the-report-of-risk-management風(fēng)險管理評審報告

1、The report of risk managementPRODUCT: TYPE: Effective date: Page: Document No.: Version: Department:Made Check ApprovalMagic stick RISK MANAGEMENT REPORT1. ForewordThis article is the report of the risk management of thi

2、s product. This report shows all the potential risks and the reason cause these risks happen, also estimate the rate and the level of all kinds of risks maybe cause the serious result, if a item can not be acceptable,

3、which need to adopt a measure to reduce the risk level and estimate the rate and level after. Finally, make all the items acceptable.2. ScopeThis report is applicable to the product of Allergy Reliever which including

4、the following parts: 1)3. Application information:3.1 Policy, directive and standard1) 93/42/EEC（“MDD”）the Directive of medical device.2) ISO 14971:2000 Medical devices — Application of risk management to medical devices

5、3) EN 60601-1:2006, EN60601-1-2:2007；No. Standard Code Standard name1 MDD 93/42/EEC European Medical Device Directive 2 EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purpos

6、es3 EN ISO 14971:2012 Medical devices. Application of risk management to medical devices4 EN 60601- 1:2006/AC:2010Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

7、5 EN 60601-1-6:2007/AC:2010General requirements for safety-Collateral standard: Usability6 EN 60601-1-11:2010 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare en

8、vironment7 EN60601-2-57:2011 Particular requirements for the basic safety and essential performance of non-laser light8 EN62471: 2008 Photobiological safety of lamps and lamp systems9 EN 60601-1- 2:2007/AC:2010General

9、 requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests10 EN ISO 10993-5：2009 Biological evaluation of medical devices - Part 5: Tests for

10、 in vitro cytotoxicity11 EN ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization 12 EN980/EN ISO15223- 1:2008Symbols for use in the labeling of medical devic

11、es13 EN ISO 15223-1-2012 Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. General requirements14 EN1041:2008 Information supplied by the manufacturer of medical