通用安全和性能要求檢查表GSPR Check List

1、 PAGE 47MDR Annex附錄一 General safety and performance requirements Checklist 通用安全和性能要求檢查表 General safety and performance requirements 通用安全和性能要求 Applica blity 適用性 Standards Used 應(yīng)用標(biāo)準(zhǔn) Evidence compliance or reason for no applicability符合性證據(jù)或不適用理由 Location -section 位置-章節(jié) CHAPTER IGENERAL REQUIREMENTS第1章 一

2、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

3、 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. 1.器械應(yīng)具備制造商預(yù)期的性能，并確保其設(shè)計和結(jié)構(gòu)在正常使用條件下適用于

4、其預(yù)期用途。器械應(yīng)安全有效，且不得對患者的臨床癥狀或安全或者使用者或其他人員（如適用）的安全和健康造成損害，在最大限度保護(hù)健康和安全的同時， 器械使用的可接受風(fēng)險與其對患者的受益相比，應(yīng)在可接受范圍內(nèi)，并應(yīng)考慮到符合現(xiàn)有認(rèn)知水平。 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. 2.本附錄中盡可能降低風(fēng)險的要求，

5、指盡可能降低風(fēng)險的同時不會對受益-風(fēng)險比產(chǎn)生不利影響。 3.Manufacturers shall establish, implement, document and maintain a risk management system. 3. 制造商應(yīng)建立、實(shí)施、記錄和維護(hù)風(fēng)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.

6、In carrying out risk management manufacturers shall: 風(fēng)險管理應(yīng)理解為在器械整個生命周期中為連續(xù)迭代過程，需定期進(jìn)行系統(tǒng)更新。進(jìn)行風(fēng)險管理制造商應(yīng)做到： establish and document a risk management plan for each device; 制訂并記錄各器械的風(fēng)險管理計劃； identify and analyse the known and foreseeable hazards associated with each device; 識別和分析與各器械相關(guān)的已知和可預(yù)見的危害； estimate a

7、nd evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse; 估計和評價在預(yù)期使用時及在可合理預(yù)見的使用不當(dāng)時產(chǎn)生的相關(guān)風(fēng)險； eliminate or control the risks referred to in point (in accordance with the requirements of Section 4; 根據(jù)第 4 節(jié)的要求消除或控制(c)點(diǎn)所述的這些風(fēng)險； evaluate the imp

8、act 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 評估生產(chǎn)階段，特別是上市后監(jiān)管體系的信息、危

9、害及其發(fā)生頻率、評估其相關(guān)風(fēng)險及總體風(fēng)險、風(fēng)險利益比和風(fēng)險可接受性。 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 根據(jù)(e)點(diǎn)所述信息影響的評估，必要時根據(jù)第 4 節(jié)的要求修改控制措施。 4.Risk control measures adopted by manufacturers for the design and

10、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 selectin

11、g the most appropriate solutions, manufacturers shall, in the following order of priority: 制造商就器械的設(shè)計和生產(chǎn)所采取的風(fēng)險控制措施應(yīng)符合安全原則，并考慮到現(xiàn)有的技術(shù)水平。為降低風(fēng)險，制造商應(yīng)對風(fēng)險進(jìn)行管理，使各危害相關(guān)的剩余風(fēng)險及總剩余風(fēng)險控制在可接受范圍內(nèi)。在選擇最合適的解決方案時，制造商應(yīng)依據(jù)下述優(yōu)先級原則： eliminate or reduce risks as far as possible through safe design and manufacture; 通過安全的設(shè)計和生產(chǎn)盡可

12、能消除或降低風(fēng)險； where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and 如適合，采取適當(dāng)保護(hù)措施，關(guān)于無法消除的風(fēng)險，包含必要時的報警；且 provide information for safety (warnings/precautions/contra -indications) and, where appropriate, training to users. 提供

13、安全信息（警戒/預(yù)防措施/禁忌），并在適當(dāng)情況下向使用者提供培訓(xùn)。 Manufacturers shall inform users of any residual risks. 制造商應(yīng)將剩余風(fēng)險告知使用者。 5.In eliminating or reducing risks related to use error, the manufacturer shall: 5.在消除或減少使用不當(dāng)相關(guān)風(fēng)險時，制造商應(yīng)： (a) reduce as far as possible the risks related to the ergonomic features of the device a

14、nd the environment in which the device is intended to be used (design for patient safety), and 盡量降低因器械人體工程學(xué)特點(diǎn)及其預(yù)期使用環(huán)境所造成的風(fēng)險（針對患者安全而設(shè)計），以及 (b) give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions

15、of intended users (design for lay, professional, disabled or other users). 針對技術(shù)知識、經(jīng)驗、教育、培訓(xùn)和使用環(huán)境，以及預(yù)期使用者醫(yī)療及身體條件（如適用）的注意事項（針對非專業(yè)、專業(yè)、殘疾或其他使用者而設(shè)計）。 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,

16、 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 manufacturers instructions. 6.

17、如器械在正常使用環(huán)境中使用并根據(jù)制造商的指示進(jìn)行適當(dāng)維護(hù)保養(yǎng)，在制造商聲稱的使用期限內(nèi)器械的特性和性能不得對患者、使用者或其他人員（如適用）的健康或安全造成損害。 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 fl

18、uctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer. 7.器械的設(shè)計、生產(chǎn)和包裝應(yīng)確保在根據(jù)制造商提供的說明和信息進(jìn)行運(yùn)輸和儲存期間（如溫度和濕度的波動），不會對器械在預(yù)期使用期間的特性和性能造成 不利影響。 8.All known and foreseeable risks, and any undesirable side-effects, shall be minimised and be accept

19、able 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. 8.與正常使用條件下器械預(yù)期性能對患者和/或使用者產(chǎn)生的潛在益處相比，所有已知和可預(yù)見的風(fēng)險及任何不良影響應(yīng)最小化并控制在可接受范圍內(nèi)。 9.For the devices referred to in Annex XVI, the general safety require

20、ments 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 products use which is consistent with a high

21、level of protection for the safety and health of persons. 9.對于在附錄十六中所列出的，制造商未聲稱用于醫(yī)療目的之器械，應(yīng)充分了解在第 1 節(jié)和第 8 節(jié)規(guī)定的通用安全要求，即在預(yù)期條件下出于預(yù)期目的而使用器械時，器械不得出現(xiàn)任何風(fēng)險，或出現(xiàn)不超過與產(chǎn)品使用相關(guān)的最大可接受風(fēng)險，這符合高水平保障人員安全和健康原則一致。 CHAPTER IIREQUIREMENTS REGARDING DESIGN AND MANUFACTURE 第2章 設(shè)計和生產(chǎn)相關(guān)要求 10.Chemical, physical and biological pro

22、perties10.化學(xué)、物理和生物學(xué)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: 器械的設(shè)計和生產(chǎn)應(yīng)當(dāng)能確保符合第 I 章中所述的特性和性能要求。特別注意： (a) the choice of materials and

23、substances used, particularly as regards toxicity and, where relevant,flammability; 使用材料和物質(zhì)的選擇，特別是毒性和易燃性（如適用） 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, absorptio

24、n, distribution,metabolism and excretion;所使用材料和物質(zhì)與生物組織，細(xì)胞及體液間的相容性，及考慮到器械使用目的及相關(guān)的吸收、分布、新陳代謝和排泄； the compatibility between the different parts of a device which consists of more than one implantable part; 器械不同部件之間的兼容性，該器械由多個可植入部件組成； the impact of processes on material properties;過程對材料性能的影響； (e)where a

25、ppropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;若適用，生物物理學(xué)或建模研究結(jié)果有效性已事先獲得證實(shí)； the mechanical properties of the materials used, reflecting, where appropriate, matters such as strength,ductility, fracture resistance, wear resistance and

26、 fatigue resistance;所使用材料的機(jī)械性能，在適當(dāng)情況下反映諸如強(qiáng)度、延展性、抗斷裂性、耐磨性和耐疲勞強(qiáng)度等問題； surface properties; and 表面活性； the confirmation that the device meets any defined chemical and/or physical specifications.確認(rèn)該器械滿足任何確定的化學(xué)和/或物理要求。 10.2.Devices shall be designed, manufactured and packaged in such a way as to minimise th

27、e 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 totissues exposed to those contaminants and residues and to the duration and f

28、requency of exposure.器械的設(shè)計、生產(chǎn)和包裝應(yīng)盡可能降低污染物和殘留物對患者造成的風(fēng)險，同時考慮到器械預(yù)期用途以及參與器械運(yùn)輸、儲存和使用的人員。 應(yīng)當(dāng)特別注意暴露于這些污染物和殘留物的組織以及暴露時間與頻率。 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

29、 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 perform

30、ance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use.器械的設(shè)計和生產(chǎn)應(yīng)以能使其可安全地與材料和物質(zhì)（包括氣體）一起使用，且在預(yù)期使用時，這些材料和物質(zhì)會與器械接觸；若器械預(yù)期用于管理醫(yī)療產(chǎn)品， 根據(jù)管理這些醫(yī)療產(chǎn)品的條款和限制，則其設(shè)計和生產(chǎn)應(yīng)使其能夠與相關(guān)的醫(yī)療產(chǎn)品兼容，并應(yīng)可根據(jù)其相應(yīng)的指示和預(yù)期用途維護(hù)醫(yī)療產(chǎn)品和器械的性能。 10.4. Substances物質(zhì) 10.4.1

31、.Design and manufacture of devices 器械的設(shè)計和生產(chǎn) substances or particles, including wear debris, degradation products and processing residues, that may be released from the device.器械的設(shè)計和生產(chǎn)應(yīng)盡可能降低由物質(zhì)或微粒（包括磨屑、降解產(chǎn)物和加工殘留物）造成的風(fēng)險，而此類物質(zhì)或微?？赡苡善餍诞a(chǎn)生。 Devices, or those parts thereof or those materials used therein t

32、hat:器械或其部件或其使用的材料： are invasive and come into direct contact with the human body,(re)administer medicines, body liquids or other substances, including gases,to/from the body, or transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body, shall o

33、nly 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:具有侵入性，并與人體直接接觸，或 （重新）為人體輸送藥物、體液或其他物質(zhì)（包括氣體），或 運(yùn)輸或儲存待（重新）為人體輸送藥物、體液或物質(zhì)（包括氣體），在根據(jù)第節(jié)進(jìn)行調(diào)整時，應(yīng)僅包含濃度高于 0.1%重量比的以下物質(zhì)： substances which are carcinogenic, mutagenic or t

34、oxic 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), or1A 或 1B 類有致癌、致突變或生育毒性(CMR)的物質(zhì)，依據(jù)歐洲議會和理事會第 1272/2008 號法規(guī)附錄 VI 第 3 部分判斷，或substances having endocrine-disrupting properties for wh

35、ich 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 Commi

36、ssion pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in有科學(xué)證據(jù)證明可能對人類健康造成嚴(yán)重影響的具有內(nèi)分泌干擾性質(zhì)的物質(zhì)，根據(jù)歐洲議會和理事會第 1907/2006 號法規(guī)（2）第 59 條規(guī)定程序識別，或者委員會根據(jù)歐洲議會和理事會第 528/2012 號法規(guī)（3）第 5（3）條第一段通過授權(quán)法案后，根據(jù)本法規(guī)規(guī)定之與人類健康相關(guān)準(zhǔn)則識別。 10.4.2. Justific

37、ation regarding the presence of CMR and/or endocrine-disrupting substances The justification for the presence of such substances shall be based upon:關(guān)于存在 CMR 和/或內(nèi)分泌干擾物的理由，存在此類物質(zhì)的理由應(yīng)基于： an analysis and estimation of potential patient or user exposure to the substance;an analysis of possible alternati

38、ve 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;argumentation as to why possible substance and/ or material

39、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

40、 or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials; andwhere applicable and available, the latest relevant scientific committee guidelines in accordance with Sections 10.4.3. and 10.4.4.對潛在患者或使用者暴露于該物質(zhì)下情況進(jìn)行分析和判斷； 對可能的替代

41、物質(zhì)、材料或設(shè)計進(jìn)行的分析，（在可用時）包括有關(guān)獨(dú)立研究、同等評審研究、相關(guān)科學(xué)委員會的科學(xué)意見等信息，以及對這些替代品可用性的分析； 論證可能的物質(zhì)和/或材料替代品（如有）或設(shè)計變更（如可行）不適用于維護(hù)產(chǎn)品功能、性能和利益-風(fēng)險比的原因；包括要考慮這些器械的預(yù)期用途是否包括兒童治療，或孕婦或哺乳婦女治療，或?qū)ζ渌貏e容易受到此類物質(zhì)和/或材料影響的患者群體的治療； 如適用和可用時，基于根據(jù)第 10.4.3 節(jié)和 10.4.4.節(jié)制定的最新相關(guān)的科學(xué)委員會指南。 10.4.3.Guidelines on phthalates 10.4.3 鄰苯二甲酸酯使用指南 For the purpose

42、s 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

43、 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

44、, designs or medical treatments. When deemed appropriate為達(dá)到本附錄第 10.4 條 的目的，委員會應(yīng)盡快并于 2018 年 5 月 26 日向相關(guān)科學(xué)委員會提供任務(wù)以制定指南，且本指南應(yīng)在 2020 年 5 月 26 日前編制好。委員會的任務(wù)至少應(yīng)包含對鄰苯二甲酸酯存在的利益風(fēng)險評價，其中鄰苯二甲酸酯屬于第 10.4.1 節(jié)要點(diǎn)（a）和（b）中所所述物質(zhì)組中的任何一組。利益風(fēng)險評價應(yīng)考慮器械、可用替代物質(zhì)和替代材料、設(shè)計和/或藥物治療使用的預(yù)期目的和環(huán)境。雖然根據(jù)最新科學(xué)證據(jù)認(rèn)為是適當(dāng)?shù)?，但?yīng)至少每五年更新一次本指南。 Regulati

45、on (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).Regulatio

46、n (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).Regulation (EU) No 528/2012 of the European Parliament and the歐洲議會和理事會于 2008 年 12 月 16 日簽發(fā)的關(guān)于物

47、質(zhì)和混合物分類、標(biāo)簽和包裝的第 1272/2008 號法規(guī)，修訂和廢除第 67/548/EEC 號指令和第 1999/45/EC 號指令，并修訂了第 1907/2006 號法規(guī)（OJ L 353, 31.12.2008, p. 1）。 歐洲議會和理事會于 2006 年 12 月 18 日簽發(fā)的關(guān)于化學(xué)品注冊、評價、授權(quán)和限制（REACH）的第 1907/2006 號法規(guī)（OJ L 396,30.12.2006, p. 1）。 歐洲議會和理事會于 2012 年 5 月 22 日簽發(fā)的關(guān)于在市場上提供和使用殺生物產(chǎn)品的第 528/2012 號法規(guī)（OJ L 167，27.06.2012,p. 1）

48、。 10.4.4Guidelines on other CMR and endocrine-disrupting substances其他CMR和內(nèi)分泌干擾物質(zhì)的指南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., wher

49、e appropriate.隨后，委員會應(yīng)授權(quán)相關(guān)科學(xué)委員會按照第 107.4.3 中所述的要求，也為第10.4.1 節(jié)要點(diǎn)（a）和（b）中所所述的其他物質(zhì)制定指南。 10.4.5 Labelling貼標(biāo)Where devices, parts thereof or materials used therein as referred to in Section10.4.1. contain substances referred to in points (a) or (b) of Section 10.4.1. in a concentration above 0,1 % weight b

50、y 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

51、 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按照第 10.4.1 節(jié)所述的要求，若此中所使用的器械、其部件或材料，包含第10.4.1 節(jié)中所述的濃度高于 0.1%重量比的物質(zhì)，則應(yīng)在器械本身和/或各單元的包裝上或，（適當(dāng)時）在銷售包裝上把此類物質(zhì)清單標(biāo)識清楚。若此類器械的預(yù)期

52、用途，包括兒童治療，或孕婦或哺乳婦女治療，或?qū)σ暈樘貏e易受到此類物質(zhì)和/或材料影響的其他患者群體的治療，則關(guān)于這些患者群體的剩余風(fēng)險、（如適用）預(yù)防措施信息，均應(yīng)在使用說明中給出。 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 n

53、ature of the environment in whichit is intended to be used. 必須合理設(shè)計及生產(chǎn)器械，以盡量降低因物質(zhì)意外進(jìn)入器械而造成的風(fēng)險，并且應(yīng)考慮到器械及其預(yù)期使用環(huán)境的性質(zhì)。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 int

54、o the patients or users body, unless they come into contact with intact skin only. Special attention shall be given to nanomaterials.器械的設(shè)計和生產(chǎn)應(yīng)盡可能減少與微粒尺寸和性能相關(guān)的風(fēng)險，除非這些微粒接觸到的是完好的皮膚，否則這些微粒會位于或可釋放到患者或使用者體內(nèi)。應(yīng)特別注意納米材料。 11. Infection and microbial contamination感染及微生物污染11.1.Devices and their manufacturing pr

55、ocesses 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:reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries,a

56、llow easy and safe handling,reduce as far as possible any microbial leakage from the device and/or microbial exposure during use, andprevent microbial contamination of the device or its content such as specimens or fluids.器械和生產(chǎn)過程的設(shè)計應(yīng)盡可能消除或減少感染患者、使用者和（適用時）其他人的風(fēng)險。設(shè)計應(yīng)： 盡可能減少并消除意外由于切割和刺破造成的風(fēng)險，例如針刺損傷； 使用

57、便捷安全； 盡可能降低器械的微生物泄漏和/或使用過程中的微生物暴露； 防止器械或其所包含之物（例如樣本或液體）受到微生物的污染。 11.2. Where necessary devices shall be designed to facilitate their safe cleaning, disinfection, and/or re-sterilisation.必要時，應(yīng)將器械設(shè)計成便于進(jìn)行安全清潔、消毒和/或再滅菌。 11.3.Devices labelled as having a specific microbial state shall be designed, manufa

58、ctured 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.應(yīng)對標(biāo)記為具有特殊微生物種群的器械進(jìn)行設(shè)計、生產(chǎn)和包裝，以確保在投放到市場時，及在制造商規(guī)定的運(yùn)輸和儲存條件下，器械依舊保持原樣。 11.4. Devices delivered in a sterile state shall be designed

59、, 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

60、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.應(yīng)根據(jù)適當(dāng)流程，對在無菌狀態(tài)下運(yùn)輸?shù)钠餍颠M(jìn)行設(shè)計、生產(chǎn)和包裝，以確保在投放到市場時，及在制造商指定的運(yùn)輸和儲存條件下，器械能保持無菌狀態(tài)，除非旨在保持其無菌狀態(tài)的包裝遭到損壞，仍保持無菌，直至保護(hù)包裝破損或出于使用目的而打開時。這些措施應(yīng)確保最終使用者可清晰可見無菌