MDD指令附录一 基本要求检查表2013版

1、基本要求 (93/42/EEC MDD Annex 1)93/42/EEC including 2007/47/EC Annex I Essential Requirements Checklist93/42/EEC包括2007/47/EC 附录一 基本要求检查表QMF-MF-33008SHGProduct name: Type(s)/Model(s): Product group: Issue date of Technical File: Revision of Technical File: Legal Manufacturer:Name : Street : Postal code:

2、PlaceCountry : Accessories: Date Name Reviewer Signature Reviewer DateName Reviewer Signature Reviewer Checklist according to annex I of the Medical Device Directive (MDD)按 医 疗 器 械 指 令 （MDD） 附 录 一 的 基 本 要 求 检 查 表A/NA适用/不适用Standards, other directives and other rules applied by manufacturer制造商引用的标准，其它

3、指令或规则Documentation (test reports, protocols, literature or reason for no applicability)支持性文件(测试报告，方案，文献或不适用的理由)Requirements fulfilled( to be filled in byNotified Body)要求满足(由公告机构填写)Ok / Fail符合 / 不符合I.General Requirements1.The devices must be designed and manufactured in such a way that, when user und

4、er the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons provided that any risks which may be associated with their use constitute acceptable risks when weighed ag

5、ainst the benefits to the patient and are compatible with a high level of health and safety.This shall include:As much as possible to reduce the equipments ergonomic features and environment of the equipment intended use (design for patient safety) arising from the misuse of riskConsider technical k

6、nowledge, experience, education and training, expected user (for non-professional personnel, professional staff, disable workers or others) medical and physical conditions. 2.The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, t

7、aking account of the generally acknowledged state of the art. In selecting the most appreciate solutions, the manufacturer must apply the following principles in the following order:-Eliminate or reduce risks as far as possible (inherently safe design and construction)-Where appropriate take adequat

8、e protection measures including alarms if necessary, in relation to risks that cannot be eliminated.-Inform users of the residual risks due to any shortcomings of the protection measures adopted. 3.The devices must achieve the performances intended by the manufacturer and be designed, manufactured a

9、nd packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (a) as specified by the manufacturer. 4.The characteristics and performance referred to in Section 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and sa

10、fety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use. 5.The devices must be designed, manufactured and packed in su

11、ch a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer. 6.Any undesirable side effect must constitute an acceptable risk when weighed ag

12、ainst the performance intended. 6a.Prove that conform to the basic requirements must be included in the appendix X clinical evaluationII.REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION7. Chemical, physical and biological properties7.1The devices must be designed and manufactured in such a way as to g

13、uarantee the characteristics and performance referred to in Selection I on the General requirements . Particular attention must be paid to:- The choice of materials used, particularly as regards toxicity and , where appropriate, flammability.- The comparability between the materials used and biologi

14、cal tissues, cells and body fluids, taking account of the intended purpose of the device. 7.2The devices must be designed, manufactured and packed in such a way as to minimize the risk posed by contaminants and residues to the persons involved in the transport, storage and use of the devices and to

15、the patients, taking account of the intended purpose of the product. Particular attention must be paid to the tissues exposed and to the duration and frequency of exposure 7.3Devices must be designed, manufactured in such a way that they can be used safely with the materials, substances and gases wi

16、th which they enter into contact during their normal use or during routine procedures; if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restricti

17、ons governing these procedures and that their performance is maintained in accordance with the intended use. 7.4If a device contains a substance as a part of, and the material when used alone can be considered to be 2001/83 EC article 1 within the meaning of drugs, and it can help the equipment prod

18、uce auxiliary function to the human body, safety, quality and effectiveness of this kind of material must pass the directive 2001/83 / EC annex I applicable method of analogy to confirmMentioned in the first paragraph of the material, when considering the intended use of the equipment to confirm the

19、 effectiveness of the proposed material as part of medical apparatus and instruments, notified body should be in accordance with the Regulation (EC) No 726/20041 of laws and regulations, and safety of the quality of the material including the clinical benefit/risk characteristics of material and equ

20、ipment integration, to a competent authority designated by the member states or the European medicines evaluation agency (EMEA), especially its committee for scientific advice.When its opinion, the competent authority or the EMEA notified body that should be considered about the material and equipme

21、nt integration of production process and the effectiveness of the data.If a device containing blood products as a part of the confirmed the effectiveness of hematic products as part of medical apparatus and instruments, and considering the intended use of the equipment on the basis of the notified b

22、ody should be the quality and safety of the products include the clinical benefit/risk characteristics of products and equipment integration, the European medicines evaluation agency (EMEA) especially its committee for scientific advice.When its opinion, the competent authority or the EMEA notified

23、body that should be considered about the material and equipment integration of production process and the effectiveness of the data.If equipment integration of auxiliary material changes, especially in relation to the process of production, notified body should be notified to the relevant competent

24、authorities of the drug (that is, the initial consultancy) consulting, to confirm the quality and safety of auxiliary material is maintained.The competent authority should consider notified body that integrate the effectiveness of the data about the material and devices to ensure that changes to inc

25、rease in established medical instrument does not negatively affect the clinical benefit/risk characteristics.When competent authorities of the relevant drug (that is, the initial consultancy) on auxiliary material to increase in established medical instrument clinical benefit/risk characteristics of

26、 the influential information, should make recommendations to notified body, whether the information affect the established medical devices increase the material of the clinical benefit/risk features.Notified body should take into account the updated scientific opinion, to rethink the evaluation of c

27、onformity assessment procedures. 7.5Equipment design and manufacturing, from equipment material must be leakage risk to a minimum.Should pay special attention to in accordance with the law on June 27, 1967, members of directive 67/548 / EEC2 committee appendices I define carcinogens, induced mutatio

28、n and reproductive toxicity substance related risk 3 on classification, packaging and labelling laws and regulations and administrative provisions.If the part of the instrument itself (or instrument) expectations for drug delivery to the body or in addition to the drugs, body fluids or other substan

29、ces, or intended for transport or storage these body fluids or substances, contains according to directive 67/548 / EEC2 class 1 or 2 of appendix I define carcinogens, induced mutation or reproductive toxicity substances of phthalates, the equipment must be in their own and/or each make a logo on th

30、e package, and appropriate on equipment sales package contains phthalates logo.If the instrument intended use including treatment for children, pregnant women or nursing mothers, manufacturers have to provide in the technical documents and operating instructions specific reasons for the use of these

31、 substances, and about the group of patients with residual risk, if applicable, and appropriate preventive measures, such as information, to meet the basic requirements, especially for the requirements of this article. 7.6The devices must be designed and manufactured in such a way as to reduce to a

32、minimum the risks posed by substance leaking from device. 8.Infection and microbial contamination8.1 The devices and manufacturing process must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and Third parties. The design must allow e

33、asy handing and, where necessary, minimize contamination of the device by the patient or vice versa during use. 8.2Tissues of animal origin must originate from, animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues. Notified bodies shall

34、retain information on the geographical origin of the animals. Processing, preservation, testing and handling of tissues, cells and substances of animal origin must be carried out so as to provide optimal security. In particular safety with regard to viruses And other transferable agents must be addr

35、essed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process. 8.3Devices delivered in a sterile state must be designed, manufactured and packed in a non-reusable pack and/or according to appropriate procedures to ensure that they are st

36、erile when placed on the market and remain sterile, under the storage and transport conditions laid down until the protective package is damaged or opened. 8.4Devices delivered in a sterile state must have been manufactured and sterilized by an appropriate validated method. 8.5Devices intended to be

37、 sterilized must be manufactured in appropriate controlled (e.g. environmental) conditions 8.6Packaging systems for non-sterile devices must keep the product without deterioration at the level if cleanliness stipulated and, if the devices are to be sterilized prior to use, minimize the risk of micro

38、bial contamination; the packaging system must be suitable taking accounting of the methods of sterilization indicated by the manufacturer 8.7The packaging and/or label of the device must distinguish between identical or similar products sold in both sterile and non-sterile condition. 9.Construction

39、and environmental properties9.1If the device is intended for use in combination with other devices or equipment, the whole combination, including the correction system must be safe and must not impair the specified performance of the devices. Any restrictions on use must be indicated on the label or

40、 in the instructions for use. 9.2Devices must be designed and manufactured in such a way as to remove or minimize as far as is possible. the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features. Risks co

41、nnected with reasonably foreseeable environmental conditions, such as magnetic fields, external electrical influence, elecstatic discharge, pressure, temperature or variations in pressure and acceleration. The risks of reciprocal interference with other devices normally used in the investigation or

42、for the treatment given. Risks arising where maintenance or calibration is not possible (as with implants), from aging of materials used or loss of accuracy of any measuring or control mechanism. 9.3Devices must be designed and manufactured in such a way as to minimize the risks of fire or explosion

43、 during normal use and in single fault condition. Particular attention must be paid to devices whose intended use includes exposure to flammable substances or to substances, which could cause combustion 10.Devices with a measuring function10.1Devices with a measuring function must be designed and ma

44、nufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of the intended purpose of the device. The manufacturer must indicate the limits of accuracy. 10.2The measurement, monitoring and display scale must be designed in line w

45、ith ergonomic principles, taking account of the intended purpose of the device 10.3The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC. 11. Protection against radiationGeneralDevices shall

46、be designed and manufactured in such a way that exposure of patients; users and other persons to radiation shall be reduced as far as possible compatible with the intended purpose whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes. 11.211.2

47、.1 Intended reactionWhere devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed a

48、nd manufactured to ensure reproducer and tolerance of relevant variable parameters 11.2.2Where devices are intended to emit potential hazardous, visible and /or invisible radiation, emissions 11.311.3.1 Unintended RadiationDevices shall be designed and manufactured in such a way that exposure of pat

49、ients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible. 11.411.4.1 InstructionsThe operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation, means of protecting the

50、 patient and the user and on the ways of avoiding misuse and of eliminating the risks inherent in installation. 11.511.5.1 Ionizing radiationDevices intended to emit ionizing radiation must be designed and manufactured in such a way as to ensure that, where practicable, the quantity, geometry and qu

51、ality of radiation emitted can be varied and controlled taking into account the intended use. 11.5.2Devices emitting ionizing radiation, intended for therapeutic radiology shall be designed and manufactured in such a way as to active appropriate image and/or output quality for the intended medical p

52、urpose whilst radiation exposure of the patient and user. 11.5.3Devices emitting ionizing radiation, intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type and where appropriate the quality

53、 of radiation. 12.Requirements for medical devices connected to or equipped with an energy source12.1Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. In the event of a singl

54、e fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks 12.1aUsed for merging software or itself is the instrument of medical software, the software development life cycle must be considered, the principle of risk management, v

55、alidation and verification, according to the current technical development level for confirmation. 12.2Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply 12.3Devices where the safety of the patient d

56、epends on an external power supply must include an alarm system to signal any power failure 12.4Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration o

57、f the patient state of health. 12.5Devices must be designed and manufactured in such a way as to minimize the risks of creating electromagnetic fields, which could impair the operation of other devices or equipment in the usual environment. 12.6.Protection against electrical risksDevices must be des

58、igned and manufactured in such a way as to avoid, as far as possible, he risks of accidental electric shocks during normal use and in single fault conditions, provided the devices are installed correctly 12.712.7.1Protection against mechanical and thermal risksDevices must be designed and manufactur

59、ed in such a way as to protect the patient and user against mechanical risks connected with, for example, resistance, stability and moving parts. 12.7.2Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the

60、devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance. 12.7.3Devices must be designed and manufactured in such away as to reduce to the lowest possible level the risks aris