials 24 8.4.1 Oxidizing materials. 24 8.4.2 Corrosive materials. 25 8.5 Chemical storage .25 8.5.1 General. 25 8.5.2 Organization and segregation 25 8.6 Chemical spills 26 8.7 Chemical waste 26 9 Physical hazards. 26 9.1 Compressed gases. 26 9.2 Ventilation and indoor air quality .27 9.2.1 General. 27 9.2.2 Chemical fume hoods. .27 9.2.3 Canopy hoods.. 28 9.2.4 Slotted benches. 28 9.2.5 Biological safety cabinets 28 9.3 Electrical 28 9.4 Radiation safety 29 9.4.1 Use of radionuclides. 29 9.4.2 Radiation protection personnel 29 9.4.3 Workplace monitoring for ionizing radiation 30 9.5 Non-ionizing radiation 30 9.5.1 Ultraviolet and laser light sources 30 9.5.2 Microwave equipment .30 9.6 Temperature and humidity 31 9.7 Noise 31 9.8 Pressure 31 10 Emergency preparedness and response 31 10.1 General. 31 10.2 First aid equipment and procedures. 32 10.3 Eyewash facilities. 32 10.3.1 General. 32 10.3.2 Facilities 32 10.3.3 Water supply 32 10.4 Emergency/drench showers 33 10.5 Spill response 33 11 Fire safety 33 11.1 Fire pre