CE认证基本要求对照表

Essential Requirement of MDD 93/42Annex Ⅰ（Including Directive 2007/47/EC）A/NA
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ⅠGenenal requirements 一般要求
1.The devices must be designed and manufactured in such a way that,when used under 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 against the benefits to the patient and are compatible with a high level of protection of health and safety.This shall include:
-reducing,as far aspossible,the risk of use error due to the ergonomic features of the device and the enviroment in which the device is intended to be used(design for patitient safety,)and
-considerration of the technical knowledge,experience,education and training and where applicable the medical and physical conditions of intend users(design for lay,professional,disabled or other users)
`如果与器械的使用可能相关的任何危险同患者的受益相比是可以接受的，并且同高度的健康和安全保护水平相适应，器械的设计和制造就必须使其在按预定用途和条件下使用时，不会危及到患者的临床状况或安全，或者使用者和其他人的安全和健康。

这些应该包括：
-尽可能的减少由于错误使用人体工程学特点和设备用于的环境（病人安全方面的设计）而引起的风险
-充分考虑技术知识、经验、教育和培训，还有可适用的医学的和物理的
Essential Requirement of MDD 93/42Annex Ⅰ（Including Directive 2007/47/EC）
MONITOR
DEVICE
预期使用条件。

Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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Evidence of Compliance
相关的证据
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2.The solutions adopted by the manufacturer for the design and construction of the devices must conform to the safety principles,taking account of the generally acknowledged state of the art.
In selecting the most appropriate 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 adequate 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.
考虑到普遍公认的技术现状，制造商设计和制造器械所采用的方案必须符合安全原则:
在选择最适合的方案时，制造商必须依次遵循以下原则：
-尽可能消除或降低危险（内在安全设计和制造）
-对不可能被消除的危险，在必要情况下，应采取适当保护措施，包括必要的警告;
-将因采用的保护措施有缺陷而遗留的危险告知使用者。

3The devices must achieve the performances intended by the manufacturer and be designed,manufactured packaged in such a way that they are suitable for one or more of the functions referred to in Article1(2)(a),as specified by the manufacturer.
器械必须达到制造商的预期性能。

器械的设计、制造和包装必须按制造商规定的适用于本指令第一条第二款(a)所述的一种或多种功能。

Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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4.The characteristics and performances referred to in Sections1,2and3must not be adversely affected to such a degree that the clinical conditions and safety 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 stresses which can occur during normal conditions of use.
在制造商规定的器械使用寿命期内，当器械在正常使用过程中处于超负荷状态时，本附录1.1、1.2和1.3所述特性与性能不得危及患者及适当时其他人的临床状况和安全。

5.The devices must be designed,manufactured and packed in such 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.
器械的设计，制造和包装必须使器械在预定使用期间，其特性和性能在按制造商提供的说明书和信息进行运输和存储过程中，不会受到有害的影响。

6.Any undesirable side-effect must constitute an acceptable risk when weighed against the performances intended.
希望的副作用所产生的危险同器械的预定性能相比是可接受的。

6a Demonstration of comformity with the essential requirements must include a clinial evaluation in accordance with annexⅩ
基本信息要求的符合性实证必须包括根据附录Ⅹ要求的临床评估。

Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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Ⅱequirements regarding design and construction关于设计和制造的要求
7.chemical,physical and biological properties化学，物理和生物学特征
7.1The devices must be designed and manufactured in such a way as to
guarantee the characteristics and performances referred to in Section1on the ‘General requirements”.Particular attention must be paid to:
-the choice of material used,particularly as regards toxicity and, where appropriate,flammability,
-the compatibility between the materials used and biological tissues, cells and body fluids,taking account of the intended purpose of the
device.
-Where appropriate,the results of biophysical or modelling research whose validaty has been demonstrated beforehand
器械的设计与制造必须保证其具备本附录1所述的特性和性能。

特别应注意：
-所用材料的选择，特别是其毒性，适当时其可燃性；
-根据器械的预定用途，所用材料与生物组织、细胞和体液之间的相容性。

-生理的和有效的模型研究结果应该在前面已经被论证了
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 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 the exposure.
根据产品的预定用途，器械的设计，制造和包装必须使污染物和残留物对器械运输、储存和使用中涉及到的人员和患者造成的危险降到最低，特别注意暴露的组织，持续时间及次数。

Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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7.3The devices must be designed,manufactured in such a way that they can be
used safely with materials,substances and gases with which enter into contact during their normal use or during routine procedures;if the devices are intended to administer medical products they must be designed and manufactured in such a way as to be compatible with the medical products concerned according to the provisions and restrictions governing these products and that their performance is maintained in accordance with the intended use.
器械的设计和制造应使其在正常使用过程中和例行程序中能安全地用于所接触的材料，物质和气体。

如果器械用于施药，则它们的设计和制造必须按照有关药品的管理规定和限制，与这些药品相适应，并确保其性能符合预定用途。

7.4Where a device incorporates,as an integral part,a substance which,if used
separately,may be considered to be medicinal product as defined in Article1 of Directive2001/83/EC and which is liable to act upon the body with action ancillary to that of the device,the safety,quality and usefulness of the substance must be verified,taking account of the intended purpose of the device,by analogy with the methods specified in Article1to Directive 2001/83/EC
如果器械含有某种作为其组成部分的物质，且当该物质单独使用时，可被认为是2001/83/EC指令定义的药品，并配合器械对人体起到辅助作用，则必须根据器械的预定用途，对该物质的安全，质量和有效性按照2001/83/EC指令规定的适当方法进行类推验证。

For the substances referred to in the first paragraph,the notified body shall, having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device,seek a scientific
Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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Evidence of Compliance
相关的证据
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opinion from one of the competent authorities designated by the Member States or the European Medicines Agency(EMEA)acting particularly through its committee in accordance with Regulation(EC)No726/2004(*) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device.When issuing its opinion,the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body
关于第一章涉及到的物质，认证机构应已证实物质在整体医疗仪器中的用途，并且已将该仪器的预期用途考虑进去，此外，还应寻求由成员国指定的权威机构给出的科学性建议，或者由欧洲药品管理局委员会严格按照EC法规第726/2004(*)条就部件的质量和安全性包括将物质组合到仪器中后的临床效益和风险所作出的建议。

无论是权威机构还是欧洲管理委员会在公布其评论的时候都应涉及组合到由认证企业指定仪器中去的物质用途的生产程序和数据。

Where a device incorporates,as an integral part,a human blood derivative, the notified body shall,having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device,seek a scientific opinion from the EMEA,acting particularly through its committee,on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the human blood derivative into the device.When issuing its opinion,the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body.
Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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关于作为仪器不可或缺部分的人体血液衍生物，认证机构在核实其作为医疗设备部件的用途，并且已将仪器的预期用途考虑进去之后，寻求由欧洲药品管理局委员会就部件的质量和安全性包括将人体血液衍生物组合到仪器中后的临床效益和风险所作出的建议。

当欧洲药品管理局公布其建议时，应涉及组合到认证机构指定仪器中去的物质用途的生产程序和数据。

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process,the notified body shall be informed of the changes and shall consult the relevant medicines competent authority(i.e.the one involved in the initial consultation),in order to confirm that the quality and safety of the ancillary substance are maintained.The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body,in order to ensure that the changes have no negative impact on the established benefit/risk profile of the addition of the substance in the medical device.
当组合到仪器中的辅助物质发生变化，特别是涉及生产程序时，为了确保辅助物质的质量和安全性的稳定，认证机构应公开此项变化并与相关医药权威机构商讨（例如，第一次商讨会中包含的）。

为确保此变化对有关新增物质的确立的效益/风险评测文件没有负面影响，权威机构应考虑组合到由认证机构指定仪器中去的有关物质用途的数据。

When the relevant medicines competent authority(i.e.the one involved in the initial consultation)has obtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device,it shall provide the notified body with advice,whether this information has an impact on the established
（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置
benefit/risk profile of the addition of the substance in the medical device or
not.The notified body shall take the updated scientific opinion into account
in reconsidering its assessment of the conformity assessment procedure.
当相关医药权威机构获取有关该辅助物质可能对医疗仪器中确立的新
增物质的效益/风险评测文件造成影响的信息时，该机构应当建议认证机
构说明该信息是否对仪器中新增物质的确立的效益/风险评测文件造成
影响。

认证机构应当在重新考虑仪器的评估程序是否一致性的同时把这
些更新的科学性建议页考虑进去。

7.5The devices must be designed and manufactured in such a way as to reduce to
a minimum the risks posed by substances leaking from the device.Special
attention shall be given to substances which are carcinogenic,mutagenic or
toxic to reproduction,in accordance with Annex I to Council Directive
67/548/EEC of27June1967on the approximation of laws,regulations and
administrative provisions relating to the classification,packaging and
labelling of dangerous substances(*).
仪器在设计和制造过程中必须将由物质从仪器中泄露出来所造成的风险
降到最低限度。

应特别注意的是，对再生物产生致癌，诱变或毒性反应
的物质应符合与1967年6月27在类似法律法规管理条款中颁布的理事会
指令67/548/EEC附录1涉及到的对危险物质的分类，包装和贴标签有关规
定。

If parts of a device(or a device itself)intended to administer and/or remove
medicines,body liquids or other substances to or from the body,or devices
intended for transport and storage of such body fluids or substances,contain
phthalates which are classified as carcinogenic,mutagenic or toxic to
reproduction,of category1or2,in accordance with Annex I to Directive
（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置67/548/EEC,these devices must be labelled on the device itself and/or on the
packaging for each unit or,where appropriate,on the sales packaging as a
device containing phthalates.
如果是预期用来管理或者移动药品、来自身体内的体液或其他物质的1
类或2类仪器的零部件，或者是预期用来运输和储存上述体液或物质的1
类或2类的仪器中包含被归为对再生物致癌，诱变或毒性的邻苯二甲酸
盐，按照理事会指令67/548/EEC附录1规定，，必须把标签贴在这些仪
器表面机身上或者整体仪器外包装上，或者合适的话，在销售包装上标
明此仪器含有邻苯二甲酸盐。

If the intended use of such devices includes treatment of children or treatment
of pregnant or nursing women,the manufacturer must provide a specific
justification for the use of these substances with regard to compliance with
the essential requirements,in particular of this paragraph,within the technical
documentation and,within the instructions for use,information on residual
risks for these patient groups and,if applicable,on appropriate precautionary
measures.
如果这些仪器的预期用途包括看护儿童、看护孕妇或者女性，生产商必
须为使用这些物质时应遵循的必要要求提供明确的解释，特别这一段，
应提供技术文件和使用说明中包含的有关这些病人群体的剩余风险的信
息的解释，如果适用的话，提供预防措施的相关解释。

7.6Devices must be designed and manufactured in such a way as to reduce,as
much as possible,risks posed by the unintentional ingress of substances into
the device taking into account the device and the nature of environment in
which it is intended to be used.
器械的设计和制造必须根据器械及其预定使用环境性质，尽可能降低由
于物质意外进入器械所造成的危险。

Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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8Infection and microbial contamination污染和微生物污染
8.1The 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 easy handling and,where necessary, minimize contamination of the device by the patient or vice versa during use.
器械和制造过程的设计必须尽可能消除和降低对患者、使用者及第三方的传染危险。

器械的设计必须便于在使用过程中的搬动，并且在必要时，减少患者对器械的污染，反之亦然。

8.2Tissues of animal origin must originate from animals that have been subjected
to veterinary controls and surveillance adapted to the intended use of tissues.
Notified bodies shall 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 transmissible agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process.
动物源组织必须来源于根据该动物组织的预定用途进行相应的兽医学控制和监督的动物体。

指定机构应保存有关动物原产地的资料。

动物的组织、细胞和物质加工、防腐试验和处理必须能提供最佳的安全性。

特别是有关病毒和其他转移剂的安全性，必须在制造过程中通过有效的消除病毒和病毒去活性方法来解决。

Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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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 sterile when placed on the market and remain sterile, under the storage and transport conditions laid down,until the protective packaging is damaged and opened.
以无菌状态提供的器械的设计、制造和包装必须执行一次性包装和/或按照适当的程序进行，以确保它们在投放市场时呈无菌状态。

并且在按规定的条件储存和运输时保持无菌状态，直至保护性包装被破坏或被打开为止。

8.4Devices delivered in a sterile state must have been manufactured and
sterilized by an appropriate,validated method.
以无菌状态提供的器械必须以适当的、经确认有效的方法制造和消毒。

8.5Devices intended to be sterilized must be manufactured in appropriately
controlled(e.g.environmental)conditions.
应预先消毒的器械必须在可适当控制（例如环境控制）的条件下制造。

8.6Packaging systems for non-sterile devices must keep the product without
deterioration at the level of cleanliness stipulated and,if the devices are to be sterilized prior to use,minimize the risk of microbial contamination;the packaging system must be suitable taking accounting of the method of sterilization indicated by the manufacturer.
非消毒器械用的包装系统必须使产品在规定的清洁度水平下不变质。

如果器械应在使用前消毒，必须将微生物的污染降到最低限度。

根据制造商指明的消毒方法，包装系统必须使适用的
Essential Requirement of MDD93/42AnnexⅠ（Including Directive2007/47/EC）A/NA
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8.7The packaging and/or label of the device must distinguish between identical
and similar products sold in both sterile and non-sterile condition.
器械的包装或标签必须能对以无菌和和非无菌状态销售的同类或类似产品进行区分。

9Construction and environmental properties制造和环境特性
9.1If the device is intended for use in combination with other devices or
equipment,the whole combination,including the connection system must be safe and must not impair the specified performances of the devices.Any restrictions on use must be indicated on the label or in the instruction for use.
如果器械预定与其他器械或设备组合使用，则整个组合包括连接系统必须使安全的，并且不能损害这些器械的规定性能。

任何使用限制必须在标签上或使用说明书中指明。

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 connected with reasonably foreseeable environmental conditions,
such as magnetic fields,external electrical influences,electrostatic
discharge,pressure,temperature or variations in pressure and
acceleration.
-the risks of reciprocal interference with other devices normally used in
the investigation or for the treatment given.
-risks arising where maintenance or calibration are not possible(as with
implants),from ageing of materials used or loss of accuracy of any
measuring or control mechanism.
（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置
器械的设计和制造必须尽可能消除和减少：
-与其物理特性有关的损害危险，包括容积/压力比，尺寸特性和适当
时人类工效学特性；
-与可合理预见的环境条件有关的危险，例如磁场，外部电影响，静
电放电，压力，温度，或压力和加速度的变化；
-与通常用于临床检查或指定治疗的其他器械发生相互干扰的危险。

-在不可能维护和校准的情况下(例如植入物)，因所用材料老化导致
的危险，或因任何测量或控制装置准确度降低造成的危险。

9.3Devices must be designed and manufactured in such a way as to minimize the
risks of fire or explosion during normal use and in signal fault condition.
Particular attention must be paid to devices whose intended use includes
exposure to flammable substances or to substances which could cause
combustion.
器械的设计和制造必须使器械在正常使用和单一故障情况下发生着火和
爆炸的危险降至最低限度。

应特别注意其预定用途包括接触易燃物质或
助燃物质的器械
10Devices with a measuring function具有测量功能的器械
10.1Devices with a measuring function must be designed and manufactured in
such a way as to provide sufficient accuracy and stability within appropriate
limits of accuracy and taking account of the intended purpose the device.The
limits of accuracy must be indicated by the manufacturer.
具有测量功能的器械在设计和制造上必须能根据其预定的用途，在适当
的准确度范围内提供足够的的准确度和稳定度。

准确度范围由制造商给
定。

（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置
10.2The measurement,monitoring and display scale must be designed in line
with ergonomic principles,taking account of the intended purpose of the
device.
测量、监控和显示范围的设计必须考虑器械的预定用途符合人类工效学
原理。

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(20)
由具有测量功能的器械所作的测量必须用符合80/181/EEC指令的法定
单位表示。

11.Protection against radiation辐射防护
11.1General概述
11.1.1Devices shall 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.
器械的设计和制造应在兼顾其用途的同时尽可能减少患者、使用者
和其他人员遭受辐射，同时又不会限制使用规定的适当剂量水平进
行治疗和诊断。

11.2Intended radiation预期辐射
11.2.1Where 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 and manufactured
to ensure reproducibility and tolerance of relevant variable parameters.
（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置
如果设计的器械所发射的危险辐射水平是特定治疗目的所需的，且该辐
射在治疗方面的益处超过了它固有的危险，则使用者必须能控制辐射的
发射能控制辐射的发射。

这类器械的设计和制造应确保相关的可变参数
和复现性和容差。

11.2.2Where devices are intended to emit potentially hazardous,visible and/or
invisible radiation,they must be fitted,where practicable,with visual
displays and/or audible warnings of such emissions.
如果器械用来发射有潜在危险的可见或不可见辐射，在可能的情况
下，这些器械必须安装目视显示装置和/或可听声警告装置。

11.3Unintended radiation非预期辐射
11.3.1Devices shall be designed and manufactured in such a way that exposure
of patients,users and other persons to the emission of unintended,stray
or scattered radiation is reduced as far as possible.
器械的设计和制造应尽可能减少患者、使用者或其他人员遭受未预
期的漫射或散射的辐射。

11.4Instructions说明书
11.4.1The operating instructions for devices emitting radiation must give
detailed information as to the nature of the emitted radiation,means of
protecting the patient and the user and on ways of avoiding misuse and of
eliminating the risks inherent in installation.
发射辐射的器械的操作说明书必须详细给出所发射的辐射的性质、
患者和使用者的防护方法、避免误用和消除安装中内在危险的途径
等信息。

（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置11.5Ionizing radiation电离辐射
11.5.1Devices intended to emit ionizing radiation must be designed and
manufactured in such a way as to ensure that,where practicable,the
quantity,geometry,and quality of radiation emitted can he varied and
controlled taking into account the intended use.
发射电离辐射的器械的设计和制造应确保在可行的情况下，发射的
辐射的数量，几何特性和质量可以根据器械的预定用途予以改变和
控制。

11.5.2Devices emitting ionizing radiation intended for diagnostic radiology
shall be designed and manufactured in such a way as to achieve
appropriate image and/or output quality for the intended medical purpose
whilst minimizing radiation exposure of the patient and user.
发射诊断放射学用电离辐射的器械，其设计和制造应确保获得适合
预定治疗目的的成像和/或输出质量，同时使患者和使用者遭受辐射
最少。

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 energy
and where appropriate the quality of radiation.
发射治疗放射学用电离辐射的器械，其设计和制造应确保对提供的
剂量、射束形式和能量以及必要时辐射的质量可靠地进行监控。

12.Requirement for medical devices connected to
or equipped with an energy source.
对连接或装配能源的医疗器械的要求
（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置
12.1Devices 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 single fault condition(in the
system)appropriate means should be adopted to eliminate or reduce as far
as possible consequent risks.
带有电子可编程系统的器械在设计上必须确保这些系统具有预定的复
见性、可靠性和性能。

如果出现个别故障，应采取适当方法尽可能消
除或减少随之发生的危险。

12.1a For devices which incorporate software or which are medical software in
themselves,the software must be validated according to the state of the art
taking into account the principles of development lifecycle,risk
management,validation and verification.
医疗器械含有软件或者本身就是软件，这个软件必须根据当时的科技发
展水平，考虑研发的生命周期，风险管理，验证和确认的原则。

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.
患者的安全取决于内装电源的器械必须配备测定电源状况的手段。

12.3Devices where the safety of the patients depends on an external power
supply must include an alarm system to signal any power failure.
患者的安全取决于外部电源的器械必须包括一个对任何电源故障发出警
报信号的系统。

（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置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 of patient’s state
of health.
用于监控患者一个或多个临床参数的器械，必须配备适当的报警系统，
提醒使用者注意可能会导致患者死亡或其健康状况受到严重损害的器械
状况。

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.
器械的设计或制造必须使器械在正常使用环境中产生的电磁场对其他设
备或器械造成的危险降至最低。

12.6Protection against electrical risks
Devices must be designed and manufactured in such a way as to avoid,as far
as possible,the risk of accidental electric shocks during normal use and in
single fault condition,provided the devices are installed correctly.
电气危险的防护
器械的设计和制造必须保证器械在正确安装的情况下，尽可能避免在正
常使用和发生个别故障时产生意外的电击危险。

12.7Protection against mechanical and thermal risks机械和热危险的防护
12.7.1Devices must be designed and manufactured in such a way as to protect the
patient and user against mechanical risks connected with,for example,
resistance,stability and moving parts.
器械的设计和制造必须保护患者和使用者免受诸如阻力，不稳定性和
活动部件相关的机械危险。

（Including Directive2007/47/EC）适用/不适用相关的证据形成的文件及存放位置12.7.2Devices must be designed manufactured in such a way as to reduce to the
lowest possible level the risks arising from vibration generated by the
devices,taking account of technical progress and of the means available
for limiting vibrations,particularly at source,unless the vibration are part
of the specified performance.
器械的设计和制造必须考虑利用技术进步和适当的限振手段，特别
是振源的限制手段将器械产生振动所导致的危险降至尽可能低的水
平，除非这种振动是器械规定性能的一部分。

12.7.3Devices must be designed and manufactured in such a way as to reduce
to the lowest possible level the risks arising from the noise emitted,
taking account of technical progress and of the means available to reduce
noise,particularly at source,unless the noise emitted is part of the
specified performance.
器械的设计和制造必须考虑技术进步和适用的减噪手段，特别是噪
音源的减噪手段将器械产生的噪音所导致的危险降至尽可能低的水
平，除非这种噪音是器械规定性能的一部分。

12.7.4Terminals and connectors to the electricity,gas or hydraulic and
pneumatic energy supplies which the user has to handle must be designed
constructed in such a way as to minimize all possible risks.
使用者必须使用电接线柱和电连接器、气体或液力和气力能源，其
设计或制造必须能使所有可能的危险降至最小。

12.7.5Accessible parts of the devices(excluding the parts or areas intended to
supply beat or reach given temperatures)and their surroundings must not
attain potentially dangerous temperature under normal use.
器械的可及部位（除用于供热或达到设定温度的部分或区域）及其
邻近区域，在正常使用过程中，不得达到具有潜在危险的温度。