YY/T / ISO 14971:2007 corrected version

Size: px

Start display at page:

Download "YY/T / ISO 14971:2007 corrected version"

Kristian Blankenship
5 years ago
Views:

1 Translated English of Chinese Standard: YY/T Buy True-PDF Auto-delivery. YY ICS C 30 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE S REPUBLIC OF CHINA YY/T / ISO 14971:2007 corrected version Replacing YY/T Medical devices - Application of risk management to medical devices 医疗器械风险管理对医疗器械的应用 (ISO 14971:2007 corrected version, IDT) YY/T How to BUY & immediately GET a full-copy of this standard? Search --> Add to Cart --> Checkout (3-steps); 3. No action is required - Full-copy of this standard will be automatically & immediately delivered to your address in 0~60 minutes. 4. Support: Sales@ChineseStandard.net. Wayne, Sales manager Issued on: January 26, 2016 Implemented on: January 01, 2017 Issued by: China Food and Drug Administration Buy True-PDF Auto-delivery. Page 1 of 110

2 Table of Contents Foreword... 4 Introduction Scope Terms and definitions General requirements for risk management Risk management process Management responsibilities Qualification of personnel Risk management plan Risk management file Risk analysis Risk analysis process Intended use and identification of characteristics related to the safety of the medical device Identification of hazards (sources) Estimation of the risk(s) for each hazardous situation Risk evaluation Risk control Risk reduction Risk control option analysis Implementation of risk control measure(s) Residual risk evaluation Risk/benefit analysis Risks arising from risk control measures Completeness of risk control Evaluation of overall residual risk acceptability Risk management report Production and post-production information Buy True-PDF Auto-delivery. Page 2 of 110

3 Annex A (informative) Rationale for requirements Annex B (informative) Overview of the risk management process for medical devices Annex C (informative) Questions that can be used to identify medical device characteristics that could impact on safety Annex D (informative) Risk concepts applied to medical devices Annex E (informative) Examples of hazards (sources), foreseeable sequences of events and hazardous situations Annex F (informative) Risk management plan Annex G (informative) Information on risk management techniques Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices Annex I (informative) Guidance on risk analysis process for biological hazards (sources) Annex J (informative) Information for safety and information about residual risk Bibliography Buy True-PDF Auto-delivery. Page 3 of 110

4 Foreword This Standard is drafted in accordance with the rules given GB/T This Standard replaces YY/T Medical devices - Application of risk management to medical devices. Compared with YY/T , in addition to editorial modifications, the main technical changes are as follows: - In order to be consistent with the terms in GB/T Guide for standardization - Part 4: Safety aspects for their inclusion in standards, revise the following terms and definitions: - REVISE damage to harm, and REVISE the definition; - REVISE danger to hazard, and REVISE the definition; - REVISE dangerous situation to hazardous situation, and REVISE the definition; - REVISE the definition of residual risk"; - REVISE the definition of risk ; - REVISE the definition of risk analysis ; - REVISE the definition of risk assessment ; - REVISE safety to safety", and REVISE the definition. - According to ISO 14971:2007 ( corrected version), amend Figure 1 A schematic representation of the risk management process. This Standard is identical to ISO 14971: 2007 Medical devices - Application of risk management to medical devices corrected version by translation method. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing organization of this document shall not be held responsible for identifying any or all such patent rights. This Standard is proposed by China Food and Drug Administration. This Standard is under the jurisdiction of National Technical Committee on Quality Management and Corresponding General Aspects for Medical Devices of Standardization Administration of China (SAC/TC 221). Drafting organization of this Standard: Beijing Hua Guang Certification of Medical Devices Co., Ltd. Buy True-PDF Auto-delivery. Page 4 of 110

5 Introduction The requirements contained in this Standard provide manufacturers with a framework within which experience, insight and judgment are applied systematically to manage the risks associated with the use of medical devices. This Standard was developed specifically for medical device/system manufacturers using established principles of risk management. For other manufacturers, e.g., in other healthcare industries, this Standard could be used as informative guidance in developing and maintaining a risk management system and process. This Standard deals with processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment and the environment. As a general concept, activities in which an individual, organization or government is involved can expose those or other stakeholders to hazards (sources) which can cause loss of or damage to something they value. Risk management is a complex subject because each stakeholder places a different value on the probability of harm occurring and its severity. It is accepted that the concept of risk has two components: a) the probability of occurrence of harm; b) the consequences of that harm, that is, how severe it might be. The concepts of risk management are particularly important in relation to medical devices because of the variety of stakeholders including medical practitioners, the organizations providing health care, governments, industry, patients and members of the public. All stakeholders need to understand that the use of a medical device entails some degree of risk. The acceptability of a risk to a stakeholder is influenced by the components listed above and by the stakeholder s perception of the risk. Each stakeholder s perception of the risk can vary greatly depending upon their cultural background, the socio-economic and educational background of the society concerned, the actual and perceived state of health of the patient, and many other factors. The way a risk is perceived also takes into account, for example, whether exposure to the hazard seems to be involuntary, avoidable, from a man-made source, due to negligence, arising from a poorly understood cause, or directed at a vulnerable group within society. The decision to use a medical device in the context of a particular clinical procedure requires the residual risks to be balanced against the anticipated benefits of the procedure. Such judgments should take into account the intended use, performance and risks associated with the medical device, as well as the risks and benefits associated with the clinical procedure or the circumstances of use. Some of Buy True-PDF Auto-delivery. Page 6 of 110

6 Medical devices - Application of risk management to medical devices 1 Scope This Standard specifies a process for a manufacturer to identify the hazards (sources) associated with medical devices [including in vitro diagnostic (IVD) medical devices], to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this Standard are applicable to all stages of the life-cycle of a medical device. This Standard does not apply to clinical decision making. This Standard does not specify acceptable risk levels. This Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system. 2 Terms and definitions For the purposes of this Standard, the following terms and definitions apply: 2.1 accompanying document Document accompanying a medical device and containing information for those accountable for the installation, use and maintenance of the medical device, the operator or the user, particularly regarding safety. NOTE: Adapted from IEC :2005, definition harm Physical injury or damage to the health of people, or damage to property or the environment. Buy True-PDF Auto-delivery. Page 8 of 110

7 Bibliography [1] GB/T Guide for standardization - Part 1: Standardization and related activities - General vocabulary (GB/T , ISO/IEC Guide 2:1996, MOD). [2] GB/T Guide for standardization - Part 4: Safety aspects for their inclusion in standards (GB/T , ISO/IEC Guide 51:1999, MOD). [3] GB/T Quality management and quality assurance standards - Part 3: Guidelines for the application of GB/T to the development, supply, installation and maintenance of computer software (GB/T , ISO :1997, IDT). [4] GB/T Software engineering - Guidelines for the application of ISO 9001:2000 to computer software (GB/T , ISO 9000:2005, IDT). [5] ISO , Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system. [6] ISO , Biological evaluation of medical devices - Part 2: Animal welfare requirements. [7] ISO , Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances. [8] YY/T Medical devices - Quality management systems - Requirements for regulatory purposes (YY/T , ISO 13485:2003, IDT). [9] ISO/TR 14969, Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003. [10] ISO , Clinical investigation of medical devices for human subjects - Part 1: General requirements. [11] ISO , Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans. [12] ISO 15189, Medical laboratories - Particular requirements for quality and competence. [13] ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. [14] ISO 15198, Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer. [15] ISO 17511, In vitro diagnostic medical devices - Measurement of quantities in Buy True-PDF Auto-delivery. Page 108 of 110

ISO INTERNATIONAL STANDARD. Medical devices Application of risk management to medical devices

ISO INTERNATIONAL STANDARD. Medical devices Application of risk management to medical devices INTERNATIONAL STANDARD ISO 14971 Second edition 2007-03-01 Corrected version 2007-10-01 Medical devices Application of risk management to medical devices Dispositifs médicaux Application de la gestion