ANNEX I
GENERAL SAFETY AND PERFORMANCE REQUIREMENTS 一般安全和性能要求
CHAPTER I
GENERAL REQUIREMENTS 一般要求
1. Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall 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, taking into account the generally acknowledged state of the art.設備應達到製造商預期的性能，並且其設計和製造應使其在正常使用條件下適合其預期目的。它們應是安全有效的，並且不得損害患者的臨床狀況或安全性，使用者或其他人的安全和健康狀況，但在稱重時，與使用有關的任何風險均應構成可接受的風險。考慮到普遍公認的最新技術水平，因此不損害患者的利益，並且與高水平的健康和安全保護相兼容。
2. The requirement in this Annex to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.本附件中要求盡可能降低風險的要求是指在不對利益風險比產生不利影響的情況下，盡可能降低風險。
3. Manufacturers shall establish, implement, document and maintain a risk management system.製造商應建立，實施，記錄和維護風險管理體系。
Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. In carrying out risk management manufacturers shall:風險管理應理解為設備整個生命週期中的連續迭代過程，需要定期進行系統更新。製造商在進行風險管理時應：
| (a) | establish and document a risk management plan for each device;建立並記錄每台設備的風險管理計劃； |
(b) |
identify and analyse the known and foreseeable hazards associated with each device;識別並分析與每個設備相關的已知和可預見的危害； |
(c) |
estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;估計和評估與預期使用以及合理可預見的濫用有關的風險，以及在預期的合理可預見的濫用中發生的風險； |
(d) |
eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;根據第4節的要求消除或控制（c）點中提到的風險； |
(e) |
evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and評估來自生產階段（尤其是來自上市後監視系統）的信息對危害及其發生頻率，相關風險的估計以及整體風險，受益風險比的影響和風險的可接受性；和 |
(f) |
based on the evaluation of the impact of the information referred to in point (e), if necessary amend control measures in line with the requirements of Section 4.根據對（e）點所指信息的影響評估，必要時根據第4節的要求修改控制措施。 |
4. Risk control measures adopted by manufacturers for the design and manufacture of the devices shall conform to safety principles, taking account of the generally acknowledged state of the art. To reduce risks, Manufacturers shall manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable. In selecting the most appropriate solutions, manufacturers shall, in the following order of priority:製造商為設計和製造設備而採取的風險控制措施應符合安全原則，並應考慮到公認的最新技術水平。為了降低風險，製造商應管理風險，以使與每種危害相關的殘留風險以及總體殘留風險被認為是可以接受的。在選擇最合適的解決方案時，製造商應按以下優先順序：
| (a) | eliminate or reduce risks as far as possible through safe design and manufacture;通過安全的設計和製造，盡可能消除或降低風險； |
(b) |
where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and |
(c) |
provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users.提供安全信息（警告/注意事項/禁忌症），並在適當的情況下對用戶進行培訓。 |
Manufacturers shall inform users of any residual risks.製造商應將任何殘留風險告知用戶。
5. In eliminating or reducing risks related to use error, the manufacturer shall:為了消除或減少與使用錯誤有關的風險，製造商應：
| (a) | reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and盡可能降低與設備的人體工程學特徵以及設備打算使用的環境有關的風險（為患者安全設計），以及 |
(b) |
give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).考慮適用的技術知識，經驗，教育，培訓和使用環境，以及預期用戶（非專業人士，專業人士，殘障人士或其他用戶的設計）的醫療和身體狀況。 |
6. The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user 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 and has been properly maintained in accordance with the manufacturer's instructions.設備的特性和性能不應受到不利影響，以免在設備的使用壽命期間損害患者或用戶以及其他人（如果適用）的健康或安全，如果設備承受正常使用條件下可能產生的應力並已按照製造商的說明進行了適當的維護，則應在製造商的指導下進行操作。
7. Devices shall be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.設備的設計，製造和包裝方式應保證其預期用途的特性和性能在運輸和存儲過程中不會受到不利影響，例如，溫度和濕度的波動應考慮到提供的說明和信息由製造商。
8. All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be acceptable when weighed against the evaluated benefits to the patient and/or user arising from the achieved performance of the device during normal conditions of use.
所有已知和可預見的風險以及任何不良副作用都應降至最低，並且在權衡正常使用條件下設備實現的性能給患者和/或用戶帶來的益處後，再進行權衡。
9. For the devices referred to in Annex XVI, the general safety requirements set out in Sections 1 and 8 shall be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product's use which is consistent with a high level of protection for the safety and health of persons.
對於附件XVI中提及的設備，第1節和第8節中規定的一般安全要求應理解為表示，在規定的條件下和預期的目的使用時，該設備完全不構成危險，或所帶來的風險不超過與產品使用相關的最大可接受風險，這與對人員安全和健康的高度保護相一致。
REQUIREMENTS REGARDING DESIGN AND MANUFACTURE有關設計和製造的要求
10. Chemical, physical and biological properties化學，物理和生物學特性
10.1. Devices shall be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in Chapter I are fulfilled. Particular attention shall be paid to:設備的設計和製造應確保滿足第一章中提到的特性和性能要求。應特別注意：
| (a) | the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;選擇所使用的材料和物質，特別是在毒性和相關的可燃性方面； |
(b) |
the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;考慮到設備的預期用途以及相關的吸收，分佈，代謝和排泄物，所使用的材料和物質與生物組織，細胞和體液之間的相容性； |
(c) |
the compatibility between the different parts of a device which consists of more than one implantable part;由多個可植入部分組成的設備不同部分之間的兼容性； |
(d) |
the impact of processes on material properties;工藝對材料性能的影響； |
(e) |
where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;在適當的情況下，事先已證明其有效性的生物物理或模型研究結果； |
(f) |
the mechanical properties of the materials used, reflecting, where appropriate, matters such as strength, ductility, fracture resistance, wear resistance and fatigue resistance;所用材料的機械性能，在適當情況下反映出諸如強度，延展性，耐斷裂性，耐磨性和耐疲勞性等事項； |
(g) |
surface properties; and表面特性和 |
(h) |
the confirmation that the device meets any defined chemical and/or physical specifications.確認設備符合任何已定義的化學和/或物理規格。 |
10.2. Devices shall be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to patients, taking account of the intended purpose of the device, and to the persons involved in the transport, storage and use of the devices. Particular attention shall be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.在設計，製造和包裝器械時，應考慮到器械的預期用途以及運輸，存放和使用器械的人員的預期目的，將污染物和殘留物對患者造成的風險降至最低。 。應特別注意暴露於這些污染物和殘留物的組織，以及暴露的持續時間和頻率。
10.3. Devices shall be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use; if the devices are intended to administer medicinal products they shall be designed and manufactured in such a way as to be compatible with the medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products and that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use.設備的設計和製造方式應使其能夠與在其預期使用中接觸的材料和物質（包括氣體）安全地使用；如果該器械旨在用於管理藥品，則其設計和製造方式應使其與有關藥品兼容，並應遵守有關該藥品的規定和限制，以及該藥品和藥品的性能。根據各自的指示和預期用途對設備進行維護。
10.4. Substances設備設計與製造
10.4.1. Design and manufacture of devices設備的設計和製造
Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.應盡可能減少可能從設備釋放的物質或顆粒（包括磨損碎片，降解產物和加工殘留物）帶來的風險。
Devices, or those parts thereof or those materials used therein that:
設備，其中的那些部分或其中使用的材料：
| — | are invasive and come into direct contact with the human body,具有侵入性，並直接與人體接觸， |
— |
(re)administer medicines, body liquids or other substances, including gases, to/from the body, or向身體/從身體（重新）給藥藥物，體液或其他物質，包括氣體，或 |
— |
transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,運輸或儲存要（重新）投放到人體的此類藥物，體液或物質（包括氣體）， |
shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2:
| (a) | substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, in accordance with Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1), or根據歐洲議會和理事會第1272/2008號法規（EC）附件VI第3部分，具有1A或1B類的致癌，致突變或對生殖有毒的物質（'CMR'）（1） ， 或者 |
(b) |
substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the criteria that are relevant to human health amongst the criteria established therein.具有破壞內分泌特性的物質，有科學證據可能對人體健康產生嚴重影響，並且已根據歐洲議會第1907/2006號法規（EC）第59條規定的程序和理事會（2）或委員會根據歐洲議會和理事會（3）第（EU）528/2012號條例（EU）第5（3）條第1款通過的委派行為，根據其中建立的標準??中與人類健康相關的標準。 |
10.4.2. Justification regarding the presence of CMR and/or endocrine-disrupting substances
The justification for the presence of such substances shall be based upon:10.4.2。關於存在CMR和/或破壞內分泌的物質的理由
存在此類物質的理由應基於：
| (a) | an analysis and estimation of potential patient or user exposure to the substance;對潛在患者或使用者接觸該物質的分析和估計； |
(b) |
an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives;分析可能的替代物質，材料或設計，包括在可能的情況下有關獨立研究，同行評審研究，相關科學委員會的科學意見的信息以及對此類替代物的可用性的分析； |
(c) |
argumentation as to why possible substance and/ or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including taking into account if the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials; and關於為什麼可能的物質和/或材料替代品（如果可用）或設計變更（如果可行）在維持產品的功能，性能和利益風險比方面不合適的論點；包括考慮此類設備的預期用途是否包括兒童的治療或孕婦或哺乳期婦女的治療，或其他被認為特別易受此類物質和/或材料影響的患者群體的治療；和 |
(d) |
where applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4.在適用和可用的情況下，根據10.4.3節提供最新的相關科學委員會指南。和10.4.4。 |
10.4.3. Guidelines on phthalates鄰苯二甲酸鹽準則
For the purposes of Section 10.4., the Commission shall, as soon as possible and by 26 May 2018, provide the relevant scientific committee with a mandate to prepare guidelines that shall be ready before 26 May 2020. The mandate for the committee shall encompass at least a benefit-risk assessment of the presence of phthalates which belong to either of the groups of substances referred to in points (a) and (b) of Section 10.4.1. The benefit-risk assessment shall take into account the intended purpose and context of the use of the device, as well as any available alternative substances and alternative materials, designs or medical treatments. When deemed appropriate on the basis of the latest scientific evidence, but at least every five years, the guidelines shall be updated.就第10.4節而言，委員會應盡快並在2018年5月26日之前向相關科學委員會提供授權，以準備應在2020年5月26日之前準備的準則。委員會的職責應包括：至少對第10.4.1節（a）和（b）所述的物質類別之一中的鄰苯二甲酸鹽的存在進行風險評估。利益風險評估應考慮設備的預期用途和使用環境，以及任何可用的替代物質和替代材料，設計或醫療方法。如果根據最新的科學證據認為適當，但至少每五年，應更新指南。
10.4.4. Guidelines on other CMR and endocrine-disrupting substances
Subsequently, the Commission shall mandate the relevant scientific committee to prepare guidelines as referred to in Section 10.4.3. also for other substances referred to in points (a) and (b) of Section 10.4.1., where appropriate.其他CMR和乾擾內分泌物質的指南
隨後，委員會應授權相關科學委員會準備第10.4.3節中提及的指南。如果適用，還適用於第10.4.1節（a）和（b）節中提到的其他物質。
10.4.5. Labelling貼標
Where devices, parts thereof or materials used therein as referred to in Section 10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight by weight (w/w), the presence of those substances shall be labelled on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances. If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.如第10.4.1節所述的裝置，其零件或其中使用的材料。包含第10.4.1節（a）或（b）所述的物質。如果濃度高於0.1％（重量）（w / w），則應在設備本身和/或每個單元的包裝上（或在適當的情況下，在銷售包裝上）對這些物質的存在進行標記，並附上標籤。此類物質清單。如果此類設備的預期用途包括兒童治療，孕婦或哺乳期婦女的治療或其他特別易受此類物質和/或物質影響的患者群體的治療，則應提供有關這些患者群體的殘留風險的信息，並在適當時提供相關信息。使用說明中應採取預防措施。
10.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by the unintentional ingress of substances into the device taking into account the device and the nature of the environment in which it is intended to be used.在設計和製造設備時，應考慮到設備及其預期使用環境的性質，盡可能降低物質無意進入設備所帶來的風險。
10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patient's or user's body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.設備的設計和製造應盡可能減少與已釋放或可釋放到患者或使用者體內的顆粒的大小和性質有關的風險，除非它們僅與完整的皮膚接觸即可。應特別注意納米材料。
11. Infection and microbial contamination感染和微生物污染
11.1. Devices and their manufacturing processes shall be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons. The design shall:器械及其製造工藝的設計應盡可能消除或降低患者，使用者和其他人（如適用）感染的風險。設計應：
| (a) | reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,盡可能減少並適當地避免意外割傷和刺傷的風險，例如針刺傷， |
(b) |
allow easy and safe handling,可以輕鬆安全地進行操作， |
(c) |
reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, and在使用過程中，盡可能減少設備中的任何微生物洩漏和/或微生物暴露，並且 |
(d) |
prevent microbial contamination of the device or its content such as specimens or fluids.防止對設備或其內容物（如標本或液體）進行微生物污染。 |
11.2. Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.必要時，應設計便於安全清潔，消毒和/或重新消毒的設備。
11.3. Devices labelled as having a specific microbial state shall be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer.標記為具有特定微生物狀態的設備應進行設計，製造和包裝，以確保在投放市場時保持該狀態，並在製造商指定的運輸和儲存條件下保持這種狀態。
11.4. Devices delivered in a sterile state shall be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use. It shall be ensured that the integrity of that packaging is clearly evident to the final user.以無菌狀態交付的器械應按照適當的程序進行設計，製造和包裝，以確保在投放市場時它們是無菌的，並且除非旨在保持其無菌狀態的包裝被破壞，否則它們將保持無菌狀態。 ，在製造商指定的運輸和儲存條件下，直到在使用時打開包裝為止。應確保最終用戶清楚地看到該包裝的完整性。
11.5. Devices labelled as sterile shall be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods.標記為無菌的設備應通過適當的，經過驗證的方法進行處理，製造，包裝和消毒。
11.6. Devices intended to be sterilised shall be manufactured and packaged in appropriate and controlled conditions and facilities.打算滅菌的設備應在適當的受控條件和設施下製造和包裝。
11.7. Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilised prior to use, minimise the risk of microbial contamination; the packaging system shall be suitable taking account of the method of sterilisation indicated by the manufacturer.非無菌器械的包裝系統應保持產品的完整性和清潔度，並且在使用前對器械進行滅菌的地方，應將微生物污染的風險降至最低；包裝系統應適當考慮製造商指示的滅菌方法。
11.8. The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile.設備的標籤應區分已投放市場的相同或相似的設備，該設備在無菌和非無菌條件下均標有用於表示設備已無菌的符號。
12. Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combinations of substances that are absorbed by or locally dispersed in the human body.包含被視為藥品的物質的器械，以及由人體吸收或局部分散在人體中的物質或物質組合組成的器械。
12.1. In the case of devices referred to in the first subparagraph of Article 1(8), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of point (2) of Article 1 of Directive 2001/83/EC, shall be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC, as required by the applicable conformity assessment procedure under this Regulation.對於第1條第（8）款第1項所指的器械，該物質的質量，安全性和實用性，如果單獨使用，將被視為是第（2）款含義內的藥用產品。應按照本法規適用的合格評定程序的要求，以類似於指令2001/83 / EC附件I中指定的方法對指令2001/83 / EC的第1條進行驗證。
12.2. Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body shall comply, where applicable and in a manner limited to the aspects not covered by this Regulation, with the relevant requirements laid down in Annex I to Directive 2001/83/EC for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under this Regulation.由擬引入人體的物質或物質組合構成的，並被人體吸收或局部分散在人體中的裝置，應在適用的情況下以符合本標準的規定為限，並應僅限於本標準未涵蓋的方面。本法規，以及指令2001/83 / EC附件I中規定的有關吸收，分佈，代謝，排泄，局部耐受性，毒性，與其他裝置，藥品或其他物質的相互作用以及潛在不良反應的評估的相關要求根據本法規適用的合格評定程序的要求進行的反應。
13. Devices incorporating materials of biological origin包含生物來源材料的設備
13.1. For devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable covered by this Regulation in accordance with point (g) of Article 1(6), the following shall apply:對於使用根據本條例第1條第（6）款（g）項規定不可行或變得不可行的人類組織或細胞的衍生物製造的器械，應適用以下規定：
| (a) | donation, procurement and testing of the tissues and cells shall be done in accordance with Directive 2004/23/EC;組織和細胞的捐贈，採購和測試應按照第2004/23 / EC號指令進行； |
(b) |
processing, preservation and any other handling of those tissues and cells or their derivatives shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process;應當對這些組織和細胞或其衍生物進行處理，保存和其他任何處理，以便為患者，使用者和其他適用的人提供安全。特別是，應通過適當的採購方法和在製造過程中實施經過驗證的消除或滅活方法，來解決與病毒和其他可傳播媒介有關的安全性； |
(c) |
the traceability system for those devices shall be complementary and compatible with the traceability and data protection requirements laid down in Directive 2004/23/EC and in Directive 2002/98/EC.這些設備的可追溯性系統應與第2004/23 / EC號指令和第2002/98 / EC號指令中規定的可追溯性和數據保護要求互補並兼容。 |
13.2. For devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable the following shall apply:對於利用動物來源的組織或細胞或其衍生物製造的，不能存活或變得不能存活的設備，應適用以下規定：
(a) |
where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives, shall originate from animals that have been subjected to veterinary controls that are adapted to the intended use of the tissues. Information on the geographical origin of the animals shall be retained by manufacturers;在可行的情況下，考慮到動物種類，動物來源的組織和細胞或其衍生物，應來源於經過獸醫控制以適應組織預期用途的動物。製造商應保留有關動物地理來源的信息； |
(b) |
sourcing, processing, preservation, testing and handling of tissues, cells and substances of animal origin, or their derivatives, shall be carried out so as to provide safety for patients, users and, where applicable, other persons. In particular safety with regard to viruses and other transmissible agents shall be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the clinical benefit of the device;應當進行動物來源的組織，細胞和物質或其衍生物的採購，加工，保存，測試和處理，以便為患者，使用者以及其他適用的人提供安全。特別是對於病毒和其他可傳播媒介的安全性，應通過在生產過程中實施經過驗證的消除或病毒滅活的方法來解決，除非使用此類方法會導致不可接受的降解，從而損害其臨床價值。設備; |
(c) |
in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply.對於使用（EU）第722/2012號規定的動物來源的組織或細胞或其衍生物製造的設備，應適用該規定中規定的特定要求。 |
13.3. For devices manufactured utilising non-viable biological substances other than those referred to in Sections 13.1 and 13.2, the processing, preservation, testing and handling of those substances shall be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain. In particular, safety with regard to viruses and other transmissible agents shall be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.
對於使用第13.1節和第13.2節中提到的物質以外的非生存性生物物質製造的設備，應進行這些物質的處理，保存，測試和處理，以為患者，使用者和其他適用的人提供安全性。人員，包括廢物處理鏈中的人員。特別是，應通過適當的採購方法以及在製造過程中實施經過驗證的消除或滅活方法，來解決與病毒和其他可傳播媒介有關的安全問題。
14. Construction of devices and interaction with their environment設備的構造及其與環境的交互
14.1. If the device is intended for use in combination with other devices or equipment the whole combination, including the connection system shall be safe and shall not impair the specified performance of the devices. Any restrictions on use applying to such combinations shall be indicated on the label and/or in the instructions for use. Connections which the user has to handle, such as fluid, gas transfer, electrical or mechanical coupling, shall be designed and constructed in such a way as to minimise all possible risks, such as misconnection如果打算將該設備與其他設備或設備組合使用，則包括連接系統在內的整個組合應是安全的，並且不得損害設備的指定性能。適用於此類組合的任何使用限制均應在標籤和/或使用說明中註明。用戶必須處理的連接，例如流體，氣體傳輸，電氣或機械連接，應以盡量減少所有可能的風險（例如錯誤連接）的方式設計和構造。.
14.2. Devices shall be designed and manufactured in such a way as to remove or reduce as far as possible:設備的設計和製造應盡可能減少或減少：
| (a) | the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features;與身體特徵有關的受傷風險，包括體積/壓力比，尺寸和適當的人體工程學特徵； |
(b) |
risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences;與合理可預見的外部影響或環境條件有關的風險，例如磁場，外部電氣和電磁效應，靜電放電，與診斷或治療程序相關的輻射，壓力，濕度，溫度，壓力和加速度的變化或無線電信號干擾; |
(c) |
the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use;在正常使用條件下，與設備接觸的材料，液體和物質（包括氣體）接觸時，與使用設備有關的風險； |
(d) |
the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts;與軟件及其在其中進行操作和交互的IT環境之間可能存在的負面交互作用相關的風險； |
(e) |
the risks of accidental ingress of substances into the device;物質意外進入設備的風險； |
(f) |
the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given; and與通常用於研究或給定治療的其他設備相互干擾的風險；和 |
(g) |
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.由於所用材料的老化或任何測量或控制機構的準確性下降，在無法進行維護或校準的情況下（如植入物）會產生風險。 |
14.3. Devices shall be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition. Particular attention shall be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion.設備的設計和製造應盡量減少正常使用和單一故障情況下著火或爆炸的風險。應特別注意其預期用途的設備，包括暴露於易燃或易爆物質或可能引起燃燒的物質或與之結合使用。
14.4. Devices shall be designed and manufactured in such a way that adjustment, calibration, and maintenance can be done safely and effectively.設備的設計和製造應能安全有效地進行調整，校準和維護。
14.5. Devices that are intended to be operated together with other devices or products shall be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.旨在與其他設備或產品一起使用的設備的設計和製造應確保互操作性和兼容性可靠且安全。
14.6 Any measurement, monitoring or display scale shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.任何測量，監視或顯示磅秤均應根據人體工程學原理進行設計和製造，並應考慮預期的目的，用戶和打算使用該設備的環境條件。
14.7. Devices shall be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person. To that end, manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.設備的設計和製造方式應有利於用戶，患者或其他人對其進行安全處置以及相關廢物的安全處置。為此，製造商應確定並測試程序和措施，以使使用後的設備可以安全處置。此類程序應在使用說明中進行描述。
15. Devices with a diagnostic or measuring function具有診斷或測量功能的設備
15.1. Diagnostic devices and devices with a measuring function, shall be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate scientific and technical methods. The limits of accuracy shall be indicated by the manufacturer.診斷設備和具有測量功能的設備的設計和製造，應基於適當的科學和技術方法，以為其預期目的提供足夠的精度，精度和穩定性。精度極限應由製造商指出。
15.2. The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Council Directive 80/181/EEC (4).具有測量功能的設備進行的測量應以符合理事會指令80/181 / EEC（4）規定的法定單位表示。
16. Protection against radiation防輻射
16.1. General一般的
| (a) | Devices shall be designed, manufactured and packaged in such a way that exposure of patients, users and other persons to radiation is reduced as far as possible, and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.設備的設計，製造和包裝應盡可能減少患者，使用者和其他人受到輻射的照射，並與預期目的兼容，同時不限制使用適當規定的設備。用於治療和診斷目的的水平。 |
(b) |
The operating instructions for devices emitting hazardous or potentially hazardous radiation shall contain detailed information as to the nature of the emitted radiation, the means of protecting the patient and the user, and on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate. Information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure shall also be specified.發出危險或潛在危險輻射的設備的操作說明應包含有關輻射輻射的性質，保護患者和使用者的方法以及避免誤用和降低安裝固有風險的詳細信息。盡可能和適當。還應指定有關驗收和性能測試，驗收標準以及維護程序的信息。 |
16.2. Intended radiation預期輻射
| (a) | Where devices are designed to emit hazardous, or potentially hazardous, levels of ionizing and/or non-ionizing radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent to the emission, it shall be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance.如果設備被設計為發射特定醫學目的所必需的危險或潛在危險的電離和/或非電離輻射水平，其益處被認為超過了發射固有的風險，則用戶應有可能控制排放。此類設備的設計和製造應確保相關可變參數的再現性在可接受的公差範圍內。 |
(b) |
Where devices are intended to emit hazardous, or potentially hazardous, ionizing and/or non-ionizing radiation, they shall be fitted, where possible, with visual displays and/or audible warnings of such emissions.如果設備打算發出危險或潛在危險的電離和/或非電離輻射，則應在可能的地方安裝視覺顯示和/或聲音警告。 |
16.3. Devices 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. Where possible and appropriate, methods shall be selected which reduce the exposure to radiation of patients, users and other persons who may be affected.設備的設計和製造應盡可能減少患者，使用者和其他人暴露於意外，雜散或散射的輻射中。在可能和適當的情況下，應選擇減少患者，使用者和其他可能受到影響的人的輻射暴露的方法。
16.4. Ionising radiation電離輻射
| (a) | Devices intended to emit ionizing radiation shall be designed and manufactured taking into account the requirements of the Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation.設計和製造旨在發射電離輻射的設備時，應考慮到指令2013/59 / Euratom的要求，該要求規定了基本的安全標準，可防止因暴露於電離輻射而引起的危險。 |
(b) |
Devices intended to emit ionising radiation shall be designed and manufactured in such a way as to ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of the radiation emitted can be varied and controlled, and, if possible, monitored during treatment.打算發射電離輻射的設備的設計和製造應確保在可能的情況下，考慮到預期的用途，可以改變和控制所發射輻射的數量，幾何形狀和質量，並且在可能的情況下，在治療過程中進行監控。 |
(c) |
Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactured in such a way as to achieve an image and/or output quality that are appropriate to the intended medical purpose whilst minimising radiation exposure of the patient and user.旨在用於診斷放射學的發射電離輻射的設備，其設計和製造方式應能達到適合於預期醫療目的的圖像和/或輸出質量，同時最大程度地減少患者和用戶的輻射暴露。 |
(d) |
Devices that emit ionising radiation and are 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, energy and, where appropriate, the quality of radiation.發射電離輻射並打算用於放射治療的設備的設計和製造方式應能夠可靠地監視和控制所輸送的劑量，射線束類型，能量以及在適當情況下的輻射質量。 |
17. Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves電子可編程系統—結合了電子可編程系統和本身就是設備的軟件的設備
17.1. Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, shall be designed to ensure repeatability, reliability and performance in line with their intended use. In the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks or impairment of performance.包含電子可編程系統的設備，包括軟件或本身就是設備的軟件，應進行設計以確保符合其預期用途的可重複性，可靠性和性能。在單一故障情況下，應採取適當的措施以消除或盡可能減少由此帶來的風險或性能損失。
17.2. For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.對於裝有軟件的設備或本身就是設備的軟件，應根據最新技術開發和製造軟件，同時應考慮開發生命週期，風險管理（包括信息安全性，驗證和確認）的原則。
17.3. Software referred to in this Section that is intended to be used in combination with mobile computing platforms shall be designed and manufactured taking into account the specific features of the mobile platform (e.g. size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise).本節中提及的旨在與移動計算平台結合使用的軟件，在設計和製造時應考慮到移動平台的特定功能（例如屏幕的尺寸和對比度）以及與其相關的外部因素使用（關於光線或噪音水平的變化環境）。
17.4. Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.製造商應制定有關硬件，IT網絡特性和IT安全措施的最低要求，包括防止按預期運行軟件所需的未經授權的訪問的保護。
18. Active devices and devices connected to them設備及其連接的設備
18.1. For non-implantable active devices, in the event of a single fault condition, appropriate means shall be adopted to eliminate or reduce as far as possible consequent risks.對於不可植入的設備，如果發生單一故障情況，則應採取適當的措施以消除或盡可能減少隨之而來的風險。
18.2. Devices where the safety of the patient depends on an internal power supply shall be equipped with a means of determining the state of the power supply and an appropriate warning or indication for when the capacity of the power supply becomes critical. If necessary, such warning or indication shall be given prior to the power supply becoming critical.患者安全取決於內部電源的設備應配備確定電源狀態的裝置，並在電源容量變得嚴重時提供適當的警告或指示。如有必要，應在電源變得嚴重之前發出警告或指示。
18.3. Devices where the safety of the patient depends on an external power supply shall include an alarm system to signal any power failure.患者安全取決於外部電源的設備應包括一個警報系統，以發出任何電源故障信號。
18.4. Devices intended to monitor one or more clinical parameters of a patient shall be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient's state of health.用於監視患者一個或多個臨床參數的設備應配備適當的警報系統，以警告用戶可能導致死亡或患者健康狀況嚴重惡化的情況。
18.5. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment.設備的設計和製造應盡可能降低產生電磁干擾的風險，這種干擾可能會損害所討論的設備或預期環境中的其他設備或設備的運行。
18.6. Devices shall be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference such that is adequate to enable them to operate as intended.設備的設計和製造應具有一定的抗電磁干擾能力，足以使它們按預期運行。
18.7. Devices shall be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer.設備的設計和製造應盡可能避免在設備的正常使用過程中和發生單個故障時對患者，用戶或其他任何人造成意外電擊的危險前提條件是設備已按照製造商的指示進行了安裝和維護。
18.8. Devices shall be designed and manufactured in such a way as to protect, as far as possible, against unauthorised access that could hamper the device from functioning as intended.設備的設計和製造應盡可能地防止未經授權的訪問，這可能會妨礙設備按預期運行。
19. Particular requirements for active implantable devices植入設備的特殊要求
19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:可植入設備的設計和製造應盡可能減少或最小化：
| (a) | risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,與使用能源有關的風險，尤其是在使用電能的情況下，存在絕緣，洩漏電流和設備過熱的風險， |
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(b) |
risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment, and與醫療有關的風險，尤其是因使用除纖顫器或高頻手術設備而引起的風險，以及 |
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(c) |
risks which may arise where maintenance and calibration are impossible, including:在無法進行維護和校準的情況下可能出現的風險，包括：
|
19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure植入裝置的設計和製造應確保
| — | if applicable, the compatibility of the devices with the substances they are intended to administer, and如果適用，設備與擬管理的物質的兼容性，以及 |
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the reliability of the source of energy.能源的可靠性。 |
19.3. Active implantable devices and, if appropriate, their component parts shall be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component parts.可植入設備及其合適的部件應是可識別的，以便在發現與設備或其組成部件有關的潛在風險後採取任何必要的措施。
19.4. Active implantable devices shall bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and its year of manufacture); it shall be possible to read this code, if necessary, without the need for a surgical operation.可植入設備應帶有可明確識別其及其製造商的代碼（尤其是關於設備的類型及其製造年份）；如有必要，應無需外科手術即可閱讀本規範。
20. Protection against mechanical and thermal risks防止機械和熱風險
20.1. Devices shall be designed and manufactured in such a way as to protect patients and users against mechanical risks connected with, for example, resistance to movement, instability and moving parts.設備的設計和製造方式應能保護患者和使用者免受機械風險的影響，例如，運動，不穩定和運動部件的阻力。
20.2. Devices shall be designed and 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 vibrations are part of the specified performance.設備的設計和製造應考慮到技術進步和可用於限制振動的手段（特別是在源頭），將設備產生的振動所產生的風險降低到最低水平，除非這些振動是指定性能的一部分。
20.3. Devices shall 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.設備的設計和製造應考慮到技術進步和降低噪音的可用方法，尤其是在源頭，將噪音產生的風險降低到盡可能低的水平，除非發出的噪音是其中的一部分。指定性能。
20.4. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, shall be designed and constructed in such a way as to minimise all possible risks.用戶或他人必須處理的電力，燃氣或液壓和氣動能源的端子和連接器的設計和構造應盡可能減少所有可能的風險。
20.5. Errors likely to be made when fitting or refitting certain parts which could be a source of risk shall be made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings.
The same information shall be given on moving parts and/or their housings where the direction of movement needs to be known in order to avoid a risk.
在裝配或重新裝配某些可能成為危險來源的零件時，可能由於這些零件的設計和構造，或者如果零件或零件本身和/或它們的外殼所提供的信息不可行，則不可能犯錯。
在需要知道運動方向以避免危險的運動部件和/或其外殼上，應提供相同的信息。
20.6. Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings shall not attain potentially dangerous temperatures under normal conditions of use.在正常使用條件下，設備的可觸及部件（不包括打算供熱或達到給定溫度的部件或區域）及其周圍環境不得達到潛在的危險溫度。
21. Protection against the risks posed to the patient or user by devices supplying energy or substances防止因供應能量或物質的設備而給患者或使用者帶來的風險
21.1. Devices for supplying the patient with energy or substances shall be designed and constructed in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of the patient and of the user.用於向患者提供能量或物質的設備的設計和構造應使所輸送的量能夠設定和保持足夠準確，以確保患者和使用者的安全。
21.2. Devices shall be fitted with the means of preventing and/or indicating any inadequacies in the amount of energy delivered or substances delivered which could pose a danger. Devices shall incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source.設備應配備有預防和/或指示可能造成危險的所輸送能量或所輸送物質的任何不足之處的裝置。設備應裝有適當的裝置，以盡可能地防止從能源和/或物質源中意外釋放危險水平的能量或物質。
21.3. The function of the controls and indicators shall be clearly specified on the devices. Where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information shall be understandable to the user and, as appropriate, the patient.控件和指示器的功能應在設備上明確規定。如果設備帶有其操作所需的說明或通過視覺系統指示操作或調整參數，則此類信息應為用戶以及適當情況下的患者所理解。
22. Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons防止製造商打算供非專業人員使用的醫療器械帶來的風險
22.1. Devices for use by lay persons shall be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the lay person's technique and environment. The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.外行人員使用的設備在設計和製造時應考慮到外行人員可用的技能和手段以及在外行人員的工作環境中可以合理預期的變化所產生的影響，以使其達到預期目的的適當性能。技術和環境。製造商提供的信息和說明應易於外行人員理解和應用。
22.2. Devices for use by lay persons shall be designed and manufactured in such a way as to:外行人員使用的設備的設計和製造應滿足以下條件：
| — | ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training and/or information,確保在整個過程的所有階段，目標用戶都可以安全，準確地使用該設備，必要時在經過適當的培訓和/或信息後， |
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reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries, and盡可能並適當地減少意外割傷和刺傷的風險，例如針刺傷，以及 |
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reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results.盡可能減少目標用戶在操作設備時以及在可能的情況下在結果解釋中出錯的風險。 |
22.3. Devices for use by lay persons shall, where appropriate, include a procedure by which the lay person:非專業人士使用的設備應酌情包括使非專業人士使用的程序：
| — | can verify that, at the time of use, the device will perform as intended by the manufacturer, and可以驗證設備在使用時是否能夠按照製造商的預期運行，並且 |
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if applicable, is warned if the device has failed to provide a valid result.如果適用，則在設備未能提供有效結果時發出警告。 |
CHAPTER III
REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE 有關設備隨附信息的要求
23. Label and instructions for use標籤和使用說明
23.1. General requirements regarding the information supplied by the manufacturer
Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website, taking into account the following:有關製造商提供的信息的一般要求
每個設備應隨附識別該設備及其製造商所需的信息，以及與用戶或任何其他人員（視情況而定）有關的任何安全和性能信息。此類信息可能會出現在設備本身，包裝上或使用說明中，並且，如果製造商有網站，則應在考慮到以下因素的情況下使網站上的信息可用並保持最新：
| (a) | The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.標籤的介質，格式，內容，易讀性和位置以及使用說明應適合於特定設備，其預期用途以及預期用戶的技術知識，經驗，教育或培訓。特別是，使用說明書應以目標用戶易於理解的術語編寫，並在適當時附以附圖和圖表。 |
(b) |
The information required on the label shall be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices.標籤上要求的信息應在設備本身上提供。如果這不可行或不適當，則某些或所有信息可能會出現在每個單元的包裝上和/或多個設備的包裝上。 |
(c) |
Labels shall be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes.標籤應以人類可讀的格式提供，並應附有機器可讀的信息，例如射頻識別（“ RFID”）或條形碼。 |
(d) |
Instructions for use shall be provided together with devices. By way of exception, instructions for use shall not be required for class I and class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this Section.使用說明應與設備一起提供。作為例外，如果I類和IIa類設備可以在沒有任何此類說明的情況下安全使用，並且除非本節其他地方另有規定，否則不需要使用說明。 |
(e) |
Where multiple devices are supplied to a single user and/or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge.在將多個設備提供給單個用戶和/或位置的情況下，如果購買者同意，則可以提供使用說明的單個副本，該購買者在任何情況下都可以要求免費提供更多副本。 |
(f) |
Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation.使用說明只能以非紙質形式（例如電子形式）提供給用戶，並且僅在（EU）207/2012號法規或根據該法規採用的任何後續實施規則規定的條件下。 |
(g) |
Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer.製造商提供的信息中應將需要傳達給用戶和/或其他人的殘留風險作為限制，禁忌症，預防措施或警告包括在內。 |
(h) |
Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS. In areas for which no harmonised standards or CS exist, the symbols and colours shall be described in the documentation supplied with the device.在適當的情況下，製造商提供的信息應採用國際認可的符號形式。使用的任何符號或標識顏色應符合協調標准或CS。在不存在統一標准或CS的區域中，符號和顏色應在設備隨附的文檔中進行說明。 |
23.2. Information on the label標籤上的信息
The label shall bear all of the following particulars:標籤應具有以下所有細節：
| (a) | the name or trade name of the device;設備的名稱或商標名稱； |
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(b) |
the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;用戶識別設備必不可少的詳細信息，包裝內容以及對於用戶而言不明顯的設備的預期用途； |
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(c) |
the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;製造商的名稱，註冊商標名稱或註冊商標以及其註冊營業地點的地址； |
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(d) |
if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;如果製造商在國際電聯以外有其註冊營業地點，則授權代表的姓名和授權代表的註冊營業地點的地址； |
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(e) |
where applicable, an indication that the device contains or incorporates:在適用的情況下，表明該設備包含或包含以下內容：
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(f) |
where applicable, information labelled in accordance with Section 10.4.5.;（如適用）根據第10.4.5節標記的信息； |
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(g) |
the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;設備的批號或序列號，後跟“ LOT NUMBER”或“ SERIAL NUMBER”或相應的符號（視情況而定）； |
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(h) |
the UDI carrier referred to in Article 27(4) and Part C of Annex VII;第27條第4款和附件VII C部分提及的UDI承運人； |
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(i) |
an unambiguous indication of t the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;明確表示安全使用或植入該設備的期限，至少在相關的年份和月份中表示； |
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(j) |
where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;除非可以安全使用，否則沒有日期的指示是生產日期。該生產日期可以作為批號或序列號的一部分提供，前提是該日期可以明確識別。 |
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(k) |
an indication of any special storage and/or handling condition that applies;指示適用的任何特殊存儲和/或處理條件； |
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(l) |
if the device is supplied sterile, an indication of its sterile state and the sterilisation method;如果設備是無菌的，則說明其無菌狀態和滅菌方法； |
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(m) |
warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users;警告或預防措施，必須引起設備用戶和任何其他人的立即註意。該信息應保持在最低限度，在這種情況下，應在考慮使用用戶的情況下，在使用說明中顯示更詳細的信息； |
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(n) |
if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union;如果該設備僅供一次性使用，則表明該事實。製造商對一次性使用的指示在整個聯盟應保持一致； |
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(o) |
if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;如果該設備是已被再處理的一次性設備，則表明該事實，已執行的再處理週期數以及有關再處理週期數的任何限制； |
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(p) |
if the device is custom-made, the words ‘custom-made device’;如果設備是定制的，則為“定制設備”； |
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(q) |
an indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;該設備是醫療設備的指示。如果該設備僅用於臨床研究，則“專門用於臨床研究”字樣； |
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(r) |
in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;如果設備是由旨在通過人體孔口引入人體或應用到皮膚並被人體吸收或局部分散在人體中的物質或物質組合構成的，則總體定性設備的組成以及有關負責實現主要預期操作的一個或多個主要成分的定量信息； |
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(s) |
for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.對於活動的可植入設備，序列號，對於其他可植入設備，序列號或批號。 |
23.3. Information on the packaging which maintains the sterile condition of a device (‘sterile packaging’)保持設備無菌狀態的包裝上的信息（“無菌包裝”）
The following particulars shall appear on the sterile packaging:無菌包裝上應顯示以下詳細信息：
| (a) | an indication permitting the sterile packaging to be recognised as such,允許無菌包裝本身被識別的指示， |
(b) |
a declaration that the device is in a sterile condition,聲明該設備處於無菌狀態， |
(c) |
the method of sterilisation,消毒方法 |
(d) |
the name and address of the manufacturer,製造商的名稱和地址， |
(e) |
a description of the device,設備的描述， |
(f) |
if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’,如果該設備用於臨床研究，則“專門用於臨床研究”一詞， |
(g) |
if the device is custom-made, the words ‘custom-made device’,如果設備是定制的，則“定制設備”一詞， |
(h) |
the month and year of manufacture,生產的月份和年份， |
(i) |
an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and明確表示使用或植入該設備的時限，至少以年和月表示，並且 |
(j) |
an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.如果在使用前無菌包裝已損壞或無意中打開，請查看使用說明以了解如何使用。 |
23.4. Information in the instructions for use使用說明中的信息
The instructions for use shall contain all of the following particulars:使用說明應包含以下所有詳細信息：
| (a) | the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2;第23.2條第（a），（c），（e），（f），（k），（l），（n）和（r）節中提及的細節; |
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(b) |
the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;設備的預期用途，並明確說明適應症，禁忌症，一個或多個患者目標群體以及適當的預期用戶； |
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(c) |
where applicable, a specification of the clinical benefits to be expected.在適用的情況下，說明預期的臨床益處。 |
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(d) |
where applicable, links to the summary of safety and clinical performance referred to in Article 32;適用時，鏈接至第32條提及的安全性和臨床表現摘要； |
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(e) |
the performance characteristics of the device;設備的性能特徵； |
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(f) |
where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories;在適用的情況下，允許醫療保健專業人員驗證設備是否適合併選擇相應軟件和附件的信息； |
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(g) |
any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard;任何殘留風險，禁忌症和任何不良副作用，包括在這方面要傳達給患者的信??息； |
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(h) |
specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it;用戶正確使用設備所需的規格，例如如果該設備具有測量功能，則要求精度； |
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(i) |
details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;在設備準備使用或使用期間進行任何準備性處理或處理的詳細信息，例如消毒，最終組裝，校準等，包括確保患者安全所需的消毒水平以及實現這些要求的所有可用方法消毒水平； |
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(j) |
any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons;對特殊設施或特殊培訓的任何要求，或設備用戶和/或其他人員的特殊資格； |
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(k) |
the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant:驗證設備是否已正確安裝並準備好安全運行並按照製造商的意圖運行所需的信息，以及相關信息：
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(l) |
if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;如果設備是無菌提供的，則在使用前，如果無菌包裝已損壞或無意間打開了說明，則應予以說明； |
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(m) |
if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation;如果以非滅菌方式提供了該設備，並且打算在使用前對其進行滅菌，則應提供相應的滅菌說明； |
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(n) |
if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses;如果設備是可重複使用的，則說明允許重新使用的適當過程的信息，包括清潔，消毒，包裝以及在適當情況下適合於放置該設備的成員國或成員國的經過驗證的重新消毒方法市場。應提供信息以識別何時不應再使用該設備，例如：材料退化的跡像或允許的最大重複使用次數的跡象； |
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(o) |
an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements;適當的指示，只有在製造商負責遵守一般安全和性能要求的情況下對其進行翻新的情況下，才可以重複使用該設備； |
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(p) |
if the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail. If in accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be made available to the user upon request;如果設備帶有單次使用的指示，則有關製造商已知的已知特性和技術因素的信息，如果要重新使用該設備可能會帶來風險。此信息應基於製造商風險管理文檔的特定部分，其中應詳細說明此類特徵和技術因素。如果符合23.1節（d）的規定。不需要使用說明，應根據要求將這些信息提供給用戶； |
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(q) |
for devices intended for use together with other devices and/or general purpose equipment:用於打算與其他設備和/或通用設備一起使用的設備：
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(r) |
if the device emits radiation for medical purposes:如果設備出於醫療目的發出輻射：
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(s) |
information that allows the user and/or patient to be informed of any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate:允許用戶和/或患者了解有關該設備的任何警告，注意事項，禁忌症，應採取的措施以及使用限制的信息。該信息應在適當時允許用戶向患者介紹有關該設備的任何警告，注意事項，禁忌症，應採取的措施以及使用限制。該信息應酌情涵蓋：
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(t) |
in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contra-indications, undesirable side-effects and risks relating to overdose;如果設備由擬引入人體的物質或物質的組合組成，並被人體吸收或局部分散在人體中，則在適當時與一般概況有關的警告和注意事項該器械及其代謝產物與其他器械，藥品和其他物質的相互作用以及禁忌症，不良副作用和與用藥過量有關的風險； |
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(u) |
in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;就可植入設備而言，有關患者可能接觸到的材料和物質的總體定性和定量信息； |
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(v) |
warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, if any. This information shall cover, where appropriate:為了便於安全處置設備，其附件和與其一起使用的消耗品，應採取警告或預防措施。該信息將在適當情況下涵蓋：
If in accordance with the point (d) of Section 23.1 no instructions for use are required, this information shall be made available to the user upon request;如果按照第23.1節（d）的要求，不需要使用說明，則應根據要求將這些信息提供給用戶； |
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(w) |
for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional;對於打算供非專業人員使用的設備，用戶應諮詢醫療保健專業人員的情況； |
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(x) |
for the devices covered by this Regulation pursuant to Article 1(2), information regarding the absence of a clinical benefit and the risks related to use of the device;對於本法規第1條第（2）款所涵蓋的器械，有關沒有臨床益處以及與使用器械有關的風險的信息； |
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(y) |
date of issue of the instructions for use or, if they have been revised, date of issue and identifier of the latest revision of the instructions for use;使用說明的發布日期，或者，如果已進行了修訂，則為發布日期和使用說明的最新版本的標識符； |
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(z) |
a notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established;通知用戶和/或患者有關設備的任何嚴重事件應報告給製造商和/或建立用戶和/或患者的成員國的主管當局； |
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(aa) |
information to be supplied to the patient with an implanted device in accordance with Article 18;根據第18條使用植入式設備提供給患者的信??息; |
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(ab) |
for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.對於包含電子可編程系統（包括軟件）或本身就是設備的軟件的設備，有關硬件，IT網絡特性和IT安全措施的最低要求（包括防止未經授權的訪問）是按預期運行軟件所必需的。 |
(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1).歐洲議會和理事會於2008年12月16日頒布的（EC）第1272/2008號條例，關於物質和混合物的分類，標籤和包裝，修改和廢除67/548 / EEC和1999/45 / EC指令，並修訂（EC）1907/2006號法規（OJ L 353，2008年12月31日，第1頁）。
(2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396, 30.12.2006, p. 1).歐洲議會和理事會於2006年12月18日頒布的關於化學品註冊，評估，授權和限制（REACH）的第1907/2006號（EC）條例（OJ L 396，2006年12月30日，第1頁） 。
(3) Regulation (EU) No 528/2012 of the European Parliament and the Council of 22 May 2012 concerning the making available on the market of and use of biocidal products (OJ L 167, 27.6.2012, p. 1).2012年5月22日，歐洲議會和理事會（EU）第528/2012號條例，關於在市場上出售和使用殺菌產品（OJ L 167，27.6.2012，第1頁）。
(4) Council Directive 80/181/EEC of 20 December 1979 on the approximation of the laws of the Member States relating to units of measurement and on the repeal of Directive 71/354/EEC (OJ L 39, 15.2.1980, p. 40).理事會1979年12月20日第80/181 / EEC號指令，該指令近似於成員國與計量單位有關的法律，並且廢除了第71/354 / EEC號指令（OJ L 39，15.2.1980，p 40）。