ДСТУ EN ISO 22367:2022 Медичні лабораторії. Застосування управління ризиками до медичних лабораторій (EN ISO 22367:2020, IDT, ISO 22367:2020, IDT)
ДСТУ EN ISO 22367:2022
(EN ISO 22367:2020, IDT, ISO 22367:2020, IDT)
Медичні лабораторії. Застосування управління ризиками до медичних лабораторій
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)
Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4.1 Risk management process
4.2 Management responsibilities
4.3 Qualification of personnel
4.4 Risk management plan
5 Risk analysis
5.1 General
5.2 Risk analysis process and documentation
5.3 Intended medical laboratory use and reasonably foreseeable misuses
5.4 Identification of characteristics related to safety
5.5 Identification of hazards
5.6 Identification of potentially hazardous situations
5.7 Identification of foreseeable patient harms
5.8 Estimation of the risk(s) for each hazardous situation
6 Risk evaluation
6.1 Risk acceptability criteria
6.2 Risk evaluation process
7 Risk control
7.1 Risk control options
7.2 Risk control verification
7.3 Role of standards in risk control
7.4 Role of IVD medical devices in risk control
7.5 Risks arising from risk control measures
7.6 Residual risk evaluation
8 Benefit-risk analysis
9 Risk management rewiew
9.1 Completeness of risk control
9.2 Evaluation of overall residual risk
9.3 Risk management report
10 Risk monitoring, analysis and control activities
10.1 Surveillance procedure
10.2 Internal sources of risk information
10.3 External sources of risk information
10.4 Immediate actions to reduce risk
Annex A (informative) Implementation of risk management within the quality management system
Annex В (informative) Developing a risk management plan
Annex C (informative) Risk acceptability considerations
Annex D (informative) Identification of characteristics related to safety
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations
Annex F (informative) Nonconformities potentially leading to significant risks
Annex G (informative) Risk analysis tools and techniques
Annex H (informative) Risk analysis of foreseeable user actions
Annex I (informative) Methods of risk assessment, including estimation of probability and severity of harm
Annex J (informative) Overall residual risk evaluation and risk management review
Annex К (informative) Conducting a benefit-risk analysis
Annex L (informative) Residual risk(s)
Bibliography
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