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歐盟修訂個人防護裝備PPE指令

歐盟最新發佈的個人防護裝備法規425/2016/EU取代了目前的PPE指令,將於2018421日起生效。

簡介

2016年3月9日,歐盟425/2016/EU規定獲得批准,並於2016年3月31日發佈在歐盟官方公報上。這一規定將廢除並取代個人防護用品指令89/686/EEC。

重要日期

  • 89/686/EEC指令於2018421被廢止。
  • 以前未經認證的產品(如烤箱隔熱手套和連指手套)在2018年4月21日之前需要停止銷售。
  • 89/686/EEC批准的EC型式檢驗認證(第10條)有效期至2023421,除非其在此日期之前終止。

EU 型式檢驗認證

EU型式檢驗認證將根據在附錄V中的模組B頒發,有效期為五年


技術檔

技術檔(附錄III)的要求已經重新規定,並適用於烤箱隔熱手套,這將包括:

1)     PPE 以及其設計用途的完整說明書;

2)     PPE 具體防護功能設計評估報告;

3)     適用於 PPE 的基本健康與安全要求清單;

4)     PPE 、元件、部件以及電路設計圖、製造圖和方案;

5)     有助於理解上述第 4 點提及的圖紙和方案以及 PPE 具體操作的說明和指南;

6)      14 條提及的用於設計和製造 PPE 的協調標準的參考資料。在只引用了部分協調標準的情況下,應明確指出已應用的部分;

7)     當未應用協調標準或已引用部分協調標準時,應提供已應用的其他技術規範的說明書,以便滿足適用的基本健康與安全要求;

8)     提供所執行的計算、檢驗與驗證的設計方案,以便驗證 PPE 是否達到適用的基本健康與安全要求 

9)     出具已完成測試的報告,以便驗證 PPE 是否達到適用的基本健康與安全要求,並且在必要的情況下,評定相關的防護等級;

10)   詳細說明製造商在生產 PPE 過程中運用到的方法,以確保生產的 PPE 符合設計規範的要求;

11)   按照附件 II  1.4 點的要求,提供一份製造說明書。

 

PPE 產品的範疇

個人防護用品(PPE)被定義為用於個人佩戴或持有、用來防止對健康和安全造成一個或多個風險所設計和製造的設備。

根據 89/686/EEC 的規定,個人隔熱用的 PPE (如烤箱隔熱手套和連指手套)不包含在內。 但現在包含這一用品 

由於I類產品僅限於防止與不超過50℃的熱表面接觸,故烤箱隔熱手套和連指手套不能包含在I類產品中而是屬於II類產品。在這種情況下,必須通過如下正式的符合性評估。

符合性評估程式

II 

EU型式檢驗(模組B)列於附錄V中,其次是列於附錄VI中的基於內部生產控制(模組C)的類型合規性。

特別是對於接觸高溫的防護,使用烤箱隔熱手套和連指手套是一項關鍵性問題。以前這是根據國家標準(如BS 6526:1998)進行符合性調查,但在將來烤箱手套很可能需要根據歐洲標準和ISO標準進行測試。目前,最適合的標準是EN 407《抗熱(高溫和/或火)防護手套》,EN 420:2003 + A1:2009《防護手套的一般要求和測試方法》以及ISO 12127-1《阻燃和防火服透過防護衣服或其材料的接觸熱傳遞的測定 - 第1部分:採用加熱汽缸產生的接觸熱的試驗方法》。

為了測試家用烤箱隔熱手套,無論是一副或單只手套,都需要按照比以往英國標準更加嚴格的ISO標準進行測試。 在多次洗滌之後,採用250℃而不是150℃進行測試,並且需要有保護手背,手掌和手指的設計。 這可能意味著需要改變之前產品的設計,例如一副手套的頂部以確保能夠適當地保護手背。特別是當更多趨向於較大的手使用的單只手套時。

製造商的義務

這是新增部分,但在第8條中摘取了89/686/EEC中的內容。重要的是,在下列條款中有附加的要求:

  • 如果 PPE 存在一定風險,為保護消費者及其他終端使用者的健康和安全,製造商應對市場上的PPE 進行抽樣檢查,必要時調查並記錄客戶投訴及不合格 PPE 及召回品,並應告知經銷商所有此類監督資訊。
  • 製造商應確保市場上流通的 PPE 帶有型號、批次或序號或其它標識元素。若 PPE 的尺寸或種類不適合帶有這些資訊,則在用品包裝或隨附檔中提供這些資訊。
  • 製造商應在 PPE 歐盟符合性聲明書或者附錄 II  1.4 點所列的說明和資訊中提供能夠訪問歐盟符合性聲明的互聯網位址。
  • 認為或有證據認為市場流通的 PPE 不符合本規定的製造商,應即刻採取必要的糾正措施使PPE 符合規定,並視情況撤回或召回用品。此外,如果 PPE 存在風險,製造商應立即通知PPE 流通的成員國國家主管部門,並提供詳細說明,特別是不合格產品的詳細資訊及採取的任何糾正措施。





EU modified PPE regulations

The newly published PPE Regulation makes it clear that oven gloves and mitts for domestic use will need to carry the CE mark starting in April 2018.  This will entail an EU type certification before they can be sold in the EU.

INTRODUCTION

On the 9 March 2016 Regulation 425/2016/EU was approved and it was published in the Official Journal of the European Union on 31.3.2016. This regulation will repeal the Personal Protective Equipment (PPE) Directive 89/686/EEC and replace it.

IMPORTANT DATES

·         Directive 89/686/EEC is repealed with effect from 21 April 2018.

·         EC type-examination certificates (Article 10) approved 89/686/EEC remain valid until 21 April 2023 unless they expire before that date.

·         Items (such as oven gloves and mitts) not previously certified will need to be withdrawn from sale before this date.

EU TYPE-EXAMINATION CERTIFICATES

EU type-examination certificates will be issued under Module B in Annex V. These will have a validity of five years.

TECHNICAL DOCUMENTATION

The requirements of the technical file (Annex III) have been re-specified and for oven gloves, this will include:

(a) a complete description of the PPE and of its intended use;

(b) an assessment of the risks against which the PPE is intended to protect;

(c) a list of the essential health and safety requirements that are applicable to the PPE;

(d) design and manufacturing drawings and schemes of the PPE and of its components, sub-assemblies and circuits;

(e) the descriptions and explanations necessary for the understanding of the drawings and schemes referred to in point (d) and of the operation of the PPE;

(f) the references of the harmonised standards referred to in Article 14 that have been applied for the design and manufacture of the PPE. In the event of partial application of harmonised standards, the documentation shall specify the parts which have been applied;

(g) where harmonised standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements;

(h) the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements;

(i) reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class;

(j) a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications;

(k) a copy of the manufacturer's instructions and information set out in point 1.4 of Annex II;

PPE PRODUCTS INCLUDED

PPE is defined as equipment designed and manufactured to be worn or held by a person for protection against one or more risks to that person's health or safety.

Under 89/686/EEC PPE for private use against heat (e.g. oven gloves and mitts) was excluded. This is now included.

As Category I products are limited to those which protect against contact with hot surfaces not exceeding 50 °C, oven gloves and mitts cannot be included in Category I and must be considered to be Category II. This will require a formal Conformity assessment as below.

CONFORMITY ASSESSMENT PROCEDURES

Category II

EU type-examination (module B) set out in Annex V, followed by conformity to type based on internal production control (module C) set out in Annex VI.

The protection against contact heat in particular is, of course, a key issue with oven gloves and mitts and whilst previously this would have been carried out against national standards such as BS 6526:1998 as a matter of due diligence, it is probable that in future oven gloves will need to be tested against European Standards. Currently the most appropriate are EN 407 “Protective gloves against thermal risks (heat and/or fire)” and EN 420:2003+A1:2009 “Protective gloves. General requirements and test methods”.  In reality it seems likely that in order to truly cover all of the essential health and safety requirements for specific items such as oven gloves and mitts and therefore assure conformity with the regulation, a combination of these 2 European standards and the British Standard (or similar national standard) may be required. Study of the next section is therefore essential to ensure that all obligations are covered.

OBLIGATIONS OF MANUFACTURERS

This is a new section but pulls information in 89/686/EEC into Article 8. Importantly there are additional requirements in the clauses shown below:

·         When deemed appropriate with regard to the risks presented by PPE, manufacturers shall, to protect the health and safety of consumers and other end-users, carry out sample testing of PPE made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming PPE and PPE recalls, and shall keep distributors informed of any such monitoring.

·         Manufacturers shall ensure that the PPE which they place on the market bears a type, batch or serial number or other element allowing its identification, or, where the size or nature of the PPE does not allow it, that the required information is provided on the packaging or in a document accompanying the PPE.

·         The manufacturer shall either provide the EU declaration of conformity with the PPE or include in the instructions and information set out in point 1.4 of Annex II the internet address at which the EU declaration of conformity can be accessed.

·         Manufacturers who consider or have reason to believe that PPE which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that PPE into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the PPE presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the PPE available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

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