【正文】 . The procedures shall define the extent of traceability and shall facilitate corrective and preventive action.主動(dòng)植入式醫(yī)療器材及植入式醫(yī)療器材，其追溯性延伸之範(fàn)圍，應(yīng)包括可能導(dǎo)致醫(yī)療器材不能符合特定要求的所有使用零件、材料及環(huán)境條件之紀(jì)錄。When defining the extent of traceability, the manufacturer shall include all ponents and materials used and records of the environmental conditions when these could cause the active implantable medical devices and implantable medical devices not to satisfy its specified requirements.製造業(yè)者應(yīng)要求其輸入廠商或經(jīng)銷商維持醫(yī)療器材銷售紀(jì)錄，且加以保存，以備查核。The manufacturer shall require that its agents or distributors maintain records of the distribution of active implantable medical devices and implantable medical devices with regard to traceability and that such records are available for inspection.九、製程管制9 Process Control(一)製造業(yè)者應(yīng)鑑定與規(guī)劃能直接影響品質(zhì)的生產(chǎn)、安裝及服務(wù)之製程，並應(yīng)確保這些製程能在管制條件下實(shí)施。管制條件應(yīng)包括下列各項(xiàng)： The manufacturer shall identify and plan the production, installation and servicing processes which directly affect quality and shall ensure that these processes are carried out under controlled conditions. Controlled conditions shall include the following:、安裝及服務(wù)的方式，若缺少作業(yè)程序會(huì)對(duì)品質(zhì)有所不利時(shí)，應(yīng)制定該等書面程序；(1) documented procedures defining the manner of production, installation and servicing, where the absence of such procedures could adversely affect quality。、安裝及服務(wù)設(shè)備以及合適的工作環(huán)境；(2) use of suitable production, installation and servicing equipment, and a suitable working environment。（法規(guī)）、品質(zhì)計(jì)畫或書面程序；(3) pliance with reference standards/codes, quality plans and /or documented procedures。；(4) monitoring and control of suitable process parameters and product characteristics。，對(duì)製程與設(shè)備實(shí)施核準(zhǔn)；(5) the approval of processes and equipment as appropriate。，應(yīng)以最清楚實(shí)用之方式予以規(guī)定（如書面標(biāo)準(zhǔn)、代表性樣品或圖例）；(6) criteria for workmanship, which shall be stipulated in the clearest practical manner (e/g. written standards, representative samples or illustrations)。，以確保持續(xù)的製程能力。(7) suitable maintenance of equipment to ensure continuing process capability.若製程結(jié)果無(wú)法由隨後的產(chǎn)品檢驗(yàn)與測(cè)試得以完全查證者，如製造產(chǎn)生之缺失僅能在產(chǎn)品使用時(shí)方可顯現(xiàn)，則此等製程必須由合格操作員執(zhí)行，或要求對(duì)製程參數(shù)作連續(xù)性監(jiān)測(cè)與管制，以確保達(dá)成規(guī)定要求。Where the results of processes cannot be fully verified by subsequent inspection and testing of the product and where, for example, processing deficiencies may bee apparent only after the product is in use, the processes shall be carried out by qualified operators and/or shall require continuous monitoring and control of process parameters to ensure that the specified requirements are met.包括相關(guān)設(shè)備與人員在製程作業(yè)之任何驗(yàn)證要求，應(yīng)予以規(guī)定。Records shall be maintained for qualified processes, equipment and personnel, as appropriate.(二)人員 Personnel，則製造業(yè)者應(yīng)以書面訂定並維持人員的健康、清潔和服裝之規(guī)定。 The manufacturer shall establish, document and maintain requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or the environment could adversely affect the quality of the product.，或於訓(xùn)練有素人員監(jiān)督下工作。 The manufacturer shall ensure that all personnel who are required to work temporarily under special conditions are appropriately trained or supervised by a trained person.(三)製程中的環(huán)境管制 Environmental Control in Manufacture醫(yī)療器材具下列情形，製造業(yè)者應(yīng)以書面訂定產(chǎn)品曝露環(huán)境的要求。For medical devices；或(1) that are supplied sterile, or，但使用前應(yīng)滅菌處理者；或(2) that are supplied nonsterile and intended for sterilisation before use, or、或其他環(huán)境條件在使用時(shí)具重大影響者；或(3) if the microbiological and/or particulate cleanliness or other environmental conditions are of significance in their use, or。(4) if the environmental conditions are of significance in their manufacture,the manufacturer shall establish and document requirements for the environment to which the product is exposed.必要時(shí)，環(huán)境條件應(yīng)予以管制或監(jiān)控。If appropriate, the environmental conditions shall be controlled and/or monitored.(四)產(chǎn)品的清潔 Cleanliness of Product如產(chǎn)品屬下列情形，則製造業(yè)者應(yīng)建立、書面化並維持對(duì)於產(chǎn)品清潔度之要求：The manufacturer shall establish, document and maintain requirements for the cleanliness of the product if，或(1) product is cleaned by the supplier prior to sterilisation and/or its use, or，但在滅菌前或使用前必須經(jīng)過(guò)清潔處理者，或(2) product is supplied nonsterile to be subjected to a cleaning process prior to sterilisation and/or its use, or，但其本身之清潔度對(duì)使用結(jié)果具重大影響者，或(3) product is supplied to be used nonsterile and its cleanliness is of significance in use, or。(4) process agents are to be removed from product during manufacture必要時(shí)，如產(chǎn)品依照上述1與2之清潔程序，則無(wú)需符合前述「人員」和「製程中的環(huán)境管制」兩節(jié)所提之特殊要求。If appropriate, product cleaned in accordance with 1) or 2) above need not be subject to the preceding particular requirements ( Personnel, and Environmental Control in Manufacture) prior to the cleaning procedure.(五)維護(hù) Maintenance如維護(hù)活動(dòng)可能影響產(chǎn)品品質(zhì)時(shí)，製造業(yè)者應(yīng)建立、書面化並維持對(duì)於維護(hù)活動(dòng)之要求。The manufacturer shall establish and document requirements for maintenance activities when such activities may affect product quality.維護(hù)紀(jì)錄應(yīng)予保存。Records of such maintenance shall be kept.(六)安裝 Installation必要時(shí)，製造業(yè)者應(yīng)建立作業(yè)指導(dǎo)文件，及關(guān)於醫(yī)療器材之安裝與檢查的允收準(zhǔn)則。If appropriate, the manufacturer shall establish and document both instructions and acceptance criteria for installing and checking medical devices.製造業(yè)者或其授權(quán)代表執(zhí)行之安裝和檢查紀(jì)錄，應(yīng)予保存。Records of installation and checking performed by the manufacturer or its authorised representative shall be retained.當(dāng)合約規(guī)定，製造業(yè)者或其授權(quán)代表不負(fù)安裝責(zé)任時(shí)，製造業(yè)者應(yīng)對(duì)採(cǎi)購(gòu)者提供安裝與檢查之書面說(shuō)明。If the contract allows installation other than by the manufacturer or its authorised representative, the supplier shall provide the purchaser with written instructions for installation and checking.(七)電腦軟體在製程管制之應(yīng)用 Computer Software Used in Process Control電腦軟體應(yīng)用於製程管制時(shí)，製造業(yè)者應(yīng)建立與維持書面化之程序以確認(rèn)該軟體之應(yīng)用，且確認(rèn)結(jié)果應(yīng)予以記錄。The manufacturer shall establish and maintain documented proce