09112006 歐盟正在審查是否將「醫療設備」納入RoHS指令範圍

歐盟正在審查是否將「醫療設備」納入RoHS指令範圍

歐盟六大限用有害物質指令（RoHS）若干要點很可能會重新再進一步舉行投票表決，包括目前尚未在RoHS指令涵蓋範圍的第八類：「醫療設備」。

◎ 歐盟委員會目前正在進行有關「醫療設備」之審查
「醫療設備」與「監視及控管設備」，分別屬於WEEE指令附件中所列舉的第八類及第九類管制範圍，目前不在RoHS指令涵蓋範疇。不過，歐盟委員會最近正在整理一份由英國ERA科技顧問公司（ERA Technology）所提供的RoHS指令相關內容之調查研究報告，並對第八類及第九類管制設備重新展開審查的動作。

總之，目前RoHS指令排外項目之「醫療設備」正在復審中，雖然結果尚未明朗化，但絕大多數人都認為未來「醫療設備」將會被納入RoHS指令管制範圍。歐盟委員會承諾會在今年七月底發表正式聲明，但至目前為止，尚未提出任何具體說明。知名的嬌生公司（Johnson & Johnson）全球事業處經理 Abbing表示：『全世界每個人都在引頸期盼歐盟委員會關於《ERA調查報告》的解釋及說明，並期待委員會如何將具體解釋導入RoHS法規中。』

除此之外，在著名的Covington & Burling LLP事務所比利時布魯塞爾辦公室工作，擅長環境方面法律的律師Molyneux也表示，歐盟委員會將於今年底或2007年初公開發表一項正式提案。同時，Molyneux更進一步預言，第八類「醫療設備」及第九類「監視及控管設備」將於2010年納入RoHS指令管制範疇內，屆時業者必需符合該指令的要求。

◎ 醫療業者為產品「可靠度」憂心忡忡
根據醫療產業的消息，業者普遍都認為產品如須符合RoHS絕非一項難題，「何時（when）」實施才是關鍵所在。美國SonoSite, Inc.副總裁 Lowell也指出，廠商一致認為醫療設備遲早會納入RoHS指令範疇，此舉勢在必行，只是時間早晚的問題。

由於醫療設備最為人所關注的即是其品質及可靠度，因此實施管制的時間點確實是關鍵。舉例來說：假如DVD數位影音播放器提早失效，只會令人覺得十分困擾而已。不過，某些醫療器材例如：心臟電擊器如果突然失靈，將導致病患生命危險，嚴重則會令人喪命。

醫療供應商提出了一項主張，希望歐盟委員會能提供RoHS符合性產品若干年內相關資料，以便精準判斷醫療設備的品質及可靠度。然而，因RoHS產品才剛開始於市場上銷售不久，因此相較其他產業而言，委員會應給予醫療產業更多時間適應RoHS指令。事實上，歐洲醫療技術產業協會（EUCOMED）已經建議委員會應至少再多給五年寬限期，延至2011年再開始進行管制。

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資料來源： 《美國Embedded.com網站》
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RoHS Exemption for Medical Devices of Category 8 is under Review

The European Union's Restriction of Hazardous Substances (RoHS) net will likely be cast further.

◎ Category 8 is being reviewed by the European Commission

The European Union's Restriction of Hazardous Substances (RoHS) net will likely be cast further. Medical devices, together with monitoring and control instruments, known as Categories 8 and 9, respectively, as defined in the WEEE directive annex, are currently excluded from RoHS. However, the European Commission is digesting a study by U.K.-based ERA Technology Ltd. that examines the implications of including the two categories within the scope of RoHS.

In short, the RoHS exemption for medical equipment is under review and is widely expected to be included in the scope of RoHS. The Commission promised to prepare a statement at the end of July, but has not yet done so. "Everyone is waiting to see how the EC interprets [the ERA report] and how its interpretation is brought into legislation," said Jean-Marc Abbing, manager of worldwide environmental affairs at Johnson & Johnson, in Leiden, The Netherlands.

Candido Garcia Molyneux, an environmental lawyer at Covington & Burling LLP in Brussels, believes the Commission will release a proposal by year's end or early 2007. He expects Categories 8 and 9 to be subject to RoHS requirements in 2010.

◎ Medical industry concerns about “reliability”

Medical industry sources believe RoHS compliance is not a question of if, but when. Lowell says the company is assuming that medical devices will fall under the scope of RoHS, it's just a question of timing.

Timing is indeed a key issue because it is tied to reliability. If a RoHS-compliant DVD player fails prematurely, it's annoying. But unexpected failure of some medical products such as a heart defibrillator could result in death.

Medical suppliers argue that they need several years of field data for RoHS-compliant products to accurately determine reliability. Because RoHS products are only now beginning to hit the market, medical should be given a longer time period to adapt to the directive than other industries. In fact, the European Medical Technology Industry Association (EUCOMED) has recommended at least five additional years to 2011.

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