产品策划设计开发控制程序指南性文件风险管理报告

Table of Contents
Chapter2 Category
2.1Category
This document is established according to standard ISO14971:2012 the risk management for medical devices. The goal is to systematically carry out the effective management of the various risk processes for the company’s R&D and manufacture of Homecare multi-parameter recorder, The document is the instructive direction for design, confirmation, production and sales, and for CE authentication, FDA authentication and SFDA authentication constituent.
2.2Relative supporting document
Chapter3 General Introduction
3.1Product Overview
ZTE homecare multi-parameter recorder is mainly composed of host
recorder(H8),3-Lead ECG cable, blood pressure cuff and SPO2 probe which for monitoring the physiological data of ECG,SPO2 and NIBP at home. It can realize data transmission between the H8 and the android Pad through the unique data transmission interface. Moreover, The recorder equipped transmission and realize user’s registration and user’s historical data records. The equipment operating system customized for android system, elaborate design is easy to operate and carry.
3.2Intended Use
This recorder is mainly used in household mode, intended use for measuring
the physiological data of elder people, provide a convenient measurement of electrocardiogram (ECG),SPO2 and non-invasive blood pressure. Provide reference data for the doctor and clinical diagnosed.
3.3Composition
The homecare multi-parameter recorder includes the following components: Power supply module, Display module, User interface, Signal collection & process module, Control module, and NIBP module, , ECG module, SpO2 module.
Chapter5 Determination of Safety Characteristics
Chapter6 Summarization of the Risk Management
Chapter7 Evaluation of the Residual Risk
After the above analysis and carrying out corresponding risk control measures, the residual risks of the potential hazards associated with the use of the device according to the intended use are acceptable. The device has passed the tests required by the harmonized standards, which also proves that risks associated with the device are acceptable.
The risk control measures have not introduced any new hazards. After all risk control measures have been implemented and verified, there are no ALARP or N/ACC risks, so the risk/benefit analysis is not necessary.
Chapter8 Completeness Evaluation of Risk All known or foreseeable hazards have been analyzed.
Chapter 9 Information updating and risk management after manufacturing
We will collect and update the information from producing client complaining, similarity design and so on, and then, according the “medical device risk management procedure review and manage the
Risk estimate method
The risk estimate of out body diagnoses instrument
-- Analysis result confidence level;
-- Specious inspection;
-- Comparison usability and use;
-- Is suitable for the medical laboratory quality assurance measure/Method;
-- Flaw/Wrong detect ability;
-- Service condition (for example emergency case);
--Specialist/Layman’s use;
-- The method provides information
Estimation of the severity of each hazard
of the likelihood of each hazard
of the acceptability of each risk
1.N/ACC: Intolerable region
2.ACC: Broadly applicable region
3.ALARP(fill):（As Low As Reasonably Practicable）region
Appendix D Contents of Tables Table 1 Qualitative and quantitative analysis
of the characteristics Table 2 Summarization
of the Risk Management
Table 3 Estimating severity of
each hazard Table 4 Estimating
likelihood of each hazard Table
5 Estimating acceptability
of each risk。