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口罩CE認證!歐盟官方通告、政策重點解說、認證資格查驗

2020/3/24 19:11:00 來源: 評論(0)2

口罩CE認證歐盟

面對新冠疫情,為滿足口罩、防護服等防疫用品日益增長的需求,歐盟開啟綠色通道,無需CE標識,可進入歐盟,供醫療工作者使用。允許部分防疫物資(如一類滅菌的醫用口罩)在符合安全有效的情況下,即使尚未獲得CE認證,也可以在歐盟市場上市銷售。


2020年3月13日,歐盟會員會在歐洲官方雜志( Official Journal of the EuropeanUnion)發布了疫情期間針對醫療器械和個人防護用品 (PPE)的符合性評價和市場監督程序的建議。


◆如果市場監督機構確定產品符合醫療器械的基本安全和性能要求,即使其符合性評價還未完成,市場監督機構可以允許其在一定的時間內進行銷售,同時該產品必須繼續完成其符合性評價過程。


個人防護用品(PPE)方面:


◆應急審批產品如果不采用PPE法規協調標準作為產品技術要求而采用其它技術要求,比如WHO的推薦要求,須確保采用的技術要求與PPE法規基本健康與安全要求同等防護水平。公告機構對這類采用其它技術要求的PPE產品進行發證時,需要立即通知主管當局和其它PPE法規的公告機構。


◆成員國主管當局也可在疫情期間評估和組織采購沒有CE標記的PPE產品,該產品僅可提供給醫療工作者使用,不能在市場上流通銷售。同時市場抽查將會重點抽查防疫相關PPE產品,以防止不合格產品導致嚴重風險。


重點如下?。?!


◆緊急物資專供醫療人員使用,不可在市場上流通;


關于CE標識


如今CE標識已經成為了全球認可的質量標志,CE標志可以證明該批在歐盟制作或進口至歐盟成員國的產品符合質量標準,滿足保護消費者健康、供應鏈安全和環境可持續發展的要求。


出口各國推薦閱讀史上最詳盡!口罩出口通關申報官方指南


在歐盟,口罩屬于PPE個人防護用品,“危及健康的物質和混合物”。2019年起,歐盟新法規PPE Regulation (EU) 2016/425強制執行,所有出口歐盟的口罩必須在新法規的要求下獲得CE認證證書。CE認證證書的有效期是5年左右,一般費用是10000-15000元人民幣。


FFP2口罩與上文提到的醫用防護口罩、KN95口罩、N95口罩過濾效率十分接近。醫療口罩必須遵循BSEN14683標準,可以分為三個等級:低標準Type、然后是Type和TypeR。上一個版本是BSEN146832014,已被新版BSEN146832019所取代。EN 14683:2019年版主要的變化之一是壓力差,Type、Type、TypeR壓力差分別由2014年版的29.4、29.4、49.0Pa/cm,上升至40、40、60Pa/cm。


01、貴司是否為NB機構? 機構號是否可以查詢?

近期,大家都在對口罩等醫療物資的歐盟標準犯愁,都是一知半解的狀態,今天Mike將歐盟通告原文貼出,大家可以自己好好研究一下每種標準的具體陳述;昨天給了鏈接后,很多人說打不開網頁,其實應該是你們的局域網問題,不過沒關系,我給你們貼出來:


COMMISSION RECOMMENDATION (EU) 2020/403


of 13 March 2020


on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 292 thereof,

Whereas:

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Article 5 of Directive 93/42/EEC and Article 8 of Regulation (EU) 2017/745 offer the possibility for manufacturers to rely on specific technical solutions, which are detailed in harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union. In accordance with this Article, should a manufacturer choose to adopt such a technical solution, the medical device is presumed to be in conformity with the requirements covered by the said harmonised standard or parts thereof. However, compliance with the harmonised standards is not mandatory. Manufacturers are free to choose other technical solutions provided that the specific solution which is retained ensures that the medical device complies with the applicable essential health and safety requirements.

Article 19 of Regulation (EU) 2016/425 lays down the specific conformity assessment procedures, which apply to the different categories of PPE. Pursuant to this Article, items of PPE of category III, such as the ones designed protect against harmful biological agents should be subjected to specific combination of conformity assessment procedures, which are described respectively in Annexes V, VII and VIII of the same Regulation. Each of the different conformity assessment procedures, which may be used, require the mandatory involvement of a third party conformity assessment body.

Article 11 of Directive 93/42/EEC and Article 52 of Regulation (EU) 2017/745, once the latter becomes applicable, lay down the specific conformity assessment procedures, which apply to the different classes of medical devices. Pursuant to these Articles, medical devices falling within Class I, other than custom-made or investigational devices, should be subjected to the conformity assessment procedure for the EC declaration of conformity, without the involvement of a third party conformity assessment body.

Notified bodies are the conformity assessment bodies designated by Member States and authorised to carry out third party conformity assessment tasks under Regulation (EU) 2016/425. According to Article 26(4) and point 7 (f) of Annex V of Regulation (EU) 2016/425, notified bodies are required to assess that a PPE product meets the applicable essential health and safety requirements. Notified bodies need to carry out this assessment not only where the manufacturer has applied the harmonised standards, but also in a situation where the manufacturer has followed other technical solutions. When delivering the conformity assessment certificates, notified bodies are required to inform their notifying authorities and may also be required to inform other notified bodies of the certificates they have issued, as set out in Article 34 of Regulation (EU) 2016/425.

Notified bodies should thus assess whether products manufactured in line with other technical solutions, such as the ones contained in the WHO recommendations on the appropriate selection of PPE also meet the applicable essential health and safety requirements. In view of the importance to ensure an efficient exchange of information between all stakeholders in the PPE supply chain, where notified bodies conclude that a PPE following another specific standard or technical solution is compliant with the essential health and safety requirements applicable to it, sharing this information will be instrumental in facilitating the assessment of other products manufactured according to the same specific standard or technical solution in a swift manner. To that effect, notified bodies can make use of the existing channels for exchange of information in the framework of the coordination groups established in accordance with Article 36 of Regulation (EU) 2016/425.

In addition, pursuant to the relevant market surveillance procedures in Regulation (EU) 2016/425 and in particular Article 38(1) and (2) thereof, where a market surveillance authority encounters a non-CE marked PPE product they are required to evaluate it. Where, in the course of the evaluation, the market surveillance authorities find that the PPE does not comply with the requirements laid down in the Regulation, they shall require the economic operator to take corrective action to bring the PPE into compliance or to recall or withdraw it, commensurate with the nature of the risk. They shall also inform the Commission and other Member State of the results of the evaluation and the actions which they have required the economic operator to take.

Accordingly, to address the shortage of PPE necessary in the context of the COVID-19 outbreak, where non-CE marked PPE are intended to enter the EU market, the relevant market surveillance authorities should evaluate the products and, if they are found to be compliant with the essential health and safety requirements laid down by the relevant Regulation should take measures allowing the placing of such PPE on the Union market for a limited period of time or while the conformity assessment procedure with the notified body is being carried out. In order to ensure that such products can be made available in other Member States and in view of the importance to ensure an efficient exchange of information as well as a coordinated response to all threats to the citizens’ health and safety, it is appropriate that the market surveillance authority carrying out such an evaluation communicates its decision to other Member States authorities and to the Commission through the regular market surveillance information exchange channels.

Considering that certain types of PPE or medical devices that are used in the context of the COVID-19 outbreak, may also be used for other purposes, it is necessary that Member States take all appropriate measures to ensure that PPE or medical devices not bearing the CE marking, which may be placed on the Union market in accordance with paragraph 8 of the present Recommendation are only made available to healthcare workers,


1. With the objective to ensure availability of PPE and medical devices for adequate protection in the COVID-19 outbreak, the Commission invites all economic operators throughout the supply chain, as well as notified bodies and market surveillance authorities to deploy all the measures at their disposal to support the efforts aimed at ensuring that the supply of PPE and medical devices throughout the EU market will match the continuously increasing demand. Such measures should nevertheless not have a detrimental effect on the overall level of health and safety and all relevant stakeholders should ensure that any PPE or medical devices, which is being placed on the EU market, continues to provide an adequate level of protection of the users’ health and safety.

CONFORMITY ASSESSMENT PROCEDURES


3.In the case of PPE products manufactured following technical solutions other than harmonised standards, the WHO recommendations on the appropriate selection of PPE may be used as a potential source of reference for such technical solutions, provided that the said technical solutions ensure an adequate level of protection corresponding to the applicable essential health and safety requirements laid down in Regulation (EU) 2016/425.


5.In the case of medical devices, the possibility for Member States to authorise derogations from conformity assessment procedures should also be considered, according to Article 11(13) of Directive 93/42/EEC and Article 59 of Regulation (EU) 2017/745 once the latter becomes applicable, also when the intervention of a notified body is not required.


6.The relevant market surveillance authorities in the Member States should as a matter of priority focus on non-compliant PPE or medical devices raising serious risks as to the health and safety of their intended users.


8.PPE or medical devices not bearing the CE marking could also be assessed and part of a purchase organised by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.


Done at Brussels, 13 March 2020.


Thierry BRETON

原文查看(實在打不開的,建議換瀏覽器或電腦試試):COVID-19威脅范圍內的合格評定和市場監督程序

歐洲委員會,考慮到《歐洲聯盟運作條約》,特別是其第292條,鑒于:


2、牢記歐盟公民的健康和安全是重中之重,因此,確保向最需要的人迅速提供最適當的個人防護設備和醫療設備,以確保提供足夠的保護,這一點至關重要。


4、有關個人防護設備的設計,制造和投放市場的要求,由歐洲議會和理事會于2016年3月9日頒布的第(EU)2016/425號條例(關于個人防護設備)以及廢除理事會第89/686號指令規定/ EEC  (1)。


6、一次性和可重復使用的口罩,可防止顆粒物危害,一次性和可重復使用的工作服,手套和眼鏡防護,用于預防和防止有害生物制劑(如病毒)屬于本法規范圍內的產品(歐盟)2016/425。


8、在發生COVID-19威脅的情況下,此類PPE和醫療設備對于參與遏制病毒并避免其進一步傳播的醫護人員,急救人員和其他人員至關重要。


10、93/42 / EEC指令和(EU)2017/745法規充分協調了醫療器械聯盟市場的設計,制造和銷售規則,并根據以下內容建立了一些基本要求以及一般安全和性能要求根據受器械預期用途支配的特定規則對醫療器械進行分類。因此,根據理事會指令93/42 / EEC和法規(EU)2017/745制造的設備可以在整個內部市場自由流通,成員國不得對此類設備的制造和投放市場引入額外的和不同的要求產品。


12、除非適用特定規則,否則與非侵入性設備相關的醫療設備屬于I類。


14、根據指令93/42 / EEC的第11條和(EU)2017/745法規的第52條,一旦后者適用,為了將醫療設備投放市場,制造商應執行適用的合格評定程序并且,如果通過適當的程序證明符合適用的基本要求或一般安全和性能要求,請貼上CE標志。會員國可應正當理由要求批準從合格評定程序中減損,以便在有關會員國領土內投放市場并在使用中保護受保護的單個設備健康。


16、93/42 / EEC指令和法規(EU)2017/745在技術上是中立的,沒有為醫療設備的設計規定任何特定的強制性技術解決方案。相反,指令93/42 / EEC的附件I設置了基本要求,法規(EU)2017/745的附件I設置了一般安全性和性能要求,醫療設備應滿足這些要求才能將其放置在市場,并在整個歐盟市場上自由流通。


18、指令93/42 / EEC的第5條和法規(EU)2017/745的第8條為制造商提供了依賴特定技術解決方案的可能性,這些解決方案在統一標準或其部分中作了詳細說明,其參考文獻已在歐盟官方雜志。根據本條,如果制造商選擇采用這種技術解決方案,則假定醫療器械符合上述協調標準或其部分所涵蓋的要求。但是,并非必須遵守協調標準。制造商可以自由選擇其他技術解決方案,前提是保留的特定解決方案可確保醫療設備符合適用的基本健康和安全要求。


20、93/42 / EEC指令的第11條和法規(EU)2017/745的第52條一旦適用,就制定適用于不同類別醫療設備的特定合格評定程序。根據這些條款,屬于第一類的醫療設備(定制或研究用設備除外)應接受EC合格聲明的合格評定程序,而無需第三方合格評定機構的參與。


22、因此,公告機構應評估根據其他技術解決方案生產的產品(例如,世衛組織關于適當選擇個人防護裝備的建議中所包含的產品)是否也符合適用的基本健康和安全要求??紤]到確保個人防護裝備供應鏈中所有利益相關者之間有效信息交換的重要性,公告機構得出結論認為,遵循另一項特定標準或技術解決方案的個人防護裝備符合適用于其的基本健康和安全要求,這些信息將有助于快速評估根據同一特定標準或技術解決方案生產的其他產品。為此,


24、因此,為了解決在COVID-19爆發時(非CE標志的PPE打算進入歐盟市場)所必需的PPE短缺的問題,相關的市場監督機構應對產品進行評估,如果發現這些產品屬于符合相關法規所規定的基本健康與安全要求的人員,應采取措施,在有限的時間內或在與指定機構進行合格評定程序的同時,將此類PPE投放到歐盟市場。為了確??梢栽谄渌麜T國提供此類產品,并考慮到確保有效交換信息以及對對公民健康和安全的所有威脅作出協調反應的重要性,


通過了此建議:


合格評定程序


 

 

 

市場監督程序

6、成員國的相關市場監督機構應優先關注不合規的個人防護設備或醫療設備,這些設備會對其預期用戶的健康和安全造成嚴重風險。

7、市場監督機構發現PPE或醫療設備可確保根據(EU)2016/425法規或93/42 / EEC指令或2017(EU)法規的基本要求確保足夠的健康和安全水平/ 745,即使尚未按照協調規則完全完成包括CE標志在內的合格評定程序,它們仍可以授權在限定的時間內在歐盟市場上提供這些產品程序正在執行中。

8、不帶CE標志的PPE或醫療設備也可以進行評估,并由相關成員國當局組織購買的一部分,前提是要確保此類產品僅在當前健康危機期間可供醫護人員使用,并確保它們沒有進入常規分銷渠道,并可供其他用戶使用。

9、市場監督機構應立即將其授予特定PPE或醫療設備的任何臨時安排告知委員會和其他成員國。對于個人防護設備,應通過用于市場監視的信息和通信系統(ICSMS)來完成。










<span style="font-family:SimSun;font-size:16px;color:#d92142;margin: 0px; padding: 0px; max-width: 100%; box-sizing: border-box !important; word-wrap: break-word !important;Helvetica Neue", Helvetica, "Hiragino Sans GB", "Microsoft YaHei", Arial, sans-serif;">附:歐盟成員國名單(27國):




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