ISO 15190-2020 PDF

Full title and description

ISO 15190:2020 — Medical laboratories — Requirements for safety. This International Standard specifies requirements and good practices to protect laboratory personnel, patients and the environment by defining safe laboratory design, work practices, equipment, emergency preparedness and management responsibilities for medical laboratories.

Abstract

ISO 15190:2020 sets out requirements for safe practices in the medical laboratory, covering hazard identification and risk assessment, laboratory layout and engineering controls, personal protective equipment, handling and transport of specimens, chemical and biological safety, radiation and electrical safety, waste management, incident reporting and emergency procedures. It is intended to be used alongside quality and competence standards for medical laboratories to ensure safe delivery of laboratory services.

General information

• Status: Published (International Standard; stage: to be revised [90.92]).
• Publication date: 24 February 2020.
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.01 (Laboratory medicine in general).
• Edition / version: 2nd edition (2020).
• Number of pages: 79.

Scope

This document specifies requirements for safe practices in the medical laboratory (hereafter referred to as "the laboratory"). It applies to the design and operation of medical laboratories and their activities that may present biological, chemical, radiological, electrical, fire or ergonomic hazards. The standard addresses organisational measures (roles, safety manuals, training), engineering controls (ventilation, containment cabinets, waste infrastructure), safe handling and transport of specimens, emergency preparedness and routine inspection and maintenance to reduce risk to staff, patients and the public.

Key topics and requirements

• Laboratory safety management: appointment of a Laboratory Safety Officer, documented safety manual, safety policies and periodic review.
• Risk assessment and hazard identification for biological, chemical, radiological and physical hazards; documentation and record-keeping of risk assessments.
• Design and engineering controls: layout, ventilation, containment devices (biological safety cabinets, fume hoods), hand-washing facilities, signage and security.
• Personal protective equipment (PPE) requirements and procedures for donning/doffing, decontamination and PPE maintenance.
• Safe handling, transport and storage of specimens and hazardous materials (including cold storage and secure containment for high-risk agents).
• Waste management: segregation, treatment and disposal of biological, chemical and sharps waste.
• Emergency preparedness and response: spill response, exposure management, evacuation, fire safety and first aid.
• Training, competence and occupational health: induction, refresher training, record of incidents, vaccinations and surveillance where applicable.
• Inspection, maintenance and verification of safety equipment and facilities, and incident reporting and corrective actions.

Typical use and users

Used by medical laboratory directors, safety officers, laboratory managers, facility designers, occupational health teams, accreditation bodies, regulators and trainers. It supports development of laboratory safety programmes, internal audits, design reviews for new or renovated facilities, staff training curricula and preparation for accreditation or regulatory compliance.

Related standards

Commonly used alongside ISO 15189 (requirements for quality and competence in medical laboratories) and ISO 22367 (application of risk management to medical laboratories). ISO 15190:2003 is the previous (withdrawn) edition replaced by the 2020 edition; a new work item (ISO/AWI 15190) is under development to revise this standard further.

Keywords

medical laboratory safety, biosafety, chemical safety, radiation safety, PPE, waste management, emergency response, laboratory design, risk assessment, ISO 15190

FAQ

Q: What is this standard?

A: ISO 15190:2020 is an International Standard that specifies requirements for safe practices in medical laboratories to protect personnel, patients and the environment.

Q: What does it cover?

A: It covers organisational safety management, risk assessment, laboratory design and engineering controls, PPE, specimen handling and transport, chemical and biological safety, radiation and electrical safety, waste management, incident reporting and emergency preparedness.

Q: Who typically uses it?

A: Laboratory directors, safety officers, facility designers, accreditation and regulatory bodies, occupational health personnel, and trainers use the standard to establish and maintain laboratory safety programmes.

Q: Is it current or superseded?

A: ISO 15190:2020 is the current (2nd) edition published in February 2020; it replaces ISO 15190:2003 and a new work item (ISO/AWI 15190) has been registered to revise/replace the 2020 edition in the ISO work programme.

Q: Is it part of a series?

A: Yes. ISO 15190 is part of the ISO/TC 212 family of standards for medical laboratories and is commonly used with ISO 15189 (quality and competence), ISO 22367 (risk management) and other laboratory-related ISO standards.

Q: What are the key keywords?

A: Medical laboratory safety, biosafety, chemical safety, PPE, waste management, emergency response, risk assessment, laboratory design, ISO 15190.